44
Aromatherapy for treatment of postoperative nausea and vomiting (Review) Hines S, Steels E, Chang A, Gibbons K This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2012, Issue 4 http://www.thecochranelibrary.com Aromatherapy for treatment of postoperative nausea and vomiting (Review) Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Page 1: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Aromatherapy for treatment of postoperative nausea and

vomiting (Review)

Hines S Steels E Chang A Gibbons K

This is a reprint of a Cochrane review prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library

2012 Issue 4httpwwwthecochranelibrarycom

Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

T A B L E O F C O N T E N T S

1HEADER 1ABSTRACT 2PLAIN LANGUAGE SUMMARY 2SUMMARY OF FINDINGS FOR THE MAIN COMPARISON 5BACKGROUND 5OBJECTIVES 5METHODS 7RESULTS

Figure 1 9Figure 2 10Figure 3 11

14ADDITIONAL SUMMARY OF FINDINGS 17DISCUSSION 18AUTHORSrsquo CONCLUSIONS 18ACKNOWLEDGEMENTS 18REFERENCES 22CHARACTERISTICS OF STUDIES 38DATA AND ANALYSES 39ADDITIONAL TABLES 40HISTORY 41CONTRIBUTIONS OF AUTHORS 41DECLARATIONS OF INTEREST 42SOURCES OF SUPPORT 42DIFFERENCES BETWEEN PROTOCOL AND REVIEW 42INDEX TERMS

iAromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

[Intervention Review]

Aromatherapy for treatment of postoperative nausea andvomiting

Sonia Hines1 Elizabeth Steels2 Anne Chang1 Kristen Gibbons3

1Mater Nursing Research Centre Queensland Centre for Evidence-Based Nursing amp Midwifery A Collaborating Centre of the JoannaBriggs Institute South Brisbane Australia 2Faculty of Health Sciences Australian College of Natural Medicine Brisbane Australia3Clinical Research Support Unit Mater Medical Research Institute South Brisbane Australia

Contact address Sonia Hines Mater Nursing Research Centre Queensland Centre for Evidence-Based Nursing amp Midwifery A Col-laborating Centre of the Joanna Briggs Institute Mater Health Servicesbdquo Level One Quarters Building Annerley Rd WoolloongabbaSouth Brisbane Queensland 4102 Australia soniahinesmaterorgau soniahinesoptusnetcomau

Editorial group Cochrane Anaesthesia GroupPublication status and date New published in Issue 4 2012Review content assessed as up-to-date 2 August 2011

Citation Hines S Steels E Chang A Gibbons K Aromatherapy for treatment of postoperative nausea and vomiting Cochrane

Database of Systematic Reviews 2012 Issue 4 Art No CD007598 DOI 10100214651858CD007598pub2

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

A B S T R A C T

Background

Postoperative nausea and vomiting is a common and unpleasant phenomenon and current therapies are not always effective for allpatients Aromatherapy has been suggested as a possible addition to the available treatment strategies

Objectives

This review sought to establish what effect the use of aromatherapy has on the severity and duration of established postoperative nauseaand vomiting and whether aromatherapy can be used with safety and clinical effectiveness comparable to standard pharmacologicaltreatments

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINEEMBASE CINAHL CAM on PubMed Meditext LILACS and ISI Web of Science as well as grey literature sources and the referencelists of retrieved articles We conducted database searches up to August 2011

Selection criteria

We included all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) where aromatherapy was used to treatpostoperative nausea and vomiting Interventions were all types of aromatherapy Aromatherapy was defined as the inhalation of thevapours of any substance for the purposes of a therapeutic benefit Primary outcomes were the severity and duration of postoperativenausea and vomiting Secondary outcomes were adverse reactions use of rescue anti-emetics and patient satisfaction with treatment

Data collection and analysis

Two review authors assessed risk of bias in the included studies and extracted data As all outcomes analysed were dichotomous weused a fixed-effect model and calculated relative risk (RR) with associated 95 confidence interval (95 CI)

1Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Main results

The nine included studies comprised six RCTs and three CCTs with a total of 402 participants The mean age and range data for allparticipants were not reported for all studies The method of randomization in four of the six included RCTs was explicitly stated andwas adequate Incomplete reporting of data affected the completeness of the analysis Compared with placebo isopropyl alcohol vapourinhalation was effective in reducing the proportion of participants requiring rescue anti-emetics (RR 030 95 CI 009 to 100 P= 005) However compared with standard anti-emetic treatment isopropyl alcohol was not effective in reducing the proportion ofparticipants requiring rescue anti-emetics (RR 066 95 CI 039 to 113 P = 013) except when the data from a possibly confoundedstudy were included (RR 066 95 CI 045 to 098 P = 004) Where studies reported data on patient satisfaction with aromatherapythere were no statistically significant differences between the groups (RR 112 95 CI 062 to 203 P = 071)

Authorsrsquo conclusions

Isopropyl alcohol was more effective than saline placebo for reducing postoperative nausea and vomiting but less effective than standardanti-emetic drugs There is currently no reliable evidence for the use of peppermint oil

P L A I N L A N G U A G E S U M M A R Y

Aromatherapy for treating postoperative nausea and vomiting

Postoperative nausea and vomiting (PONV) is a common and unpleasant side effect of surgery with 20 to 30 of all patientssuffering moderate to severe nausea and vomiting following general anaesthesia using volatile agents (inhaled anaesthesia) Nausea isan abdominal discomfort or queasiness that may be accompanied by vomiting (the forceful expulsion of stomach contents throughthe mouth) Current drug treatments may not always work effectively or they may have unpleasant adverse effects Aromatherapyis sometimes recommended for treating nausea and vomiting though currently there is not sufficient evidence that it is effectiveAromatherapy uses inhalation of the vapour of essential oils or other substances to treat or alleviate physical and emotional symptomsWe examined nine studies of aromatherapy for PONV with a total of 402 participants Six studies of the brief inhalation of isopropylalcohol vapours showed that it can have some effect in reducing postoperative nausea and vomiting however it seems to be less effectivethan standard drug treatments There was a moderate risk of bias due to the design of some of the studies Isopropyl alcohol is alsoknown as rubbing alcohol and is commonly found in the type of rsquoprep-padrsquo used to clean skin prior to injection There is currentlyno reliable evidence to support the use of other aromatherapies such as peppermint oil to treat postoperative nausea and vomiting Noincluded studies reported any adverse effects from the aromatherapies used

2Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

SU

MM

AR

YO

FF

IN

DI

NG

SF

OR

TH

EM

AI

NC

OM

PA

RI

SO

N[E

xpla

nati

on]

Isopropylalcoholcomparedtostandardtreatmentfortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

ComparisonStandardtreatment

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

Standardtreatment

Isopropylalcohol

Requirementforrescue

anti-emetics

Studypopulation

1RR066

(045to098)

215

(4studies)

oplusoplus

copycopy

low

23

392per1000

259per1000

(176

to384)

Mediumriskpopulation

1

275per1000

182per1000

(124

to270)

Adverseeffects4

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

3Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Calculatedusingcontrolgroupresults

2StudybyMerritt(2002)wasnotadequatelyrandom

ised

3Totalnum

berofeventsislessthan300

4Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxxx

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xxxx

xxxx

xxxx

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xxxx

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4Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 2: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

T A B L E O F C O N T E N T S

1HEADER 1ABSTRACT 2PLAIN LANGUAGE SUMMARY 2SUMMARY OF FINDINGS FOR THE MAIN COMPARISON 5BACKGROUND 5OBJECTIVES 5METHODS 7RESULTS

Figure 1 9Figure 2 10Figure 3 11

14ADDITIONAL SUMMARY OF FINDINGS 17DISCUSSION 18AUTHORSrsquo CONCLUSIONS 18ACKNOWLEDGEMENTS 18REFERENCES 22CHARACTERISTICS OF STUDIES 38DATA AND ANALYSES 39ADDITIONAL TABLES 40HISTORY 41CONTRIBUTIONS OF AUTHORS 41DECLARATIONS OF INTEREST 42SOURCES OF SUPPORT 42DIFFERENCES BETWEEN PROTOCOL AND REVIEW 42INDEX TERMS

iAromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

[Intervention Review]

Aromatherapy for treatment of postoperative nausea andvomiting

Sonia Hines1 Elizabeth Steels2 Anne Chang1 Kristen Gibbons3

1Mater Nursing Research Centre Queensland Centre for Evidence-Based Nursing amp Midwifery A Collaborating Centre of the JoannaBriggs Institute South Brisbane Australia 2Faculty of Health Sciences Australian College of Natural Medicine Brisbane Australia3Clinical Research Support Unit Mater Medical Research Institute South Brisbane Australia

Contact address Sonia Hines Mater Nursing Research Centre Queensland Centre for Evidence-Based Nursing amp Midwifery A Col-laborating Centre of the Joanna Briggs Institute Mater Health Servicesbdquo Level One Quarters Building Annerley Rd WoolloongabbaSouth Brisbane Queensland 4102 Australia soniahinesmaterorgau soniahinesoptusnetcomau

Editorial group Cochrane Anaesthesia GroupPublication status and date New published in Issue 4 2012Review content assessed as up-to-date 2 August 2011

Citation Hines S Steels E Chang A Gibbons K Aromatherapy for treatment of postoperative nausea and vomiting Cochrane

Database of Systematic Reviews 2012 Issue 4 Art No CD007598 DOI 10100214651858CD007598pub2

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

A B S T R A C T

Background

Postoperative nausea and vomiting is a common and unpleasant phenomenon and current therapies are not always effective for allpatients Aromatherapy has been suggested as a possible addition to the available treatment strategies

Objectives

This review sought to establish what effect the use of aromatherapy has on the severity and duration of established postoperative nauseaand vomiting and whether aromatherapy can be used with safety and clinical effectiveness comparable to standard pharmacologicaltreatments

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINEEMBASE CINAHL CAM on PubMed Meditext LILACS and ISI Web of Science as well as grey literature sources and the referencelists of retrieved articles We conducted database searches up to August 2011

Selection criteria

We included all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) where aromatherapy was used to treatpostoperative nausea and vomiting Interventions were all types of aromatherapy Aromatherapy was defined as the inhalation of thevapours of any substance for the purposes of a therapeutic benefit Primary outcomes were the severity and duration of postoperativenausea and vomiting Secondary outcomes were adverse reactions use of rescue anti-emetics and patient satisfaction with treatment

Data collection and analysis

Two review authors assessed risk of bias in the included studies and extracted data As all outcomes analysed were dichotomous weused a fixed-effect model and calculated relative risk (RR) with associated 95 confidence interval (95 CI)

1Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Main results

The nine included studies comprised six RCTs and three CCTs with a total of 402 participants The mean age and range data for allparticipants were not reported for all studies The method of randomization in four of the six included RCTs was explicitly stated andwas adequate Incomplete reporting of data affected the completeness of the analysis Compared with placebo isopropyl alcohol vapourinhalation was effective in reducing the proportion of participants requiring rescue anti-emetics (RR 030 95 CI 009 to 100 P= 005) However compared with standard anti-emetic treatment isopropyl alcohol was not effective in reducing the proportion ofparticipants requiring rescue anti-emetics (RR 066 95 CI 039 to 113 P = 013) except when the data from a possibly confoundedstudy were included (RR 066 95 CI 045 to 098 P = 004) Where studies reported data on patient satisfaction with aromatherapythere were no statistically significant differences between the groups (RR 112 95 CI 062 to 203 P = 071)

Authorsrsquo conclusions

Isopropyl alcohol was more effective than saline placebo for reducing postoperative nausea and vomiting but less effective than standardanti-emetic drugs There is currently no reliable evidence for the use of peppermint oil

P L A I N L A N G U A G E S U M M A R Y

Aromatherapy for treating postoperative nausea and vomiting

Postoperative nausea and vomiting (PONV) is a common and unpleasant side effect of surgery with 20 to 30 of all patientssuffering moderate to severe nausea and vomiting following general anaesthesia using volatile agents (inhaled anaesthesia) Nausea isan abdominal discomfort or queasiness that may be accompanied by vomiting (the forceful expulsion of stomach contents throughthe mouth) Current drug treatments may not always work effectively or they may have unpleasant adverse effects Aromatherapyis sometimes recommended for treating nausea and vomiting though currently there is not sufficient evidence that it is effectiveAromatherapy uses inhalation of the vapour of essential oils or other substances to treat or alleviate physical and emotional symptomsWe examined nine studies of aromatherapy for PONV with a total of 402 participants Six studies of the brief inhalation of isopropylalcohol vapours showed that it can have some effect in reducing postoperative nausea and vomiting however it seems to be less effectivethan standard drug treatments There was a moderate risk of bias due to the design of some of the studies Isopropyl alcohol is alsoknown as rubbing alcohol and is commonly found in the type of rsquoprep-padrsquo used to clean skin prior to injection There is currentlyno reliable evidence to support the use of other aromatherapies such as peppermint oil to treat postoperative nausea and vomiting Noincluded studies reported any adverse effects from the aromatherapies used

2Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

SU

MM

AR

YO

FF

IN

DI

NG

SF

OR

TH

EM

AI

NC

OM

PA

RI

SO

N[E

xpla

nati

on]

Isopropylalcoholcomparedtostandardtreatmentfortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

