research article a 3-arm, randomized, controlled trial of...

Research ArticleA 3-Arm Randomized Controlled Trial of Heat-SensitiveMoxibustion Therapy to Determine Superior Effect amongPatients with Lumbar Disc Herniation

Rixin Chen1 Mingren Chen1 Tongsheng Su2 Meiqi Zhou3 Jianhua Sun4

Jun Xiong1 Zhenhai Chi1 Dingyi Xie1 and Bo Zhang1

1 The Affiliated Hospital with Jiangxi University of TCM No 445 Bayi Avenue Nanchang 330006 China2 Shanxi TCM Hospital Xian 710003 China3The First Affiliated Hospital with Anhui University of TCM Hefei 230031 China4 Jiangsu TCM Hospital Nanjing 210029 China

Correspondence should be addressed to Rixin Chen chenrixin321163com

Received 15 April 2014 Revised 16 June 2014 Accepted 7 July 2014 Published 24 July 2014

Academic Editor Xueyong Shen

Copyright copy 2014 Rixin Chen 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

Systematic reviews of moxibustion for LDH have identified ponderable evidence especially for heat-sensitive moxibustion (HSM)Therefore we designed and carried out the large sample trial to evaluate it 456 patients were recruited from 4 centers in Chinaand were randomly divided into three groups by the ratio of 1 1 1 to HSM (152) group conventional moxibustion (152) groupand conventional drug plus acupuncture (152) group Compared with usual care there was a statistically significant reduction inmean M-JOA score at 2 weeks and 6 months for HSM (38 plusmn 26 versus 85 plusmn 29 37 plusmn 22 versus 101 plusmn 29) and conventionalmoxibustion (79 plusmn 30 versus 85 plusmn 29 89 plusmn 31 versus 101 plusmn 29) Compared with conventional moxibustion group HSM groupshowed greater improvement in all the outcomes The mean dose of moxibustion was 4113 plusmn 526 (range 21ndash60) minutes in theHSM group We found that HSM was more effective in treating patients with LDH compared with conventional moxibustion andconventional drug plus acupuncture This finding indicated that the application of moxibustion on the heat-sensitive points is agood moxibustion technique in treating disease

1 Background

Therapies to strengthen the motor function and relieve lowback pain are the most commonly recommended treatmentfor lumbar disc herniation (LDH) such as acupuncture andmoxibustion [1] They have the advantage better than othertherapies (especially surgery) that they have no physical side-effects or adverse reactions [2 3] Moxibustion is a traditionaloriental therapy that treats diseases through thermal stimula-tion of burning herbs primarilyArtemisia vulgaris at specificacupuncture and moxibustion point on the skin [4] Tradi-tional Chinese medicine (TCM) considers LDH to be theresult of an unbalanced state among interfunctioning organsor a block vital energy (called Qi) condition with character-istic blood symptoms [5] A large number of clinical studieshave shown positive results ofmoxibustion remedies on LDH

[6] And moxibustion therapy has been important treatmentin China In particular moxibustion treatment is effective forfunctional limitation and pain symptom because it provideswarm energy expels Qi-blood stagnation and enhanceslocal blood circulation [7] Experimental studies showedmoxibustion had anti-inflammatory or immunomodulatoryeffects against chronic inflammatory conditions in humans[8]

For moxibustion therapy many factors influenced thetherapeutic effect However the first thing to think about isthe selection of location for manipulating moxa [9] Conven-tional moxibustion applied moxibustion on fix acupuncturepoints based on pattern differentiation Different patientsreceived treatments on the same acupuncture points How-ever heat-sensitive moxibustion (HSM) selected locationthat received moxibustion differently [10] Heat-sensitive

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2014 Article ID 154941 7 pageshttpdxdoiorg1011552014154941

2 Evidence-Based Complementary and Alternative Medicine

moxibustion administered moxibustion on heat-sensitiveacupuncture points which are extremely sensitive to the heatstimulation of burning moxa [11] By using such acupuncturepoints it is easier for channel Qi to transmit and to allow astrong response to be produced by weak stimulation Patientsfelt heat-sensitive sensation on these acupuncture points [12]

