Acupuncture for Benign Prostatic Hyperplasia

Acupuncture for benign prostatic hyperplasia (Protocol)

Zhang W, Weina P, Liu Z, Wu T

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane

Library 2009, Issue 2

http://www.thecochranelibrary.com

Acupuncture for benign prostatic hyperplasia (Protocol)

Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iAcupuncture for benign prostatic hyperplasia (Protocol)


[Intervention Protocol]

Acupuncture for benign prostatic hyperplasia

Wei Zhang1, Peng Weina2, Zhishun Liu1, Taixiang Wu3

1Department of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine, Beijing, China. 2Acupuncture,

Guanganmen Hospital, Beijing, China. 3Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University,

Chengdu, China

Contact address: Wei Zhang, Department of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine,

Guang AnMenHopital, No.5 Bei Xian Ge Street, Beijing, Xuanwu District, 100053, China. [email protected]. (Editorial

group: Cochrane Prostatic Diseases and Urologic Cancers Group.)

Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)


DOI: 10.1002/14651858.CD006016

This version first published online: 19 April 2006 in Issue 2, 2006. (Help document - Dates and Statuses explained)

This record should be cited as: Zhang W, Weina P, Liu Z, Wu T. Acupuncture for benign prostatic hyperplasia. Cochrane Database

of Systematic Reviews 2006, Issue 2. Art. No.: CD006016. DOI: 10.1002/14651858.CD006016.

A B S T R A C T

This is the protocol for a review and there is no abstract. The objectives are as follows:

Our objective is to conduct a systematic review, and if possible, a quantitative meta-analysis, with evidence available from randomized

controlled trials to assess the efficacy and safety of acupuncture therapy for BPH.

1Acupuncture for benign prostatic hyperplasia (Protocol)


B A C K G R O U N D

Benign prostatic hyperplasia (BPH) is a nonmalignant enlarge-

ment of the prostate commonly encountered among aged men.

Histological investigations have shown that more than 40% of

men in their fifties and nearly 90% of men in their eighties suffer

from BPH (Berry 1984). Lower urinary tract symptoms (LUTS)

associated with BPH include obstructive symptoms (weak uri-

nary stream, hesitancy, intermittency, incomplete bladder empty-

ing, terminal urine dribbling, abdominal straining), and irritative

symptoms (urinary frequency, urgency and nocturia) (Christensen

1990, Caine 1987). In the United States treatment of BPH ac-

counts for approximately 1.7million physician-office visits (Guess

1992) and results in more than 300,000 prostatectomies annually

(McConnell 1994). In China, prostate specimens from 321 de-

ceased were collected from 1989 to 1992. The frequency of BPH

was 13.2% among those 41 to 50 years old and increased until

it reached 83.3% among those 81 to 90 years old. The histologic

frequency of BPH in China was similar to that in Western coun-

tries (Gu 1994).

Treatment of BPH includes minimally invasive therapy (MIT),

surgery and medical therapy.

Acupuncture is a very important part of Traditional Chinese

Medicine (TCM). It has a literary history of more than 2000

years. Acupuncture is a therapy that inserts needles into certain

points, called Xue Wei, of the human body. Many centuries

ago acupuncture developed into a discipline, with its own theory

and practice. It is believed in TCM theory that acupuncture can

strengthen the human bodys vital essence, called Qi, and can

remove the blockage of channels. Acupuncture is also helpful with

a wide range of other diseases.

In China, BPH has been treated with acupuncture, and the pro-

cedures efficacy has been tested by some research. In an animal

model it has been reported that acupuncture can neutralize patho-

logical changes in low levels of nitric oxide synthase (NOS), as

well as impaired kidney function, as manifested by high blood

urea nitrogen (BUN) and serum creatinine (Cr) (Xu 2002). Cur-

rently, researchers outside China are treating LUTS with acupunc-

ture. Using the International Prostate Symptom Score, a random-

ized controlled trial (RCT) has assessed the effects of acupunc-

ture on LUTS, as well as prostate specific antigen (PSA). It found

that acupuncture to the kidney-bladder meridian relieves neither

LUTS nor affects PSA (Johnstone 2003).

To date, the clinical application of acupuncture for BPH and its

reporting has been anecdotal, and its effects has not been system-

atically reviewed.

O B J E C T I V E S

Our objective is to conduct a systematic review, and if possible, a

quantitative meta-analysis, with evidence available from random-

ized controlled trials to assess the efficacy and safety of acupunc-

ture therapy for BPH.

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomized controlled clinical trials

Types of participants

Men with symptomatic benign prostatic hyperplasia

Types of interventions

Acupuncture therapy with needle insertion, including body , au-

ricular , scalp, as well as electroacupuncture, will be considered.