ComparisonStandardtreatment

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

Standardtreatment

Isopropylalcohol

Requirementforrescue

anti-emetics

Studypopulation

1RR066

(045to098)

215

(4studies)

oplusoplus

copycopy

low

23

392per1000

259per1000

(176

to384)

Mediumriskpopulation

1

275per1000

182per1000

(124

to270)

Adverseeffects4

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

3Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Calculatedusingcontrolgroupresults

2StudybyMerritt(2002)wasnotadequatelyrandom

ised

3Totalnum

berofeventsislessthan300

4Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

4Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 3: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

[Intervention Review]

Aromatherapy for treatment of postoperative nausea andvomiting

Sonia Hines1 Elizabeth Steels2 Anne Chang1 Kristen Gibbons3

1Mater Nursing Research Centre Queensland Centre for Evidence-Based Nursing amp Midwifery A Collaborating Centre of the JoannaBriggs Institute South Brisbane Australia 2Faculty of Health Sciences Australian College of Natural Medicine Brisbane Australia3Clinical Research Support Unit Mater Medical Research Institute South Brisbane Australia

Contact address Sonia Hines Mater Nursing Research Centre Queensland Centre for Evidence-Based Nursing amp Midwifery A Col-laborating Centre of the Joanna Briggs Institute Mater Health Servicesbdquo Level One Quarters Building Annerley Rd WoolloongabbaSouth Brisbane Queensland 4102 Australia soniahinesmaterorgau soniahinesoptusnetcomau

Editorial group Cochrane Anaesthesia GroupPublication status and date New published in Issue 4 2012Review content assessed as up-to-date 2 August 2011

Citation Hines S Steels E Chang A Gibbons K Aromatherapy for treatment of postoperative nausea and vomiting Cochrane

Database of Systematic Reviews 2012 Issue 4 Art No CD007598 DOI 10100214651858CD007598pub2

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

A B S T R A C T

Background

Postoperative nausea and vomiting is a common and unpleasant phenomenon and current therapies are not always effective for allpatients Aromatherapy has been suggested as a possible addition to the available treatment strategies

Objectives

This review sought to establish what effect the use of aromatherapy has on the severity and duration of established postoperative nauseaand vomiting and whether aromatherapy can be used with safety and clinical effectiveness comparable to standard pharmacologicaltreatments

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINEEMBASE CINAHL CAM on PubMed Meditext LILACS and ISI Web of Science as well as grey literature sources and the referencelists of retrieved articles We conducted database searches up to August 2011

Selection criteria

We included all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) where aromatherapy was used to treatpostoperative nausea and vomiting Interventions were all types of aromatherapy Aromatherapy was defined as the inhalation of thevapours of any substance for the purposes of a therapeutic benefit Primary outcomes were the severity and duration of postoperativenausea and vomiting Secondary outcomes were adverse reactions use of rescue anti-emetics and patient satisfaction with treatment

Data collection and analysis

Two review authors assessed risk of bias in the included studies and extracted data As all outcomes analysed were dichotomous weused a fixed-effect model and calculated relative risk (RR) with associated 95 confidence interval (95 CI)

1Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Main results

The nine included studies comprised six RCTs and three CCTs with a total of 402 participants The mean age and range data for allparticipants were not reported for all studies The method of randomization in four of the six included RCTs was explicitly stated andwas adequate Incomplete reporting of data affected the completeness of the analysis Compared with placebo isopropyl alcohol vapourinhalation was effective in reducing the proportion of participants requiring rescue anti-emetics (RR 030 95 CI 009 to 100 P= 005) However compared with standard anti-emetic treatment isopropyl alcohol was not effective in reducing the proportion ofparticipants requiring rescue anti-emetics (RR 066 95 CI 039 to 113 P = 013) except when the data from a possibly confoundedstudy were included (RR 066 95 CI 045 to 098 P = 004) Where studies reported data on patient satisfaction with aromatherapythere were no statistically significant differences between the groups (RR 112 95 CI 062 to 203 P = 071)

Authorsrsquo conclusions

Isopropyl alcohol was more effective than saline placebo for reducing postoperative nausea and vomiting but less effective than standardanti-emetic drugs There is currently no reliable evidence for the use of peppermint oil

P L A I N L A N G U A G E S U M M A R Y

Aromatherapy for treating postoperative nausea and vomiting

Postoperative nausea and vomiting (PONV) is a common and unpleasant side effect of surgery with 20 to 30 of all patientssuffering moderate to severe nausea and vomiting following general anaesthesia using volatile agents (inhaled anaesthesia) Nausea isan abdominal discomfort or queasiness that may be accompanied by vomiting (the forceful expulsion of stomach contents throughthe mouth) Current drug treatments may not always work effectively or they may have unpleasant adverse effects Aromatherapyis sometimes recommended for treating nausea and vomiting though currently there is not sufficient evidence that it is effectiveAromatherapy uses inhalation of the vapour of essential oils or other substances to treat or alleviate physical and emotional symptomsWe examined nine studies of aromatherapy for PONV with a total of 402 participants Six studies of the brief inhalation of isopropylalcohol vapours showed that it can have some effect in reducing postoperative nausea and vomiting however it seems to be less effectivethan standard drug treatments There was a moderate risk of bias due to the design of some of the studies Isopropyl alcohol is alsoknown as rubbing alcohol and is commonly found in the type of rsquoprep-padrsquo used to clean skin prior to injection There is currentlyno reliable evidence to support the use of other aromatherapies such as peppermint oil to treat postoperative nausea and vomiting Noincluded studies reported any adverse effects from the aromatherapies used

2Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

SU

MM

AR

YO

FF

IN

DI

NG

SF

OR

TH

EM

AI

NC

OM

PA

RI

SO

N[E

xpla

nati

on]

Isopropylalcoholcomparedtostandardtreatmentfortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

ComparisonStandardtreatment

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

Standardtreatment

Isopropylalcohol

Requirementforrescue

anti-emetics

Studypopulation

1RR066

(045to098)

215

(4studies)

oplusoplus

copycopy

low

23

392per1000

259per1000

(176

to384)

Mediumriskpopulation

1

275per1000

182per1000

(124

to270)

Adverseeffects4

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

3Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Calculatedusingcontrolgroupresults

2StudybyMerritt(2002)wasnotadequatelyrandom

ised

3Totalnum

berofeventsislessthan300

4Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

4Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 4: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Main results

The nine included studies comprised six RCTs and three CCTs with a total of 402 participants The mean age and range data for allparticipants were not reported for all studies The method of randomization in four of the six included RCTs was explicitly stated andwas adequate Incomplete reporting of data affected the completeness of the analysis Compared with placebo isopropyl alcohol vapourinhalation was effective in reducing the proportion of participants requiring rescue anti-emetics (RR 030 95 CI 009 to 100 P= 005) However compared with standard anti-emetic treatment isopropyl alcohol was not effective in reducing the proportion ofparticipants requiring rescue anti-emetics (RR 066 95 CI 039 to 113 P = 013) except when the data from a possibly confoundedstudy were included (RR 066 95 CI 045 to 098 P = 004) Where studies reported data on patient satisfaction with aromatherapythere were no statistically significant differences between the groups (RR 112 95 CI 062 to 203 P = 071)

Authorsrsquo conclusions

Isopropyl alcohol was more effective than saline placebo for reducing postoperative nausea and vomiting but less effective than standardanti-emetic drugs There is currently no reliable evidence for the use of peppermint oil

P L A I N L A N G U A G E S U M M A R Y

Aromatherapy for treating postoperative nausea and vomiting

Postoperative nausea and vomiting (PONV) is a common and unpleasant side effect of surgery with 20 to 30 of all patientssuffering moderate to severe nausea and vomiting following general anaesthesia using volatile agents (inhaled anaesthesia) Nausea isan abdominal discomfort or queasiness that may be accompanied by vomiting (the forceful expulsion of stomach contents throughthe mouth) Current drug treatments may not always work effectively or they may have unpleasant adverse effects Aromatherapyis sometimes recommended for treating nausea and vomiting though currently there is not sufficient evidence that it is effectiveAromatherapy uses inhalation of the vapour of essential oils or other substances to treat or alleviate physical and emotional symptomsWe examined nine studies of aromatherapy for PONV with a total of 402 participants Six studies of the brief inhalation of isopropylalcohol vapours showed that it can have some effect in reducing postoperative nausea and vomiting however it seems to be less effectivethan standard drug treatments There was a moderate risk of bias due to the design of some of the studies Isopropyl alcohol is alsoknown as rubbing alcohol and is commonly found in the type of rsquoprep-padrsquo used to clean skin prior to injection There is currentlyno reliable evidence to support the use of other aromatherapies such as peppermint oil to treat postoperative nausea and vomiting Noincluded studies reported any adverse effects from the aromatherapies used

2Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

SU

MM

AR

YO

FF

IN

DI

NG

SF

OR

TH

EM

AI

NC

OM

PA

RI

SO

N[E

xpla

nati

on]

Isopropylalcoholcomparedtostandardtreatmentfortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

ComparisonStandardtreatment

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

Standardtreatment

Isopropylalcohol

Requirementforrescue

anti-emetics

Studypopulation

1RR066

(045to098)

215

(4studies)

oplusoplus

copycopy

low

23

392per1000

259per1000

(176

to384)

Mediumriskpopulation

1

275per1000

182per1000

(124

to270)

Adverseeffects4

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

3Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Calculatedusingcontrolgroupresults

2StudybyMerritt(2002)wasnotadequatelyrandom

ised

3Totalnum

berofeventsislessthan300

4Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

4Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 5: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

SU

MM

AR

YO

FF

IN

DI

NG

SF

OR

TH

EM

AI

NC

OM

PA

RI

SO

N[E

xpla

nati

on]

Isopropylalcoholcomparedtostandardtreatmentfortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

ComparisonStandardtreatment

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

Standardtreatment

Isopropylalcohol

Requirementforrescue

anti-emetics

Studypopulation

1RR066

(045to098)

215

(4studies)

oplusoplus

copycopy

low

23

392per1000

259per1000

(176

to384)

Mediumriskpopulation

1

275per1000

182per1000

(124

to270)

Adverseeffects4

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

3Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Calculatedusingcontrolgroupresults

2StudybyMerritt(2002)wasnotadequatelyrandom

ised

3Totalnum

berofeventsislessthan300

4Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

4Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

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1Calculatedusingcontrolgroupresults

2StudybyMerritt(2002)wasnotadequatelyrandom

ised

3Totalnum

berofeventsislessthan300

4Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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4Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxxx

xxxx

xxxx

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xxxx

xxxx

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xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 7: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

B A C K G R O U N D

Aromatherapy has been recommended for the treatment of post-operative nausea and vomiting (PONV) (Bone 1990 Maddocks-Jennings 2004) It is known that this therapy is inexpensivenon-invasive and generally has low levels of adverse effects (Price2007) particularly in comparison to standard pharmacologicaltreatments What is not known is whether the clinical effectivenessjustifies its use

Nausea is an abdominal discomfort or queasiness that may be ac-companied by vomiting (the forceful expulsion of stomach con-tents through the mouth) Postoperative nausea and vomiting(PONV) is one of the most common adverse reactions to surgeryand all types of anaesthesia with 20 to 30 of all patients suf-fering moderate to severe nausea and vomiting following generalanaesthesia using volatile agents (Watcha 1992)

Aside from the distressing nature of PONV itself as a result ofPONV patients may experience such adverse effects as wound de-hiscence dehydration electrolyte imbalances or aspiration pneu-monia (Kovac 2000) Other adverse effects may include increasedpatient bed days unplanned readmissions (particularly in the caseof day surgery) (Kovac 2000) and decreased patient satisfaction(Myles 2000) Certain patients are more pre-disposed than othersto suffering from PONV and risk factors include being femalea non-smoker having a history of PONV or perioperative opi-oid exposure (Koivuranta 1997) Along with postoperative painPONV is one of the main concerns of patients facing surgery andone of the main causes of patient dissatisfaction (Myles 2000)

Current treatment involves either the prophylactic or symptomaticadministration of anti-emetic drugs such as droperidol meto-clopramide or 5-HT3 receptor antagonists such as ondansetron(White 1999) Despite a wide range of available treatments somepatients will still experience PONV in varying levels of severity(Kazemi-Kjellberg 2001) Clinically the severity of PONV is gen-erally measured by means of a visual analogue scale (VAS) whichprovides a visual representation of the patientrsquos condition over anumerical range (for example 0 to 5) or verbal descriptive scales(for example no nausea some nausea very nauseated retchingvomiting) (Boogaerts 2000) The effectiveness of the various drugsfor PONV has already been the subject of a Cochrane review(Carlisle 2006) however no existing review has examined the ef-fectiveness of aromatherapy to treat this condition

The use of aromatherapy oils is recognized as an effective treatmentfor nausea in general (Chiravalle 2005 Mamaril 2006 Merritt2002 Tate 1997) Aromatherapy uses the application of essentialoils or other substances to any part of the body for the purpose ofinhalation of the vapours or absorption of the oil into the skin totreat or alleviate physical and emotional symptoms (Price 2007)Essential oils can be absorbed through the skin and may exert aphysiological effect on cellular and organ function although thisis not clinically understood (Ernst 2001) Aromatherapy is wellaccepted by many health consumers who find it more pleasant

and acceptable than the ingestion or injection of conventionaldrugs (Eisenberg 1998) A significant number of health consumersalready self-prescribe and administer aromatherapy products forvarious common conditions or consult qualified or unqualifiedaromatherapy practitioners for health advice (Eisenberg 1998)