According to acupuncture point sensitized theory thereare two kinds of state in acupuncture points in humanbody stimulated state and resting state When people getsick the acupoints on the body surface area are activatedand sensitized Our research found that the heat-sensitivephenomenon to acupuncture point or an area is a new typeof reaction in a pathological state The sensitive areas aresusceptible to heat stimulation and called ldquoheat-sensitiveacupuncture pointsrdquo A feature of these areas is that theseareas are specific or closely relevant to acupuncture pointsand produce the same clinical effect as ldquoa small stimulationinduces a large responserdquo This heat-sensitive acupuncturepoint is not only the pathological phenomenon reflectionof the diseases but also an effective stimulating locationwith acupuncture and moxibustion These heat-sensitizedlocations are not fixed but may during the progression ofdisease dynamically change within a certain range centeredon acupuncture points [13] Our empirical evidence engagedus in formulating the following hypothesis moxibustion atthe heat-sensitive acupuncture points showed better efficacythan that at fixed acupuncture points

However TCM theory in China agreed that the best placeto apply moxibustion was on heat-sensitive acupuncturepoints because using them led to better stimulation andtransmission of channel Qi When Qi arrives at one partof the body it can treat the diseases nearby In the partof Miraculous pivot the chapter of nine needles and twelvesources said ldquoThe key point of acupuncture is the arrival ofQi it ensures therapeutic effectrdquo However there is little high-quality clinical evidence of its effectiveness Therefore wedesigned and carried out the large sample trial to evaluate it

The results of a recent meta-analysis of six randomizedcontrolled trials (RCTs) on moxibustion for LDHmanifestedthat heat-sensitive therapy presented a favorable effect onLDH symptom scores compared with that of the drug [RR =191 95 CI (101 360)] [14] However because of thenumber of eligible RCTs and the high risk of bias in theassessment of the available RCTs the evidence supportingthis conclusion is limited Therefore this well-designed andbig sample RCT was needed to establish the efficacy of heat-sensitive moxibustion for LDH

2 Methods

21 Objective The aim of this study is to assess the effec-tiveness of heat-sensitive moxibustion for treating LDHcompared with conventional drug plus acupuncture as wellas conventional moxibustion

22 Sample Size An effect size on the M-JOA was soughtwhen comparing the heat-sensitive with conventional moxi-bustion In our previous pilot study the effective rate in heat-sensitive moxibustion group is 65 and 45 in the other

groups An allocation ratio of 1 1 1 was chosen in order toincrease power to detect statistically significant differencesbetween the three groups With 90 power and a two-sidedsignificance level of 5 the required group sizes were 126Allowing for 20 attrition the total sample size required was456 (ie groups of 152 152 152 resp)

119899 =

1199011times (1 minus 119901

1) + 1199012times (1 minus 119901

2)

(1199012minus 1199011)2

times 119891 (120572 120573) (1)

23 Design We performed a multicenter (four centers inChina) randomized assessor blinded and positive con-trolled trial Our trial was carried out in four hospitals inChina including the Affiliated Hospital of Jiangxi Universityof Traditional Chinese Medicine (TCM) in Nanchang thefirst Affiliated Hospital of Anhui University of TCM in HefeiJiangsu TCMHospital in Nanjing and Shanxi TCMHospitalin Xian Patients were recruited through hospital-basedrecruitment and newspaper advertisements After a baselinephase of one week we used a central randomization system(random list generated with computer telephone integrationby the statistician from China Academy of Chinese MedicalSciences) to randomize patients [15] All study participantsprovided written informed consent and the study con-formed to common guidelines for clinical trials (Declarationof Helsinki ICH-GCP including certification by externalaudit) The evaluation of participants and the analysis of theresults were performed by professionals blinded to the groupallocation

24 Participants

241 Recruitment Patients were recruited in China fromDecember 30 2011 to January 30 2013 Informed consentwas obtained from each subject and the Ethics Committee ofAffiliated Hospital of Jiangxi Institute of Traditional ChineseMedicine China approved the study protocol authorizationnumber 2008(11)

242 InclusionCriteria Inclusion criteria were a diagnosis ofLDH according to the guiding principle of clinical researchon new drugs (GPCRND) [16] at least 10 scores in M-JOA in the baseline period age 18ndash65 years pain occurringin lower back and radiating to the lower limb completedbaseline LDH diary and written informed consent Mean-while heat-sensitive acupuncture points were found in thetriangle region formedwith bilateral Dachangshu (BL25) andYaoshu (Du2) of patients (Dachangshu-Yaoshu-contralateralDachangshu intraregion)

