Review Article Analysis of the Registration Information on Interventions of Acupuncture and ...

13 Pages·2017·1.53 MB·English

Hindawi
Evidence-Based Complementary and Alternative Medicine
Volume 2018, Article ID 1054629, 12 pages
https://doi.org/10.1155/2018/1054629
Review Article
Analysis of the Registration Information on
Interventions of Acupuncture and Moxibustion Trials in
the International Clinical Trials Registry Platform
YaliLiu ,1,2,3WenjieChen,4YingxinTan,4XingyueYang ,5JiaLiu ,1TingtingLu,3
ShiyanYan,1LiyunHe,1andBaoyanLiu 6
1InstituteofBasicResearchinClinicalMedicine,ChinaAcademyofChineseMedicalSciences,Beijing100700,China
2PostdoctoralResearchStation,ChinaAcademyofChineseMedicalSciences,Beijing100700,China
3EvidenceBasedMedicineCenter,SchoolofBasicMedicalSciences,LanzhouUniversity,Lanzhou,Gansu730000,China
4TheFirstClinicalMedicalCollegeofLanzhouUniversity,Lanzhou,Gansu730000,China
5BeijingUniversityofChineseMedicine,Beijing100700,China
6ChinaAcademyofChineseMedicalSciences,Beijing100700,China
CorrespondenceshouldbeaddressedtoBaoyanLiu;[email protected]
Received 3 August 2017; Accepted 15 November 2017; Published 15 January 2018
AcademicEditor:CaiganDu
Copyright©2018YaliLiuetal.ThisisanopenaccessarticledistributedundertheCreativeCommonsAttributionLicense,which
permitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.
Purpose. To analyze and compare the clinical registration information about acupuncture and moxibustion for intervention
characteristics.Methods.ClinicaltrialsfromtheInternationalClinicalTrialsRegistryPlatformoftheWorldHealthOrganizationin
acupunctureandmoxibustionwerecomprehensivelycollectedfrom2013to2015;datawereindependentlyscreenedandextracted
bytworetrievers,andrelevantdatainvolvingeitherbasicdescriptionsorinterventioncharacteristicswereanalyzed.Results.425
acupunctureandmoxibustionregisteredclinicaltrialswereincluded;88.00%(374/425)weredesignedascontrolledstudies,among
which38.59%(164/425)hadshamacupunctureasthecontrolgroup.Themostcommondiseaseswerepain-relatedatapproximately
19.29%(82/425)oftrials.Reportsontheinterventioninformationintheseacupunctureandmoxibustionclinicalstudieswerenot
sufficientlypresented;thesereportsincludedthereportingofnamesofpoints(39.8%),themethodofneedlestimulation(32.5%),
needletype(29.6%),needleretentiontime(34.1%),thenumberoftreatmentsessions(22.4%),andthefrequencyanddurationof
treatmentsessions(38.1%).Conclusion.Theregistrationinformationfortheclinicaltrialsofacupunctureandmoxibustionwas
quitelowaccordingtothisinvestigationalstudy.Stepsshouldbetakentoimprovethequalityofacupunctureandmoxibustion
registrationinformation.
1.Introduction Since the 20th century, acupuncture and moxibustion
clinical trials have progressed into a bustling and booming
AcupunctureandmoxibustionhavebeenpracticedinChina era not only in the quantity of studies but also in quality;
for more than 3000 years and are considered to be com- in addition, the diseases included in clinical trials have
plementary and alternative therapy [1]. Benefits from these expandedoverthesedecades[4,5].Manyproblemsandcon-
therapiesincluderelativesafety,effectiveness,feasibility,and cernsmanifestedduringthistimeperiod;forexample,there
economicwellbeing.Since1979,theWorldHealthOrganiza- was a shortage of well-designed and strictly implemented
tion (WHO) has promulgated 43 diseases with indications clinicalstudies[6].Evidencefromtheseclinicalstudiescould
applicable to acupuncture and moxibustion [2]. Therefore, not be cited and generalized to improve acupuncture and
these traditional Chinese therapies have become publicly moxibustionpractice.Thebarrierhasbeendiminishingwith
acceptableinclinicalpracticeintheWest[3]. solidevidence.