In particular ginger fennel and peppermint as either a topicalapplication (massage or a compress) or via inhalation are well-known treatments (Price 2007) The effectiveness of the oils maybe due to analgesic and anti-emetic properties (with peppermintoil and ginger oil) or anti-spasmodic properties (peppermint oiland fennel oil) Peppermint oil is well recognized for its role indigestion disorders due principally to the presence of menthols(see Appendix 1 for details) There have been a number of studiesconducted using ginger oil with conflicting results (Arfeen 1995Bone 1990 Meyer 1995 Phillips 1993) Isopropyl alcohol is saidto be a traditional nausea remedy from South America (Anderson2004 Mamaril 2006 Spencer 2004) however none of the pa-pers citing this provided a primary source for this informationIsopropyl alcohol also known as rubbing alcohol and commonlyfound in the type of rsquoprep-padrsquo used to clean skin prior to injec-tion does appear to be widely used in some postanaesthesia careunits to treat PONV (Cotton 2007 Merritt 2002 Pellegrini 2009Spencer 2004 Wang 1999 Winston 2003) It is the subject ofseveral effectiveness studies

O B J E C T I V E S

To establish

bull what effect the use of aromatherapy has on the severity ofestablished postoperative nausea and vomiting

bull what effect the use of aromatherapy has on the duration ofestablished postoperative nausea and vomiting

bull whether aromatherapy can be used with safety and clinicaleffectiveness comparable to standard pharmacological treatmentsto treat established postoperative nausea and vomiting

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered any randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) that evaluated the effect of aromather-apy on established PONV In order to obtain the widest range ofstudies we set no date of publication or language limits

5Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 8: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Types of participants

We considered all studies that included patients (both adult andpaediatric paediatric being children aged less than 18 years of age)having any type of surgical procedure under general anaesthesiaregional anaesthesia or sedation either as hospital inpatients or inday or ambulatory facilities who were given aromatherapy treat-ments for management of existing PONV For the purposes of thisreview we considered postoperative to be the period from day ofsurgery to discharge from hospital or in the case of day hospitalpatients up to the fifth postdischarge dayWe excluded studies of non-surgical patients (medical oncology)We also excluded studies in which aromatherapy was used solelyto prevent postoperative nausea and vomiting

Types of interventions

Interventions of interest were those where aromatherapy prod-ucts were used by any delivery method (for example direct inhala-tion diffusion massage or compress) to treat symptoms of estab-lished postoperative nausea and vomiting either in comparisonto a placebo or compared with standard anti-emetic treatmentsAromatherapy was defined as the inhalation of the vapours of anysubstance for the purposes of a therapeutic benefit

Types of outcome measures

Primary outcomes

bull Severity of nausea or vomiting or both post-initiation oftreatment as measured by a validated scale or medical or nursingobservation

bull Duration of nausea or vomiting or both post-initiation oftreatment as measured by patient report or medical or nursingobservation

Secondary outcomes

bull Use of pharmacological anti-emeticsbull Any adverse reactions or events (common reactions to

aromatherapy include skin rashes dyspnoea headache cardiacarrhythmias hypotension hypertension or dizziness (Price2007))

bull Patient satisfaction with treatment as measured by avalidated scale

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials(CENTRAL) (The Cochrane Library 2011 Issue 3) MEDLINE

(via Ovid) (1966 to 2 August 2011) EMBASE (1966 to 2 August2011) CINAHL (EBSCOhost) (1982 to 2 August 2011) CAMon PubMed (1966 to 2 August 2011) Meditext (1995 to 2 August2011) LILACS (1982 to 2 August 2011) ISI Web of Science(1985 to 2 August 2011)We developed a specific strategy for each database We based eachsearch strategy on that developed for MEDLINE (see Appendix2 for details) We combined the MEDLINE search strategy withthe Cochrane highly sensitive search strategy phases one and twoas contained in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011)

Searching other resources

We also identified trials by manually searching abstracts of rele-vant conference proceedings such as the National Association forHolistic Aromatherapy ConferenceWe checked the reference lists of relevant articles and attempted tocontact relevant trial authors to identify any additional or ongoingstudiesWe also searched for relevant trials on specific sites

1 Current Controlled Trials at httpwwwcontrolled-trialscom

2 Clinical Study Results at httpwwwclinicalstudyresultsorg

3 SIGLE at httpopensigleinistfr (grey literature)4 New York Library of Medicine Grey Literature Report at

httpwwwnyamorglibrarypagesgrey_literature_report (greyliterature)

5 National Institute of Clinical Studies at httpwwwnhmrcgovaunicsindexhtm

6 Sciencegov at httpwwwsciencegovbrowsew_127htm(grey literature)We did not apply language or publication date restrictions

Data collection and analysis

Selection of studies

Two authors (SH and ES) independently scanned the titles andabstracts of reports identified by the described variety of searchstrategies We retrieved and evaluated potentially relevant studieschosen by at least one author in full-text versions We retrievedand translated any articles which appeared relevant but were notpublished in full in English Two authors (SH and ES) indepen-dently assessed the congruence of trials with the reviewrsquos inclusioncriteria using a checklist that was designed in advance for that pur-pose (Appendix 3) The third author (AC) settled any disagree-ments

6Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 9: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Data extraction and management

Two authors (SH and ES) independently extracted data using atool developed and piloted by the authors (Appendix 4) We re-solved any disagreements through consultation with the third au-thor (AC)

Assessment of risk of bias in included studies

We assessed the risk of bias using the tool provided in the RevMan51 software based on the work of The Cochrane Collaboration(Higgins 2011) Any disagreements were adjudicated by the thirdauthor (AC) We used the following five criteria to assess risk of biasfor each individual study random sequence generation allocationconcealment blinding incomplete outcome data and selectivereporting

Measures of treatment effect

Because of the subjective nature of nausea measures of treatmenteffect were largely limited to patient-reported effects measured byvarious scales including visual analogue scales (VAS) verbal nu-merical rating scales (VRNS) and descriptive ordinal scales (DOS)We included other measures of effect such as number of vomitingepisodes or retching and the use of pharmacological rsquorescuersquo anti-emetics All outcome measures that were evaluated were dichoto-mous and as such we used relative risk (RR) with 95 confidenceinterval (95 CI) to measure treatment effect

Unit of analysis issues

For cross-over trials a paired t-test was to be used to analyse par-ticipant data had sufficient data been available Had cluster ran-domized trials been included effect estimates and standard errorswould have been meta-analysed using the generic inverse-variancemethod in RevMan

Dealing with missing data

Where necessary we contacted authors of included studies regard-ing missing study information We were able to contact some au-thors to retrieve missing data such as details about randomizationstatistical detail and standard deviations however others did notreply or were not contactable Where data were found to be miss-ing and the authors were not contactable where possible we cal-culated missing statistics (such as standard deviations) from otherquoted statistics (such as standard errors or CIs) If missing dataremained then we performed an available case analysis excludingdata where outcome information was unavailable

Assessment of heterogeneity

We assessed statistical heterogeneity through the use of the Chi2

test as well as by reviewing the I2 statistic If either the Chi2 testresulted in a P value less than 010 or the I2 statistic was greater

than 40 further investigation of the reasons for heterogeneitywas carried out Clinically diverse studies were analysed separatelywherever appropriate

Assessment of reporting biases

Due to the small number of studies included in this review andthe small number that could be included in the meta-analyseswe considered it inappropriate to generate funnel plots to assessreporting biases (Egger 1997) We did consider studies from awide range of locations languages and publications which webelieve has reduced the likelihood of reporting biases affecting ourfindings (Higgins 2011)

Data synthesis

We entered all trials included in the systematic review into Re-view Manager (RevMan 51) and combined data quantitativelywhere possible We presented the main outcomes in this reviewas dichotomous variables We calculated pooled estimates usingthe fixed-effect model with the Mantel-Haenszel method as thestudies were homogenous and small numbers of events were ob-served We determined the levels of heterogeneity by the I2 statis-tic (Higgins 2011) We used a random-effects model when the I2

was more than 50

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were conducted where data were available asdescribed by Deeks et al (Deeks 2001) and as recommended inSection 88 of the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011) We planned to comparebull adults and childrenbull different types of surgery (eg orthopaedic and

gynaecologic surgery)bull types of aromatherapy delivery methods (eg inhalation

massage ingestion)bull trial quality (eg RCT CCT)

Due to the limited data available we were unable to perform anysubgroup analyses

Sensitivity analysis

Because of considerable concern about the risk of bias due toconfounding in Merritt 2002 we performed a sensitivity analysisand have reported findings both with and without the results ofthis study

R E S U L T S

7Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 10: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Description of studies

See Characteristics of included studies Characteristics of excludedstudiesThe studies were randomized controlled trials (RCTs) or con-trolled clinical trials (CCTs) conducted on postoperative adultand paediatric patients in postanaesthesia care units (PACU) andsame-day surgery units (SDSU) The intervention groups weregiven aromatherapy treatments to treat complaints of postopera-tive nausea and vomiting The control groups were treated witheither a saline placebo or standard anti-emetic drugs

Results of the search

We conducted searches in a wide range of databases andsources MEDLINE CAM on PubMed CENTRAL EMBASECINAHL Meditext LILACS Web of Science Current Con-trolled Trials Clinical Study Results SIGLE New York Libraryof Medicine Grey Literature Report National Institute of ClinicalStudies Google Scholar (English German Spanish) Sciencegov(grey literature) Conference Proceedings of the National Associ-ation for Holistic Aromatherapy and reference listsOf the 1386 articles we identified 44 were deemed relevantenough to be retrieved for further evaluation After appraisal ofthe full version of each study nine studies were found to meet thecriteria for inclusion in the review For further details see Figure 1

8Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 11: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Figure 1 Results of searches

9Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 12: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Included studies

We included nine studies comprised of six RCTs (Anderson 2004Cotton 2007 Kamalipour 2002 Pellegrini 2009 Wang 1999Winston 2003) and three CCTs (Langevin 1997 Merritt 2002Tate 1997) with a total of 402 participants The mean age andrange data for all participants were not available for all studies SeeCharacteristics of included studies for further details

Excluded studies

We excluded 35 studies for not meeting the inclusion criteria ei-ther by study design (not RCT or CCT) or by study outcomes (pre-vention of PONV not treatment) See Characteristics of excludedstudies for details

Risk of bias in included studies

We assessed the risk of bias in terms of allocation sequence gener-ation blinding incomplete reporting of outcome data and selec-tive reporting Risk of bias was found to be moderate to high acrossall included studies For details of the risk of bias assessment seeFigure 2 and Figure 3

Figure 2 Methodological quality graph review authorsrsquo judgements about each methodological quality

item presented as percentages across all included studies

10Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 13: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Figure 3 Methodological quality summary review authorsrsquo judgements about each methodological quality

item for each included study

11Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 14: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Allocation

Methods of allocation varied across the included studies Infour studies the method of randomization was explicitly statedWang 1999 utilized a rsquorandom number tablersquo Cotton 2007 andPellegrini 2009 utilized a rsquocomputer generated random numberstablersquo and Anderson 2004 used a rsquorandom number generatorrsquo ForKamalipour 2002 the treatment and control groups were ldquoran-domly selectedrdquo but the authors did not state what method ofrandomization was used Similarly in Winston 2003 participantswere ldquorandomly assignedrdquo to receive either the treatment or controlbut the method of sequence generation was not stated In Langevin1997 which used a cross-over clinical trial design the test agentswere administered in a ldquorandom sequencerdquo but again the methodof randomization was not stated The study by Merritt 2002 was aCCT and participants were not randomly allocated rather assign-ment to the treatment and control groups was alternated by dayThe participants in Tate 1997 were ldquorandomly allocatedrdquo to wardswhich had been assigned to the separate treatments the controland placebo arms of the studyAllocation concealment appeared to have been undertaken for fourstudies (Anderson 2004 Cotton 2007 Pellegrini 2009 Winston2003) The remaining five studies did not report data on whetherallocation was concealed

Blinding

Five included studies (Anderson 2004 Langevin 1997 Merritt2002 Tate 1997 Wang 1999) appeared to have undertaken at leastsome blinding of participants and assessors published details wereunclear for two (Kamalipour 2002 Pellegrini 2009) and for twostudies (Cotton 2007 Winston 2003) blinding was explicitly notdone Three included studies (Anderson 2004 Langevin 1997Wang 1999) explicitly blinded assessors

Incomplete outcome data

Data appeared to have been reported for all participants and out-comes in seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Pellegrini 2009 Tate 1997 Wang 1999 Winston 2003)however it was unclear whether this had occurred in the remainingtwo studies (Langevin 1997 Merritt 2002)

Selective reporting

For seven studies (Anderson 2004 Cotton 2007 Kamalipour2002 Langevin 1997 Merritt 2002 Pellegrini 2009 Wang 1999)it was unclear whether there was any degree of selective reportingand for two studies it appeared that a degree of selective reportinghad taken place (Tate 1997 Winston 2003)