243 Exclusion Criteria Main exclusion criteria werepatients with serious life-threatening disease such as diseaseof the heart and brain blood vessels liver kidney and hema-topoietic system pregnant or lactating female and psychoticpatients We also excluded patients with a single nerve palsyor cauda equina nerve palsymanifested asmuscle paralysis orhaving rectumor bladder problems complicatedwith lumbarspinal canal stenosis and space-occupying lesions or for

Evidence-Based Complementary and Alternative Medicine 3

other reasons complicated with lumbar spine tumors infec-tions tuberculosis complicated with moxibustion syncopeand unwilling to be treated with moxibustion patients donot sign informed consent

25 Study Interventions We developed the study interven-tions in a consensus process with China acupuncture expertsand societies Physicians trained and experienced (at leastfive years) in acupuncture delivered the interventions Alltreatment regimens were standardized between four centerspractitioners via video hands-on training and internetworkshops In the moxibustion groups 22mm (diameter) times120mm (length) moxa-sticks (Jiangxi Traditional ChineseMedicineHospital China) were usedThe patient was usuallyin the comfortable supine position for treatment with 24∘Cto 30∘C temperature in the room

251 Heat-Sensitive Moxibustion Group For the heat-sensi-tive moxibustion group moxibustion treatment was definedas burning a moxa-stick with the patient lying on his or herback The moxa-sticks were lit by the therapist and held overthe region among two Dachangshu (BL25) and Yaoshu (Du2) of patients The moxa-stick suspended at an approximatedistance of 3 cm was used to search for acupuncture pointsshowing the heatsensitisation phenomenon The followingpatients sensation suggested the special heat-sensitizationacupuncture points heat penetration patients reporting heatpenetrating from the skin into subcutaneous tissues heatexpansion heat expanding away from the stimulation siteto surrounding cutaneous and subcutaneous tissues heattransmission patients perceiving a stream of heat conductingin certain directions or perceiving heat in some body regionsor into the joint cavity nonthermal sensations instead ofthermal sensations some patients perceiving aching heav-iness pain numbness pressure or cold in local or distantlocations of stimulation When such an acupuncture pointwas found the therapists marked the point We tried our bestto seek all the special acupuncture points in each patient bythe repeated manipulation

The therapists began to treat patients from the most heat-sensitive intensity acupoint Treatment sessions ended whenpatients felt the acupoint heat-sensitization phenomenon haddisappeared Generally speaking one point was selected eachtime One point was treated 30sim60minutes Patients receivedthe treatment for two times daily in the first four days and forone time daily in remaining ten days The whole treatmentcontained 18 sessions over 14 days

252 Conventional Moxibustion Group A licensed doctorperformed fixed acupuncture point moxibustion Commonpractices were similar to the first groupThe different manip-ulation was that the therapists carry out warming moxibus-tion in traditional acupuncture point selecting Dachangshu(BL25) Weizhong (BL40) and A-shi Xue One point istreated 15 minutes a time The whole process of moxibustiontook about 45 minutes for each session Patients usuallyfelt local warmth without burning pain and might experi-ence mild hyperemia in the local region The sensation of

acupuncture point heat-sensitization phenomenon was notpursued and not avoided in the treatment Patients receivedthe treatment for two times daily in the first four days and forone time daily in the remaining ten daysThewhole treatmentcontained 18 sessions over 14 days

253 Conventional Drug Plus Acupuncture Group For con-ventional drug patients received the 20 mannitol (250mLintravenously) and Voltaren tablets (75mg 2 times a day) inthe first 3 days Voltaren tablets were continued to be used inthe subsequent 11 days At the same time acupuncture nee-dles were used and acupuncture points selected from BladderMeridian of Foot-Taiyang and Gallbladder Meridian of Foot-Shaoyang Acupoints included Dachangshu (BL25) Yaojiaji(EX-B2) Huantiao (GB30) Weizhong (BL40) Yanglingquan(GB34) Xuanzhong (GB39) and Qiuxu (GB40) We selectedbilateral acupoints located in waist and ipsilateral acupointslocated in lower limbs Needles remained in acupuncturepoint for 30 minutes Patients received the acupunctureneedle treatment one timeday in two weeks for a total of 14sessions over 14 days