Also includedwill be acupuncture combinedwith other treatments

or medications, such as herbals. Excluded will be any stimulation

other than a needle, such as acupressure, seed stimulation or sur-

face electrodes (TENS).

The control interventions will include: no intervention, placebo

acupuncture, sham acupuncture, pharmacological treatments

(herbal medicine or conventional medicine, such as 5-alpha re-

ductase inhibitors and alpha blockers), or any other interventions.

Placebo acupuncture refers to a needle attached to the skin surface

(not penetrating the skin but at the same acupoints) (van Tulder

2000).

Sham acupuncture refers to:

(1) a needle placed in an area close to but not in an acupuncture

point (van Tulder 2000);

(2) subliminal skin electrostimulation via electrodes attached to

the skin (SCSSS 1999).

Types of outcome measures

The primary outcomemeasures will be change in urological symp-

toms as measured by validated urologic symptom scores, includ-

ing Boyarsky, the American Urologic Association Symptom Score,

and the International Prostate Symptom Score (IPSS).

Secondary outcome measures will include:

1. Quality of life score (QOL);

2. Adverse events, such as intolerable pain during acupuncture,

bleeding during or after the session, breaking or winding of the

needle, injury to organs (e.g., pneumothorax), and fainting. The

number and severity of adverse events should be recorded;

3. Urodynamic measures, which are defined as change in peak

urine flow (measured in mL/sec), mean urine flow (measured in

mL/sec), residual urine volume (measured in mL), nocturia (mea-

sured in times per evening), and changes in prostate size (measured

in cc).

Search methods for identification of studies



See the Cochrane Prostatic Diseases and Urologic Cancers Group

search strategy.

Electronic searches

We will search the following electronic databases irrespective of

language and publication status:

1. The Trials Registers of the Cochrane Prostatic Diseases and

Urologic Cancers Group;

2. The Cochrane Central Register of Controlled Trials (CEN-

TRAL) on The Cochrane Library (Issue 4, 2004);

3. MEDLINE (1966-2004);

4. EMBASE (1998-2004);

5. Chinese Biomedical Database (1979-2004).

A highly sensitive search strategy will be used for identifying ran-

domized controlled trials, and will be provided for reviewers. We

will use MEDLINE on the Ovid web site to locate these trials.

Below is a further search strategy for MEDLINE:

#30 benign prostatic hyperplasia or bph/

#31 lower urinary tract symptoms or luts/

#32 or/30-31

#33 acupuncture/

#34 acupuncture points/

#35 (electroacupuncture or electroacupuncture).tw.

#36 electroacupuncture.tw.

#37 acupuncture$.tw.

#38 acupoints.tw.

#39 meridians/

#40 or /33-39

#41 29 and 32 and 40

The reference lists of all identified papers will be searched for fur-

ther information. Wewill contact authors for unpublished studies.

Data collection and analysis

Eligibility:

Two reviewers, Zhang and Peng, will independently decide on

eligibility.

Data extraction

A data extraction form will be developed and study data will be

assessed and extracted independently by two reviewers, Zhang and

Peng. The following data will be extracted from each included

study: patients demographic characteristics, including maximum,

minimum and mean age; inclusion and exclusion criteria; and

type, frequency and treatment course of acupuncture therapy and

outcomes. Type, severity and number of adverse effects, as well as

number and reasons for dropouts, withdrawals, and lost of follow-

up will also be recorded. Information not available in the trials will

be sought from authors by e-mail or telephone. Extracted data will

be reviewed by the principal reviewer (Zhang) and discrepancies

will be judged by the arbitrator, Liu.

QUALITY ASSESSMENT

Quality assessment will be carried out by two independent review-

ers (Zhang and Peng), and will be made according to the empirical

evidence (Schulz 1995, Jadad 1996, Juni 2001, Kjaergard 2001).

We intend to assess the methodological quality as described by

Kjaergard et al. (Kjaergard 2001) and the Cochrane Reviewers

Handbook 4.2.2.

A third party (Liu) will resolve disagreements.

Data analyses

Analyses will be implemented with the Cochrane Collaboration

Review Manager (RevMan 4.3) software. All the primary and sec-

ondary outcome measures will be combined and analyzed for ev-

idence of homogeneity (P>0.1) using a fixed-effects model. Di-

chotomous results will be expressed as relative risk (RR) and ra-

tio of risk of the treatment group versus the control group, with

95%confidence intervals (CI). For continuous variables, weighted

mean differences (WMD)--the difference between treatment and

control pooled means at endpoint--along with their 95% confi-

dence intervals, will be calculated. A random-effects model will be

used in case heterogeneity exists.