Other potential sources of bias

Other potential sources of bias were evident in two studies Dueto the design of the study by Tate 1997 it was possible there wassome demand characteristic effect (an effect where participantsinterpret the purpose of the study and modify their behaviour orreporting accordingly (Orne 1962)) on patient self-reporting ofresults The authors of Merritt 2002 reported that their study wasprobably confounded by the aggressive preoperative anti-emeticprophylaxis given to 104 out of the 111 participants enrolled intothe study Four studies appeared free of other potential sourcesof bias (Cotton 2007 Pellegrini 2009 Wang 1999 Winston2003) It was unclear from the minimal data reported in Langevin1997 and Kamalipour 2002 whether there were any other potentialsources of bias

Effects of interventions

See Summary of findings for the main comparison Isopropylalcohol compared to standard treatment for treatment ofpostoperative nausea and vomiting Summary of findings

2 Isopropyl alcohol compared to saline for treatment ofpostoperative nausea and vomitingSeven studies examined the effectiveness of isopropyl alcohol (IPA)as an anti-emetic and two studies investigated the effectivenessof peppermint oil (one study trialled both interventions) All in-cluded studies measured nausea as a chief outcome Five studiesalso reported data on the number of participants requiring rescueanti-emetics for unresolved nausea All analyses resulted in signif-icance values for heterogeneity testing of greater than 010 and I2

values less than 40 indicating that statistical heterogeneity wasnot present

Primary outcome severity and duration of nausea

The only studies able to be compared for this outcome with com-patible drug administration times were the Langevin 1997 andKamalipour 2002 studies However the primary outcome analysiscould not be performed on these two studies The only measureof nausea for the Kamalipour study was percentage of patientswho responded to the treatment and this measure could not becompared with the Langevin study as there was ambiguity in thepaperrsquos definition of responseThe Anderson 2004 study could not be compared with theLangevin and Kamalipour studies for this outcome as the timesfor drug administration were reporting nausea two minutes laterthen three minutes later which is different to the drug adminis-tration times for the two other studiesThe two studies examining isopropyl alcohol versus standard drugtreatment also could not be compared as the number of applica-tions of isopropyl alcohol differed between the studies For the

12Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 15: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Cotton 2007 study the maximum number of isopropyl alcoholapplications was three whereas for the Winston 2003 study themaximum number of applications was twoFinally the two studies which looked at peppermint aromather-apy (Anderson 2004 Tate 1997) could not be compared due todiffering drug administration times and units of measurementThe single paediatric study that was included (Wang 1999) com-pared isopropyl alcohol and saline in a population of 39 childrenhaving elective outpatient surgery under general anesthesia Thisstudy found that while isopropyl alcohol did have an effect onpostoperative nausea at 20 minutes post-treatment (P = 005) thiseffect could not be sustained at 60 minutes (RR 285 95 CI032 to 2507 P = 035) No effect on postoperative vomiting wasdemonstrated at 20 minutes or 60 minutes (RR 127 95 CI033 to 493)

Primary outcome duration of nausea

Findings for studies measuring time to relief of nausea whichcould not be combined statistically are presented in Table 1

Primary outcome severity of nausea

Studies measuring severity of nausea by nausea scale measure-ments which could not be combined statistically are presented inTable 2

Secondary outcome use of rescue anti-emetics

Four studies with a total of 215 participants compared isopropylalcohol to standard treatment (ondansetron or promethazine) andreported the number of participants in each group who requiredrescue anti-emetics The studies by Cotton 2007 Merritt 2002Pellegrini 2009 and Winston 2003 were able to be combined ina meta-analysis which showed a statistically significant effect (RR066 95 CI 045 to 098 P = 004) (Analysis 11) Howeverdue to the likely confounding of the study by Merritt 2002 fromthe administration of preoperative prophylactic anti-emetics to94 out of the 111 original participants a sensitivity analysis wasperformed Without the Merritt data there was no statisticallysignificant evidence of an effect (RR 066 95 CI 039 to 113 P= 013) (Analysis 21) These findings are summarized in Summaryof findings for the main comparisonSeparating out results for participants with nausea only as reportedin Cotton 2007 Winston 2003 and Pellegrini 2009 we found thatthe proportion requiring rescue anti-emetics was not significantlydifferent between the experimental and control groups (RR 06695 CI 039 to 113 P = 013) (Analysis 21)Three studies of adult patients (Anderson 2004 Kamalipour 2002Langevin 1997) with a total of 135 participants compared iso-propyl alcohol and saline and measured the number of partici-pants who required rescue anti-emetics These studies were com-bined Meta-analysis showed a trend toward evidence of an effect

(RR 030 95 CI 009 to 100 P = 005) (Analysis 41) Thesefindings are summarized in Summary of findings 2One study of 39 paediatric patients having day surgical proce-dures (Wang 1999) also compared isopropyl alcohol and salineand measured the number of participants requiring rescue anti-emetics For participants with nausea only 60 of those in theplacebo (saline) group required rescue anti-emetics compared to9 of those in the isopropyl alcohol group (RR 015 95 CI002 to 105) For participants with vomiting 89 of the salinegroup required rescue anti-emetics compared to 67 of the iso-propyl alcohol group (RR 075 95 CI 023 to 112)One RCT (Anderson 2004) trialled a comparison of isopropyl al-cohol peppermint oil and saline inhalations This study random-ized 33 participants to receive either isopropyl alcohol pepper-mint oil or saline to treat reported nausea in a postoperative careunit Of the participants receiving isopropyl alcohol 45 requiredrescue anti-emetics while 60 of participants in the peppermintoil group and 50 of the control (saline) group required rescueanti-emetics This study found no significant difference betweenthe treatment and control groups (no significance value reported)

Secondary outcome adverse reactions

No data on adverse reactions to the experimental substances werereported by any of the included studies

Secondary outcome patient satisfaction with treatment

Four studies measured patient satisfaction with treatmentCotton 2007 (comparing isopropyl alcohol to ondansetron) useda four-point ordinal scale on which the participants were asked torate their postoperative experience as poor fair good or excellentparticipants in both the treatment and control groups reportedtheir experience as good or excellent resulting in no statisticallysignificant difference between the groups (P gt 005)Winston 2003 also measured patient satisfaction using a four-point ordinal scale (0 = poor 1 = fair 2 = good and 3 = ex-cellent) For the ondansetron group 0 = 1 participant (3) 1= 2 participants (6) 2 = 17 participants (52) and 3 = 13participants (39) For the isopropyl alcohol group the satisfac-tion numbers were 0 = 0 participants 1 = 0 participants 2 = 18participants (47) and 3 = 20 participants (53) The authorsstated that although these findings were not statistically signifi-cant they nonetheless regarded them as clinically significant (un-reported data supplied via email) Results from Cotton 2007 andWinston 2003 were collapsed into binary data (good or excellentinterpreted as satisfied) and combined in Analysis 51Patients also reported high levels of satisfaction with their treat-ment regardless of allocation in Pellegrini 2009 with a medianscore of 4 on a 5-point ordinal scale (1 totally dissatisfied 2somewhat dissatisfied 3 somewhat satisfied 4 satisfied 5 totallysatisfied)Anderson 2004 measured patient satisfaction on a VAS (0 mm

13Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 16: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

extremely dissatisfied 100 mm fully satisfied) Participants acrossall three groups reported high levels of satisfaction with their treat-ment isopropyl alcohol 903 (SD 149) peppermint oil 863 (SD323) saline 837 (SD 256)The results from all studies reporting on this outcome are collatedin Table 3

14Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxxx

xxxx

xxxx

xxxx

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16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 17: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

AD

DI

TI

ON

AL

SU

MM

AR

YO

FF

IN

DI

NG

S[E

xpla

nati

on]

Isopropylalcoholcomparedtosalinefortreatmentofpostoperativenauseaandvomiting

Patientorpopulationpatientswithtreatmentofpostoperativenauseaandvomiting

SettingsPost-anaesthesiaCareAreas

InterventionIsopropylalcohol

Comparisonsaline

Outcomes

Illustrative

comparativerisks

(95CI)

Relativeeffect

(95CI)

NoofParticipants

(studies)

Qualityoftheevidence

(GRADE)

Com

ments

Assumed

risk

Correspondingrisk

saline

Isopropylalcohol

Requirementforrescue

anti-emetics1

2

count

Studypopulation

3RR023

(014to038)

135

(3studies)

oplusoplus

copycopy

low

45

868per1000

200per1000

(122

to330)

Lowriskpopulation

3

100per1000

23per1000

(14to38)

Adverseeffects6

Seecomment

Seecomment

Notestimable

0 (0)

Seecomment

The

basisfortheassumedrisk

(egthemediancontrolgroupriskacross

studies)isprovided

infootnotesThecorrespondingrisk(and

its95confidence

interval)isbasedon

the

assumedriskinthecomparison

groupandtherelativeeffectoftheintervention(andits95CI)

CIConfidenceintervalRRRiskratio

GRADEWorkingGroupgradesofevidence

HighqualityFurtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect

ModeratequalityFurtherresearchislikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandmaychangetheestimate

LowqualityFurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate

VerylowqualityWeareveryuncertainabouttheestimate

15Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 18: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

1Participantsenrolledintostudyon

complaintofnauseaandorvomiting

2Calculatedusingcontrolgroupresults

3RiskcalculationsbasedonPierreSBenaisHPouymayou

JApfelrsquossimplifiedscoremayfavourablypredicttheriskofpostoperative

nauseaandvomitingCanadianJournalofAnesthesiaJournalCanadiendrsquoAnesthesie200249(3)237-42

4StudybyLangevin(1997)iscontrolledclinicaltrialand

notrandom

ised

5Totalnum

berofeventsislessthan300

6Nodataon

thisoutcom

e

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

xxxx

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xxx

16Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 19: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

D I S C U S S I O N

Summary of main results

This review was able to include studies of isopropyl alcohol andpeppermint oil aromatherapy compared to a saline placebo on-dansetron promethazine or other unspecified rsquostandard anti-emeticrsquo treatments All aromatherapy was delivered via direct in-halation There were 311 adult and 91 paediatric patients in theincluded studies The majority of patients were women Studieswere conducted in both inpatient and day surgery settings Out-comes measured were time to reduction in nausea severity of nau-sea number of nausea and vomiting events the use of rsquorescuersquo anti-emetics patient satisfaction recurrence of symptoms and cost oftreatmentIsopropyl alcohol (IPA) has been tested in several studies bothagainst standard pharmacological treatments and against otheraromatherapies and placebo in both adults and children In com-parison to saline placebo IPA appears effective in reducing thenumber of patients requiring rescue anti-emetics (Kamalipour2002 Langevin 1997) and in providing short-term relief of symp-toms in children (Wang 1999) In two studies (Cotton 2007Winston 2003) IPA provided a faster time to 50 relief of symp-toms than ondansetron and promethazine (Pellegrini 2009) how-ever when meta-analysed there was no statistically significant dif-ference in the number of participants requiring rescue anti-emet-ics in the combined results of these three studiesPeppermint oil inhalations are often recommended for PONV(Chiravalle 2005 Pompeo 2007 Price 2007) however this reviewwas unable to find sufficient evidence to support this Two stud-ies examined the use of peppermint as a treatment for PONV(Anderson 2004 Tate 1997) but only Anderson 2004 was ade-quately randomized and blinded Tate 1997 reported evidence ofan effect however methodological concerns mean that these resultsshould be viewed with caution Anderson 2004 found that theeffect of peppermint oil inhalation was not statistically differentfrom the effect of inhalations of isopropyl alcohol or salineNo adverse reactions were reported by any of the included studiesPatient satisfaction with aromatherapy treatment appeared highin studies that measured this outcome (Anderson 2004 Cotton2007 Pellegrini 2009 Winston 2003) with patients reportinghigh levels of satisfaction with their experience However it shouldbe noted that all participants in these studies (treatment and com-parison groups) reported high levels of satisfaction

Overall completeness and applicability ofevidence

It seems likely that further studies of isopropyl alcohol to treatpostoperative nausea and vomiting could provide different resultsfrom those described here Well-conducted studies of peppermintoil or other aromatherapies may provide definitive evidence for the

effectiveness of these therapies The evidence base for aromather-apy to treat PONV is currently incomplete with only one studyof children meeting the inclusion criteria and many aromather-apy treatments incompletely investigated or tested While thereappears to be no evidence of adverse reactions from the use ofthe included interventions it is unclear from the included studieswhether data were collected on any possible adverse reactions ex-perienced by participants In the context of current postoperativepractice there is a place for adjunct therapies to treat PONV andwhile isopropyl alcohol vapour inhalation is a simple and inexpen-sive treatment that seems to be more effective than placebo thereis currently no evidence to suggest that it can replace pharmaco-logical anti-emeticsOf additional concern are the early time points utilised by allincluded studies except Tate 1997 which did measure PONV at 24and 48 hours but only reported average daily scores for each groupApfel 2002 recommends that study authors measure PONV forearly (greater than two hours) and late (to 24 hours) outcomesThe data able to be included in this review are incomplete foreffects longer than 60 minutesDue to the many risk factors for and influences on PONV suchas type of anaesthesia narcotic medication intake sex and typeof surgery it was a concern that there were differences betweengroups that might account for some of the effect Examination ofthe demographic and procedural data however shows that controland experimental groups were very similar and that confoundingdue to risk factors was unlikelyIt should be remembered that we have not included any evidenceof effectiveness for aromatherapy in the prevention of PONV andthat all results apply only to treatment of an existing complaint