26 Outcome Measures Our primary outcome measure wasthe M-JOA The JOA has proposed a series of criteria todefine patient response in the context of clinical trials ofLDH M-JOA scale is a modified edition of JOA BackPain Evaluation Questionnaire According to these criteriaa patient with LDH is assessed for pain the ability to conductdaily life and work functional impairment and particularclinical examinations M-JOA scores range from 0 to 24 withLDH considered mild (0ndash9) moderate (10ndash20) or severe(21 and above) The M-JOA was used as a preference-basedmeasure of health outcome All patients were assessed beforerandomization (baseline phase) 2weeks after randomizationand 6 months after the last treatmentThis trial also recordedadverse effects reported by patients during treatment

We ensured assessor blinding in this trial Patients wereinformed not to tell outcome assessors the treatment theyreceivedThe outcome assessor was not involved in treatmentadministration

27 Statistical Methods Data were analysed on an intention-to-treat (ITT) basis including all randomised participantswith at least one measurable outcome report The statisticianconducting the analyses remained blinded to treatmentgroups All analyses were conducted using SPSS 115 Thegroups were compared on 2 weeks with 119905-tests used toassess changes between baseline and 2 weeks within eacharm ANOVA was used to compare these changes amongthe three treatment arms of the trial Where a significancedifference was found among the three groups pair-wise testswere used to determine specifically which groups differedsignificantly Student-Newman-Keuls was used for pairwisecomparisonAll adverse reactionsmanifestedwere listedwithdetailed explanations A significance level of 5 was used inall analyses


Assessed for eligibility (n = 760)

Excluded (n = 304)

Heat-sensitive moxibustiongroup (n = 152)

Enrolled (n = 456)

Conventional drug and acupuncture group

Central randomization system

Conventional moxibustion group (n = 152)

ITT population n = 152Excluded from analysis(give reasons) (n = 0)

Received allocatedintervention (n = 152)

Lost to follow-up (give reasons)(n = 3)

2 weeks

6 months

Analysis

Baseline


Received allocated intervention (n = 152)





∙ Not meeting inclusion criteria (n = 211)

∙ Other reasons (n = 24)

(n = 152)

∙Refusal of participation (n = 69)

Figure 1 A flowchart of the study process

3 Results

31 Population and Baseline Participants were recruitedfrom outpatients and inpatients in the four study centersPatient flow in the trial was presented in Figure 1 Afterscreening 760 patients 456 were randomly assigned totreatment 304 could not be included in the study mainlybecause they did not meet all eligibility criteria After six

months 7 patients missed Reasons for missing follow-updata were not contactable Participants had amean age of 463years and 524 were female Table 1 presented the historyof LDH of the subjects The mean M-JOA score was 176Baseline patient characteristics were balanced between thetrial arms There was no difference in attrition rate amongthe groups at 6-month follow-up (119875 gt 005 Fisher exacttest)


Table 1 Baseline characteristics of participants

Items Heat-sensitive moxibustion Conventional moxibustion Conventional drug plus acupuncturegroup group group

Age mean (SD) years 455 (106) 473 (112) 466 (105)Age minsimmax years 18sim59 20sim58 18sim59Age gt60 y 119899 () 9 (592) 10 (66) 9 (592)Sex 119899 ()

Female 78 (513) 80 (526) 81 (533)Male 74 (487) 72 (474) 71 (467)

Duration of pain 119899 ()lt1m 32 (211) 30 (197) 30 (197)2sim6m 40 (263) 42 (276) 43 (282)7sim12m 40 (263) 33 (217) 31 (203)1sim5 y 33 (217) 38 (251) 40 (263)gt5 y 7 (46) 9 (59) 8 (52)

BMI mean (SD) kgm1015840 222 (33) 224 (31) 211 (40)BMI minsimmax kgm1015840 143sim301 162sim292 131sim289M-JOA score 119899 ()

Severe 115 (756) 113 (734) 119 (783)Moderate 37 (244) 39 (256) 33 (217)

M-JOA score mean (SD) 186 (38) 175 (33) 172 (44)BMI Body Mass Index M-JOA Improvement Japanese Orthopedic Association (M-JOA) Lumbago Score Scale SD standard deviation LDH lumbar discherniation