2 Evidence-BasedComplementaryandAlternativeMedicine
In November 2004 in Mexico City, the WHO was India), Cuban Public Registry of Clinical Trials (RPCEC,
regarded as the lead organization in establishing the Inter- Cuba), German Clinical Trials Register (DRKS, German),
nationalClinicalTrialsRegistryPlatform(ICTRP)[7].This IranianRegistryofClinicalTrials(IRCT,Iran),ISRCTN.org
milestone event was a consensus decision during the Min- (British), Japan Primary Registries Network (JPRN, Japan),
isterial Summit on Health Research [8]. It was in May Pan African Clinical Trial Registry (PAC-TR, Africa), Sri
2007 when the ICTRP officially broke ground [9], and the Lanka Clinical Trials Registry (SLCTR, Sri Lanka), the
importanceoftrialregistrationhasbeengraduallyaccepted Netherlands National Trial Register (NTR, Netherlands),
[10–12].Todate,16dataproviders,includingtheUnitedStates BrazilianClinicalTrialsRegistry(ReBec,Brazil),EUClinical
and China, have been authorized as the first registration Trials Register (EU-CTR, EU), and Thai Clinical Trials
institutionsoftheWHOICTRP[13].InMay2007,theWHO Registry(TCTR,Thailand).
TrialRegistrationDataSet(TRDS)wasannounced,settinga
minimumof20itemsfortrialregistration[14].International 2.3. Data Extraction. Using a predefined data extraction
clinical trial registration has been implemented to a large formthatcollectedinformationforthisstudy,twoevaluators
extenttoimprovethequalityofclinicaltrials,aswellasform independently extracted data (Wenjie Chen and Yingxin
a transparent presentation of trial progress and execution Tan);disagreementsinthedataextractionwereresolvedby
[15]. another evaluator (Yali Liu) after further consultation. The
This study aims to collect and analyze the 20 items of contentofthedataextractionformswascategorizedintothe
the WHO TRDS and other registry information from the followingsections.
16 clinical trial register centers of the WHO ICTRP; pro-
videanoverviewoftheregisteredacupuncture-moxibustion 2.3.1. Basic Registry Information on the 16 Clinical Trial
clinical trials for manipulation specifications and reporting RegistryCenters. Thisinformationincludedthenameofthe
performance; and propose the necessity to establish the registry platform, nationality/region, website, language, the
Acupuncture-MoxibustionClinicalTrialRegistry(AMCTR) date in which the platform was established, the setup and
center. dispositionofthe16first-ratestudycentersworldwide,and
the20itemsintheWorldHealthOrganization(WHO)Trial
2.MaterialsandMethods RegistrationDataSet(TRDS).
Thecategoriesfortheregistryinformationwereformu-
2.1.Inclusion/ExclusionCriteria. Allacupunctureandmox- latedbythe16ICTRPclinicalstudycenters;theseincluded
ibustion clinical trials registered in the WHO ICTRP were theregisteredtitlefortheplatform,updatetime,registrytime,
eligibleforinclusion.Nocriteriafordiseasewereapplied,nor statusoftheregistrynumber,informationontheapplicant,
were criteria applied for participant age, sex, and ethnicity; approval-related report from the institutional ethics board,
the studied interventions were acupuncture and moxibus- information on the study-center that conducted the desig-
tion, including Filiform needle, percussopunctator, Auricular nated trials, funding and financial resources, study design
Acupuncture, or transcutaneous electrical acupoint stimula- (disease,studycategory/type,purpose,design,methodology,
tion, indicated as the major medical treatment. The control inclusionandexclusioncriteria,interventions,outcomes,and
group for any comparison was placebo, no intervention, or endpoints), study time (initiation, duration, and close-out),
another intervention. There was no definition for endpoint designated study sites, human histology samples collected,
outcomes. Exclusion criteria included incomplete registry subjectrecruitmentandenrollment,studydatamanagement
information, no information indicating that acupuncture institution, and any commissioned/contracted data analysis
or moxibustion had been used to intervene in the disease companies/agents.
studiedorthatacupunctureormoxibustionwereonlyused
as a secondary concomitanttherapy. Acupuncture, needling, 2.3.2. Basic Information Registered Clinical Trials in the
acupressure,moxibustion,auriculotherapy,andacupointwere Acupuncture and Moxibustion Fields. These fields involved
usedaskeywordsearchterms,regardlessoftheinitialregistry registrytime,thenameoftheclinicaltrialsregistryplatform,
language. studytype,samplesize,theobjectdisease/symptoms,inter-
vention(s),andendpointoutcomes.
