9
Hindawi Publishing Corporation Evidence-Based Complementary and Alternative Medicine Volume 2013, Article ID 309831, 8 pages http://dx.doi.org/10.1155/2013/309831 Research Article Integrative TCM Conservative Therapy for Low Back Pain due to Lumbar Disc Herniation: A Randomized Controlled Clinical Trial Wei An Yuan, 1 Shi Rong Huang, 1 Kai Guo, 1 Wu Quan Sun, 2 Xiao Bing Xi, 3 Ming Cai Zhang, 1 Ling Jun Kong, 2 Hua Lu, 1 Hong Sheng Zhan, 1 and Ying Wu Cheng 2 1 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China 2 Yueyang Integrative Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China 3 Ruijin Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200025, China Correspondence should be addressed to Hong Sheng Zhan; [email protected] and Ying Wu Cheng; [email protected] Received 10 April 2013; Revised 22 May 2013; Accepted 7 June 2013 Academic Editor: Wolfgang Weidenhammer Copyright © 2013 Wei An Yuan et al. is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Low back pain due to lumbar disc herniation (LDH) is very common in clinic. is randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3 : 1. e primary outcome was the pain by the visual analogue scale (VAS). e secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately aſter treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, 16.62 points, < 0.001 in VAS; 15.55 points, < 0.001 in C-SFODI). e difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (7.68 points, < 0.001). No serious adverse events were observed. ese findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH. 1. Introduction Lumbar disc herniation (LDH) is a common disease and a major contributing factor of low back pain [1, 2]. Although many studies have confirmed that surgery is more effective for LDH [35], conservative therapies have also been recognized for their therapeutic efficacy [3, 4]. Considering the fact that 20% of patients still have pain aſter surgery [6], 7% to 15% of surgical patients may have failed back surgery syndrome [7], and some patients are scared of surgery, conservative treatment is still one of the primary means for LDH. In China, TCM is one of the main conservative treatments for LDH. Previous studies have confirmed that some TCM therapies have certain effects on low back pain due to LDH. ese include acupuncture [8, 9], oral administration of Chinese medicine [10], external application of Chinese medicine [11], Chinese Tuina (massage) [12], and TCM- characteristic functional exercise [13]. Clinically, these ther- apeutic methods are not used alone but oſten in combination [12]. Recently, the clinical pathway of treating LDH with integrative TCM therapy has attracted attention [14]. e Shi’s Traumatology Medical Center of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine is well recognized for its long-term commitment to the research on conservative treatment for LDH, coupled with a package protocol for LDH. However, high-quality research evidence is needed to support the effectiveness of the protocol.

Research Article Integrative TCM Conservative …downloads.hindawi.com/journals/ecam/2013/309831.pdflower back pain without any relief or even aggravated, the prescription of pain

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Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2013 Article ID 309831 8 pageshttpdxdoiorg1011552013309831

Research ArticleIntegrative TCM Conservative Therapy for Low Back Paindue to Lumbar Disc Herniation A Randomized ControlledClinical Trial

Wei An Yuan1 Shi Rong Huang1 Kai Guo1 Wu Quan Sun2 Xiao Bing Xi3

Ming Cai Zhang1 Ling Jun Kong2 Hua Lu1 Hong Sheng Zhan1 and Ying Wu Cheng2

1 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineShanghai 201203 China

2 Yueyang Integrative Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University ofTraditional Chinese Medicine Shanghai 200437 China

3 Ruijin Hospital Affiliated to Shanghai Jiaotong University Shanghai 200025 China

Correspondence should be addressed to Hong Sheng Zhan 13774269261163com and Ying Wu Cheng ywching126com

Received 10 April 2013 Revised 22 May 2013 Accepted 7 June 2013

Academic Editor Wolfgang Weidenhammer

Copyright copy 2013 Wei An Yuan et al This is an open access article distributed under the Creative Commons Attribution Licensewhich permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited

Low back pain due to lumbar disc herniation (LDH) is very common in clinic This randomized controlled trial was designed toinvestigate the effects of integrative TCM conservative therapy for low back pain due to LDH A total of 408 patients with low backpain due to LDHwere randomly assigned to an experimental group with integrative TCM therapy and a control group with normalconservative treatment by the ratio of 3 1 The primary outcome was the pain by the visual analogue scale (VAS) The secondaryoutcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI) Immediately aftertreatment patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with thecontrol group (between-group difference in mean change from baseline minus1662 points 119875 lt 0001 in VAS minus1555 points 119875 lt0001 in C-SFODI) The difference remained at one-month followup but it is only significant in C-SFODI at six-month followup(minus768 points 119875 lt 0001) No serious adverse events were observed These findings suggest that integrative TCM therapy may be abeneficial complementary and alternative therapy for patients with low back pain due to LDH

1 Introduction

Lumbar disc herniation (LDH) is a common disease and amajor contributing factor of low back pain [1 2] Althoughmany studies have confirmed that surgery ismore effective forLDH [3ndash5] conservative therapies have also been recognizedfor their therapeutic efficacy [3 4] Considering the fact that20 of patients still have pain after surgery [6] 7 to 15of surgical patients may have failed back surgery syndrome[7] and some patients are scared of surgery conservativetreatment is still one of the primary means for LDH

InChina TCM is one of themain conservative treatmentsfor LDH Previous studies have confirmed that some TCMtherapies have certain effects on low back pain due to

LDH These include acupuncture [8 9] oral administrationof Chinese medicine [10] external application of Chinesemedicine [11] Chinese Tuina (massage) [12] and TCM-characteristic functional exercise [13] Clinically these ther-apeutic methods are not used alone but often in combination[12] Recently the clinical pathway of treating LDH withintegrative TCM therapy has attracted attention [14] TheShirsquos Traumatology Medical Center of Shuguang HospitalAffiliated to Shanghai University of Traditional ChineseMedicine is well recognized for its long-term commitmentto the research on conservative treatment for LDH coupledwith a package protocol for LDH However high-qualityresearch evidence is needed to support the effectiveness of theprotocol

2 Evidence-Based Complementary and Alternative Medicine

This clinical trial aims to study the efficacy and safetyof integrative TCM therapy for LDH and thus confirm itsclinical effect

2 Materials and Methods

21 Design We conducted a multicenter randomized con-trolled trial to evaluate the effectiveness of integrative TCMconservative treatment for patients with low back pain dueto LDH Patients were randomly assigned to an experimentalgroup and a control group by the ratio of 3 1 using computer-generated numbers The randomized treatment assignmentswere sealed in opaque envelopes and opened individuallyfor each patient who agreed to be in the study The nursewho had no role in the design and conduct of the studyprepared the envelopes Patients in the experimental groupwere treated with integrative TCM therapy once a dayfor two weeks whereas patients in the control group weretreated with a two-week normal conservative interventionAt baseline immediately after treatment one and six monthsafter treatment visual analogue scale (VAS) and the ChineseShort Form Oswestry Disability Index (C-SFODI) were usedas outcome assessment This trial is registered in ChineseClinical Trial Registry (No ChiCTR-TRC-11001343)

22 Subjects Patients were recruited from Shuguang Hospi-tal Affiliated to Shanghai University of Traditional ChineseMedicine Ruijin Hospital Affiliated to Shanghai JiaotongUniversity and Yueyang Integrative Traditional Chinese andWestern Medicine Hospital Affiliated to Shanghai Universityof Traditional Chinese Medicine between January 2011 andAugust 2012

Inclusion criteria (1) aging 20ndash60 years (2) having lowback pain due to LDH (MRI scan confirmed lumbar diskherniation) and ruling out other relevant ongoing pathologiessuch as fractures lumbar spondylolisthesis tumor osteo-porosis or infection (3) willing to participate in this studyand signing the informed consent

Exclusion criteria (1) having other pain syndromes (2)experiencing a history of spinal surgery (3) having neurolog-ical disease (4) having psychiatric disease (5) having seriouschronic diseases that could interfere with the outcomes(eg cardiovascular disease rheumatoid arthritis epilepsyor other disqualifying conditions) (6) scared of acupuncture(7) pregnant or planning to become pregnant during thestudy (8) having other diseases that the researchers believeis not suitable for the study

23 Treatment

231 Experimental Group Patients in the experimentalgroup receive a two-week integrative TCM treatment Theywere further divided into three subgroups (according to theduration from initial low back pain to getting treatment)for different treatment methods acute stage (0ndash14 days)subacute stage (15ndash30 days) and chronic stage (gt30 days)

Acute stage (1) Electroacupuncture + (2) Chinese herbalinjection (Salvia miltiorrhiza injection) + (3) external plaster

(Compound Redbud Injury-healing Cataplasms) Subacutestag (1) Chinese Tuina (massage) + (2) hot compress usingChinese medicine + (3) external plaster (Compound RedbudInjury-healing Cataplasms) Chronic stage (1) TCM func-tional exercise + (2) external plaster (Compound RedbudInjury-healing Cataplasms)

Treatment Parameters

Electroacupuncture Points bilateral Dachangshu (BL 25) andBaihuanshu (BL 30)

Method Insert the needles (the sterile disposable nee-dles 03times75mmmanufactured by SuzhouMedical SuppliesFactory Co Ltd) 25 to 28 cun UponDeQi (needling sensa-tion) connect the needles with the electroacupuncture device(Model G6805-II manufactured by Guangzhou KangMaiMedical Devices Co Ltd) using a continuous wave anelectrical stimulation pulse wave of approximately 06ms anda frequency of 20Hz The treatment was conducted onceevery day 30min for each treatment

External Plaster Compound Redbud Injury-healing Cata-plasms (Approval no Z19991106 manufactured by ShanghaiLEYrsquos Pharmaceutical Co Ltd)

Main ingredients Zi Jing Pi (Cortex Cercis Chinensis)Huang Jing Zi (Negundo Chastetree Fruit) Da Huang (Radixet Rhizoma Rhei) Chuan Xiong (Rhizoma Chuanxiong) TianNan Xing (Rhizoma Arisaematis) and Ma Qian Zi (SemenStrychni)

Functions Circulates blood resolves stasis eliminatesswelling and alleviates pain

Method Apply the cataplasms to the most painful areaone plaster each time once a day

Chinese Herbal Injection Salvia miltiorrhiza injection(Approval no Z51021303 manufactured by Sichuan ShengHePharmaceutical Co Ltd)

The main ingredient of the injection is Salvia root PE Itacts to circulate blood and resolve stasis

Method Intravenous dripping of 20mL salvia miltior-rhiza injection and 250 mL 5 glucose once a day