Quality of the evidence

The included studies were comprised of six RCTs and three CCTswith total of 402 participants The overall quality of the retrievedevidence was low with incomplete reporting and unavailable datahampering the comparison of most studies Due to the age of sev-eral studies further data were either not available or the authorswere not contactable The nine included studies measured the ef-fectiveness of only two aromatherapy treatments for postoperativenausea and vomiting neither of which were shown to be effectivein comparison to standard pharmacological anti-emetics althoughisopropyl alcohol appears to be more effective than placebo

Agreements and disagreements with otherstudies or reviews

A recent systematic review of the effectiveness of noninvasive com-plementary therapies for reducing PONV in women having ab-dominal laparoscopic hysterectomy (Hewitt 2009) found simi-larly to this review that there was no strong evidence to support

17Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 20: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

the use of aromatherapy for PONV We have been unable to findany other systematic reviews of aromatherapy for treating PONV

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

From the evidence of this review it seems that using isopropyl alco-hol vapour inhalation as an adjunct therapy for PONV is unlikelyto be harmful and may reduce nausea for some adult patients Itmay provide a useful therapeutic option particularly when thealternative is no treatment at all As an inexpensive readily avail-able therapy (in the form of injection site rsquoprep-padsrsquo) isopropylalcohol vapour inhalation could be considered for use in situationswhere standard pharmacological anti-emetics are unavailable re-fused by patients or contra-indicated

Included studies that examined this intervention used one prep-pad or isopropyl alcohol-soaked cotton ball or gauze pad per treat-ment and most asked the patient to take two or three deep breathswhile the pad was held close to their nose without touching Treat-ments were repeated up to three times without any adverse effectsbeing reported

There is currently no evidence to show that using peppermint oilaromatherapy reduces PONV however there is no evidence of itsuse being harmful

Implications for research

It is important that future trials fully report their methodologydemography and findings Full descriptions of the results of in-

terventions would enable clinicians to make more informed de-cisions about the uptake of these therapies in their clinical set-ting Improved reporting would also benefit future updates of thisreview There is an absence of large well-reported trials in thisarea particularly of therapies other than isopropyl alcohol Furtherstudies in paediatric populations are needed before aromatherapycan be recommended for treatment of PONV in children Futuretrials should include measures for longer time intervals (two to 24hours) and report discrete data on both postoperative nausea andpostoperative vomiting

A C K N O W L E D G E M E N T S

We thank Mathew Zacharias Jung T Kim NL Pace Peter Krankeand Anne Lyddiatt for their help and advice during the preparationof the systematic review

We also thank Mathew Zacharias Katrina Farber Milli ReddyJung T Kim and Janet Wale for their help and editorial adviceduring the preparation of the protocol for the systematic review

The authors wish to acknowledge Kathy Hibberd (Librarian Uni-versity of Queensland Medical Library) for her invaluable assis-tance in preparing and conducting the searches for this reviewand Leandra Blake for her comments on the protocol and reviewWe also thank Kate Kynoch and Lisa Brown for assisting with thetesting of the data extraction tool

Thanks to Marie Kristensson for the Swedish translations AbbasBreesem for the Farsi translation and Laurie Bay at the Institute ofModern Languages at the University of Queensland for the Frenchtranslation

R E F E R E N C E S

References to studies included in this review

Anderson 2004 published and unpublished data

Andersen L Gross J Aromatherapy with peppermintisopropyl alcohol or placebo is equally effective in reducingpostoperative nausea Journal of Perianesthesia Nursing

200419(1)29ndash35 [PUBMED 14770380 ]

Cotton 2007 published and unpublished data

Cotton JW Rowell LR Hood RR Pellegrini JE Acomparative analysis of isopropyl alcohol and ondansetronin the treatment of postoperative nausea and vomiting fromthe hospital setting to the home American Association of

Nurse Anesthetists Journal 200775(1)21 [PUBMED17304779]

Kamalipour 2002 published data only (unpublished sought but not

used)

Kamalipour H Parviz Kazemi A The effect of isopropyl

alcohol sniffing on the treatment of post-operative nauseaand vomiting Journal of Medical Research (JMR) 20021(1)15ndash9

Langevin 1997 published data only (unpublished sought but not

used)

Langevin P Brown M A simple innocuous and inexpensivetreatment for postoperative nausea and vomitingAnesthesiology 199784 Suppl971 [ ISSN 0003ndash3022]

Merritt 2002 published data only

Merritt BA Okyere CP Jasinski DM Isopropyl alcoholinhalation Alternative treatment of postoperativenausea and vomiting Nursing Research 200251(2)125[PUBMED 11984383]

Pellegrini 2009 published and unpublished data

Pellegrini J DeLoge J Bennett J Kelly J Comparison ofinhalation of isopropyl alcohol vs promethazine in thetreatment of postoperative nausea and vomiting (PONV)

18Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 21: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

in patients identified as at high risk for developing PONVAmerican Association of Nurse Anesthetists Journal 200977

(4)293ndash9 [PUBMED 19731848]

Tate 1997 published and unpublished data

Tate S Peppermint oil A treatment for postoperativenausea Journal of Advanced Nursing 199726(3)543ndash9[PUBMED 9378876]

Wang 1999 published data only (unpublished sought but not used)

Wang SM Hofstadter MB Kain ZN An alternativemethod to alleviate postoperative nausea and vomiting inchildren Journal of Clinical Anesthesia 199911(3)231ndash4[PUBMED 10434220]

Winston 2003 published and unpublished data

Winston AW Rinehart RS Riley GP Vacchiano CAPellegrini JE Comparison of inhaled isopropyl alcohol andintravenous ondansetron for treatment of postoperativenausea American Association of Nurse Anesthetists Journal

200371(2)127ndash32 [PUBMED 12776641]

References to studies excluded from this review

Apariman 2006 published data only

Apariman S Ratchanon S Wiriyasirivej B Effectivenessof ginger for prevention of nausea and vomiting aftergynecological laparoscopy Journal of the Medical Association

of Thailand 200689(12)2003ndash9 [PUBMED 17214049]

Apfel 2001 published data only

Apfel C Kranke P Greim C Roewer N What can beexpected from risk scores for predicting postoperativenausea and vomiting British Journal of Anaesthesia 200186(6)822ndash7 [PUBMED 11573590]

Arfeen 1995 published data only

Arfeen Z Owen H Plummer J Ilsley A Sorby-Adams RDoecke C A double blind randomized controlled trialof ginger for the prevention of postoperative nausea andvomiting Anaesthesia and Intensive Care 199523449ndash52[PUBMED 7485935 ]

Betz 2005 published data only

Betz O Kranke P Geldner G Wulf H Eberhart L Isginger a clinically relevant antiemetic A systematic reviewof randomised controlled studies [Ist ingwer ein klinischrelevantes antiemetikum Eine systematische uumlbersichtrandomisierter kontrollierter studien] Logo 200512(1)14ndash23 [DOI 101159000082536]

Bone 1990 published data only

Bone M Wilkinson D Young J McNeil J CharltonS Ginger root a new antiemetic The effect of gingerroot on postoperative nausea and vomiting after majorgynaecological surgery Anaesthesia 199045(8)669ndash71[PUBMED 2205121]

Buckle 1999 published data only

Buckle J Aromatherapy in perianesthesia nursing Journal

of Perianesthesia Nursing 199914(6)336ndash44 [PUBMED10839071]

Chaiyakunapruk 2006 published data only

Chaiyakunapruk N Kitikannakorn N Nathisuwan SLeeprakobboon K Leelasettagool C The efficacy of ginger

for the prevention of postoperative nausea and vomiting Ameta-analysis American Journal of Obstetrics and Gynecology

2006194(1)95ndash9 [PUBMED 16389016]

Chiravalle 2005 published data only

Chiravalle P McCaffrey R Alternative therapy applicationsfor postoperative nausea and vomiting Holistic Nursing

Practice 200519(5)207ndash10 [PUBMED 16145329]

Chrubasik 2005 published data only

Chrubasik S Pittler MH Roufogalis BD Zingiberisrhizoma A comprehensive review on the ginger effectand efficacy profiles Phytomedicine 200512(9)684ndash701[PUBMED 16194058]

Couture 2006 published data only

Couture D Maye J OrsquoBrien D Beldia Smith ATherapeutic modalities for the prophylactic management ofpostoperative nausea and vomiting Journal of Perianesthesia

Nursing 200621(6)398ndash403 [PUBMED 17169749]

DePradier 2006 published data only

de Pradier E A trial of a mixture of three essential oilsin the treatment of postoperative nausea and vomiting[Essai drsquoun melange de trois huiles essentielles dans letraitement des nausees et vomissements postoperatoires]International Journal of Aromatherapy 200616(1)15ndash20 [ INISTndashCNRS Cote INIST 27514354000139205670030]

Eberhart 2003 published data only

Eberhart L Mayer R Betz O Tsolakidis S Hilpert WMorin A et alGinger does not prevent postoperative nauseaand vomiting after laparoscopic surgery Anesthesia and

Analgesia 200396995ndash8 [PUBMED 12651648]

Eberhart 2006 published data only

Eberhart L Frank S Lange H Morin A Scherag A Wulf Het alSystematic review on the recurrence of postoperativenausea and vomiting after a first episode in the recoveryroom - implications for the treatment of PONV andrelated clinical trials BMC Anesthesiology 20066(1)14[PUBMED 17166262]

Ekenberg 2007 published data only

Ekenberg M Larsson A The non-pharmacological care ofnausea and vomiting [Sjukskoumlterskans ickendashfarmakologiskaomvaringrdnadsaringtgaumlrder vid illamaringende och kraumlkningar]unpublished dissertation 2007 [ httphdlhandlenet20774746]

Ernst 2000 published data only

Ernst E Pittler M Efficacy of ginger for nausea andvomiting A systematic review of randomized clinicaltrials British Journal of Anaesthesia 200084(3)367ndash71[PUBMED 10793599]

Fujii 2008 published data only

Fujii Y Current prevention and treatment of postoperativenausea and vomiting after gynecological laparoscopicsurgery Current Drug Therapy 20083(1)14ndash25 [DOI102174157488508783331180]

19Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 22: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Geiger 2005 published data only

Geiger JL The essential oil of ginger zingiber officinaleand anaesthesia International Journal of Aromatherapy

200515(1)7ndash14 [DOI 101016jijat200412002]

Golembiewski 2005 published data only

Golembiewski J Chernin E Chopra T Prevention andtreatment of postoperative nausea and vomiting American

Journal of Health-System Pharmacy 200562(12)1247[PUBMED 15947124]

Keifer 2007 published data only

Keifer D Ulbricht C Abrams T Basch E Giese N GilesM et alPeppermint (mentha piperita) An evidence-based systematic review by the natural standard researchcollaboration Journal of Herbal Pharmacotherapy 20077(2)91ndash143 [PUBMED 18285310]

Kim 2006 published data only

Kim JT Wajda M Cuff G Serota D Schlame MAxelrod DM et alEvaluation of aromatherapy in treatingpostoperative pain Pilot study Pain Practice 20066(4)273ndash7 [PUBMED 17129308]

Kim 2007 published data only

Kim JT Ren CJ Fielding GA Pitti A Kasumi T WajdaM et alTreatment with lavender aromatherapy in thepost-anesthesia care unit reduces opioid requirements ofmorbidly obese patients undergoing laparoscopic adjustablegastric banding Obesity Surgery 200717(7)920ndash5[PUBMED 17894152]

King 2009 published and unpublished data

King L Reagan S Thomason H Clements F BotchuckJ Hardin S Quease Ease Aromatherapy for Treatmentof PONV 2009 National Teaching Institute ResearchAbstracts American Journal of Critical Care 2009 Vol18e1ndashe17 [ httpajccaacnjournalsorgcgireprint183e1]

Koretz 2004 published data only

Koretz RL Rotblatt M Complementary and alternativemedicine in gastroenterology The good the bad and theugly Clinical Gastroenterology and Hepatology 20042(11)957ndash67 [PUBMED 15551247]

Mamaril 2006 published data only

Mamaril ME Windle PE Burkard JF Prevention andmanagement of postoperative nausea and vomiting A lookat complementary techniques Journal of Perianesthesia

Nursing 200621(6)404ndash10 [PUBMED 17169750]

Morin 2004 published data only

Morin A Betz O Kranke P Geldner G Wulf H EberhartL Is ginger a relevant antiemetic for postoperative nauseaand vomiting [Ist ingwer ein sinnvolles antiemetikum fuumlrdie postoperative phase] Anasthesiologie Intensivmedizin

Notfallmedizin Schmerztherapie Ains 200439(5)281ndash5[PUBMED 15156419]

Nale 2007 published data only

Nale R Bhave S Divekar DS A comparative study of gingerand other routinely used antiemetics for prevention of postoperative nausea and vomiting Journal of Anaesthesiology