311 Total M-JOA Score There was a significant reductionin mean M-JOA score from baseline in all three groups(119875 lt 001) ANOVA test showed significant difference inthe three groups at both time points Mixed-effects modelanalysis (119902-test) showed that subjects in the heat-sensitivemoxibustion group had significantly greater reduction in M-JOA scores than those in conventional moxibustion groupor conventional drug plus acupuncture group at 2 weeksand 6 months however there was no significant differencebetween conventional moxibustion and conventional drugplus acupuncture at both time points (Table 2)

32 Moxibustion Time in the Heat-Sensitive MoxibustionGroup Different from the conventional moxibustion groupmoxibustion dose was individual in the heat-sensitive mox-ibustion group According to the record of individual moxi-bustion time the dose differed in terms of patientsrsquo conditionsand moxibustion sensation which had been measured about21sim60 minutes in the treatment of LDH The range of meanmoxibustion dose was about 4113 plusmn 526 minutes in theconventional moxibustion group We used a linear correla-tion to measure the strength of a relationship betweenchange in M-JOA score and stimulation duration in theconventional moxibustion group The Pearson coefficient119903 = 00006 showing a poor correlation between the twovalues

33 Safety No adverse events were reported in the 456 par-ticipants

4 Discussions

The heat-sensitive moxibustion intervention tested in thisstudywas significantlymore effective than conventionalmox-ibustion treatment and significantly more effective than theconventional drug plus acupuncture intervention in patientswith LDH No serious cases of adverse reactions related totreatment were reported This study had a clear and practicalresearch question with an appropriate trial design namelya pragmatic randomized controlled trial which modelledclosely what would happen if patient refers to moxibustionCompared with available studies of moxibustion for LDHwhich included a maximum amount of 120 patients [17ndash19]our study has a much larger sample size Other advantagesincluded adherence to current guidelines for acupuncturetrials strictly concealed central randomization blinded eval-uation of statistics and measurement interventions basedon expert consensus provided by qualified and experiencedmedical acupuncturists and high follow-up rates Trial physi-cians could not be blinded It was not possible to blindthe conventional drug plus acupuncture patients Thereforethe large and significant difference between HSM and con-ventional moxibustion and between HSM and conventionaldrug plus acupuncture could be due to performance biasand detection bias The results of this study proved thesuperiority of heat-sensitivemoxibustion in patients sufferingfrom LDH That is selecting the heat-sensitive acupuncturepoint obtained therapeutic effect far better than moxibustionat acupuncture point of routine resting states These heat-sensitive acupuncture points are not fixed but may dur-ing the progression of disease dynamically change within


Table 2 Comparison of M-JOA scores

Variable Week 2 Month 6Mean (SD) 95 CI Mean (SD) 95 CI

Group A 38 (26) 34sim42 37 (22) 33sim41Group B 79 (30) 74sim84 89 (31) 84sim94Group C 85 (29) 80sim90 101 (29) 95sim106Comparison between the three groups119865 value 38 52119875 value 0016 0008

Group A versus Group B119902 value 41 59119875 value 0022 0013

Group A versus Group C119902 value 51 67119875 value 0017 0002

Group C versus Group B119902 value 20 32119875 value 0146 0041

Comparison between the three groups by ANOVA test Pairwise comparison for the two groups by Student-Newman-Keuls (119902-test) All data are intendedto treat Each group 119899 = 152 SD standard deviation M-JOA Improvement Japanese Orthopedic Association (M-JOA) Lumbago Score Scale SD standarddeviation LDH lumbar disc herniation Group A Heat-sensitive moxibustion group Group B Conventional moxibustion group Group C Conventionaldrug plus acupuncture group

a certain range centered on acupuncture points Severaltypes of heat-sensitization responses might appear aloneor in combination Patients become thermally sensitized tomoxibustion stimulation at certain locations on the bodyindicated by sensations of strong warmth or heat penetratinginto the body (heat penetration) warmth spreading aroundthe stimulation site (heat expansion) warmth conductingin certain directions and reaching some body regions oreven internal organs remote from stimulation sites (heattransmission) or other nonthermal sensations [20] Theseresponses gradually disappear with disease recovery

In summary we have provided high-quality evidence thatheat-sensitive moxibustion showed significant reduction insymptoms of LDH in the short and long term comparedwith other two treatments (conventional moxibustion con-ventional acupuncture plusmedicine)The importance of thetherapeutic relationship providing heat-sensitive acupunc-ture point should not be underestimated in the moxibustiontherapy Therefore the success of this project is more thanproviding the efficacy of heat-sensitive moxibustion as atreatment modality in patients with LDH The findings willbe helpful to provide better therapeutic options to enhancethe efficacy of moxibustion and to perfect acupuncture pointheat-sensitive theory