Hot Compress Using Chinese Medicine Ingredients 20 g ofCang Zhu (Rhizoma Atractylodis) Qin Jiao (Radix Gen-tianae Macrophyllae) Sang Zhi (Ramulus Mori) Mu Gua(Fructus Chaenomelis) Hong Hua (Flos Carthami) ChuanXiong (Rhizoma Chuanxiong) Hai Feng Teng (Caulis PiperisKadsurae) and Lei Gong Teng (Radix Tripterygii Wilfordii)respectively All herbs were provided by Shanghai HongqiaoPharmaceutical Co Ltd and have been tested and qualified

Method Place the previous medicinal into a gauze bagdecoct with water for 20mins and take it out After thetemperature cooled to 40sim45∘C apply the back to the affectedlow back area for 30ndash40 minutes once a day The hotcompress can help circulate blood and resolve stasis

TCM Functional Exercise The exercise is known as ldquoFei YanShirdquo (literally meaning ldquothe flying swallow stylerdquo) in Chinese

Evidence-Based Complementary and Alternative Medicine 3

Method Ask the patient to take a prone position extendboth hands backwards lift the chest and lower limbs off thebed using the abdomen as a pivot and then relax Conductthis exercise once a day and repeat 4-5 times each time

Functions Strengthens the power of back musclesincreases the stability of the spine and thus prevents relapses

Chinese Tuina (Massage) Ask the patient to take a proneposition and find the tenderness spots on the low back Thenapply gun-rolling (10min) Anrou-pressing and kneading(10min) and Tanbo-plucking (5min) manipulation to thetenderness spots and surrounding areas Conclude withoblique pulling manipulation of the low back Conduct thetreatment once a day

Functions Relaxes spasm of the low back muscles andadjusts lumbar subluxation

After one week TCM treatment if the patientrsquos lower backpain without any relief or even aggravated the prescription ofpainmedication was adjusted according to clinical guidelines[15] detailed records the type and dose of pain medicationtaken by patients and the patient was identified as no effect

232 Control Group Patients in the control group receivea two-week normal conservative treatment [3] Interventionmeasures include three sections (1) health education Thepatients were invited to receive LDH health education twicea week in outpatient the health education was designedexclusively to inform patients about the natural course oftheir illness and the expectation of successful recovery irre-spective of the initial intensity of their pain educate patientsto avoid some bad habits that aggravate the disease such as asitting position for a long time and carrying heavy loads andencourage patients to participate in social activities (2) Restin addition to the normal sleep the patients need to rest inbed for at least 1-2 hours a day (3) Painmedication or physicaltherapy after one week health education if the patientrsquoslower back pain without any relief or even aggravated theprescription of pain medication was adjusted according toclinical guidelines [15] detailed records the type and dose ofpain medication taken by patients And if the patients do notwant to take pain medication then the patients were referredto a physiotherapist

24 Measurements All outcomes were assessed by observersunaware of the grouping at baseline (M1) immediatelyafter the last intervention (M2) The followup included theassessments at one month (M3) and six months (M4) afterthe last intervention

The primary outcome measure was the change in pain bythe visual analogue scale (VAS) scores range 0 to 100 and ahigher score indicates a greater pain 0 means no pain and100 means intolerable pain

The secondary outcome measure was the change in theChinese Short Form Oswestry Disability Index (C-SFODI)range 0 to 100 The C-SFODI consists of nine questionswhich come from Oswestry Disability Index (ODI) omit thesex life question in Section 8 because this question is always

unacceptable by Chinese The C-SFODI calculation formulais actual cumulative score45times 100 with higher percentageindicating more severe functional disability And the studyhas shown that the C-SFODI has good reliability and validity[16]

25 Statistical Analysis Our pretrial power calculation indi-cated that 81 patients in experimental group were requiredto detect a difference in pain relief based on the preliminaryexperiment data at a significant level of 5 (a two-sided t-test) with 80 power In anticipation of a 20 attrition ratewe sought 102 patients at least in experimental group Takinginto account the poor effect of control therapy 102 patientswere included in the control group

Between-group difference at baseline was analyzed usingindependent-samples t-test or Chi-square test Changes incontinuous measures were analyzed by analysis of variance(ANOVA) Effects were evaluated on an intention-to-treatbasis (ITT) and participants who did not complete thefollowup period were considered not having any changes inscores A two-sided119875 value of less than 005 indicated statisti-cal significance Results are presented as mean and standarddeviation (SD) at M1 and as between-group difference with95 confidence intervals (CI) at M2 M3 and M4

26 Quality Control Before the beginning of the study allresearchers have to receive protocol training A clinicresearch coordinator (CRC) was employed to assistresearchers in each center A monitor was also appointed toensure the quality of the research

3 Results

Between January 2011 and August 2012 a total of 480 patientswith low back pain due to LDH were recruited 72 wererejected due to exclusion criterions and 408 eligible patientswere randomly assigned in accordance with the ratio of 3 1to the experimental group and the control group 306 in theexperimental group and 102 in the control group Patients inthe experimental group all completed a two-week treatmentIn the control group at the second week one patient in thecontrol group was unwilling to continue to participate andwithdrew his informed consent and two patients took Fenbid(500mg for each dose 2 doses a day) since the pain worsenedduring treatment (Figure 1)

31 Baseline Characteristics of the Patients Table 1 showsthe baseline data for the 408 participants The mean age ofall patients is 45 years and 51 were women In terms ofdisease staging experimental group and control group werecomparable And the baseline outcome including VAS scoresand C-SFODI were also reasonably well balanced betweenexperimental group and control group

32 Improvement in the Primary Outcome The changes inthe primary outcomes from baseline to six-month followupare shown in Table 2 and Figure 2 Immediately after theintervention two groups showed significant decrease in VAS

4 Evidence-Based Complementary and Alternative Medicine

Recruited 480 patients with low back pain due to LDH

72 were rejected due to exclusion criterions

408 were included and underwent randomization

305 completed the evaluation in1-month followup

297 completed the evaluation in6-month followup

101 completed the evaluation in1-month followup

99 completed the evaluation in6-month followup

1 was lost to followup

6 were lost to followup2 were out of Shanghai 2 were lost to followup

306 were assigned to experimental group 102 were assigned to control

306 completed all interventions 101 completed all interventions

1 patient withdrewinformed consent

Figure 1 Screening randomization and completion evaluations from the baseline to six-month followup LDH = lumbar disc herniation

0

10

20

30

40

50

60

M1 M2 M3 M4

VAS

scor

es

Experimental groupControl group

(a)

Experimental groupControl group

0

10

20

30

40

50

60

M1 M2 M3 M4

C-SF

OD

I (

)

(b)

Figure 2 Mean changes of the primary and secondary outcomes The means of outcomes are shown for the experimental group (diamond)and the control group (squares) Measurements were obtained at baseline (M1) immediately after the last intervention (M2) The followupincluded the assessments at one month (M3) and six months (M4) after the last intervention Visual analogue scale (VAS scores rang 0 to100) with higher scores indicating greater pain The Chinese Short Form Oswestry Disability Index (C-SFODI range 0 to 100) consists of 9questions with higher percentage indicating more severe functional disability

Evidence-Based Complementary and Alternative Medicine 5

Table 1 Baseline characteristics of the study participantslowast

Variable Experimental group (119873 = 306) Control group (119873 = 102)Sex no of patients ()

Male () 147 (480) 53 (520)Female () 159 (520) 49 (480)

Age (years) 4591 plusmn 1073 4358 plusmn 1210Stage of the diseasesect no of patients ()

Acute stage (0sim14 days) 109 (356) 38 (373)Subacute stage (15sim30 days) 101 (330) 32 (314)Chronic stage (gt30 days) 96 (314) 32 (314)

Segments of lumbar disc herniationamp no of patients ()One segment (L3L4 or L4L5 or L5S1) 61 (199) 19 (186)Two segments (L3L4 and L4L5 or L4L5 and L5S1) 196 (641) 67 (657)Three segments (L3L4 and L4L5 and L5S1) 49 (160) 16 (157)

VAS scores (0sim100) 5394 plusmn 1960 5600 plusmn 1961C-SFODIdagger (0sim100) 4607 plusmn 2056 4959 plusmn 2253lowastPlus-minus values are means plusmn SD unless otherwise notedsectStage of the disease is divided according to duration of the low back pain symptoms first appeared of this time acute stage (0sim14 days) subacute stage (15sim30days) and chronic stage (gt30 days)Visual analogue scale (VAS range 0 to 100) with higher scores indicating greater painampBased on imaging examination to determine the segments of lumbar disc herniation L3L4 means disc herniation between the third and fourth lumbar andthe others are the samedaggerTheChinese Short FormOswestryDisability Index (C-SFODI range 0 to 100) consists of 9 questions A higher percentage indicates amore severe functionaldisability

than the baseline And the experimental group showed amore significant decrease than the control group (minus1662points [95 confidence interval CI minus2025 to minus1298] 119875 lt0001)

One month after intervention two groups also hadsignificantly greater reduction in VAS than the baseline Andagain the experimental group showed a more significantdecrease than the control group (minus637 points [95CIminus1020to minus254] 119875 = 0001)

Six months after intervention compared with the base-line the changes in VAS remained significant in the experi-mental group and control group but between-group differ-ence was not significant (119875 = 0091)

33 Improvement in the Secondary Outcome Immediatelyafter intervention two groups had significant improvementin C-SFODI than the baseline and the experimental groupshowed a more significant improvement than the controlgroup (minus1555 points [95 CI minus1892 to minus1218] 119875 lt 0001)

One month after intervention two groups also hadsignificant improvement in C-SFODI than the baseline Andagain the experimental group improved more (minus1137 points[95 CI minus1462 to minus811] 119875 lt 0001)

Six months after intervention two groups also main-tained significant improvement and the experimental groupshowed superiority (minus768 points [95 CI minus1142 to minus394]119875 lt 0001)

34 Adverse Events One patient in the experiment group hadmild fainting during acupuncture remission by bed rest andthen completed the remaining treatment Two patients in the

control group were given Fenbid orally due to aggravatedlow back pain No other adverse events were noted in eitherexperimental group or control group

4 Discussion

Although the mechanism of low back pain caused by lumbardisc herniation (LDH) is still not very clear the prevailingview is that low back pain due to LDHwas found to occur notonly in response to mechanical stimuli but also to chemicalirritation around the nerve root sheath and sinuvertebralnerve [17]

Different TCM therapies have different advantages in thetreatment of LDH Pain is the main symptom in the acutestage of LDH acupuncture has good analgesic effect on lowback pain due to LDH [8] Lumbar dysfunction is the mainsymptom in the remission stage Chinese massage has goodeffect on improving dysfunction [12] Oral Chinese herbalformulae [10] external use of Chinese medicine [11] andChinese herbal injection [18] also showed good effect inrelieving pain and improving dysfunction caused by LDHAnd one study also found that Salvia miltiorrhiza injectionespecially works better and faster for the acute stage whencompared with mannitol [19] Although the mechanism ofacupuncture Chinesemassage and traditional Chinese herbsin the treatment of LDH remains unclear it is generallyagreed that these treatment methods play a role by increasinglocal blood circulation relieving nerve root edema andspeeding up the metabolism of the local inflammatory medi-ators In recovery stage of the disease the major task is tostrengthen the muscles of the waist and abdomen to preventrelapse [20] and TCM functional exercise has advantages in