2.2. Database Sources. DatafromtheWHOICTRP(http://
apps.who.int/trialsearch/Default.aspx)registryrecordsbetween 2.3.3. Specific Information on Interventions in Registered
2013 and 2015 were used. This registry platform included Clinical Trials in the Acupuncture and Moxibustion Fields.
Australia,NewZealand,China,Korea,UnitedStates,India, Based on the Standards for Reporting Interventions in
Cuba, Germany, Iran, United Kingdom (UK), Japan, Pan Clinical Trials of Acupuncture (STRICTA) [16], the data
African Region, Sri Lanka, Netherlands, Belgium, and the extraction form was used to investigate the manipulation
EuropeanUnion(EU)Region.Thespecificnamesofthereg- procedures.Theinformationcollectedincludedthenumber
istriesareasfollows:AustralianNewZealandClinicalTrials of needle insertions per subject per session, names (or
Registry (ANZCTR, Australia, and New Zealand), Chinese locationifnostandardname)ofpointsused,depthofinser-
Clinical Trial Register (ChiCTR, China), Clinical Research tion, response sought, needle stimulation, needle retention
InformationService(CRIS,RepublicofKorea),ClinicalTri- time, needle type, and the registry information on sham
als.gov(UnitedStates),ClinicalTrialsRegistry,India(CTRI, acupuncture.
Evidence-BasedComplementaryandAlternativeMedicine 3
Table1:ThecharacteristicinformationofplatformsinICTRP.
Thetimeof
Platform Countries/District Internetsite Language
establishment
ANZCTR Australia/NewZealand http://www.anzctr.org.au/ English 2003
ChiCTR China http://www.chictr.org.cn/ English,Chinese 2005
CRIS Kore http://cris.nih.go.kr/ English,Korean
1988
ClinicalTrials.gov UnitedStates http://www.clinicaltrials.gov/ English
1997
CTRI India http://www.ctri.nic.in/ English 2005
RPCEC Cuba http://registroclinico.sld.cu/ English,Spanish
DRKS Germany http://www.germanctr.de/ English,German 2008
IRCT Iran http://www.irct.ir/ English,Arabic
ISRCTN.org UnitedKingdom http://www.isrctn.org/ English 2007
JPRN Japan http://rctportal.niph.go.jp/ English,Japanese 1988
PAC-TR Africa http://www.pactr.org/ English 2005
SLCTR SriLanka http://www.slctr.lk/ English
NTR Netherlands http://www.trialregister.nl/ English
ReBec Brazil http://www.ensaiosclinicos.gov.br/ English,Portuguese
EU-CTR Europe https://www.clinicaltrialsregister.eu/ English 2004
TCTR Thailand http://www.clinicaltrials.in.th/ English,Thai
2.4.DataAnalysis. MicrosoftExcel(Version2007)wasused and164(38.59%)werecomparedwithshamacupuncture;187
toanalyzethecodeddataitemsforanystatisticallysignificant and50studiesrecruitedparticipantsfromChina(including
differences.Categoricaldataispresentedasnumber(𝑛)and HongKongandTaiwan)andtheUnitedStates,respectively.
percent(%). Thelargestsamplesizewas1000subjects(Table4).Clinical
Trials.gov, ChiCTR, and CRIS had the most clinical studies
3.Results (Table5). Pain symptoms were the main indication for
treatmentwithacupunctureormoxibustion,comprising82
3.1.BasicInformationoftheRegisteredClinicalTrialCenters (19.29%)ofthestudies;theotherdiseasesandsymptomswere
ofICTRP. Todate,16registrieshavebeendesignatedbythe neoplasm (7.29%, 31/425), stroke (4.00%, 17/425), arthritis
WHOICTRPasfirst-rateclinicaltrialregistrycenterswhich (3.53%, 15/425), depression (3.06%, 13/425), and insomnia
coverallsixcontinents.ThesearesummarizedinTable1. (2.59%,11/428)(Table6).