Conflict of Interests

The authors declare that they have no conflict of interests

Authorsrsquo Contribution

Mingren Chen and Rixi Chen obtained fund of the researchproject Jun Xiong wrote the final paper Rixin Chen Tong-sheng Su Jianhua SunMeiqi Zhou Zhenhai Chi Dingyi Xie

and Bo Zhang contributed to the trial implement All authorsread and approved the final paper Rixin Chen and MingrenChen contributed equally to this work

Acknowledgments

This study was supported by the Major State Basic ResearchDevelopment Program of China (Grant no 2009CB522902)the National Natural Science Foundation of China (Grantno 81160453) the National Natural Science Foundationof China (Grant no 81202854) Jiangxi Key RampD Projectand traditional Chinese medicine scientific research plan ofJiangxi Province Health Department (Grant no 2012A113)

References

[1] L C Paramore ldquoUse of alternative therapies estimates from the1994RobertWood JohnsonFoundationNationalAccess toCareSurveyrdquo Journal of Pain and Symptom Management vol 13 no2 pp 83ndash89 1997

[2] A K Hopton S Curnoe M Kanaan and H MacPhersonldquoAcupuncture in practice mapping the providers the patientsand the settings in a national cross-sectional surveyrdquoBMJOpenvol 2 no 1 Article ID e000456 2012

[3] K J Thomas J P Nicholl and P Coleman ldquoUse and expen-diture on complementary medicine in England a populationbased surveyrdquo ComplementaryTherapies in Medicine vol 9 no1 pp 2ndash11 2001

[4] World Health Organization WHO International Standard Ter-minologies onTraditionalMedicine in theWestern Pacific RegionWorld Health Organization Western Pacific Region MaynilaPhilippines 2007

[5] L Fanrong Acupuncture (Zhen Jiu Xue ) China TraditionalChinese Medicine Publishing Beijing China 2005


[6] X H Wang ldquoAdvances in lumbar disc herniation treatmentresearchrdquo Chinese Journal of Health Industry vol 10 no 8 pp38ndash39 2012 (Chinese)

[7] Z H Cho S C Hwang E K Wong et al ldquoNeural substratesexperimental evidences and functional hypothesis of acupunc-ture mechanismsrdquo Acta Neurologica Scandinavica vol 113 no6 pp 370ndash377 2006

[8] W Chen A Yang M Dai and Q Fu ldquoObservation on thera-peutic effect of electroacupuncture under continuous tractionfor treatment of lumbar disc herniationrdquo Zhongguo Zhen Jiuvol 29 no 12 pp 967ndash969 2009 (Chinese)

[9] C RiXin and K Mingfei Acupuncture Point Heat-SensitiveMoxibustion and New Therapy Peoplersquos Medical PublishingHouse Beijing China 2006

[10] C RiXin C Mingren and K Mingfei An Practical Book ofHeat-Sensitive Moxibustion Press by Peoplersquos Medical Publish-ing House Beijing China 1st edition 2009

[11] R Chen and M Kang ldquoClinical application of acupoint heat-sensitizationrdquo Zhongguo zhen jiu vol 27 no 5 pp 199ndash2022007 (Chinese)

[12] R Chen and M Kang ldquoKey point of moxibustion arrival of qiproduces curative effectrdquo Zhongguo Zhen Jiu vol 28 no 1 pp44ndash46 2008

[13] X Dingyi L Zhongyong and H Xiaoqin ldquoHeat sensitizationin suspended moxibustion features and clinical relevancerdquoAcupuncture in Medicine vol 31 no 4 pp 422ndash424 2013

[14] R Chen J Xiong Z Chi and B Zhang ldquoHeat-sensitivemoxibustion for lumbar disc herniation a meta-analysis ofrandomized controlled trialsrdquo Journal of Traditional ChineseMedicine vol 32 no 3 pp 322ndash328 2012 (Chinese)

[15] B Liu T Wen C Yao et al ldquoThe central randomization systeminmulti-center clinical trialsrdquoChinese Journal of NewDrugs andClinical Remedies vol 12 no 3 pp 931ndash935 2006 (Chinese)