6 Evidence-Based Complementary and Alternative Medicine

Table2Ch

angesinprim

aryandsecond

aryou

tcom

eslowast

Varia

ble

Outcomes

ofdifferent

timepoints(meansplusmnSD

)998787Meanchange

from

baselin

e(95CI

)Be

tween-grou

pdifference(95CI

)119875valuesect

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

versus

controlgroup

VASscores

n

M1

5394plusmn1960

5600plusmn1961

mdashmdash

mdash0358

M2

2448plusmn1773

4316plusmn2075

minus2946(minus3152

tominus2740)

minus1284(minus1558tominus98

3)minus1662(minus2025tominus1298)

lt0001

M3

740plusmn652

1583plusmn1161

minus46

54(minus4850tominus44

57)minus40

17(minus4326tominus3707)

minus637

(minus1020tominus254)

0001

M4

232plusmn229

794plusmn676

minus5162(minus5373tominus4951)minus4806(minus5145tominus44

67)

minus356

(minus76

9to

057)

0091

C-SFODIdagger

M1

4607plusmn2056

4959plusmn2253

mdashmdash

mdash0145

M2

2020plusmn1379

3926plusmn2284

minus2588(minus2770tominus2405)

minus1033

(minus1317

tominus74

8)minus1555(minus1892tominus1218

)lt0001

M3

669plusmn598

2157plusmn1535

minus3938(minus4133

tominus3744)minus2802(minus3064tominus2539

)minus1137

(minus1462tominus811)

lt0001

M4

216plusmn201

1336plusmn1064

minus4391(minus46

07tominus4175)minus3623(minus3930tominus3316

)minus76

8(minus1142tominus394)

lt0001

lowast

Valuesarem

eans

with

meansplusmnSD

orthe9

5confi

dence(CI

)M1measurementswereo

btainedatbaselin

eM2im

mediatelyaft

erthelastinterventionM3on

emon

thaft

erthelastinterventionM4six

mon

ths

after

thelastintervention

998787

TheV

ASscores

means

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-sub

jectse

ffectstestsof

different

timepointsm

eans119865=1381914119875lt0001

Between-subjectseffectstests

ofdifferent

grou

pmeans119865=46322119875lt0001Th

eC-SFO

DIm

eans

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-

subjectseffectstests

ofdifferent

timepointsm

eans119865=1076327119875lt0001B

etween-subjectseffectstests

ofdifferent

grou

pmeans119865=78879119875lt0001

sect 119875values

werec

alculated

with

independ

ent-s

amples119905-te

stform

eanchange

from

baselin

ebetweentwogrou

ps

nVisualanalogue

scale(VA

Sscores

range0

to100)

with

high

erscores

indicatin

ggreaterp

ain

dagger

TheC

hinese

ShortF

orm

Osw

estryDisa

bilityIndex(C

-SFO

DIrange0

to100

)con

sistsof

9qu

estio

nsw

ithhigh

erpercentage

indicatin

gmores

everefun

ctionald

isability

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

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Disease Markers

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Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

2 Evidence-Based Complementary and Alternative Medicine

This clinical trial aims to study the efficacy and safetyof integrative TCM therapy for LDH and thus confirm itsclinical effect

2 Materials and Methods

21 Design We conducted a multicenter randomized con-trolled trial to evaluate the effectiveness of integrative TCMconservative treatment for patients with low back pain dueto LDH Patients were randomly assigned to an experimentalgroup and a control group by the ratio of 3 1 using computer-generated numbers The randomized treatment assignmentswere sealed in opaque envelopes and opened individuallyfor each patient who agreed to be in the study The nursewho had no role in the design and conduct of the studyprepared the envelopes Patients in the experimental groupwere treated with integrative TCM therapy once a dayfor two weeks whereas patients in the control group weretreated with a two-week normal conservative interventionAt baseline immediately after treatment one and six monthsafter treatment visual analogue scale (VAS) and the ChineseShort Form Oswestry Disability Index (C-SFODI) were usedas outcome assessment This trial is registered in ChineseClinical Trial Registry (No ChiCTR-TRC-11001343)

22 Subjects Patients were recruited from Shuguang Hospi-tal Affiliated to Shanghai University of Traditional ChineseMedicine Ruijin Hospital Affiliated to Shanghai JiaotongUniversity and Yueyang Integrative Traditional Chinese andWestern Medicine Hospital Affiliated to Shanghai Universityof Traditional Chinese Medicine between January 2011 andAugust 2012

Inclusion criteria (1) aging 20ndash60 years (2) having lowback pain due to LDH (MRI scan confirmed lumbar diskherniation) and ruling out other relevant ongoing pathologiessuch as fractures lumbar spondylolisthesis tumor osteo-porosis or infection (3) willing to participate in this studyand signing the informed consent

Exclusion criteria (1) having other pain syndromes (2)experiencing a history of spinal surgery (3) having neurolog-ical disease (4) having psychiatric disease (5) having seriouschronic diseases that could interfere with the outcomes(eg cardiovascular disease rheumatoid arthritis epilepsyor other disqualifying conditions) (6) scared of acupuncture(7) pregnant or planning to become pregnant during thestudy (8) having other diseases that the researchers believeis not suitable for the study

23 Treatment

231 Experimental Group Patients in the experimentalgroup receive a two-week integrative TCM treatment Theywere further divided into three subgroups (according to theduration from initial low back pain to getting treatment)for different treatment methods acute stage (0ndash14 days)subacute stage (15ndash30 days) and chronic stage (gt30 days)

Acute stage (1) Electroacupuncture + (2) Chinese herbalinjection (Salvia miltiorrhiza injection) + (3) external plaster

(Compound Redbud Injury-healing Cataplasms) Subacutestag (1) Chinese Tuina (massage) + (2) hot compress usingChinese medicine + (3) external plaster (Compound RedbudInjury-healing Cataplasms) Chronic stage (1) TCM func-tional exercise + (2) external plaster (Compound RedbudInjury-healing Cataplasms)

Treatment Parameters

Electroacupuncture Points bilateral Dachangshu (BL 25) andBaihuanshu (BL 30)

Method Insert the needles (the sterile disposable nee-dles 03times75mmmanufactured by SuzhouMedical SuppliesFactory Co Ltd) 25 to 28 cun UponDeQi (needling sensa-tion) connect the needles with the electroacupuncture device(Model G6805-II manufactured by Guangzhou KangMaiMedical Devices Co Ltd) using a continuous wave anelectrical stimulation pulse wave of approximately 06ms anda frequency of 20Hz The treatment was conducted onceevery day 30min for each treatment

External Plaster Compound Redbud Injury-healing Cata-plasms (Approval no Z19991106 manufactured by ShanghaiLEYrsquos Pharmaceutical Co Ltd)

Main ingredients Zi Jing Pi (Cortex Cercis Chinensis)Huang Jing Zi (Negundo Chastetree Fruit) Da Huang (Radixet Rhizoma Rhei) Chuan Xiong (Rhizoma Chuanxiong) TianNan Xing (Rhizoma Arisaematis) and Ma Qian Zi (SemenStrychni)

Functions Circulates blood resolves stasis eliminatesswelling and alleviates pain

Method Apply the cataplasms to the most painful areaone plaster each time once a day

Chinese Herbal Injection Salvia miltiorrhiza injection(Approval no Z51021303 manufactured by Sichuan ShengHePharmaceutical Co Ltd)

The main ingredient of the injection is Salvia root PE Itacts to circulate blood and resolve stasis

Method Intravenous dripping of 20mL salvia miltior-rhiza injection and 250 mL 5 glucose once a day

Hot Compress Using Chinese Medicine Ingredients 20 g ofCang Zhu (Rhizoma Atractylodis) Qin Jiao (Radix Gen-tianae Macrophyllae) Sang Zhi (Ramulus Mori) Mu Gua(Fructus Chaenomelis) Hong Hua (Flos Carthami) ChuanXiong (Rhizoma Chuanxiong) Hai Feng Teng (Caulis PiperisKadsurae) and Lei Gong Teng (Radix Tripterygii Wilfordii)respectively All herbs were provided by Shanghai HongqiaoPharmaceutical Co Ltd and have been tested and qualified

Method Place the previous medicinal into a gauze bagdecoct with water for 20mins and take it out After thetemperature cooled to 40sim45∘C apply the back to the affectedlow back area for 30ndash40 minutes once a day The hotcompress can help circulate blood and resolve stasis

TCM Functional Exercise The exercise is known as ldquoFei YanShirdquo (literally meaning ldquothe flying swallow stylerdquo) in Chinese

Evidence-Based Complementary and Alternative Medicine 3

Method Ask the patient to take a prone position extendboth hands backwards lift the chest and lower limbs off thebed using the abdomen as a pivot and then relax Conductthis exercise once a day and repeat 4-5 times each time

Functions Strengthens the power of back musclesincreases the stability of the spine and thus prevents relapses

Chinese Tuina (Massage) Ask the patient to take a proneposition and find the tenderness spots on the low back Thenapply gun-rolling (10min) Anrou-pressing and kneading(10min) and Tanbo-plucking (5min) manipulation to thetenderness spots and surrounding areas Conclude withoblique pulling manipulation of the low back Conduct thetreatment once a day

Functions Relaxes spasm of the low back muscles andadjusts lumbar subluxation

After one week TCM treatment if the patientrsquos lower backpain without any relief or even aggravated the prescription ofpainmedication was adjusted according to clinical guidelines[15] detailed records the type and dose of pain medicationtaken by patients and the patient was identified as no effect

232 Control Group Patients in the control group receivea two-week normal conservative treatment [3] Interventionmeasures include three sections (1) health education Thepatients were invited to receive LDH health education twicea week in outpatient the health education was designedexclusively to inform patients about the natural course oftheir illness and the expectation of successful recovery irre-spective of the initial intensity of their pain educate patientsto avoid some bad habits that aggravate the disease such as asitting position for a long time and carrying heavy loads andencourage patients to participate in social activities (2) Restin addition to the normal sleep the patients need to rest inbed for at least 1-2 hours a day (3) Painmedication or physicaltherapy after one week health education if the patientrsquoslower back pain without any relief or even aggravated theprescription of pain medication was adjusted according toclinical guidelines [15] detailed records the type and dose ofpain medication taken by patients And if the patients do notwant to take pain medication then the patients were referredto a physiotherapist