3.2. Categorization of the Registry Information Designated 3.4. Characteristics of the Acupuncture and Moxibustion
by the ICTRP Clinical Trial Registry Centers. There are 20 TrialsintheWHOICTRP. AssummarizedinTable7,there
items in the TRDS stipulated by the WHO ICTRP that are were no sufficiently specific descriptions of acupuncture
reportedbythefirstsixteenregistryplatforms,asshownin and moxibustion manipulation or the procedures in these
Table2. Moreover, specific registry information from these reportsoftheclinicaltrialsregisteredbetween2013and2015.
centerssupplementsthefundamentalTRDS.InTable3,some These trials mainly covered Acu-point [39.8% (169/425)],
supplemental data are included, except for the 20 items in the method for acupuncture stimulation [32.4% (138/425)],
the WHO TRDS; in this study, a total of 45 registry items the instrumental needle type [29.6% (126/425)], needling
areincluded.ItisnotabletomentionthattheANZCTRhad keep-in time [34.1% (145/425)], unit number for acupunc-
definedmorethan30itemsforitsregistryinformation;other ture therapy [22.4% (95/425)], therapeutic frequency, and
centershavesetsofitemsthatvaryfrom15to25. the timing of each acupuncture scheme/regimen [38.1%
(162/425)]. Among the countries of recruitment in these
3.3. Basic Registry Information for Acupuncture and Moxi- platforms, China represented 1.6% (3/187), 34.8% (65/187),
bustion Clinical Trials. We reviewed 425 acupuncture and 10.7%(20/187),8.0%(15/187),39.6%(74/187),29.4%(55/187),
moxibustion clinical trials that had completed registration 17.1% (32/187), 16.0% (30/187), and 32.1% (60/187), respec-
between 2013 and 2015. Among them, 124 (29.18%) were tively. Fewer trials reported other details of the acupunc-
registeredin2013,123(28.94%)wereregisteredin2014,and ture intervention. For example, only 11.8% (50/425) of the
178 (41.89%) were registered in 2015. The studies that were trialsreportedanchoringdepth,8.9%(38/425)reportedifa
registered in the WHO ICTRP were mainly interventional somaticresponsewastriggered(suchasspecificself-sensual
studies (89.18%, 379/425); only 3.53% (14/425) were obser- response from a receiver), and 4.9% (21/425) reported the
vational studies; 88.00% (374/425) were controlled studies number of needles. The manipulation in these registered
4 Evidence-BasedComplementaryandAlternativeMedicine
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6 Evidence-BasedComplementaryandAlternativeMedicine
Table4:Thenumberofclinicaltrialsofacupuncture-moxibustioninWHOICTRP.
Numberof
Category Characteristic 𝑛=425(%)
2013 124
Registertime
2014 123
(year)
2015 178
Interventionstudy 379
Studytype Observationstudy 14
Others 32
Withcontrolgroup 374
Shamacupunctureincontrolgroup 164
Studydesign
Acupunctureversusnonacupuncture
163
(e.g.,pharmacologictreatment,physiotherapy)
Theothertreatmentprogram 97
China 187∗
UnitedStates 50
Countriesofrecruitment Korea 47
OtherCountries 120
Unclear 21
Samplesize Maximum/minimum 1000/4
∗
IncludingHongkongandTaiwan.
Table5:Thenumberofclinicaltrialsofacupuncture-moxibustionin16countriesinWHOICTRP.