Clinical Pharmacology 200723(4)405ndash10 [ httpwwwjoacporgindexphpoption=com˙journalamptask=check˙subscriptionampid=642]

Nanthakomon 2006 published data only

Nanthakomon T Pongrojpaw D The efficacy of gingerin prevention of postoperative nausea and vomiting aftermajor gynecologic surgery Journal of the Medical Association

of Thailand 200689(4)S130ndash6 [PUBMED 17725149]

Phillips 1993 published data only

Phillips S Ruggier R Hutchinson SE Zingiber officinale(ginger) - an antiemetic for day case surgery Anaesthesia

199348(8)715ndash7 [PUBMED 8214465]

Pompeo 2007 published data only

Pompeo DA Nicolussi AC Galvatildeo CM Sawada NNursing interventions for the prevention and relief ofnausea and vomiting during the immediate postoperativeperiod [Intervenciones de enfermeria para nausea y vomitoen el periodo postoperativo immediato] Acta Paulista de

Enfermagem 200720191ndash8 [ LILACS 457066]

Pongrojpaw 2003 published data only

Pongrojpaw D Chiamchanya C The efficacy of ginger inprevention of post-operative nausea and vomiting afteroutpatient gynecological laparoscopy Journal of the Medical

Association of Thailand 200386(3)244ndash50 [PUBMED12757064]

Roseacuten 2006 published data only

Roseacuten E Jackson K Nursing interventions to prevent andor relieve postoperative nausea and vomiting [Foumlrebyggandeocheller lindrande omvaringrdnadsaringtgaumlrder vid illamaringende ochkraumlkning efter operativa ingrepp] Unpublished Thesis2006 [ httpurnkbseresolveurn=urnnbnseorudivandash700]

Spencer 2004 published data only

Spencer KW Isopropyl alcohol inhalation as treatment fornausea and vomiting Plastic Surgical Nursing 200424(4)149 [PUBMED 15632723]

Tavlan 2006 published data only

Tavlan A Tuncer S Erol A Reisli R Aysolmaz G OtelciogluS Prevention of postoperative nausea and vomiting afterthyroidectomy Combined antiemetic treatment withdexamethasone and ginger versus dexamethasone aloneClinical Drug Investigation 200626(4)209 [PUBMED17163253]

Tramer 2001 published data only

Tramer MR A rational approach to the control ofpostoperative nausea and vomiting Evidence fromsystematic reviews Part 1 Efficacy and harm ofantiemetic interventions and methodological issuesActa Anaesthesiologica Scandinavica 200145(1)4ndash13[PUBMED 11152031]

Visaylaputra 1998 published data only

Visalyaputra S Petchpaisit N Somcharoen K ChoavaratanaR The efficacy of ginger root in the prevention ofpostoperative nausea and vomiting after outpatient

20Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 23: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

gynaecological laparoscopy Anaesthesia 199853(5)506ndash10 [PUBMED 9659029]

Additional references

Apfel 2002

Apfel C Roewer N Korttila K How to study postoperativenausea and vomiting Acta Anaesthesiologica Scandinavica

200246(8)921ndash8 [PUBMED 12190791]

Boogaerts 2000

Boogaerts JG Vanacker E Seidel L Albert A Bardiau FMAssessment of postoperative nausea using a visual analoguescale Acta Anaesthesiologica Scandinavica 200044(4)470ndash4 [PUBMED 10757584 ]

Carlisle 2006

Carlisle JB Stevenson CA Drugs for preventingpostoperative nausea and vomiting Cochrane Database

of Systematic Reviews 2006 Issue 3 [DOI 10100214651858CD004125pub2]

Dalvi 1991

Dalvi SS Nadkarni PM Pardesi R Gupta KC Effect ofpeppermint oil on gastric emptying in man a preliminarystudy using a radiolabelled solid test meal Indian

Journal of Physiology and Pharmacology 199135(3)212ndash4[PUBMED 1791066]

Deeks 2001

Deeks JJ Altman DG Bradburn MJ Egger M Davey Smith

G Altman DG editor(s) Systematic Reviews in Health Care

Meta-Analysis in Context Statistical methods for examining

heterogeneity and combining results from several studies in

metaanalysis 2nd Edition London BMJ PublicationGroup 2001

Egger 1997

Egger M Davey Smith G Schneider M Minder C Biasin meta-analysis detected by a simple graphical test BMJ

1997315(7109)629ndash34 [PUBMED 9310563]

Eisenberg 1998

Eisenberg DM Davis R Ettner S Appel S Wilkey S VonRompay M et alTrends in alternative medicine use in theUnited States 1990-1997 results of a follow-up nationalsurvey JAMA 1998280(18)1569ndash75 [PUBMED9820257 ]

Ernst 2001

Ernst E (editor) Aromatherapy The desktop guide to

complementary and alternative medicine An evidence-

based approach Edinburgh United Kingdom HarcourtPublishers Limited 200133-5 [ ISBN 0ndash723ndash43383ndash6]

Hewitt 2009

Hewitt V Watts R The effectiveness of non-invasivecomplementary therapies in reducing postoperativenausea and vomiting following abdominal laparoscopicsurgery in women a systematic review The JBI Library

of Systematic Reviews 20097(19)850ndash907 [ httpwacebnmcurtineduaureviewsSR˙81˙revised˙WApdf ]

Higgins 2011

Higgins JPT Green S editors Cochrane Handbook forSystematic Reviews of Interventions Version 510 [updatedMarch 2011] The Cochrane Collaboration 2011Available from wwwcochrane-handbookorg

Hills 1991

Hills JM Aaronson PI The mechanism of action ofpeppermint oil on gastrointestinal smooth muscleAn analysis using patch clamp electrophysiology andisolated tissue pharmacology in rabbit and guinea pigGastroenterology 1991101(1)55ndash65 [PUBMED1646142]

Kazemi-Kjellberg 2001

Kazemi-Kjellberg F Henzi I Tramer M Treatment ofestablished postoperative nausea and vomiting quantitativesystematic review BMC Anaesthesiology 2001 Vol 1issue 2 [PUBMED 11734064 ]

Koivuranta 1997

Koivuranta M Laumlaumlrauml E Snaringre L Alahuhta S A survey ofpostoperative nausea and vomiting Anaesthesia 199752443ndash9 [PUBMED 9165963]

Kovac 2000

Kovac A Prevention and treatment of postoperative nauseaand vomiting Drugs 200059(2)213ndash43 [PUBMED10730546]

Leicester 1982

Leicester RJ Hunt RH Peppermint oil to reduce colonicspasm during endoscopy Lancet 19822(8305)989[PUBMED 6127488]

Lis-Balchin 2006

Lis-Balchin M Aromatherapy Science LondonPharmaceutical Press 2006 [ ISBN 85369 578 4]

Maddocks-Jennings 2004

Maddocks-Jennings W Wilkinson J Aromatherapy practicein nursing literature review Journal of Advanced Nursing

200448(1)93ndash103 [PUBMED 15347415]

May 1996

May B Kuntz HD Kieser M KoEgravehler S Efficacy of afixed peppermint oilcaraway oil combination in non-ulcerdyspepsia Arzneimittel-ForschungDrug Research 1996461149ndash53 [PUBMED 9006790]

Meyer 1995

Meyer K Schwartz J Crater D Keyes B Zingiberofficinale (ginger) used to prevent 8-Mop associated nauseaDermatology Nursing 19957(4)242ndash4 [PUBMED7646942]

Myles 2000

Myles P Williams D Hendrata M Anderson H Weeks APatient satisfaction after anaesthesia and surgery results ofa prospective survey of 10811 patients British Journal of

Anaesthesia 200084(1)6ndash10 [PUBMED 10740539]

Orne 1962

Orne MT On the social psychology of the psychologicalexperiment With particular reference to demand

21Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 24: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

characteristics and their implications American Psychologist

196217(11)776ndash83 [DOI 101037h0043424]

Price 2007

Price S Price L (editors) Aromatherapy for Health

Professionals 3rd Edition Edinburgh ChurchillLivingstone 2007 [ ISBN 0ndash443ndash06210ndash2]

RevMan 51

The Nordic Cochrane Centre The Cochrane CollaborationReview Manager (RevMan) Version 51 CopenhagenThe Nordic Cochrane Centre The Cochrane Collaboration2011

Rogers 1988

Rogers J Tay H Misiewicz J Peppermint oil Lancet 1988332(8602)98ndash9 [PUBMED 2898713 ]

Sigmund 1969

Sigmund CJ McNally EF The action of a carminative on

the lower esophageal sphincter Gastroenterology 196956

(1)13ndash8 [PUBMED 5765428]

Watcha 1992

Watcha M White P Postoperative nausea and vomiting Itsetiology treatment and prevention Anesthesiology 199277

(1)162ndash84 [PUBMED 1609990]

Westphal 1996

Westphal J Houmlrning M Leonhardt K Phytotherapy infunctional abdominal complaints results of a clinical studywith a preparation of several plants Phytomedicine 19962285ndash91 [CENTRAL CNndash00254483]

White 1999

White P Watcha M Postoperative nausea and vomitingprophylaxis versus treatment Anesthesia and Analgesia

199989(6)1337ndash9 [PUBMED 10589604]lowast Indicates the major publication for the study

22Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 25: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Anderson 2004

Methods Randomized controlled trial of peppermint oil isopropyl alcohol or normal saline aro-matherapy to treat postoperative nausea and vomitingSetting Postanaesthesia care unit (PACU) acute hospital USA

Participants 33 patients aged 18 years+ having surgery under general or regional anaesthesia or deepIV sedation who reported nausea in postanaesthesia care unit Treatment groups didnot differ in the percentage having general anaesthesia the type of surgery age or genderdistributionExclusions patients who were unable to give informed consent patients who did notrequire anaesthesia services

Interventions On the patientrsquos spontaneous report of postoperative nausea they were instructed to takethree slow deep breaths to inhale the vapours from a pre-prepared gauze pad soaked witheither peppermint oil isopropyl alcohol or normal saline placebo held directly undertheir nostrils After 2 minutes the patient was asked to rate their nausea by VAS and giventhe choice to continue aromatherapy or have standard IV anti-emetics At 5 minutespost the initial treatment the patient was again asked to rate their nausea and if theywould like to continue aromatherapy or have standard IV anti-emetics

Outcomes 1 Severity of nausea as measured on 100 mm VAS at 2 minutes and 5 minutes aftertreatment Visual analogue scale from rsquono nausearsquo to rsquoworst possible nausearsquo2 Choosing to use rsquorescuersquo anti-emetics3 Satisfaction with management of nausea as measured by 100 mm VAS with rangefrom 0 = extremely dissatisfied to 100 = fully satisfied

Notes Possible lack of accuracy with some participants self-recording data in PACU if they hadpoor or blurred vision Authors Lynn Anderson and Dr Jeffrey Gross emailed to requestfurther information on group sizes which was supplied by Dr Gross

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquogroup assignments were made in a ran-domized double-blind fashionrdquoComment probably done Nurses admin-istering treatment were unaware of con-tents of each package of treatment mate-rials Patients who had consented to par-ticipate entered study when they sponta-neously reported nausea

23Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 26: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Anderson 2004 (Continued)

Allocation concealment (selection bias) Low risk ldquoA random number generator determinedthe contents of each serially numbered bagrdquo ldquoprepared by an individual not other-wise involved in the studyrdquoData ldquoanalysed by investigator unaware oftreatment allocationrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Staff administering treatment blinded byuse of ldquolightly scentedrdquo surgical masksHowever patients were self-reporting sub-jective assessment of nausea and were notblindedComment Due to the strong aroma ofthe peppermint oil it would be impos-sible to blind the patients receiving thisto their allocation once treatment com-menced Probably not done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment outcomes reported for all par-ticipants

Selective reporting (reporting bias) Unclear risk Comment results reported for all statedoutcomes however original study protocolnot available

Other bias Low risk Comment study appears to be free of othersources of bias

Cotton 2007

Methods Prospective randomized study of isopropyl alcohol inhalation as compared to IV on-dansetron for PONV Replication of study Winston 2003Setting PACUsame day surgery unit USA

Participants 100 women aged 18-65 who were scheduled for laparoscopic same-day surgery (ASAphysical status I II or III)Exclusions patients who had recent upper respiratory tract infections inability or im-paired ability to breathe through the nose or history of hypersensitivity to IPA 5HT3antagonists promethazine or any other anaesthesia protocol medication had used ananti-emetic within 24 hours of surgery were pregnant or breastfeeding had history ofinner ear pathology motion sickness or migraine headaches or were taking disulframcefoperazone or metronidazole

Interventions Comparison of inhaled isopropyl alcohol to intravenous ondansetron for treatment ofPONVOndansetron (control) group nausea treated with ondansetron 4mg IV every 15 minutesto a maximum 8mg dose Time dose and VNRS score recorded

24Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 27: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Cotton 2007 (Continued)

IPA (experimental) group nausea treated by holding a folded alcohol pad approximately12 inch from the participantrsquos nares and instructing them to take 3 deep breaths in andout through the nose Treatments given every 5 minutes up to a total of 3 administrationsBreakthrough PONV was treated with promethazine suppositories for both groupsParticipants were also given supplies of IPA and promethazine to use as needed at homeafter discharge and asked to record any occurrences of PONV with a data collection toolprovided by the researchers