24 Measurements All outcomes were assessed by observersunaware of the grouping at baseline (M1) immediatelyafter the last intervention (M2) The followup included theassessments at one month (M3) and six months (M4) afterthe last intervention

The primary outcome measure was the change in pain bythe visual analogue scale (VAS) scores range 0 to 100 and ahigher score indicates a greater pain 0 means no pain and100 means intolerable pain

The secondary outcome measure was the change in theChinese Short Form Oswestry Disability Index (C-SFODI)range 0 to 100 The C-SFODI consists of nine questionswhich come from Oswestry Disability Index (ODI) omit thesex life question in Section 8 because this question is always

unacceptable by Chinese The C-SFODI calculation formulais actual cumulative score45times 100 with higher percentageindicating more severe functional disability And the studyhas shown that the C-SFODI has good reliability and validity[16]

25 Statistical Analysis Our pretrial power calculation indi-cated that 81 patients in experimental group were requiredto detect a difference in pain relief based on the preliminaryexperiment data at a significant level of 5 (a two-sided t-test) with 80 power In anticipation of a 20 attrition ratewe sought 102 patients at least in experimental group Takinginto account the poor effect of control therapy 102 patientswere included in the control group

Between-group difference at baseline was analyzed usingindependent-samples t-test or Chi-square test Changes incontinuous measures were analyzed by analysis of variance(ANOVA) Effects were evaluated on an intention-to-treatbasis (ITT) and participants who did not complete thefollowup period were considered not having any changes inscores A two-sided119875 value of less than 005 indicated statisti-cal significance Results are presented as mean and standarddeviation (SD) at M1 and as between-group difference with95 confidence intervals (CI) at M2 M3 and M4

26 Quality Control Before the beginning of the study allresearchers have to receive protocol training A clinicresearch coordinator (CRC) was employed to assistresearchers in each center A monitor was also appointed toensure the quality of the research

3 Results

Between January 2011 and August 2012 a total of 480 patientswith low back pain due to LDH were recruited 72 wererejected due to exclusion criterions and 408 eligible patientswere randomly assigned in accordance with the ratio of 3 1to the experimental group and the control group 306 in theexperimental group and 102 in the control group Patients inthe experimental group all completed a two-week treatmentIn the control group at the second week one patient in thecontrol group was unwilling to continue to participate andwithdrew his informed consent and two patients took Fenbid(500mg for each dose 2 doses a day) since the pain worsenedduring treatment (Figure 1)

31 Baseline Characteristics of the Patients Table 1 showsthe baseline data for the 408 participants The mean age ofall patients is 45 years and 51 were women In terms ofdisease staging experimental group and control group werecomparable And the baseline outcome including VAS scoresand C-SFODI were also reasonably well balanced betweenexperimental group and control group

32 Improvement in the Primary Outcome The changes inthe primary outcomes from baseline to six-month followupare shown in Table 2 and Figure 2 Immediately after theintervention two groups showed significant decrease in VAS

4 Evidence-Based Complementary and Alternative Medicine

Recruited 480 patients with low back pain due to LDH

72 were rejected due to exclusion criterions

408 were included and underwent randomization

305 completed the evaluation in1-month followup

297 completed the evaluation in6-month followup

101 completed the evaluation in1-month followup

99 completed the evaluation in6-month followup

1 was lost to followup

6 were lost to followup2 were out of Shanghai 2 were lost to followup

306 were assigned to experimental group 102 were assigned to control

306 completed all interventions 101 completed all interventions

1 patient withdrewinformed consent

Figure 1 Screening randomization and completion evaluations from the baseline to six-month followup LDH = lumbar disc herniation

0

10

20

30

40

50

60

M1 M2 M3 M4

VAS

scor

es

Experimental groupControl group

(a)

Experimental groupControl group

0

10

20

30

40

50

60

M1 M2 M3 M4

C-SF

OD

I (

)

(b)

Figure 2 Mean changes of the primary and secondary outcomes The means of outcomes are shown for the experimental group (diamond)and the control group (squares) Measurements were obtained at baseline (M1) immediately after the last intervention (M2) The followupincluded the assessments at one month (M3) and six months (M4) after the last intervention Visual analogue scale (VAS scores rang 0 to100) with higher scores indicating greater pain The Chinese Short Form Oswestry Disability Index (C-SFODI range 0 to 100) consists of 9questions with higher percentage indicating more severe functional disability

Evidence-Based Complementary and Alternative Medicine 5

Table 1 Baseline characteristics of the study participantslowast

Variable Experimental group (119873 = 306) Control group (119873 = 102)Sex no of patients ()

Male () 147 (480) 53 (520)Female () 159 (520) 49 (480)

Age (years) 4591 plusmn 1073 4358 plusmn 1210Stage of the diseasesect no of patients ()

Acute stage (0sim14 days) 109 (356) 38 (373)Subacute stage (15sim30 days) 101 (330) 32 (314)Chronic stage (gt30 days) 96 (314) 32 (314)

Segments of lumbar disc herniationamp no of patients ()One segment (L3L4 or L4L5 or L5S1) 61 (199) 19 (186)Two segments (L3L4 and L4L5 or L4L5 and L5S1) 196 (641) 67 (657)Three segments (L3L4 and L4L5 and L5S1) 49 (160) 16 (157)

VAS scores (0sim100) 5394 plusmn 1960 5600 plusmn 1961C-SFODIdagger (0sim100) 4607 plusmn 2056 4959 plusmn 2253lowastPlus-minus values are means plusmn SD unless otherwise notedsectStage of the disease is divided according to duration of the low back pain symptoms first appeared of this time acute stage (0sim14 days) subacute stage (15sim30days) and chronic stage (gt30 days)Visual analogue scale (VAS range 0 to 100) with higher scores indicating greater painampBased on imaging examination to determine the segments of lumbar disc herniation L3L4 means disc herniation between the third and fourth lumbar andthe others are the samedaggerTheChinese Short FormOswestryDisability Index (C-SFODI range 0 to 100) consists of 9 questions A higher percentage indicates amore severe functionaldisability

than the baseline And the experimental group showed amore significant decrease than the control group (minus1662points [95 confidence interval CI minus2025 to minus1298] 119875 lt0001)

One month after intervention two groups also hadsignificantly greater reduction in VAS than the baseline Andagain the experimental group showed a more significantdecrease than the control group (minus637 points [95CIminus1020to minus254] 119875 = 0001)

Six months after intervention compared with the base-line the changes in VAS remained significant in the experi-mental group and control group but between-group differ-ence was not significant (119875 = 0091)

33 Improvement in the Secondary Outcome Immediatelyafter intervention two groups had significant improvementin C-SFODI than the baseline and the experimental groupshowed a more significant improvement than the controlgroup (minus1555 points [95 CI minus1892 to minus1218] 119875 lt 0001)

One month after intervention two groups also hadsignificant improvement in C-SFODI than the baseline Andagain the experimental group improved more (minus1137 points[95 CI minus1462 to minus811] 119875 lt 0001)

Six months after intervention two groups also main-tained significant improvement and the experimental groupshowed superiority (minus768 points [95 CI minus1142 to minus394]119875 lt 0001)

34 Adverse Events One patient in the experiment group hadmild fainting during acupuncture remission by bed rest andthen completed the remaining treatment Two patients in the

control group were given Fenbid orally due to aggravatedlow back pain No other adverse events were noted in eitherexperimental group or control group

4 Discussion

Although the mechanism of low back pain caused by lumbardisc herniation (LDH) is still not very clear the prevailingview is that low back pain due to LDHwas found to occur notonly in response to mechanical stimuli but also to chemicalirritation around the nerve root sheath and sinuvertebralnerve [17]

Different TCM therapies have different advantages in thetreatment of LDH Pain is the main symptom in the acutestage of LDH acupuncture has good analgesic effect on lowback pain due to LDH [8] Lumbar dysfunction is the mainsymptom in the remission stage Chinese massage has goodeffect on improving dysfunction [12] Oral Chinese herbalformulae [10] external use of Chinese medicine [11] andChinese herbal injection [18] also showed good effect inrelieving pain and improving dysfunction caused by LDHAnd one study also found that Salvia miltiorrhiza injectionespecially works better and faster for the acute stage whencompared with mannitol [19] Although the mechanism ofacupuncture Chinesemassage and traditional Chinese herbsin the treatment of LDH remains unclear it is generallyagreed that these treatment methods play a role by increasinglocal blood circulation relieving nerve root edema andspeeding up the metabolism of the local inflammatory medi-ators In recovery stage of the disease the major task is tostrengthen the muscles of the waist and abdomen to preventrelapse [20] and TCM functional exercise has advantages in

6 Evidence-Based Complementary and Alternative Medicine

Table2Ch

angesinprim

aryandsecond

aryou

tcom

eslowast

Varia

ble

Outcomes

ofdifferent

timepoints(meansplusmnSD

)998787Meanchange

from

baselin

e(95CI

)Be

tween-grou

pdifference(95CI

)119875valuesect

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

versus

controlgroup

VASscores

n

M1

5394plusmn1960

5600plusmn1961

mdashmdash

mdash0358

M2

2448plusmn1773

4316plusmn2075

minus2946(minus3152

tominus2740)

minus1284(minus1558tominus98

3)minus1662(minus2025tominus1298)

lt0001

M3

740plusmn652

1583plusmn1161

minus46

54(minus4850tominus44

57)minus40

17(minus4326tominus3707)

minus637

(minus1020tominus254)

0001

M4

232plusmn229

794plusmn676

minus5162(minus5373tominus4951)minus4806(minus5145tominus44

67)

minus356

(minus76

9to

057)

0091

C-SFODIdagger

M1

4607plusmn2056

4959plusmn2253

mdashmdash

mdash0145

M2

2020plusmn1379

3926plusmn2284

minus2588(minus2770tominus2405)

minus1033

(minus1317

tominus74

8)minus1555(minus1892tominus1218

)lt0001

M3

669plusmn598

2157plusmn1535

minus3938(minus4133

tominus3744)minus2802(minus3064tominus2539

)minus1137

(minus1462tominus811)

lt0001

M4

216plusmn201

1336plusmn1064

minus4391(minus46

07tominus4175)minus3623(minus3930tominus3316

)minus76

8(minus1142tominus394)

lt0001

lowast

Valuesarem

eans

with

meansplusmnSD

orthe9

5confi

dence(CI

)M1measurementswereo

btainedatbaselin

eM2im

mediatelyaft

erthelastinterventionM3on

emon

thaft

erthelastinterventionM4six

mon

ths

after

thelastintervention

998787

TheV

ASscores

means

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-sub

jectse

ffectstestsof

different

timepointsm

eans119865=1381914119875lt0001

Between-subjectseffectstests

ofdifferent

grou

pmeans119865=46322119875lt0001Th

eC-SFO

DIm

eans

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-

subjectseffectstests

ofdifferent

timepointsm

eans119865=1076327119875lt0001B

etween-subjectseffectstests

ofdifferent

grou

pmeans119865=78879119875lt0001

sect 119875values

werec

alculated

with

independ

ent-s

amples119905-te

stform

eanchange

from

baselin

ebetweentwogrou

ps

nVisualanalogue

scale(VA

Sscores

range0

to100)

with

high

erscores

indicatin

ggreaterp

ain

dagger

TheC

hinese

ShortF

orm

Osw

estryDisa

bilityIndex(C

-SFO

DIrange0

to100

)con

sistsof

9qu

estio

nsw

ithhigh

erpercentage

indicatin

gmores

everefun

ctionald

isability

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

Evidence-Based Complementary and Alternative Medicine 3

Method Ask the patient to take a prone position extendboth hands backwards lift the chest and lower limbs off thebed using the abdomen as a pivot and then relax Conductthis exercise once a day and repeat 4-5 times each time