Thenumberof Thenumberof
The Total
Countries/district Internetsite clinicaltrialsin clinicaltrialsIn
others number
acupuncture moxibustion
Platform
ClinicalTrials.gov UnitedStates http://www.clinicaltrials.gov/ 178(176+2∗) 3(1+2∗) 22 201
ChiCTR China http://www.chictr.org.cn/ 99 3 4 106
CRIS Kore http://cris.nih.go.kr/ 28(27+1∗) 2(1+1∗) 1 30
IRCT Iran http://www.irct.ir/ 13 0 8 21
Australia/New
ANZCTR http://www.anzctr.org.au/ 8 0 4 12
Zealand
ISRCTN.org UnitedKingdom http://www.isrctn.org/ 16 0 1 17
JPRN Japan http://rctportal.niph.go.jp/ 16(14+2∗) 4(1+2∗) 0 18
DRKS Germany http://www.germanctr.de/ 4 0 1 5
ReBec Brazil http://www.ensaiosclinicos.gov.br/ 5 0 1 6
TCTR Thailand http://www.clinicaltrials.in.th/ 6 0 0 6
NTR Netherlands http://www.trialregister.nl/ 1 0 0 1
PAC-TR Africa http://www.pactr.org/ 1 0 0 1
CTRI India http://www.ctri.nic.in/ 1 0 0 1
Total 425
∗
Reportbothacupunctureandmoxibustionintitles.
studies was mainly manual acupuncture(55.06%, 234/425); Among the 425 trials, 164 (38.59%) trials used sham
in the others it was electrical stimulation (22.59%, 96/425), acupuncture as a control, but specific information, such as
acupressure (4.23%, 18/425), auricular acupuncture (3.53%, the application materials (0.61%, 1/164), needle stimulation
15/425), dry needling (4.70%, 20/425), laser acupuncture (14.02%, 23/164), depth of insertion (11.59%, 19/164), and
(4.23%,18/425),moxibustion(2.35%,10/425),auricularacu- needle retention time (0.61%, 1/164), was reported at a low
pressure(0.47%,2/425),thermotherapy(0.70%,3/425),and rate; 61 (32.70%) trials did not report any details about the
pharmaco-acupuncture(0.23%,1/425)(Table8). shamacupuncture(Table9).
Evidence-BasedComplementaryandAlternativeMedicine 7
Table6:TheconditionfocusoninthetrailsinICTRP.
Conditionfocusedoninthestudies Acupuncture Moxibustion Theothers Totalnumber
Pain 75 1 6 82
Cancer 28 0 3 31
Stroke 17(16+1∗) 1∗ 0 17
Arthritis 11 0 4 15
Depression 11 0 2 13
Insomnia 11 0 0 11
Polycysticovariansyndrome 9 0 1 10
Obesity 7 0 2 9
Hypertension 6 0 1 7
Theothers 208(202+6∗) 11(5+6∗) 24 237
Total 376 6 43 425#
∗Reportbothacupunctureandmoxibustionintitles.#Seventrialswith2diseasesintitles(2withpain+cancer,2withcancer+insomnia,2withstroke+
depression,2withdepression+insomnia).
4.Discussion of integrative therapy, directly influencing the authenticity
andreliabilityofstudies.
4.1.CurrentStatusoftheRegistrationInformationintheWHO
Controlled studies are fundamental to assessing effects
ICTRP. In this overview, we have compared the registry
in clinical trials. The purpose of controlled studies is to
itemsofthe16clinicalcentersthatweredesignatedaccording
minimizeconfoundingfactorsandprovideareliable,cogent
to the recommendations of the WHO ICTRT. Generally,
conclusion. Because of their unique manipulation process,
the minimum 20 items in the WHO TRDS were followed;
acupuncture and moxibustion have encountered difficulties
however,informationoutsideofthese20itemsvariedwidely
indevelopingandvalidatingplaceboneedlesasappropriate
betweendifferentcountries.Themaininformationreported
controls[20].Researchersdesignateshamacupunctureasa
wasabriefsummary,purpose,trialcompletiontime(registry
control group, such as sham treatment with invasive skin
updatedate,timetotrialtermination),methodologicdetails
or needling at inappropriate points or at nonacupuncture
(inclusion criteria, age of the subjects, study phase, and
points, needling with blunt needles, sham laser, and sham
design including groups/distribution/blinding of subjects
electroacupuncture [16, 21–24]. However, the rationale for
andblindingofgroups/interventions/drugnames),andother
thesesimulationdesignsandtheiranticipatedplacebo-effect
information(dropouts,ethicalissues,datamonitoringcom-
iscloselyrelatedtoconscientiouspseudo-manipulationand,
mittee,andupdatesonimportantinformation).
consequently, rigid implementation. Detailed reports are
needed about sham acupuncture materials, sham-acupoint,
4.2. Deficiencies in the Characteristics of Clinical Trials
orlocationswithoutstandardnames,manipulationmethods,
of Acupuncture and Moxibustion Registered in the ICTRP.
and procedures (stimulation methods, depth of insertion).