Sensitivity Analyses

We will implement a sensitivity analyses in order to explore the

influence of the following factors on effect size:

Exclude unpublished studies (if there are any);

Analyze study quality;

Exclude any trials with long study duration or are too

large to establish how much they dominate the results;

Exclude trials using the following filters: diagnostic cri-

teria, language of publication and race.

Subgroup Analyses

Here we will compare the effects between subgroups by

different acupuncture types

other comparisons

location.

Publication Bias

Potential biases will be investigated using the funnel plot .We will

use linear regression to measure funnel plot asymmetry on the

logarithmic scale of relative risk (RR).



R E F E R E N C E S

Additional references

AUA 2003

American Urological Association, Inc. The management of benign

prostatic hyperplasia.. American Urological Association, Inc 2003.

Berry 1984

Berry SL, Coffey, DS, Walsh PC, Ewing LL. The development of

human benign prostatic hyperplasia with age.. J Urol 1984;132:

4749.

Caine 1987

Caine M, Schuger L. The capsule in benign prostatic hypertrophy..

NIH Publication No. 87-2881 1987.

Christensen 1990

Christensen MM, Bruskewitz RC. Clinical manifestations of benign

prostatic hyperplasia and the indications for therapeutic interven-

tion.. Urol Clin North Am 1990;17:50916.

Gu 1994

Gu FL, Xia TL, Kong XT. Preliminary study of the frequency of

benign prostatic hyperplasia and prostatic cancer in China.. Urology.

1994;44(5):68891.

Guess 1992

Guess HA. Benign prostatic hyperplasia antecedents and natural his-

tory.. Epidemiol Rev 1992;14:13153.

Jadad 1996

Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gav-

aghan DJ, et al.Assessing the quality of reports of randomized clini-

cal trials: is blinding necessary?. Controlled Clinical Trials 1996;17:

112.

Johnstone 2003

Johnstone, P. A. Bloom, T. L, Niemtzow, R. C, Crain, D, Riffen-

burgh, R. H, Amling. C. L. A prospective, randomized pilot trial of

acupuncture of the kidney-bladder distinct meridian for lower uri-

nary tract symptoms.. Journal of Urology. 2003;169(3):10379.

Juni 2001

Juni Peter, Altman DG, Egger M. Assessing the quality of controlled

clinical trials. BMJ 2001;323(7303):426.

Kjaergard 2001

Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality

and discrepancies between large and small randomized trials in meta-

analyses. Annals of Internal Medicine 2001;135(11):9829.

McConnell 1994

McConnell JD, Barry MJ, Bruskewitz RC. Benign prostatic hyper-

plasia: Diagnosis and treatment.. Clinical Practice Guideline. No.

8, AHCPR Publication No. 94-0582 Edition. Rockville, MD:

Agency for Health Care Policy and Research, Public Health Service,

US Department of Health and Human Services 1994.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of

bias: dimensions of methodological quality associated with estimates

of treatment effects in controlled trials. AMA 1995;273:40812.

SCSSS 1999

Swedish Collaberation on Sensory Stimulation in Stroke. Sensory

stimulation after stroke: a randomized controlled trial.. Cerebrovasc

Dis 1999;9(suppl 1):28.

van Tulder 2000

vanTulderMW,CherkinDC, BermanB, Lao L, Koes BW. Acupunc-

ture for low back pain.. Cochrane Library, 2000, Issue 4.

Xu 2002

Xu JF, YangZG.Howacupuncture influence theNOS activity and re-

nal function of mice with prostatic hyperplasia.. Shang Hai acupunc-

ture Journal 2002;21(6):3637. Indicates the major publication for the study

WH A T S N E W

8 November 2008 Amended Converted to new review format.

H I S T O R Y

Protocol first published: Issue 2, 2006



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

Zhang Wei designed and wrote the protocol. Zhang will take part in the whole procedure, including data extraction, contacting with

editors, statistical analysis, quality assessment, and completing the SR. Wu Taixiang gave support and guidance on methodology and

the protocol. Liu Zhishun reviewed and commented on the protocol. Liu worked as arbitrator. PengWeina and Zhang Wei will extract

data and assess quality.

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

None known.

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

Internal sources

Department of Acupuncture and Moxibustion,Guang An Men Hospital,Chinese Academy of TCM, China.

External sources

Chinese Cochrane Center,Chinese Centre of Evidence-based Medicine,West China Hospital of Sichuan University, China.



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Acupuncture for Benign Prostatic Hyperplasia