Functions Strengthens the power of back musclesincreases the stability of the spine and thus prevents relapses

Chinese Tuina (Massage) Ask the patient to take a proneposition and find the tenderness spots on the low back Thenapply gun-rolling (10min) Anrou-pressing and kneading(10min) and Tanbo-plucking (5min) manipulation to thetenderness spots and surrounding areas Conclude withoblique pulling manipulation of the low back Conduct thetreatment once a day

Functions Relaxes spasm of the low back muscles andadjusts lumbar subluxation

After one week TCM treatment if the patientrsquos lower backpain without any relief or even aggravated the prescription ofpainmedication was adjusted according to clinical guidelines[15] detailed records the type and dose of pain medicationtaken by patients and the patient was identified as no effect

232 Control Group Patients in the control group receivea two-week normal conservative treatment [3] Interventionmeasures include three sections (1) health education Thepatients were invited to receive LDH health education twicea week in outpatient the health education was designedexclusively to inform patients about the natural course oftheir illness and the expectation of successful recovery irre-spective of the initial intensity of their pain educate patientsto avoid some bad habits that aggravate the disease such as asitting position for a long time and carrying heavy loads andencourage patients to participate in social activities (2) Restin addition to the normal sleep the patients need to rest inbed for at least 1-2 hours a day (3) Painmedication or physicaltherapy after one week health education if the patientrsquoslower back pain without any relief or even aggravated theprescription of pain medication was adjusted according toclinical guidelines [15] detailed records the type and dose ofpain medication taken by patients And if the patients do notwant to take pain medication then the patients were referredto a physiotherapist

24 Measurements All outcomes were assessed by observersunaware of the grouping at baseline (M1) immediatelyafter the last intervention (M2) The followup included theassessments at one month (M3) and six months (M4) afterthe last intervention

The primary outcome measure was the change in pain bythe visual analogue scale (VAS) scores range 0 to 100 and ahigher score indicates a greater pain 0 means no pain and100 means intolerable pain

The secondary outcome measure was the change in theChinese Short Form Oswestry Disability Index (C-SFODI)range 0 to 100 The C-SFODI consists of nine questionswhich come from Oswestry Disability Index (ODI) omit thesex life question in Section 8 because this question is always

unacceptable by Chinese The C-SFODI calculation formulais actual cumulative score45times 100 with higher percentageindicating more severe functional disability And the studyhas shown that the C-SFODI has good reliability and validity[16]

25 Statistical Analysis Our pretrial power calculation indi-cated that 81 patients in experimental group were requiredto detect a difference in pain relief based on the preliminaryexperiment data at a significant level of 5 (a two-sided t-test) with 80 power In anticipation of a 20 attrition ratewe sought 102 patients at least in experimental group Takinginto account the poor effect of control therapy 102 patientswere included in the control group

Between-group difference at baseline was analyzed usingindependent-samples t-test or Chi-square test Changes incontinuous measures were analyzed by analysis of variance(ANOVA) Effects were evaluated on an intention-to-treatbasis (ITT) and participants who did not complete thefollowup period were considered not having any changes inscores A two-sided119875 value of less than 005 indicated statisti-cal significance Results are presented as mean and standarddeviation (SD) at M1 and as between-group difference with95 confidence intervals (CI) at M2 M3 and M4

26 Quality Control Before the beginning of the study allresearchers have to receive protocol training A clinicresearch coordinator (CRC) was employed to assistresearchers in each center A monitor was also appointed toensure the quality of the research

3 Results

Between January 2011 and August 2012 a total of 480 patientswith low back pain due to LDH were recruited 72 wererejected due to exclusion criterions and 408 eligible patientswere randomly assigned in accordance with the ratio of 3 1to the experimental group and the control group 306 in theexperimental group and 102 in the control group Patients inthe experimental group all completed a two-week treatmentIn the control group at the second week one patient in thecontrol group was unwilling to continue to participate andwithdrew his informed consent and two patients took Fenbid(500mg for each dose 2 doses a day) since the pain worsenedduring treatment (Figure 1)

31 Baseline Characteristics of the Patients Table 1 showsthe baseline data for the 408 participants The mean age ofall patients is 45 years and 51 were women In terms ofdisease staging experimental group and control group werecomparable And the baseline outcome including VAS scoresand C-SFODI were also reasonably well balanced betweenexperimental group and control group

32 Improvement in the Primary Outcome The changes inthe primary outcomes from baseline to six-month followupare shown in Table 2 and Figure 2 Immediately after theintervention two groups showed significant decrease in VAS

4 Evidence-Based Complementary and Alternative Medicine

Recruited 480 patients with low back pain due to LDH

72 were rejected due to exclusion criterions

408 were included and underwent randomization

305 completed the evaluation in1-month followup

297 completed the evaluation in6-month followup

101 completed the evaluation in1-month followup

99 completed the evaluation in6-month followup

1 was lost to followup

6 were lost to followup2 were out of Shanghai 2 were lost to followup

306 were assigned to experimental group 102 were assigned to control

306 completed all interventions 101 completed all interventions

1 patient withdrewinformed consent

Figure 1 Screening randomization and completion evaluations from the baseline to six-month followup LDH = lumbar disc herniation

0

10

20

30

40

50

60

M1 M2 M3 M4

VAS

scor

es

Experimental groupControl group

(a)

Experimental groupControl group

0

10

20

30

40

50

60

M1 M2 M3 M4

C-SF

OD

I (

)

(b)

Figure 2 Mean changes of the primary and secondary outcomes The means of outcomes are shown for the experimental group (diamond)and the control group (squares) Measurements were obtained at baseline (M1) immediately after the last intervention (M2) The followupincluded the assessments at one month (M3) and six months (M4) after the last intervention Visual analogue scale (VAS scores rang 0 to100) with higher scores indicating greater pain The Chinese Short Form Oswestry Disability Index (C-SFODI range 0 to 100) consists of 9questions with higher percentage indicating more severe functional disability

Evidence-Based Complementary and Alternative Medicine 5

Table 1 Baseline characteristics of the study participantslowast

Variable Experimental group (119873 = 306) Control group (119873 = 102)Sex no of patients ()

Male () 147 (480) 53 (520)Female () 159 (520) 49 (480)

Age (years) 4591 plusmn 1073 4358 plusmn 1210Stage of the diseasesect no of patients ()

Acute stage (0sim14 days) 109 (356) 38 (373)Subacute stage (15sim30 days) 101 (330) 32 (314)Chronic stage (gt30 days) 96 (314) 32 (314)

Segments of lumbar disc herniationamp no of patients ()One segment (L3L4 or L4L5 or L5S1) 61 (199) 19 (186)Two segments (L3L4 and L4L5 or L4L5 and L5S1) 196 (641) 67 (657)Three segments (L3L4 and L4L5 and L5S1) 49 (160) 16 (157)

VAS scores (0sim100) 5394 plusmn 1960 5600 plusmn 1961C-SFODIdagger (0sim100) 4607 plusmn 2056 4959 plusmn 2253lowastPlus-minus values are means plusmn SD unless otherwise notedsectStage of the disease is divided according to duration of the low back pain symptoms first appeared of this time acute stage (0sim14 days) subacute stage (15sim30days) and chronic stage (gt30 days)Visual analogue scale (VAS range 0 to 100) with higher scores indicating greater painampBased on imaging examination to determine the segments of lumbar disc herniation L3L4 means disc herniation between the third and fourth lumbar andthe others are the samedaggerTheChinese Short FormOswestryDisability Index (C-SFODI range 0 to 100) consists of 9 questions A higher percentage indicates amore severe functionaldisability

than the baseline And the experimental group showed amore significant decrease than the control group (minus1662points [95 confidence interval CI minus2025 to minus1298] 119875 lt0001)

One month after intervention two groups also hadsignificantly greater reduction in VAS than the baseline Andagain the experimental group showed a more significantdecrease than the control group (minus637 points [95CIminus1020to minus254] 119875 = 0001)

Six months after intervention compared with the base-line the changes in VAS remained significant in the experi-mental group and control group but between-group differ-ence was not significant (119875 = 0091)

33 Improvement in the Secondary Outcome Immediatelyafter intervention two groups had significant improvementin C-SFODI than the baseline and the experimental groupshowed a more significant improvement than the controlgroup (minus1555 points [95 CI minus1892 to minus1218] 119875 lt 0001)

One month after intervention two groups also hadsignificant improvement in C-SFODI than the baseline Andagain the experimental group improved more (minus1137 points[95 CI minus1462 to minus811] 119875 lt 0001)

Six months after intervention two groups also main-tained significant improvement and the experimental groupshowed superiority (minus768 points [95 CI minus1142 to minus394]119875 lt 0001)

34 Adverse Events One patient in the experiment group hadmild fainting during acupuncture remission by bed rest andthen completed the remaining treatment Two patients in the

control group were given Fenbid orally due to aggravatedlow back pain No other adverse events were noted in eitherexperimental group or control group

4 Discussion

Although the mechanism of low back pain caused by lumbardisc herniation (LDH) is still not very clear the prevailingview is that low back pain due to LDHwas found to occur notonly in response to mechanical stimuli but also to chemicalirritation around the nerve root sheath and sinuvertebralnerve [17]

Different TCM therapies have different advantages in thetreatment of LDH Pain is the main symptom in the acutestage of LDH acupuncture has good analgesic effect on lowback pain due to LDH [8] Lumbar dysfunction is the mainsymptom in the remission stage Chinese massage has goodeffect on improving dysfunction [12] Oral Chinese herbalformulae [10] external use of Chinese medicine [11] andChinese herbal injection [18] also showed good effect inrelieving pain and improving dysfunction caused by LDHAnd one study also found that Salvia miltiorrhiza injectionespecially works better and faster for the acute stage whencompared with mannitol [19] Although the mechanism ofacupuncture Chinesemassage and traditional Chinese herbsin the treatment of LDH remains unclear it is generallyagreed that these treatment methods play a role by increasinglocal blood circulation relieving nerve root edema andspeeding up the metabolism of the local inflammatory medi-ators In recovery stage of the disease the major task is tostrengthen the muscles of the waist and abdomen to preventrelapse [20] and TCM functional exercise has advantages in