Outcomes Time to reduction in nausea score as measured by Verbal Numeric Rating Scale (VRNS)(range 0-10 where 0 = no nausea and 10 = worst imaginable nausea) Collected forbaseline at preop then immediately postop in PACU and at any time the participantcomplained of nausea Additionally participants who complained of nausea were assessedevery 5 minutes following treatment for 30 minutes and then every 15 minutes untildischarge from PACUParticipants also reported data on PONV for the 24 hours post-discharge as well ratingtheir anaesthesia experience overall

Notes Author Joseph Pellegrini contacted for further data Some was provided however due todata corruption problems not all requested data was available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquopatient was randomly assigned to the con-trol group or the experimental group byusing a computer-generated random num-bers programrdquoComment done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no information given regard-ing blinding Does not appear to have beendone

Incomplete outcome data (attrition bias)All outcomes

Low risk 28 participants ldquodisenrolled due to proto-col violationsrdquo 12 from control group whowere given IPA postoperatively 6 from ex-perimental group given other anti-emeticsin PACU before IPA and 10 who lost theirIPA or promethazine following dischargeto home

25Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 28: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Cotton 2007 (Continued)

Comment probably done

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Results reported for all stated out-comes

Other bias Low risk Comment study appears to be free of othersources of bias

Kamalipour 2002

Methods Randomized controlled trial of ISO versus normal saline placebo for treatment of PONVSetting postoperative care unit acute hospital Iran

Participants 82 consecutive patients randomized into experimental and control groups No age dataor demographic except 48 female34 male

Interventions 2 sniffs of ISO (treatment) or 2 sniffs normal saline (control) (on reporting symptoms)and re-treated at 5 minutes if necessary Patients who did not respond the 2nd timereceived metoclopramide injection

Outcomes Response to treatmentcessation of symptoms recurrence of symptoms use of rescueanti-emetics

Notes Attempted to contact author Dr H Kamalipour via email however no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe patients were randomly divided intotwo groupsrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all stated out-comes

Selective reporting (reporting bias) Unclear risk Comment brief report with little detail

Other bias Unclear risk Comment unable to ascertain from detailsreported

26Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 29: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Langevin 1997

Methods Double-blinded cross-over clinical trialpilot studySetting acute hospital USA

Participants 15 consecutive patients in PACU who complained of nausea or vomiting after electivesurgery

Interventions Either 05 ml saline or 05 ml isopropyl alcohol on a cotton ball (according to randomsequence) was held under participantsrsquo noses and the participant was instructed to snifftwice If symptoms recurred the test agents were re-administered in random sequenceWhen neither test agent was effective standard anti-emetics were given and the PONVassessed every 5 minutes until participant left PACU

Outcomes Severity of PONV as assessed with VAS VAS range from 0 = none to 10 = vomitingTreatment failure attributed to the last agent given

Notes No demographic data supplied in brief report Letter sent to author Dr Paul Langevinto ask for more data no response received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquothe test agents were readministered in therandomized sequencerdquoComment no information on how this se-quence was generated

Allocation concealment (selection bias) Unclear risk Comment no information reported onwho conducted the allocation and how

Blinding (performance bias and detectionbias)All outcomes

Unclear risk ldquoWe designed a randomized double-blinded studyrdquo ldquoNurses who adminis-tered the test therapy were blinded to groupassignment by applying an ISO-soakedBand-Aid under their noses while anotherperson applied the test agent to a cottonball which was attached to a sponge stickrdquoComment participants would not havebeen blinded to the treatment due to thedistinctive odour of the isopropyl alcoholUnclear where the rsquodouble-blindingrsquo oc-curred

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol notavailable

Selective reporting (reporting bias) Low risk Comment data reported for all partici-pants no apparent losses to follow-up

27Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 30: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Langevin 1997 (Continued)

Other bias Unclear risk Comment minimal data reported in thispublication

Merritt 2002

Methods Controlled clinical trial of isopropyl alcohol inhalation for treatment of PONVSetting acute hospital USA

Participants 111 adults having surgery (40 with nausea were evaluated for study) Age range 19-80years mean age = 43 Types of surgery included intra-abdominal (297) orthopaedicextremity (234) perineal (198) neuro-skeletal (108) extra-thoracic (63) eyesearsnosethroat (63) neck (36)Of 40 patients evaluated for study 21 received IPA and 18 were controls 1 patiententered into the study had their PONV resolve spontaneouslyInclusion criteria were (a) requirements for general anaesthesia (b) ability to breathethrough nose before and after procedure (c) minimum of 18 years of age (d) AmericanSociety of Anesthesiologists (ASA) physical status of I II or III and (e) ability to readand write EnglishExclusion criteria were (a) allergy to IPA (b) alcohol abuse (c) no recent history of nauseaor vomiting within the last 8 hours (d) no recent intake of cefoperazone Antabuse ormetronidazole (e) ability to communicate in recovery room (f ) regional anaesthesiaand (g) monitored anaesthesia care

Interventions Isopropyl alcohol inhalation for treatment of PONV ldquoIf nausea or vomiting was presentin control participants an appropriate anti-emetic was given Experimental participantswere given IPA via nasal inhalation using standard hospital alcohol pads The participantwas instructed to take three deep sniffs with the pad one inch from the nose This wasrepeated every five minutes for three doses or until nausea and vomiting was relieved Ifnausea and vomiting continued after three doses of IPA then an intravenous drug wasgivenrdquo

Outcomes Severity of PONV as measured by a descriptive ordinal scale (DOS) from ldquo0 to 10 with0 being no nausea or vomiting and 10 being the worst nausea and vomiting they couldimaginerdquoCost of treatment in USD

Notes Anti-emetic prophylaxis was given to patients in both groups

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

High risk ldquoGroup assignment was alternated by dayexperimental one day and control the nextrdquoComment study is controlled clinical trial

28Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 31: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Merritt 2002 (Continued)

Allocation concealment (selection bias) Unclear risk Comment allocators and caregivers appearto have been aware of the allocation

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoParticipants were blinded to which treat-ment they were to receiverdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment original study protocol unavail-able Stated outcomes were all addressed inreport

Selective reporting (reporting bias) Unclear risk Comment no apparent loss to follow-upNo P values reported for main findings ofpre and post-test DOS though P value forcost differences reported

Other bias Unclear risk ldquoOnly 40 of the 111 participants recruitedhad PONV This is explained by aggres-sive prophylactic treatment at the study fa-cility where only 7 (63) of 111 partici-pants did not receive prophylactic medica-tion and none of these 7 participants hadPONV Additionally the researchers specu-late that pain may have been a confoundingfactor in accurate assessment on the DOSrdquoComment several possible confounders

Pellegrini 2009

Methods Randomized controlled trial comparing 70 isopropyl alcohol inhalation to promet-hazine to treat breakthrough nausea in surgical patients at high risk of PONVSetting day hospital USA

Participants 85 surgical patients scheduled for general anaesthesia of more than 60 minutesrsquo durationand having 2 of the 4 individual riskfactors for PONV (female gender nonsmoker history of PONV or motion sickness)(IPA group 42 promethazine group 43)Excluded recent upper respiratory infection documented allergy to IPA ondansetronpromethazine or metoclopramide anti-emetic or psychoactive drug use within 24 hoursinability to breathe through the nose pregnancy history of inner ear pathology andortaking disulfiram cefoperazone or metronidazole

Interventions Control group 125 to 25 mg IV promethazine for complaints of PONV in thepostanaesthesia care unit (PACU) and same-day surgery unit (SDSU) and by promet-hazine suppository self-administration following discharge to homeExperimental group administration of inhaled 70 IPA

29Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 32: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Pellegrini 2009 (Continued)

Outcomes Nausea measured by Verbal Numeric Rating Scale (VNRS) (0-10 0 = no nausea 10 =worst imaginable nausea)Incidence of nausea events in PACU SDSU or at home (number)Doses of promethazine required as rescue anti-emetic (number)Promethazine requirements in PACU SDSU or at home (mg)Time in minutes to 50 reduction of nausea scoresParticipant satisfaction

Notes All participants received anti-emetic prophylaxis prior to surgery Author J Pellegriniemailed to request numeric data for results published in graph form Data receivedOther clarifications requested and some were received

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoAll subjects were then randomly assignedusing a computer-generated random num-bers process into a control or an experimen-tal grouprdquoComment probably done

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquo (emailed author re-sponse)Comment probably done

Blinding (performance bias and detectionbias)All outcomes

Unclear risk Comment no data on blinding It appearsthat participants and assessors were awareof group allocations during study

Incomplete outcome data (attrition bias)All outcomes

Low risk ldquoA total of 96 subjects were enrolled but11 subjects were withdrawn leaving a to-tal of 85 subjects (IPA group 42 promet-hazine group 43) whose data would be in-cluded in the final analysis Reasons forwithdrawal included 4 subjects who re-ceived additional anti-emetics intraopera-tively (2 in each group) 1 subject inadver-tently enrolled despite being scheduled fora nasal surgical procedure (IPA group) and6 subjects who required postoperative inpa-tient hospitalization for reasons unrelatedto PONV (3 in each group)rdquoComment probably done

30Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 33: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Pellegrini 2009 (Continued)

Selective reporting (reporting bias) Unclear risk Comment all outcomes stated in the articlehave data reported however original studyprotocol is not available

Other bias Low risk Comment no other sources of bias appar-ent

Tate 1997

Methods Three-arm controlled clinical trial of peppermint oil inhalations peppermint essenceinhalations (placebo) and no treatment (control) to treat PONV in womenSetting acute hospital UK

Participants 18 women undergoing major gynaecological surgery Mean weight group 1 152lb group2 1395lb group 3 1442lb Mean height group 1 642in group 2 625in group 3643in Mean age group 1 54 years group 2 432 years group 3 455 years Participantswere assessed as having no significant differences in personal characteristics past medicalhistory or preoperative anxiety levels There were no statistically significant differences inpreoperative fasting times anaesthetic and recovery times or postoperative fasting timesFive of the experimental group had intra-abdominal surgery compared with three ineach of the other two groups

Interventions Participants were given bottles of their assigned substance postoperatively and instructedto inhale the vapours from the bottle whenever they felt nauseous

Outcomes Self-reported nausea as measured by VAS of 0-4 where 0 = ldquonot experiencing any nauseardquoand 4 = ldquoabout to vomitrdquo reported as the average score per person per dayCost of treatment in GBPPatient satisfaction with treatment reported narratively

Notes Participants may or may not have received standard anti-emetics in PACU AuthorSylvina Tate supplied some extra data on group allocation methods

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Unclear risk ldquoThe subjects were assigned to one of threegroupsrdquoComment author states that participantswere ldquorandomly assignedrdquo to ward areas

Allocation concealment (selection bias) Unclear risk Comment no information reported re-garding concealment

Blinding (performance bias and detectionbias)

Low risk Comment use of peppermint essence asplacebo blinded experimental and placebo

31Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 34: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Tate 1997 (Continued)

All outcomes group patients to treatment allocation

Incomplete outcome data (attrition bias)All outcomes

Unclear risk Comment no mention of patients lost tofollow-up however group numbers are notreported (Group numbers clarified by au-thor via email)

Selective reporting (reporting bias) High risk Comment trialists did not provide mea-sure of statistical significance or measuresof variance for daily average nausea scoreseven though they state rsquostatistically signif-icant difference in the amount of self-re-ported nausea between the placebo and ex-perimental groups

Other bias Unclear risk Comment due to study design entirelypossible there was some demand-charac-teristic effect on patient self-reporting ofresults However experimental group re-ceived rsquoon average slightly lessrsquo postoper-ative anti-emetics and more postoperativeopioids than placebo group which wouldtend to indicate evidence of an effect

Wang 1999

Methods Double-blind randomized controlled study of isopropyl alcohol as a treatment for PONVldquoWhen any episode of vomiting or nausea occurred patients were randomized using arandom number table to receive a cotton ball soaked with ISO or saline placed under thepatientrsquos nose by the nursing staff The patient was instructed to sniff twice by a nursewho was blind to group assignment It should be emphasized that the nursing staffs wereinstructed not to smell the content of cotton ball and to hold it away from themselveswhen administering to patientIf the severity of nausea or vomiting improved after a single treatment a VAS assess-ment of nausea was obtained every 5 minutes until the patient was discharged or PONVsymptoms recurred Improvement of nausea was defined as a decrease of at least 40in initial VAS score and improvement of vomiting was defined as no further episodesof vomiting If after treatment severity of nausea did not improve or retchingvomit-ing persisted a second treatment with the same agent was given Treatment sequenceswere repeated for a maximum of three times in a 15-minute period When severity ofeither nausea or vomiting failed to improve despite three treatments intravenous (IV)ondansetron 01 mgkg (maximum 4 mg) was administered If symptoms persisted asecond dose of ondansetron was administered For patients who failed to improved aftertwo ondansetron doses (maximum dose 8mg) other IV ant-emetic medications (ie200 mgkg of metoclopramide 10 mgkg droperidol) were givenrdquoSetting acute paediatric day surgery centre

32Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 35: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Wang 1999 (Continued)