Acupunctureandmoxibustionareacorepartoftraditional
Moreover, the rationale for sham-needling or its purported
Chinese medicine and are also very important in comple-
placebo-effectshouldalsobeexplained;otherwise,thereader
mentary and alternative medicine. Compared with surgery
of the study cannot comprehend or be persuaded to trust
and other modern medical interventions, acupuncture and
the sham-needling maneuvers to enhance the accuracy of
moxibustion are characterized by obvious differences. To
measuring intervention effectiveness. Among the 164 trials
standardize clinical study reporting on acupuncture and
reporting the use of sham acupuncture, some necessary
moxibustion, STRICTA and STRICTOM (Standards for
informationsuchasmaterials,stimulationmethods,depthof
Reporting Interventions in Clinical Trials of Moxibustion)
insertion,anddurationarenotavailablebecauseofthelow
have been issued as an extended section in the CONSORT
incidenceofreporting.
statement[17–19].
SixcriteriahavebeensetasSTRICTAitems:acupuncture The reporting rate of the characteristics of acupuncture
rationale,detailsofneedling,treatmentregimen,othercom- andmoxibustionintheWHOICTRPforbothChineseand
ponents of treatment, practitioner background, and control clinicaltrialsandthosefromothercountrieswaslow.Therea-
orcomparatorinterventions[17].Inthisstudy,adataextrac- sonsmaybeasfollows:(1)all16clinicaltrialsregistrycenters
tionformwasdesignedbasedontheSTRICTAtocollectand werefoundedbasedonthemodeorconventionofWestern-
analyzetheregistrationinformation.Astheresultsindicated, medicine-oriented registry format design, which may not
necessary information, such as instrumental needle type, havesufficientlyconsideredthecharacteristics/specifications
name of points used, depth of insertion, method of needle ofacupunctureandmoxibustion;(2)clinicaltrialsreported
stimulation, needle retention time, response sought, and and delineated acupuncture interventions in a meticulous
treatmentsessions,wasincompletelyreported(lessthan40% manner, and completing registration information was done
accordingtoouranalysis).However,thisinformationneeds withlittledetail;(3)theinclusionandexclusioncriteriafor
tobedescribedindetailbecauseitisanimportantcomponent theclinicaltrials,suchasthePICO,havenotbeenincluded
8 Evidence-BasedComplementaryandAlternativeMedicine
r
Totalumbe 1210630201105211718100606 ∗187 504712021425
n
Frequencyanddurationoftreatmentsessions𝑛(%) 7(58.3)9(8.5)25(83.3)90(44.8)1(100.0)02(40.0)8(38.1)11(64.7)2(11.1)1(100.0)004(66.7)02(33.3) 60(32.1)21(42.0)35(76.6)37(30.8)9(42.9)162(38.1)
Numberoftreatmentsessions𝑛(%) 4(33.3)6(5.7)13(43.3)56(27.9)002(40.0)2(9.5)5(29.4)2(11.1)1(100.0)004(66.7)00 30(16.0)17(34.0)18(38.3)26(21.7)4(19.0)95(22.4)
WHOICTRP. Needletype(diameter,length,andmanufacturerormaterial)𝑛(%) 9(75.0)5(4.7)17(56.7)82(40.8)002(40.0)3(14.3)4(23.5)00001(16.7)03(50.0) 32(17.1)23(46.0)25(53.2)38(31.7)8(38.1)126(29.6)
n
i
n
oxibustio Needleretentiontime𝑛(%) 7(58.3)12(11.3)16(53.3)85(42.3)101(20.0)11(52.3)5(29.4)1(5.6)0004(66.7)02(33.3) 55(29.4)13(26.0)25(53.2)41(34.2)11(52.4)145(34.1)
m
-
acupuncture Needlestimulatione.g.,manual,electrical)𝑛(%) 7(58.3)35(33.01)8(26.7)75(37.3)001(20.0)1(4.8)2(11/8)6(33.3)0002(33.3)01(16.7) 74(39.6)11(22.0)17(36.2)30(25.0)6(28.6)138(32.5)