6 Evidence-Based Complementary and Alternative Medicine

Table2Ch

angesinprim

aryandsecond

aryou

tcom

eslowast

Varia

ble

Outcomes

ofdifferent

timepoints(meansplusmnSD

)998787Meanchange

from

baselin

e(95CI

)Be

tween-grou

pdifference(95CI

)119875valuesect

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

versus

controlgroup

VASscores

n

M1

5394plusmn1960

5600plusmn1961

mdashmdash

mdash0358

M2

2448plusmn1773

4316plusmn2075

minus2946(minus3152

tominus2740)

minus1284(minus1558tominus98

3)minus1662(minus2025tominus1298)

lt0001

M3

740plusmn652

1583plusmn1161

minus46

54(minus4850tominus44

57)minus40

17(minus4326tominus3707)

minus637

(minus1020tominus254)

0001

M4

232plusmn229

794plusmn676

minus5162(minus5373tominus4951)minus4806(minus5145tominus44

67)

minus356

(minus76

9to

057)

0091

C-SFODIdagger

M1

4607plusmn2056

4959plusmn2253

mdashmdash

mdash0145

M2

2020plusmn1379

3926plusmn2284

minus2588(minus2770tominus2405)

minus1033

(minus1317

tominus74

8)minus1555(minus1892tominus1218

)lt0001

M3

669plusmn598

2157plusmn1535

minus3938(minus4133

tominus3744)minus2802(minus3064tominus2539

)minus1137

(minus1462tominus811)

lt0001

M4

216plusmn201

1336plusmn1064

minus4391(minus46

07tominus4175)minus3623(minus3930tominus3316

)minus76

8(minus1142tominus394)

lt0001

lowast

Valuesarem

eans

with

meansplusmnSD

orthe9

5confi

dence(CI

)M1measurementswereo

btainedatbaselin

eM2im

mediatelyaft

erthelastinterventionM3on

emon

thaft

erthelastinterventionM4six

mon

ths

after

thelastintervention

998787

TheV

ASscores

means

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-sub

jectse

ffectstestsof

different

timepointsm

eans119865=1381914119875lt0001

Between-subjectseffectstests

ofdifferent

grou

pmeans119865=46322119875lt0001Th

eC-SFO

DIm

eans

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-

subjectseffectstests

ofdifferent

timepointsm

eans119865=1076327119875lt0001B

etween-subjectseffectstests

ofdifferent

grou

pmeans119865=78879119875lt0001

sect 119875values

werec

alculated

with

independ

ent-s

amples119905-te

stform

eanchange

from

baselin

ebetweentwogrou

ps

nVisualanalogue

scale(VA

Sscores

range0

to100)

with

high

erscores

indicatin

ggreaterp

ain

dagger

TheC

hinese

ShortF

orm

Osw

estryDisa

bilityIndex(C

-SFO

DIrange0

to100

)con

sistsof

9qu

estio

nsw

ithhigh

erpercentage

indicatin

gmores

everefun

ctionald

isability

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

4 Evidence-Based Complementary and Alternative Medicine

Recruited 480 patients with low back pain due to LDH

72 were rejected due to exclusion criterions

408 were included and underwent randomization

305 completed the evaluation in1-month followup

297 completed the evaluation in6-month followup

101 completed the evaluation in1-month followup

99 completed the evaluation in6-month followup

1 was lost to followup

6 were lost to followup2 were out of Shanghai 2 were lost to followup

306 were assigned to experimental group 102 were assigned to control

306 completed all interventions 101 completed all interventions

1 patient withdrewinformed consent

Figure 1 Screening randomization and completion evaluations from the baseline to six-month followup LDH = lumbar disc herniation

0

10

20

30

40

50

60

M1 M2 M3 M4

VAS

scor

es

Experimental groupControl group

(a)

Experimental groupControl group

0

10

20

30

40

50

60

M1 M2 M3 M4

C-SF

OD

I (

)

(b)

Figure 2 Mean changes of the primary and secondary outcomes The means of outcomes are shown for the experimental group (diamond)and the control group (squares) Measurements were obtained at baseline (M1) immediately after the last intervention (M2) The followupincluded the assessments at one month (M3) and six months (M4) after the last intervention Visual analogue scale (VAS scores rang 0 to100) with higher scores indicating greater pain The Chinese Short Form Oswestry Disability Index (C-SFODI range 0 to 100) consists of 9questions with higher percentage indicating more severe functional disability

Evidence-Based Complementary and Alternative Medicine 5

Table 1 Baseline characteristics of the study participantslowast

Variable Experimental group (119873 = 306) Control group (119873 = 102)Sex no of patients ()

Male () 147 (480) 53 (520)Female () 159 (520) 49 (480)

Age (years) 4591 plusmn 1073 4358 plusmn 1210Stage of the diseasesect no of patients ()

Acute stage (0sim14 days) 109 (356) 38 (373)Subacute stage (15sim30 days) 101 (330) 32 (314)Chronic stage (gt30 days) 96 (314) 32 (314)

Segments of lumbar disc herniationamp no of patients ()One segment (L3L4 or L4L5 or L5S1) 61 (199) 19 (186)Two segments (L3L4 and L4L5 or L4L5 and L5S1) 196 (641) 67 (657)Three segments (L3L4 and L4L5 and L5S1) 49 (160) 16 (157)

VAS scores (0sim100) 5394 plusmn 1960 5600 plusmn 1961C-SFODIdagger (0sim100) 4607 plusmn 2056 4959 plusmn 2253lowastPlus-minus values are means plusmn SD unless otherwise notedsectStage of the disease is divided according to duration of the low back pain symptoms first appeared of this time acute stage (0sim14 days) subacute stage (15sim30days) and chronic stage (gt30 days)Visual analogue scale (VAS range 0 to 100) with higher scores indicating greater painampBased on imaging examination to determine the segments of lumbar disc herniation L3L4 means disc herniation between the third and fourth lumbar andthe others are the samedaggerTheChinese Short FormOswestryDisability Index (C-SFODI range 0 to 100) consists of 9 questions A higher percentage indicates amore severe functionaldisability

than the baseline And the experimental group showed amore significant decrease than the control group (minus1662points [95 confidence interval CI minus2025 to minus1298] 119875 lt0001)

One month after intervention two groups also hadsignificantly greater reduction in VAS than the baseline Andagain the experimental group showed a more significantdecrease than the control group (minus637 points [95CIminus1020to minus254] 119875 = 0001)

Six months after intervention compared with the base-line the changes in VAS remained significant in the experi-mental group and control group but between-group differ-ence was not significant (119875 = 0091)

33 Improvement in the Secondary Outcome Immediatelyafter intervention two groups had significant improvementin C-SFODI than the baseline and the experimental groupshowed a more significant improvement than the controlgroup (minus1555 points [95 CI minus1892 to minus1218] 119875 lt 0001)

One month after intervention two groups also hadsignificant improvement in C-SFODI than the baseline Andagain the experimental group improved more (minus1137 points[95 CI minus1462 to minus811] 119875 lt 0001)

Six months after intervention two groups also main-tained significant improvement and the experimental groupshowed superiority (minus768 points [95 CI minus1142 to minus394]119875 lt 0001)

34 Adverse Events One patient in the experiment group hadmild fainting during acupuncture remission by bed rest andthen completed the remaining treatment Two patients in the

control group were given Fenbid orally due to aggravatedlow back pain No other adverse events were noted in eitherexperimental group or control group

4 Discussion

Although the mechanism of low back pain caused by lumbardisc herniation (LDH) is still not very clear the prevailingview is that low back pain due to LDHwas found to occur notonly in response to mechanical stimuli but also to chemicalirritation around the nerve root sheath and sinuvertebralnerve [17]

Different TCM therapies have different advantages in thetreatment of LDH Pain is the main symptom in the acutestage of LDH acupuncture has good analgesic effect on lowback pain due to LDH [8] Lumbar dysfunction is the mainsymptom in the remission stage Chinese massage has goodeffect on improving dysfunction [12] Oral Chinese herbalformulae [10] external use of Chinese medicine [11] andChinese herbal injection [18] also showed good effect inrelieving pain and improving dysfunction caused by LDHAnd one study also found that Salvia miltiorrhiza injectionespecially works better and faster for the acute stage whencompared with mannitol [19] Although the mechanism ofacupuncture Chinesemassage and traditional Chinese herbsin the treatment of LDH remains unclear it is generallyagreed that these treatment methods play a role by increasinglocal blood circulation relieving nerve root edema andspeeding up the metabolism of the local inflammatory medi-ators In recovery stage of the disease the major task is tostrengthen the muscles of the waist and abdomen to preventrelapse [20] and TCM functional exercise has advantages in

6 Evidence-Based Complementary and Alternative Medicine

Table2Ch

angesinprim

aryandsecond

aryou

tcom

eslowast

Varia

ble

Outcomes

ofdifferent

timepoints(meansplusmnSD

)998787Meanchange

from

baselin

e(95CI

)Be

tween-grou

pdifference(95CI

)119875valuesect

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

versus

controlgroup

VASscores

n

M1

5394plusmn1960

5600plusmn1961

mdashmdash

mdash0358

M2

2448plusmn1773

4316plusmn2075

minus2946(minus3152

tominus2740)

minus1284(minus1558tominus98

3)minus1662(minus2025tominus1298)

lt0001

M3

740plusmn652

1583plusmn1161

minus46

54(minus4850tominus44

57)minus40

17(minus4326tominus3707)

minus637

(minus1020tominus254)

0001

M4

232plusmn229

794plusmn676

minus5162(minus5373tominus4951)minus4806(minus5145tominus44

67)

minus356

(minus76

9to

057)