Participants 91 children aged 6-16 years having surgery under general anaesthesia ASA physical statusI and II Of these 39 developed PONV and were enrolled into treatment or controlgroups Treament n = 20 Control n = 19 No significant differences in demographicdata across groupsExclusions children with a history of chronic illness or developmental delay

Interventions Inhalations of isopropyl alcohol or saline placebo Intervention repeated up to threetimes IV ondansetron was used as rsquorescue therapyrsquo if PONV continued

Outcomes 1 Severity of nausea and vomiting as measured by 100 mm VAS with a range of 0 = nonausea to 100 = extreme nausea2 Use of rescue anti-emetics as measured by drug and number of doses

Notes Study author Dr Shu-Ming Wang contacted for any further data however due to theage of the study there was none available

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquoIf any episode of vomiting or nausea oc-curred patients were randomized using arandom number table to receive a cottonball soaked with ISO or saline placed underthe patientrsquos nose by the nursing staffrdquoComment probably done

Allocation concealment (selection bias) Unclear risk Comment no data on who conducted theallocation and any degree of separationfrom the conduct of the study

Blinding (performance bias and detectionbias)All outcomes

Low risk ldquoThe patient was instructed to sniff twiceby a nurse who was blind to group assign-ment It should be emphasized that thenursing staffs were instructed not to smellthe content of cotton ball and to hold itaway from themselves when administeringto patientrdquoComment probably done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment data reported for all partici-pants No apparent losses to follow-up

Selective reporting (reporting bias) Unclear risk Comment original study protocol notavailable All stated outcomes reported

33Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 36: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Wang 1999 (Continued)

Other bias Low risk Comment no other sources of bias appar-ent

Winston 2003

Methods Randomized controlled trial of isopropyl alcohol for treatment of PONV Participantswere randomized to receive either isopropyl alcohol inhalations or 4mg ondansetronSetting same day surgery centre USA

Participants 100 women aged 18-65 years who were scheduled for diagnostic laparoscopy operativelaparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I II or III) ina day surgery unitExclusions inability or impaired ability to breathe through the nose or history of sensi-tivity to IPA or ondansetron had used an anti-emetic within 24 hours of surgery preg-nant or breastfeeding reported existing nausea history of significant PONV resistant toanti-emetics using disulfram or had a history of alcoholism

Interventions Comparison of inhaled 70 isopropyl alcohol to ondansetron for treatment of PONVOndansetron (control) group at first request for treatment participants in this groupreceived IV ondansetron 4mg repeated once in 15 minutes if required70 IPA (experimental) group a standard alcohol prep pad was held under the partici-pantrsquos nose and she was instructed to take 3 consecutive deep breaths through the noseNausea score collected for baseline at preop then immediately postop in PACU and at anytime the participant complained of nausea Additionally participants who complainedof nausea were assessed every 5 minutes following treatment for 30 minutes and thenevery 15 minutes until discharge from PACU

Outcomes 1 Nausea score as measured by Verbal Numeric Rating Scale (VRNS) (range 0-10 where0 = no nausea and 10 = worst imaginable nausea)2 Number of emetic events defined as episodes of nausea or vomiting more than oneminute apart3 Time to reduction of PONV in minutes4 Cost5 Patient satisfaction with anaesthesia care

Notes This study was replicated by Cotton 2007 with the number and frequency of IPAinhalations increased Author J Pellegrini provided additional data via email

Risk of bias

Bias Authorsrsquo judgement Support for judgement

Random sequence generation (selectionbias)

Low risk ldquosubjects were randomly assigned to receiveinhaled 70 IPA (experimental group) orIV ondansetron (control group) for thetreatment of PONrdquo ldquodespite the use ofblock randomizationrdquoComment author states via email that ran-

34Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 37: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Winston 2003 (Continued)

domization was conducted using a com-puter generated random numbers table

Allocation concealment (selection bias) Low risk ldquoBlock randomization was used for all ofthe studies using a computer generated ran-domization program done by an indepen-dent party (myself ) who was not involvedin the data collectionrdquoComment probably done

Blinding (performance bias and detectionbias)All outcomes

High risk ldquothis did not allow us to blind the studyinterventionrdquoComment it appears that no blinding ofparticipants or caregivers was done

Incomplete outcome data (attrition bias)All outcomes

Low risk Comment it appears that data was re-ported for all participants no evidence ofexclusions or attrition

Selective reporting (reporting bias) Unclear risk Comment original study protocol unavail-able Despite stating collection of data onpatient satisfaction with anaesthetic experi-ence no results for this were reported how-ever this data was made available by an au-thor via email

Other bias Low risk Comment no other sources of bias appar-ent

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Apariman 2006 Prevention of PONV not treatment

Apfel 2001 Not RCTCCT Not aromatherapy

Arfeen 1995 Prevention of PONV not treatment

Betz 2005 Not RCTCCT

Bone 1990 Prevention of PONV not treatment

Buckle 1999 Not RCTCCT

Chaiyakunapruk 2006 Prevention of PONV not treatment

35Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 38: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

(Continued)

Chiravalle 2005 Not RCTCCT

Chrubasik 2005 Not RCTCCT

Couture 2006 Prevention of PONV not treatment

DePradier 2006 Not RCTCCT

Eberhart 2003 Prevention of PONV not treatment

Eberhart 2006 Not RCTCCT

Ekenberg 2007 Not RCTCCT

Ernst 2000 Not RCTCCT

Fujii 2008 Not RCTCCT

Geiger 2005 Not RCTCCT

Golembiewski 2005 Not RCTCCT

Keifer 2007 Not RCTCCT

Kim 2006 Not PONV

Kim 2007 Not PONV

King 2009 Not RCTCCT

Koretz 2004 Not RCTCCT

Mamaril 2006 Not RCTCCT

Morin 2004 Not RCTCCT

Nale 2007 Prevention of PONV not treatment

Nanthakomon 2006 Prevention of PONV not treatment

Phillips 1993 Prevention of PONV not treatment

Pompeo 2007 Not RCTCCT

Pongrojpaw 2003 Prevention of PONV not treatment

Roseacuten 2006 Not RCTCCT

Spencer 2004 Not RCTCCT

36Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 39: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

(Continued)

Tavlan 2006 Prevention of PONV not treatment

Tramer 2001 Not RCTCCT

Visaylaputra 1998 Prevention of PONV not treatment

37Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 40: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

D A T A A N D A N A L Y S E S

Comparison 1 Isopropyl alcohol versus standard treatment for PONV

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

4 215 Risk Ratio (M-H Fixed 95 CI) 066 [045 098]

Comparison 2 Isopropyl alcohol versus standard treatment for PON sensitivity analysis

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 3 Isopropyl alcohol versus standard treatment for PON

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 176 Risk Ratio (M-H Fixed 95 CI) 066 [039 113]

Comparison 4 Isopropyl alcohol versus saline

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Proportion requiring rescue anti-emetics

3 135 Risk Ratio (M-H Random 95 CI) 030 [009 100]

38Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 41: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Comparison 5 Aromatherapy versus standard anti-emetics

Outcome or subgroup titleNo of

studies

No of

participants Statistical method Effect size

1 Patient satisfaction 2 172 Risk Ratio (M-H Random 95 CI) 112 [062 203]

A D D I T I O N A L T A B L E S

Table 1 Table 1 Studies measuring time to relief of nausea

Study Design InterventionControl Outcome Findings

Cotton 2007 RCT IPAondansetron Time to 50 reduction in nausea(VNRS1)

IPA mean 1500 (SD106mins)Ondansetron mean 3388 (SD 232mins)

Kamalipour 2002 RCT IPAsaline Percentage ldquoresponserdquo2 to treatmentwithin 5 minutes

IPA 78Saline 73

Langevin 1997 CCT IPAsaline Percent with complete relief of nau-sea in 5 minutes

IPA 80Saline 0

Pellegrini 2009 RCT IPAPromethazine Mean time to 50 reduction in nau-sea scores (VNRS1)

IPA (mean +- SD)PACU3 643 +- 378 minutesSDSU4 833 +- 482 minutesHOME5 1658 +- 69 minutesPromethazine (mean +- SD)PACU3 205 +- 18236 minutesSDSU4 233 +- 1886 minutesHOME5 2667 +- 125 minutes

Winston 2003 RCT IPAondansetron Mean time to 50 reduction ofVNRS1

IPA 63 minutesOndansetron277 minutes

1VRNS Verbal Numeric Rating Scale2Meaning of response not defined by study authors3PACU Postanaesthesia Care Unit4SDSU Same Day Surgery Unit5Home Participantrsquos residence post-discharge

39Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 42: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

Table 2 Table 2 Studies measuring a decrease in nausea scores

Study Design InterventionControl Outcome Findings

Merritt 2002 CCT IPAstandard anti-emetics Decrease in mean nausea score(DOS1) 0-10 (0 = no nausea 10 =worst nausea and vomiting imag-inable)

IPA Mean DOS1 score Pre-treat-ment 571 Post-treatment 27Standard treatment Pre-treat-ment 611 Post-treatment 194

Tate 1997 CCT Peppermint oilpeppermintessencestandard treatment

Mean daily nausea scores (DOS1)0-4 (0 = no nausea 4 = about tovomit)

Standard treatment mean dailynausea score = 0975Peppermint essence mean dailynausea score (placebo) 161Peppermint oil mean daily nauseascore 05

Wang 1999 RCT IPAsaline Percentage of participants withdecrease in nausea after 3 treat-ments (VAS) 0-100 (0 = no nau-sea 100 = extreme nausea)

IPA 91Saline 40

1DOS Descriptive Ordinal Scale

Table 3 Patient satisfaction

Study Design InterventionComparison Measure Satisfied

Cotton 2007 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellent Intervention3838Comparison 3434

Winston 2003 RCT IPAondansetron 4-point DOS(poor fair good excellent)

Good or excellentIntervention 3850Comparison 3050

Pellegrini 2009 RCT IPAPromethazine 5-point DOS(1 = totally unsatisfied 5 = totally

satisfied)

Both groups report median score 4

Anderson 2004 RCT IPASalinePeppermint 100mm VAS (0 mm extremely dis-satisfied 100 mm fully satisfied)

IPA 903 (SD 149)peppermint 863 (SD 323)saline 837 (SD 256)

40Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 43: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

H I S T O R Y

Protocol first published Issue 1 2009

Review first published Issue 4 2012

Date Event Description

15 March 2010 Amended Change in authorrsquos name Kristen Gibbons was previously known as Kristen Gilshenan Previouscitation read Hines S Steels E Chang A Gilshenan K

C O N T R I B U T I O N S O F A U T H O R S

Conceiving the review Sonia Hines (SH)

Designing the review SH

Co-ordinating the review SH

Undertaking manual searches SH

Screening search results SH Elizabeth Steels (ES)

Organizing retrieval of papers SH

Screening retrieved papers against inclusion criteria SH ES

Appraising quality of papers SH ES Anne Chang (AC)

Abstracting data from papers SH ES Kirsten Gibbons (KG)

Writing to authors of papers for additional information SH

Providing additional data about papers SH AC

Obtaining and screening data from unpublished studies SH ES

Data management for the review SH

Entering data into Review Manager (RevMan 51) SH KG

Analysis of data SH ES KG

Interpretation of data SH ES AC KG

Writing the review SH AC KG

Securing funding for the review SH

Performing previous work that was the foundation of the present study SH

Guarantor for the review (one author) SH

Statistical analysis KG AC

41Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Page 44: Aromatherapy for treatment of postoperative nausea and ...eprints.qut.edu.au/54475/4/54475b.pdf · [Intervention Review] Aromatherapy for treatment of postoperative nausea and vomiting

D E C L A R A T I O N S O F I N T E R E S T

Sonia Hines Queensland Health Nursing and Midwifery Research Grant received by Sonia Hines to assist with the conduct of thereview (AUD 5906) The granting body had no influence on the findings of this review

All other authors no conflict of interest is known

S O U R C E S O F S U P P O R T

Internal sources

bull Nursing Research Centre Mater Health Services AustraliaTime and facilities

External sources

bull Queensland Health AustraliaNursing and Midwifery Research Grant ($5906) awarded to Sonia Hines

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

The original protocol stated ldquoWe will judge the study quality using a validated critical appraisal checklist developed by the JoannaBriggs Institute and based on the work of The Cochrane Collaboration and the Centre for Reviews and Dissemination (Figure 2) Thischecklist assesses selection allocation treatment and attrition biasesrdquo Due to changes in the Cochrane requirements we have used theCochrane risk of bias assessment instead

We had originally planned to search the website httpwwwnhmrcgovaunicsaspindexasp however this no longer exists and httpwwwnhmrcgovaunicsindexhtm was searched instead

I N D E X T E R M S

Medical Subject Headings (MeSH)

2-Propanol [lowastadministration amp dosage] Administration Inhalation Antiemetics [lowastadministration amp dosage] Aromatherapy[lowastmethods] Controlled Clinical Trials as Topic Plant Oils [lowastadministration amp dosage] Postoperative Nausea and Vomiting [lowasttherapy]Salvage Therapy [methods]

MeSH check words

Humans

42Aromatherapy for treatment of postoperative nausea and vomiting (Review)

Copyright copy 2012 The Cochrane Collaboration Published by John Wiley amp Sons Ltd