of (
clinicaltrials Responsesought(e.g.,deqiormuscletwitchresponse)𝑛(%) 2(16.7)4(3.8)5(16.7)23(11.4)00003(17.6)0000001(16.7) 15(8.0)1(2.0)8(17.0)10(8.3)4(19.0)38(8.9)
of
sticinformation Depthofinsertion,basedonaspecifiedunitofmeasurement,oronaparticulartissuelevel𝑛(%) 02(1.9)6(20.0)37(18.4)0001(4.8)4(23.5)0000000 20(10.7)2(4.0)12(25.5)12(10.0)4(19.0)50(11.8)
ri
e7:Thecharacte Names(orlocationifnostandardname)ofpointsused(uni/bilateral)𝑛(%) 5(41.7)18(17.0)23(76.7)93(46.3)00011(52.3)9(52.9)3(16.7)000403(50.0) 65(34.8)14(28.0)36(76.6)43(35.8)11(52.4)169(39.8)
l
b e
Ta Numberofneedleinsertionspersubjectpersession(meanndrangewherrelevant)𝑛(%) 02(1.9)5(16.7)12(6.0)0001(4.8)000001(16.7)00 3(1.6)7(14.0)7(14.9)3(2.5)1(4.8)21(4.9)
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PlatformANZCTRChiCTRCRISClinicalTrials.goCTRIRPCECDRKSIRCTISRCTN.orgJPRNPAC-TRSLCTRNTRReBecEU-CTRTCTRCountriesofrecruitChinaUnitedStatesKoreaOthercountriesUnclearTotal IncludingHongkong
∗
Evidence-BasedComplementaryandAlternativeMedicine 9
harmaco-upuncture00010000000000001
Pac
n
o
xibusti 032200000310000013
o
m
ure
aserunct3211100100000000018
Lp
u
ac
y
ype. Heatherap10020000000000003
t t
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n/needl uncture
nipulatio Electroacup 33054300012600030196
a
m
uncture Electricalstimulation00000000000000000
p
u
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bouta Dryneedlin2001600000000000220
a
ndetail Dryupping00000002000000002
i c
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-moxibusti Battlefieldacupuncture00030000000000003
e
acupunctur Auricularacupuncture000900221000010015
n
ni arure
rmatio Auriculacupress00020000000000002
o
nf
ei ure
8:Th upunct 3642210200210139001103229
le Ac
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u
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Platform ANZCTRChiCTRCRISClinicalTriCTRIRPCECDRKSIRCTISRCTN.orJPRNPAC-TRSLCTRNTRReBecEU-CTRTCTRTotal
10 Evidence-BasedComplementaryandAlternativeMedicine
n
atedatio
relrm 621622001013000100 313818161
oo
Nnf
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ure onofmentons
punct Duratitreatsessi 0000000100000000 000101
u
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usti ofs ptherti 00115000010001100 2318519
b es
oxi ails Din
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ure in onh
acupunct approach Stimulatiapproac 08013000002000000 12128023
of al
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nicaltrials Operatio Material 0001000000000000 100001
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nre mesoint 020223000752000000 325514359
i ap
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reincontrol Acupunctureversusshamacupuncture 649974001877001200 781216499164
u
ationaboutshamacupunct dydesignincontrolgroup Acupunctureversustheotherinterventions(e.g.,differentacupuncturemethod) 316946003268000104 3118938298
Table9:Theinform Thestucupunctureversustheotherinterventionswithoutacupuncture(e.g.,drugsandphysiotherapy) 34112811011143100302 632022499163
A
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PlatformANZCTRChiCTRCRISClinicalTrials.goCTRIRPCECDRKSIRCTISRCTN.orgJPRNPAC-TRSLCTRNTRReBecEU-CTRTCTRCountriesofrecruitChinaUnitedStatesKoreaOthercountriesUnclearTotal