0091

C-SFODIdagger

M1

4607plusmn2056

4959plusmn2253

mdashmdash

mdash0145

M2

2020plusmn1379

3926plusmn2284

minus2588(minus2770tominus2405)

minus1033

(minus1317

tominus74

8)minus1555(minus1892tominus1218

)lt0001

M3

669plusmn598

2157plusmn1535

minus3938(minus4133

tominus3744)minus2802(minus3064tominus2539

)minus1137

(minus1462tominus811)

lt0001

M4

216plusmn201

1336plusmn1064

minus4391(minus46

07tominus4175)minus3623(minus3930tominus3316

)minus76

8(minus1142tominus394)

lt0001

lowast

Valuesarem

eans

with

meansplusmnSD

orthe9

5confi

dence(CI

)M1measurementswereo

btainedatbaselin

eM2im

mediatelyaft

erthelastinterventionM3on

emon

thaft

erthelastinterventionM4six

mon

ths

after

thelastintervention

998787

TheV

ASscores

means

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-sub

jectse

ffectstestsof

different

timepointsm

eans119865=1381914119875lt0001

Between-subjectseffectstests

ofdifferent

grou

pmeans119865=46322119875lt0001Th

eC-SFO

DIm

eans

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-

subjectseffectstests

ofdifferent

timepointsm

eans119865=1076327119875lt0001B

etween-subjectseffectstests

ofdifferent

grou

pmeans119865=78879119875lt0001

sect 119875values

werec

alculated

with

independ

ent-s

amples119905-te

stform

eanchange

from

baselin

ebetweentwogrou

ps

nVisualanalogue

scale(VA

Sscores

range0

to100)

with

high

erscores

indicatin

ggreaterp

ain

dagger

TheC

hinese

ShortF

orm

Osw

estryDisa

bilityIndex(C

-SFO

DIrange0

to100

)con

sistsof

9qu

estio

nsw

ithhigh

erpercentage

indicatin

gmores

everefun

ctionald

isability

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

Evidence-Based Complementary and Alternative Medicine 5

Table 1 Baseline characteristics of the study participantslowast

Variable Experimental group (119873 = 306) Control group (119873 = 102)Sex no of patients ()

Male () 147 (480) 53 (520)Female () 159 (520) 49 (480)

Age (years) 4591 plusmn 1073 4358 plusmn 1210Stage of the diseasesect no of patients ()

Acute stage (0sim14 days) 109 (356) 38 (373)Subacute stage (15sim30 days) 101 (330) 32 (314)Chronic stage (gt30 days) 96 (314) 32 (314)

Segments of lumbar disc herniationamp no of patients ()One segment (L3L4 or L4L5 or L5S1) 61 (199) 19 (186)Two segments (L3L4 and L4L5 or L4L5 and L5S1) 196 (641) 67 (657)Three segments (L3L4 and L4L5 and L5S1) 49 (160) 16 (157)

VAS scores (0sim100) 5394 plusmn 1960 5600 plusmn 1961C-SFODIdagger (0sim100) 4607 plusmn 2056 4959 plusmn 2253lowastPlus-minus values are means plusmn SD unless otherwise notedsectStage of the disease is divided according to duration of the low back pain symptoms first appeared of this time acute stage (0sim14 days) subacute stage (15sim30days) and chronic stage (gt30 days)Visual analogue scale (VAS range 0 to 100) with higher scores indicating greater painampBased on imaging examination to determine the segments of lumbar disc herniation L3L4 means disc herniation between the third and fourth lumbar andthe others are the samedaggerTheChinese Short FormOswestryDisability Index (C-SFODI range 0 to 100) consists of 9 questions A higher percentage indicates amore severe functionaldisability

than the baseline And the experimental group showed amore significant decrease than the control group (minus1662points [95 confidence interval CI minus2025 to minus1298] 119875 lt0001)

One month after intervention two groups also hadsignificantly greater reduction in VAS than the baseline Andagain the experimental group showed a more significantdecrease than the control group (minus637 points [95CIminus1020to minus254] 119875 = 0001)

Six months after intervention compared with the base-line the changes in VAS remained significant in the experi-mental group and control group but between-group differ-ence was not significant (119875 = 0091)

33 Improvement in the Secondary Outcome Immediatelyafter intervention two groups had significant improvementin C-SFODI than the baseline and the experimental groupshowed a more significant improvement than the controlgroup (minus1555 points [95 CI minus1892 to minus1218] 119875 lt 0001)

One month after intervention two groups also hadsignificant improvement in C-SFODI than the baseline Andagain the experimental group improved more (minus1137 points[95 CI minus1462 to minus811] 119875 lt 0001)

Six months after intervention two groups also main-tained significant improvement and the experimental groupshowed superiority (minus768 points [95 CI minus1142 to minus394]119875 lt 0001)

34 Adverse Events One patient in the experiment group hadmild fainting during acupuncture remission by bed rest andthen completed the remaining treatment Two patients in the

control group were given Fenbid orally due to aggravatedlow back pain No other adverse events were noted in eitherexperimental group or control group

4 Discussion

Although the mechanism of low back pain caused by lumbardisc herniation (LDH) is still not very clear the prevailingview is that low back pain due to LDHwas found to occur notonly in response to mechanical stimuli but also to chemicalirritation around the nerve root sheath and sinuvertebralnerve [17]

Different TCM therapies have different advantages in thetreatment of LDH Pain is the main symptom in the acutestage of LDH acupuncture has good analgesic effect on lowback pain due to LDH [8] Lumbar dysfunction is the mainsymptom in the remission stage Chinese massage has goodeffect on improving dysfunction [12] Oral Chinese herbalformulae [10] external use of Chinese medicine [11] andChinese herbal injection [18] also showed good effect inrelieving pain and improving dysfunction caused by LDHAnd one study also found that Salvia miltiorrhiza injectionespecially works better and faster for the acute stage whencompared with mannitol [19] Although the mechanism ofacupuncture Chinesemassage and traditional Chinese herbsin the treatment of LDH remains unclear it is generallyagreed that these treatment methods play a role by increasinglocal blood circulation relieving nerve root edema andspeeding up the metabolism of the local inflammatory medi-ators In recovery stage of the disease the major task is tostrengthen the muscles of the waist and abdomen to preventrelapse [20] and TCM functional exercise has advantages in

6 Evidence-Based Complementary and Alternative Medicine

Table2Ch

angesinprim

aryandsecond

aryou

tcom

eslowast

Varia

ble

Outcomes

ofdifferent

timepoints(meansplusmnSD

)998787Meanchange

from

baselin

e(95CI

)Be

tween-grou

pdifference(95CI

)119875valuesect

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

versus

controlgroup

VASscores

n

M1

5394plusmn1960

5600plusmn1961

mdashmdash

mdash0358

M2

2448plusmn1773

4316plusmn2075

minus2946(minus3152

tominus2740)

minus1284(minus1558tominus98

3)minus1662(minus2025tominus1298)

lt0001

M3

740plusmn652

1583plusmn1161

minus46

54(minus4850tominus44

57)minus40

17(minus4326tominus3707)

minus637

(minus1020tominus254)

0001

M4

232plusmn229

794plusmn676

minus5162(minus5373tominus4951)minus4806(minus5145tominus44

67)

minus356

(minus76

9to

057)

0091

C-SFODIdagger

M1

4607plusmn2056

4959plusmn2253

mdashmdash

mdash0145

M2

2020plusmn1379

3926plusmn2284

minus2588(minus2770tominus2405)

minus1033

(minus1317

tominus74

8)minus1555(minus1892tominus1218

)lt0001

M3

669plusmn598

2157plusmn1535

minus3938(minus4133

tominus3744)minus2802(minus3064tominus2539

)minus1137

(minus1462tominus811)

lt0001

M4

216plusmn201

1336plusmn1064

minus4391(minus46

07tominus4175)minus3623(minus3930tominus3316

)minus76

8(minus1142tominus394)

lt0001

lowast

Valuesarem

eans

with

meansplusmnSD

orthe9

5confi

dence(CI

)M1measurementswereo

btainedatbaselin

eM2im

mediatelyaft

erthelastinterventionM3on

emon

thaft

erthelastinterventionM4six

mon

ths

after

thelastintervention

998787

TheV

ASscores

means

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-sub

jectse

ffectstestsof

different

timepointsm

eans119865=1381914119875lt0001

Between-subjectseffectstests

ofdifferent

grou

pmeans119865=46322119875lt0001Th

eC-SFO

DIm

eans

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-

subjectseffectstests

ofdifferent

timepointsm

eans119865=1076327119875lt0001B

etween-subjectseffectstests

ofdifferent

grou

pmeans119865=78879119875lt0001

sect 119875values

werec

alculated

with

independ

ent-s

amples119905-te

stform

eanchange

from

baselin

ebetweentwogrou

ps

nVisualanalogue

scale(VA

Sscores

range0

to100)

with

high

erscores

indicatin

ggreaterp

ain

dagger

TheC

hinese

ShortF

orm

Osw

estryDisa

bilityIndex(C

-SFO

DIrange0

to100

)con

sistsof

9qu

estio

nsw

ithhigh

erpercentage

indicatin

gmores

everefun

ctionald

isability

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

6 Evidence-Based Complementary and Alternative Medicine

Table2Ch

angesinprim

aryandsecond

aryou

tcom

eslowast

Varia

ble

Outcomes

ofdifferent

timepoints(meansplusmnSD

)998787Meanchange

from

baselin

e(95CI

)Be

tween-grou

pdifference(95CI

)119875valuesect

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

(119873=306)

Con

trolgroup

(119873=102)

Experim

entalgroup

versus

controlgroup

VASscores

n

M1

5394plusmn1960

5600plusmn1961

mdashmdash

mdash0358

M2

2448plusmn1773

4316plusmn2075

minus2946(minus3152

tominus2740)

minus1284(minus1558tominus98

3)minus1662(minus2025tominus1298)

lt0001

M3

740plusmn652

1583plusmn1161

minus46

54(minus4850tominus44

57)minus40

17(minus4326tominus3707)

minus637

(minus1020tominus254)

0001

M4

232plusmn229

794plusmn676

minus5162(minus5373tominus4951)minus4806(minus5145tominus44

67)

minus356

(minus76

9to

057)

0091

C-SFODIdagger

M1

4607plusmn2056

4959plusmn2253

mdashmdash

mdash0145

M2

2020plusmn1379

3926plusmn2284

minus2588(minus2770tominus2405)

minus1033

(minus1317

tominus74

8)minus1555(minus1892tominus1218

)lt0001

M3

669plusmn598

2157plusmn1535

minus3938(minus4133

tominus3744)minus2802(minus3064tominus2539

)minus1137

(minus1462tominus811)

lt0001

M4

216plusmn201

1336plusmn1064

minus4391(minus46

07tominus4175)minus3623(minus3930tominus3316

)minus76

8(minus1142tominus394)

lt0001

lowast

Valuesarem

eans

with

meansplusmnSD

orthe9

5confi

dence(CI

)M1measurementswereo

btainedatbaselin

eM2im

mediatelyaft

erthelastinterventionM3on

emon

thaft

erthelastinterventionM4six

mon

ths

after

thelastintervention

998787

TheV

ASscores

means

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-sub

jectse

ffectstestsof

different

timepointsm

eans119865=1381914119875lt0001

Between-subjectseffectstests

ofdifferent

grou

pmeans119865=46322119875lt0001Th

eC-SFO

DIm

eans

atdifferent

timepointsb

etweentwogrou

pswerea

nalyzedby

repeated

measuresa

nalysis

ofvaria

nceWith

in-

subjectseffectstests

ofdifferent

timepointsm

eans119865=1076327119875lt0001B

etween-subjectseffectstests

ofdifferent

grou

pmeans119865=78879119875lt0001

sect 119875values

werec

alculated

with

independ

ent-s

amples119905-te

stform

eanchange

from

baselin

ebetweentwogrou

ps

nVisualanalogue

scale(VA

Sscores

range0

to100)

with

high

erscores

indicatin

ggreaterp

ain

dagger

TheC

hinese

ShortF

orm

Osw

estryDisa

bilityIndex(C

-SFO

DIrange0

to100

)con

sistsof

9qu

estio

nsw

ithhigh

erpercentage

indicatin

gmores

everefun

ctionald

isability

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

Evidence-Based Complementary and Alternative Medicine 7

this regard and can subsequently increase the lumbar stabilityto prevent recurrence [13]