[16] ldquoJOA Back Pain Evaluation Questionnairerdquo Japanese Ortho-pedic Association httpwwwjoaorjpenglishenglish framehtml

[17] F Y Tang C J Huang R X Chen M Xu B X Liu andZ Liang ldquoObservation on therapeutic effect of moxibustionon temperature-sensitive points for lumbar disc herniationrdquoChinese Acupuncture ampMoxibustion vol 29 no 5 pp 382ndash3842009 (Chinese)

[18] C Zhang H Xiao and R Chen ldquoObservation on curative effectof moxibustion on heat-sensitive points on pressure soresrdquoChina Journal of Traditional Chinese Medicine and Pharmacyvol 25 no 6 pp 478ndash488 2010 (Chinese)

[19] M F Kang R X Chen and Y Fu ldquoObservation on cura-tive effect of moxibustion on heat-sensitive points on kneeosteoarthritisrdquo Jiangxi Journal of Traditional Chinese Medicineand Pharmacy vol 18 no 2 pp 27ndash28 2006 (Chinese)

[20] C Rixin C Mingren and K Mingfei Heat-sensitive Moxi-bustion Therapy Peoplersquos Medical Publishing House BeijingChina 1st edition 2012

Submit your manuscripts athttpwwwhindawicom

Stem CellsInternational

Hindawi Publishing Corporationhttpwwwhindawicom Volume 2014


MEDIATORSINFLAMMATION

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Behavioural Neurology

EndocrinologyInternational Journal of



Disease Markers


BioMed Research International

OncologyJournal of



Oxidative Medicine and Cellular Longevity


PPAR Research

The Scientific World JournalHindawi Publishing Corporation httpwwwhindawicom Volume 2014

Immunology ResearchHindawi Publishing Corporationhttpwwwhindawicom Volume 2014

Journal of

ObesityJournal of



Computational and Mathematical Methods in Medicine

OphthalmologyJournal of


Diabetes ResearchJournal of



Research and TreatmentAIDS


Gastroenterology Research and Practice


Parkinsonrsquos Disease

Evidence-Based Complementary and Alternative Medicine

Volume 2014Hindawi Publishing Corporationhttpwwwhindawicom


moxibustion administered moxibustion on heat-sensitiveacupuncture points which are extremely sensitive to the heatstimulation of burning moxa [11] By using such acupuncturepoints it is easier for channel Qi to transmit and to allow astrong response to be produced by weak stimulation Patientsfelt heat-sensitive sensation on these acupuncture points [12]

According to acupuncture point sensitized theory thereare two kinds of state in acupuncture points in humanbody stimulated state and resting state When people getsick the acupoints on the body surface area are activatedand sensitized Our research found that the heat-sensitivephenomenon to acupuncture point or an area is a new typeof reaction in a pathological state The sensitive areas aresusceptible to heat stimulation and called ldquoheat-sensitiveacupuncture pointsrdquo A feature of these areas is that theseareas are specific or closely relevant to acupuncture pointsand produce the same clinical effect as ldquoa small stimulationinduces a large responserdquo This heat-sensitive acupuncturepoint is not only the pathological phenomenon reflectionof the diseases but also an effective stimulating locationwith acupuncture and moxibustion These heat-sensitizedlocations are not fixed but may during the progression ofdisease dynamically change within a certain range centeredon acupuncture points [13] Our empirical evidence engagedus in formulating the following hypothesis moxibustion atthe heat-sensitive acupuncture points showed better efficacythan that at fixed acupuncture points

However TCM theory in China agreed that the best placeto apply moxibustion was on heat-sensitive acupuncturepoints because using them led to better stimulation andtransmission of channel Qi When Qi arrives at one partof the body it can treat the diseases nearby In the partof Miraculous pivot the chapter of nine needles and twelvesources said ldquoThe key point of acupuncture is the arrival ofQi it ensures therapeutic effectrdquo However there is little high-quality clinical evidence of its effectiveness Therefore wedesigned and carried out the large sample trial to evaluate it

The results of a recent meta-analysis of six randomizedcontrolled trials (RCTs) on moxibustion for LDHmanifestedthat heat-sensitive therapy presented a favorable effect onLDH symptom scores compared with that of the drug [RR =191 95 CI (101 360)] [14] However because of thenumber of eligible RCTs and the high risk of bias in theassessment of the available RCTs the evidence supportingthis conclusion is limited Therefore this well-designed andbig sample RCT was needed to establish the efficacy of heat-sensitive moxibustion for LDH

2 Methods

21 Objective The aim of this study is to assess the effec-tiveness of heat-sensitive moxibustion for treating LDHcompared with conventional drug plus acupuncture as wellas conventional moxibustion

22 Sample Size An effect size on the M-JOA was soughtwhen comparing the heat-sensitive with conventional moxi-bustion In our previous pilot study the effective rate in heat-sensitive moxibustion group is 65 and 45 in the other

groups An allocation ratio of 1 1 1 was chosen in order toincrease power to detect statistically significant differencesbetween the three groups With 90 power and a two-sidedsignificance level of 5 the required group sizes were 126Allowing for 20 attrition the total sample size required was456 (ie groups of 152 152 152 resp)

119899 =

1199011times (1 minus 119901

1) + 1199012times (1 minus 119901

2)

(1199012minus 1199011)2

times 119891 (120572 120573) (1)

23 Design We performed a multicenter (four centers inChina) randomized assessor blinded and positive con-trolled trial Our trial was carried out in four hospitals inChina including the Affiliated Hospital of Jiangxi Universityof Traditional Chinese Medicine (TCM) in Nanchang thefirst Affiliated Hospital of Anhui University of TCM in HefeiJiangsu TCMHospital in Nanjing and Shanxi TCMHospitalin Xian Patients were recruited through hospital-basedrecruitment and newspaper advertisements After a baselinephase of one week we used a central randomization system(random list generated with computer telephone integrationby the statistician from China Academy of Chinese MedicalSciences) to randomize patients [15] All study participantsprovided written informed consent and the study con-formed to common guidelines for clinical trials (Declarationof Helsinki ICH-GCP including certification by externalaudit) The evaluation of participants and the analysis of theresults were performed by professionals blinded to the groupallocation

24 Participants

241 Recruitment Patients were recruited in China fromDecember 30 2011 to January 30 2013 Informed consentwas obtained from each subject and the Ethics Committee ofAffiliated Hospital of Jiangxi Institute of Traditional ChineseMedicine China approved the study protocol authorizationnumber 2008(11)

242 InclusionCriteria Inclusion criteria were a diagnosis ofLDH according to the guiding principle of clinical researchon new drugs (GPCRND) [16] at least 10 scores in M-JOA in the baseline period age 18ndash65 years pain occurringin lower back and radiating to the lower limb completedbaseline LDH diary and written informed consent Mean-while heat-sensitive acupuncture points were found in thetriangle region formedwith bilateral Dachangshu (BL25) andYaoshu (Du2) of patients (Dachangshu-Yaoshu-contralateralDachangshu intraregion)

243 Exclusion Criteria Main exclusion criteria werepatients with serious life-threatening disease such as diseaseof the heart and brain blood vessels liver kidney and hema-topoietic system pregnant or lactating female and psychoticpatients We also excluded patients with a single nerve palsyor cauda equina nerve palsymanifested asmuscle paralysis orhaving rectumor bladder problems complicatedwith lumbarspinal canal stenosis and space-occupying lesions or for














Excluded (n = 304)


Enrolled (n = 456)







2 weeks

6 months

Analysis

Baseline









(n = 152)



3 Results







Female 78 (513) 80 (526) 81 (533)Male 74 (487) 72 (474) 71 (467)



Severe 115 (756) 113 (734) 119 (783)Moderate 37 (244) 39 (256) 33 (217)





4 Discussions

















Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of





























Excluded (n = 304)


Enrolled (n = 456)







2 weeks

6 months

Analysis

Baseline









(n = 152)



3 Results







Female 78 (513) 80 (526) 81 (533)Male 74 (487) 72 (474) 71 (467)



Severe 115 (756) 113 (734) 119 (783)Moderate 37 (244) 39 (256) 33 (217)





4 Discussions

















Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of




















Female 78 (513) 80 (526) 81 (533)Male 74 (487) 72 (474) 71 (467)



Severe 115 (756) 113 (734) 119 (783)Moderate 37 (244) 39 (256) 33 (217)





4 Discussions

















Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of































Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of





































of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of
















research article a 3-arm, randomized, controlled trial of...

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