Treating LDH according to different stages has beenmore and more accepted In China LDH is mainly dividedinto three stages including acute stage subacute stage (orremission stage) and chronic stage (or recovery stage) [2122] Studies have proven that treating LDH according todifferent stages has obtained a good clinical effect [23] Inaddition studies have also suggested that it can obtain a bettereffect than treatment without differentiating different stages[24]

The past 20 years of clinical practice have witnessed thesafety of the treatment regimens used in this study At thesame time its efficacy has been preliminarily confirmedhowever high quality research evidence is still neededIn the treatment regimens different TCM therapies wereselected according to the characteristics of different stagesSpecifically acupuncture and Chinese herbal injections wereused in the acute stage for fast pain relief Chinese Tuina(massage) and external application of Chinesemedicine wereused in the subacute stage for improvement of the lumbarfunctions and low back muscle exercise was used in thechronic stage to increase the stability of the spine and preventrelapses

In China nonsurgical treatment of lumbar disc hernia-tion mainly uses drugs physical therapy or TCM treatmentTCM treatment used in the experimental group has beenused in clinical routine and is considered to have good clinicalefficacy the efficacy of conservative treatment used in thecontrol group is considered very weak usually as auxiliarytreatment of other therapies Ethics Committee considersthat in order to maximize the protection of the interests ofthe patients it is necessary to let the patients have moreopportunity to receive TCM treatment so in this research thesample size of the experimental group and the control groupis 3 1

The findings of this study have shown that immediatelyand one month after intervention integrative TCM conser-vative treatment can significantly reduce the VAS scores andC-SFODI and at six month after intervention integrativeTCM conservative treatment can also significantly reduce theC-SFODI but two groups have no significant difference inreducing VAS score VAS is an international general painvisual analog scale and C-SFODI is the improved versionof the ODI (Oswestry Disability Index) and it consists of9 questions a higher percentage indicating a more severefunctional disability

Regarding adverse events one patient had mild faintingin the experiment group two patients in the control groupwere given Fenbid oral due to low back pain aggravation andno other adverse events were noted in either experimentalgroup or control group The mechanism of integrative TCMconservative treatment for LDH remains unclear and it willbe our future research orientation

The main limitation of this study is the short followuptime As a result we failed to conduct comprehensive eval-uation regarding the long-term efficacy of integrative TCMconservative treatment for LDH

5 Conclusions

This randomized controlled clinical trial provides reliableevidence regarding the effectiveness of integrative TCMconservative treatment for patients with low back pain due tolumbar disc herniation A large sample of long-term followupis further needed for future research

Conflict of Interests

No potential conflict of interests relevant to this study wasreported

Acknowledgments

This work is supported by the Key Discipline of TCMOrthopaedic and Traumatic of the Ministry of Education ofthe Peoplersquos Republic of China (100508) the Medical KeyProject of Shanghai Science and Technology Commission(09411953400) the project of Shanghai Medical leadingtalent (041) the National Natural Science Foundation ofChina (81073114 81001528) the National Key New DrugsCreation Project innovative drug research and developmenttechnology platform (no 2012ZX09303009-001) ShanghaiUniversity Innovation Team Construction Project of theSpine Disease of Traditional Chinese Medicine (2009-26)

References

[1] B K Cypress ldquoCharacteristics of physician visits for backsymptoms a national perspectiverdquo American Journal of PublicHealth vol 73 no 4 pp 389ndash395 1983

[2] M Heliovaara K Sievers O Impivaara et al ldquoDescriptiveepidemiology and public health aspects of low back painrdquoAnnals of Medicine vol 21 no 5 pp 327ndash333 1989

[3] W C Peul H C van Houwelingen W B van Den Hout et alldquoSurgery versus prolonged conservative treatment for sciaticardquoNew England Journal of Medicine vol 356 no 22 pp 2245ndash2256 2007

[4] J NWeinstein T D Tosteson J D Lurie et al ldquoSurgical versusnonoperative treatment for lumbar spinal stenosis four-yearresults of the spine patient outcomes research trialrdquo Spine vol35 no 14 pp 1329ndash1338 2010

[5] W C H Jacobs M van Tulder M Arts et al ldquoSurgery versusconservative management of sciatica due to a lumbar herniateddisc a systematic reviewrdquo European Spine Journal vol 20 no 4pp 513ndash522 2011

[6] M Kosteljanetz J O Espersen H Halaburt and T MileticldquoPredictive value of clinical and surgical findings in patientswith lumbago-sciatica A prospective study (Part I)rdquo ActaNeurochirurgica vol 73 no 1-2 pp 67ndash76 1984

[7] T M Markwalder and M Battaglia ldquoFailed back surgery syn-drome Part II surgical techniques implant choice and opera-tive results in 171 patients with instability of the lumbar spinerdquoActa Neurochirurgica vol 123 no 3-4 pp 129ndash134 1993

[8] J H Lee T Y Choi M S Lee et al ldquoAcupuncture for acute lowback pain a systematic reviewrdquoTheClinical Journal of Pain vol29 no 2 pp 172ndash185 2013

[9] M Xu S Yan X Yin et al ldquoAcupuncture for chronic low backpain in long-term follow-up a meta-analysis of 13 randomized

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

8 Evidence-Based Complementary and Alternative Medicine

controlled trialsrdquoTheAmerican Journal of ChineseMedicine vol41 no 1 pp 1ndash19 2013

[10] D Li X J Dong and S B Li ldquoClinical observation on lumbardisc Herniation using method of clearing away heat and toxinrdquoLiaoning Journal of Traditional Chinese Medicine vol 39 no 9pp 1750ndash1751 2012 (Chinese)

[11] C W Zhao J X Li X Y Leng et al ldquoClinical analysis onthe curative effect of external application of traditional Chinesemedicine on lumbar disc herniationrdquoThe Journal of TraditionalChinese Orthopedics and Traumatology vol 22 no 12 pp 21ndash222010 (Chinese)

[12] L J KongM Fang H S Zhan et al ldquoTuina-focused integrativechinese medical therapies for inpatients with low back pain asystematic review and meta-analysisrdquo Evidence-Based Comple-mentary and Alternative Medicine vol 2012 Article ID 57830517 pages 2012

[13] J W Qiu R Q Wei and F G Zhang ldquoThe function of lowback muscle exercise in the evaluation of long-term curativeeffect of patients with lumbar disc herniationrdquo Chinese Journalof Gerontology vol 31 no 3 pp 413ndash414 2010 (Chinese)

[14] Z H Li L J Liu and Y Q Han ldquoEvaluation of clinical pathwayChinesemedicine treatment of lumbar disc herniationrdquoChineseJournal of Gerontology vol 31 no 2 pp 322ndash323 2010 (Chi-nese)

[15] W C Peul H C van Houwelingen W B van der Hout et alldquoProlonged conservative treatment or rsquoearlyrsquo surgery in sciaticacaused by a lumbar disc herniation rationale and design of arandomized trialrdquoBMCMusculoskeletal Disorders vol 6 article8 2005

[16] G X Zheng X O Zhao and G L Liu ldquoReliability of themodified oswestry disability index for evaluating patients withlow back painrdquoChinese Journal of Spine and Spinal Cord vol 12no 1 pp 13ndash15 2010 (Chinese)

[17] S R Anderson G B Racz and J Heavner ldquoEvolution ofepidural lysis of adhesionsrdquoPain Physician vol 3 no 3 pp 262ndash270 2000

[18] J Liu L Fang W D Xu et al ldquoEffects of intravenous drip ofcompound Danshen injection on plasma NO and SOD levelsin patients with lumbar intervertebral disc prolapserdquo ChineseJournal of Clinical Health Care vol 7 no 4 pp 272ndash274 2004(Chinese)

[19] L H Pan ldquo120573-aescin sodium combined with Danshen injectionin the treatment of lumbar disc herniationrdquo China ModernDoctor vol 48 no 23 pp 117ndash121 2010 (Chinese)

[20] H S Rhee Y H Kim and P S Sung ldquoA randomized controlledtrial to determine the effect of spinal stabilization exercise inter-vention based on pain level and standing balance differences inpatients with low back painrdquo Medical Science Monitor vol 18no 3 pp CR174ndashCR181 2012

[21] K Wu Y Y Li Y F He et al ldquoOverview on clinical stagingmethod of protrusion of lumbar intervertebral discrdquo Journal ofLiaoning University of Traditional Chinese Medicine vol 11 no12 pp 44ndash45 2010 (Chinese)

[22] C H Li S H Cai S Q Chen et al ldquoThe investigation of stagingcomprehensive program treatment for lumbar disc herniationrdquoJournal of Fujian University of Traditional ChineseMedicine vol20 no 6 pp 7ndash9 2010 (Chinese)

[23] L Li H S Zhan B Chen et al ldquoClinical observation of stageTreatment on 110 cases of lumbar disc herniationrdquo ChineseJournal of TraditionalMedical Traumatology ampOrthopedics vol19 no 1 pp 11ndash15 2011 (Chinese)

[24] C H Li Q K Zheng K M Zhang et al ldquoPhased comprehen-sive treatment for lumbar disc herniation in 60 casesrdquo Journalof Beijing University of Traditional Chinese Medicine(ClinicalMedicine) vol 18 no 6 pp 10ndash12 2011 (Chinese)

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

MEDIATORSINFLAMMATION

of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Behavioural Neurology

EndocrinologyInternational Journal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Disease Markers

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

BioMed Research International

OncologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Oxidative Medicine and Cellular Longevity

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Computational and Mathematical Methods in Medicine

OphthalmologyJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Diabetes ResearchJournal of

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Research and TreatmentAIDS

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Gastroenterology Research and Practice

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom