Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA) : Extending the CONSORT statement

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Revised standards for reporting interventions in clinical trials of

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MacPherson, Hugh orcid.org/0000-0003-4255-4768, Altman, D.G., Hammerschlag,

Richard et al. (4 more authors) (2015) Revised standards for reporting interventions in

clinical trials of acupuncture (STRICTA) : Extending the CONSORT statement.

Acupuncture and Related Therapies. pp. 35-46.

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ContentslistsavailableatScienceDirect

Acupuncture

and

Therapies

j ou rn a l h om ep a g e :w w w . e l s e v i e r . c o m / l o c a t e / a r t h e

Revised

Standards

for

Reporting

Interventions

in

Clinical

Trials

of

Acupuncture

(STRICTA):

Extending

the

CONSORT

statement

夽

Hugh

MacPherson

a,∗

_,

_Douglas

_G.

_Altman

b

_,

_Richard

_Hammerschlag

c

_,

_Li

_Youping

d

_,

Wu

Taixiang

d

_,

_Adrian

_White

e

_,

_David

_Moher

f

_,

_on

_behalf

_of

_the

_STRICTA

_Revision

_Group

1

a_Department_of_Health_Sciences,_University_of_York,_York,_United_Kingdom b_Centre_for_Statistics_in_Medicine,_University_of_Oxford,_Oxford,_United_Kingdom c_Department_of_Research,_Oregon_College_of_Oriental_Medicine,_Portland,_OR,_United_States

d_Chinese_Cochrane_Centre,_Chinese_{Evidence-Based}_Medicine_Centre,_West_China_Hospital,_Sichuan_University,_China e_Primary_Care_Research,_Peninsula_Medical_School,_Universities_of_Exeter_and_Plymouth,_Plymouth,_United_Kingdom,

f_Ottawa_Methods_Centre,_Ottawa_Hospital_Research_Institute,_Department_of_Epidemiology_and_Community_Medicine,_Faculty_of_Medicine,_University_of

Ottawa,Ottawa,Canada,Canada

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Availableonline12April2016

a

b

s

t

r

a

c

t

TheStandardsforReportingInterventionsinClinicalTrialsofAcupuncture(STRICTA)werepublishedin fivejournalsin2001and2002.Theseguidelines,intheformofachecklistandexplanationsforuseby authorsandjournaleditors,weredesignedtoimprovereportingofacupuncturetrials,particularlythe interventions,therebyfacilitatingtheirinterpretationandreplication.Subsequentreviewsofthe appli-cationandimpactofSTRICTAhavehighlightedthevalueofSTRICTAaswellasscopeforimprovements andrevision.

Tomanagetherevision processa collaborationbetweenthe STRICTAGroup,theCONSORTGroup,andtheChineseCochrane Centrewasdevelopedin2008.Anexpertpanelwith47participants wasconvenedthatprovidedelectronicfeedbackonareviseddraft ofthechecklist.Atasubsequentface-to-facemeetinginFreiburg,a groupof21participantsfurtherrevisedtheSTRICTAchecklistand planneddissemination.

ThenewSTRICTAchecklist, which isan officialextensionof CONSORT, includes six items and 17 sub-items. These set out reportingguidelinesfortheacupuncturerationale,thedetailsof

夽 _This_is_an_open-access_article_distributed_under_the_terms_of_the_Creative CommonsAttributionLicense,whichpermitsunrestricteduse,distribution,and reproductioninanymedium,providedtheoriginalauthorandsourceare cred-ited.InordertoencouragedisseminationoftheSTRICTAStatement,thisarticle is freely accessibleon the Acupunctureand Related Therapies website and willbealsopublishedinAcupunctureinMedicine,AustralianJournalof Acupunc-ture and Chinese Medicine, Journal of Alternative & Complementary Medicine, JournalofEvidence-basedMedicine,MedicalAcupunctureandPLoSMedicine.For details onciting and usingSTRICTA guidelines and theCONSORT statement, seehttp://www.stricta.info/citations.htmlorhttp://www.consort-statement.org/ consort-statement/citing-and-using-consort/respectively.

∗_{Corresponding}_author.

E-mailaddress:hugh.macpherson@york.ac.uk(H.MacPherson).

1 _Membership_of_the_STRICTA_Revision_Group_is_provided_in_the

Acknowledg-ments.

needling,thetreatmentregimen,othercomponentsoftreatment, thepractitionerbackground,andthecontrolorcomparator inter-ventions. In addition, and as part of this revision process, the explanationsforeachitem havebeenelaborated,and examples ofgoodreportingforeachitemareprovided.Inaddition,theword “controlled”inSTRICTAisreplacedby“clinical”,toindicatethat STRICTAisapplicabletoabroadrangeofclinicalevaluationdesigns, includinguncontrolledoutcomestudiesandcasereports.

ItisintendedthattherevisedSTRICTA,inconjunctionwithboth themainCONSORTStatementandextensionfornonpharmacologic treatment, willraisethequalityof reportingofclinicaltrialsof acupuncture.

1. Introduction

The STRICTA(Standards for Reporting Interventions in Clin-ical Trials of Acupuncture) reporting guidelines, first published in2001[1–9],weredesigned toimprovethecompletenessand transparencyofreportingofinterventionsincontrolledtrialsof acupuncture,inorderthatsuchtrialsmaybemoreaccurately inter-pretedandreadilyreplicated.STRICTAcomprisedachecklistthat expandedthegenericcontentofItem5oftheCONSORTstatement

[10,11],whichrelatestothereportingoftheintervention. Asurveyofauthorsofclinicaltrialsandsystematicreviewswas subsequentlyconductedtodeterminetheusefulnessofSTRICTAin

http://dx.doi.org/10.1016/j.arthe.2016.03.001

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helpingthemwritetheirreports[12].Inaddition,asurveyof90 acupuncturetrialswasundertakentoassesswhetheruseofthe STRICTAchecklistwasassociatedwithimprovedreportingover time[13].Theresultsoftheseinitiativesledtoconclusionsthat mostSTRICTAitemswerefoundtobenecessaryandeasytouse, thoughsomewereseenaspoorlyreported,ambiguousorpossibly redundant,andanumberofsuggestionsweremadeforadditional items.ArevisionofSTRICTAwasthereforeproposed.

Meanwhile,extensionstoCONSORThavebeen developedto coverthereportingofnon-pharmacologicaltreatments[14,15]and pragmatictrials[16].Sincethereareacupuncturespecificaspects toreportingnotcoveredbytheseextensions,itwasdecidedthat STRICTAshouldberevisedinamannercongruentwithCONSORT anditsextensionsfornon-pharmacologicaltreatmentsand prag-matictrials.

Thecombinationofthesedevelopmentsledtoanagreement betweentheCONSORTGroupandtheSTRICTAGroup,in collabora-tionwiththeChineseCochraneCentreandtheChineseCentrefor Evidence-basedMedicine,toreviseSTRICTAasaformalextension toCONSORT.Therevisionprocesseshavebeendescribedinmore detailelsewhere[17].Thispaperdescribestheoutcomeintermsof anewchecklist,updatedexplanations,andpublishedexamplesof goodreporting.

2. Methods

Inthesummerof2008,agroupof47expertsfromthe orig-inalSTRICTAGroup,theCONSORTGroup,theWorld Federation ofAcupunctureandMoxibustionSocieties,theAcupuncture Trial-ists’Collaboration[18],theSocietyforAcupunctureResearch[19], andclinicaltrialauthorswere surveyed[12].Theexpertswere from15countries,41hadacademicpositions,31were acupunc-turists,18wereinvolvedwithjournals,suchasboardmembers,15 werephysicians,and11hadbeeninvolvedpreviouslyin develop-ingreportingguidelines.Theseexpertswereconsultedinregard toadraftofrevisedSTRICTAitemsthathadevolvedfromprevious research[12,13].Feedbackwascollatedandforwarded(with per-mission)tothoseinvitedtoaconsensusdevelopmentworkshop, thenextphaseoftherevisionprocess.

Twenty-one individuals attended a workshop in Freiburg, Germany, in October 2008. The attendees included experts in epidemiology,trialmethodology, statistics,and medical journal editing.Justoverhalftheparticipantswereacupuncturistsfrom avarietyofbackgrounds,includingphysicianandnon-physician. Allattendeesreceivedcollatedfeedbackfromthe47experts,along withadraftrevisedSTRICTAchecklistforconsideration.

The workshop comprised presentations about the history of STRICTA, CONSORT, and the then new CONSORT non-pharmacologicaltreatmentsextension[14,15].Theresultsoftwo investigationsintotheutilityandacceptabilityofSTRICTA[12,13], andthesubsequentconsultationwiththe47experts,werealso presented.Ageneraldiscussionandagreementongenericissues relatingtoSTRICTAwerefollowedbyadiscussionofeach nomi-natedchecklistitem.Theaimwastoagree,wherepossible,onthe contentoftheupdateddraftchecklistaswellastodeveloparevised setofexplanationsforeachincludeditem.

Subsequenttotheworkshop,asmallwritinggroupediteddrafts oftherevisedSTRICTAchecklist,identifyingforeachitemoneor moreexemplarsofgoodreporting,anddevelopedtextexplaining therationaleanddiscussingrelevantevidence.Takingintoaccount furtherfeedbackfromthoseattendingtheFreiburgworkshop,the writinggroupfinalisedtheSTRICTAchecklist,theexplanationsand theexamplesofgoodreporting.

3. Results

TherewasagreementthatSTRICTAshouldcontinuetofunction asastand-aloneguidelineforreportingacupuncturestudies,and beanofficialextensionofCONSORTforreportingrandomized con-trolledtrials.Therewasalsoconsensusonaminorchangeofname, inthattheword“controlled” inSTRICTAshouldbereplacedby “clinical”,toindicatethatitwasapplicableforreportingabroad rangeofclinicalevaluationdesigns,includinguncontrolled out-comestudiesandcasereports.Thegroupagreedthattherationale behindreportingshouldbetoprovidetheinformationneededto allowreplicationofastudy,reduceambiguityandenhance trans-parency.Thegrouprecognisedthatacupuncturetrialsinevitably differinthedegreeofindividualisationofcarethatispermitted, andagreedthatthereportingguidelineshouldacknowledgethis andbeapplicableacrossthewholerangeofdesigns.Thegroupalso suggestedthat therevisedSTRICTAstatement,when published, shouldbepresentedasembeddedwithinthetwo-groupparallel trialCONSORTchecklist[10] anditsnon-pharmacological treat-mentextensionchecklist[14].

TherevisedSTRICTAchecklistcomprisessixitemsbrokenout into seventeen sub-items (Table 1). Table 2 presents how the revisedSTRICTAchecklistfitswithintheCONSORTchecklist[10]

anditsextensionfornon-pharmacologicaltreatments[14].Below weprovidethechecklisttextforeachofthesixitemsandtheir sub-items,aswellasexplanationsontheneedfortheiradequate reportingandexamplesofgoodreportingfromthepublished lit-erature.

3.1. STRICTAitem1:acupuncturerationale

3.2. Item1a

Style of acupuncture (e.g. Traditional Chinese Medicine, Japanese,Korean,Westernmedical,FiveElement,earacupuncture, etc.).

3.2.1. Explanation

Acupuncturehasalonghistoryinmanyculturesandis charac-terisedbyabroaddiversityofstylesandapproachesinbothEast AsiaandtheWest[20].Inorderforthereaderstocontextualize thetrialwithintherangeofcurrentclinicalpractices,researchers shouldstatetheoverallstyleorapproachonwhichtheyhavebased thetreatments.Iftheresearcherbelievesthetreatmentapproach iscompletelynovel,thenthisshouldbeclearlystated.

3.2.1.1. Examples2.

(i)WebasedtheacupuncturepointselectionsonTraditional Chi-neseMedicinemeridiantheorytotreatkneejointpain,known asthe“Bi”syndrome[21].

(ii)Participantswererandomizedtotwostylesofacupuncture: Japanesestyle(Kiiko-Matsumoto’sForm)andTraditional Chi-neseMedicinestyle[22].

(iii)Four out of five of the acupuncturists primarily practised theFiveElementstylewithadiagnosticfocusonindividual ‘Causative Factors’, (ref) and one used the Traditional Chi-neseMedicine(TCM)stylewithdiagnosisprimarilybasedon syndromepatterns(ref).Bothstylesarerootedintraditional acupuncture theory,and theyare themost common

tradi-2_Note_:_In_the_Examples_that_follow,_the_embedded_terms_(ref)_and_(refs)_refer_to

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Table1

STRICTA2010checklistofinformationtoincludewhenreportinginterventionsinaclinicaltrialofacupuncture.

Item Detail

1.Acupuncturerationale 1a)Styleofacupuncture(e.g.TraditionalChineseMedicine,Japanese,Korean,Westernmedical,FiveElement,ear

acupuncture,etc.)

1b)Reasoningfortreatmentprovided,basedonhistoricalcontext,literaturesources,and/orconsensusmethods,with referenceswhereappropriate

1c)Extenttowhichtreatmentwasvaried

2.Detailsofneedling 2a)Numberofneedleinsertionspersubjectpersession(meanandrangewhererelevant)

2b)Names(orlocationifnostandardname)ofpointsused(uni/bilateral)

2c)Depthofinsertion,basedonaspecifiedunitofmeasurement,oronaparticulartissuelevel 2d)Responsesought(e.g.deqiormuscletwitchresponse)

2e)Needlestimulation(e.g.manual,electrical) 2f)Needleretentiontime

2g)Needletype(diameter,length,andmanufacturerormaterial)

3.Treatmentregimen 3a)Numberoftreatmentsessions

3b)Frequencyanddurationoftreatmentsessions

4.Othercomponentsoftreatment 4a)Detailsofotherinterventionsadministeredtotheacupuncturegroup(e.g.moxibustion,cupping,herbs,exercises, lifestyleadvice)

4b)Settingandcontextoftreatment,includinginstructionstopractitioners,andinformationandexplanationsto patients

5.Practitionerbackground 5)Descriptionofparticipatingacupuncturists(qualificationorprofessionalaffiliation,yearsinacupuncturepractice, otherrelevantexperience)

6.Controlorcomparatorinterventions 6a)Rationaleforthecontrolorcomparatorinthecontextoftheresearchquestion,withsourcesthatjustifythischoice 6b)Precisedescriptionofthecontrolorcomparator.Ifshamacupunctureoranyothertypeofacupuncture-like controlisused,providedetailsasforItems1–3above.

Note:Thischecklist,whichshouldbereadinconjunctionwiththeexplanationsoftheSTRICTAitemsprovidedinthemaintext,isdesignedtoreplaceCONSORT2010’sitem 5whenreportinganacupuncturetrial.

tionalapproachesusedbyprofessionalacupuncturistsinthe UKtoday(ref)[23].

(iv)Eachpatientwastreatedwithnon-localneedleacupuncture (accordingtothe theoryofchannels ofTraditionalChinese Medicine)atdistantpoints,anddryneedlingoflocal myofas-cialtriggerpoints[24].

3.3. Item1b

Reasoning for treatment provided, based on historical con-text,literaturesources,and/orconsensusmethods,withreferences whereappropriate.

The author(s) should provide the reasoning for the chosen treatment,includingrationale fordiagnosis,pointselection and treatmentprocedures. The “rules” that were used in providing treatmentsshouldbedescribed.Whentreatmentswereselected thathaverootsintraditionalpractice,itisrecommendedthatthe historicalandculturalcontextbesupplied.Thisisrelevantfor inter-ventionswithinstylessuchas“TraditionalChineseMedicine”or “TCM”,wherethebroaddiversityofapproachesrequirescareful identificationofwhereandwhenthetreatmentparameterswere developed.Whereconsensusmethods,expertclinicalpanels, prac-titionersurveysorsomecombinationofsourceshavebeenusedto definethetreatmentprotocol,itisrecommendedthatfulldetailsof themethodologybegiven.Literatureandothersourcesshouldbe providedwhererelevant,inorderthatotherscanreplicatethetrial byconsultingthesesource(s)and/ordevelopmentalmethodson whichtreatmentwasbased.Authorsareencouragedtoreference publishedworksthatareeasilyobtainable,suchasabookor jour-nalarticle.Ifthereferenceisathesis,non-publishedwork,written materialonlyavailableinadifferentlanguagefromthejournal arti-cle,oraverbalcommunication,authorsareencouragedtopresent orsummarisetheinformationinanappendixormakeit other-wisegenerallyavailable(e.g.onawebsite).Forfullyindividualised trialswherethegoalistohaverepresentativepractitionerswho areencouragedtopracticeastheynormallydo,itisappropriateto specifytheselectionprocessforthepractitioners,providingdetails ofcriteriafortheirinclusion.It isimportanttonotethatwhere

detailsoftheintendedinterventionaredefinedinadvance,itis possiblethatwhatwasactuallyadministeredmayhavediffered.In suchcases,precisedetailsofthetreatmentsthatwereprovidedare alsonecessary.

3.3.1.1. Examples.

(i)ThisstudyemployedastyleofJapaneseacupuncture devel-opedbyShimaandChace(ref)andManaka(ref),andfollows the Japanese acupuncture training curriculum at the New England School of Acupuncture. In comparison to typical traditional Chinese medicine (TCM) acupuncture, Japanese acupuncture uses smaller needles and inserts needles less deeplyandwithlessmanipulation(ref).Forthesereasons,we believed Japanese acupuncturewouldbeless invasivethan TCM,andthusbetterreceivedbyouradolescentpopulation. Japaneseacupuncturehasbeenshowntobeeffectivein treat-ing certain pain conditions (ref). The specific acupuncture protocolsemployedinthisstudyarebrieflydescribedbelow anddiscussedingreaterdetailinacompanionpaper(ref)[25]. (ii)WebasedpointselectiononindividualisedWestern acupunc-turetechniquesbyusingalistofpointspreviouslyreportedas beingeffectiveinneckpain(refs)andbyreachinga consen-susaccordingtoourownclinicalandteachingpractice(ref). Thespecificpointsforeachindividualweredefinedateach treatmentsession,dependingonthepatient’spain distribu-tionandpalpationoftheneckandthoraxtodetermineah-shi

points,orlocaltenderpoints,foracupuncture.Atleastone dis-talpointwasused.Pointlocationanddepthofinsertionwere asdescribedintraditionaltexts(ref)[26].

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Table2

CONSORT2010checklistwiththeNon-pharmacologicalTrialsExtensiontoCONSORT(withSTRICTA2010extendingCONSORTItem5foracupuncturetrials).

Section/Topic Item# CONSORT2010Statementa_:_Checklist_item_[10]_._Describe: _Additional_items_from_the_{Non-pharmacological}_Trials

ExtensiontoCONSORT[14].Add:

TITLEAND ABSTRACT

1.a Identificationasarandomizedtrialinthetitle Intheabstract,descriptionoftheexperimentaltreatment, comparator,careproviders,centersandblindingstatus. 1.b Structuredsummaryoftrialdesign,methods,results,and

conclusions;forspecificguidanceseeCONSORTfor Abstracts[58,59]

INTRODUCTION Backgroundand objectives

2.a Scientificbackgroundandexplanationofrationale

2.b Specificobjectivesorhypotheses METHODS

Trialdesign 3.a Descriptionoftrialdesign(e.g.,parallel,factorial) includingallocationratio

3.b Importantchangestomethodsaftertrialcommencement (e.g.eligibilitycriteria),withreasons

Participants 4.a Eligibilitycriteriaforparticipants Whenapplicable,eligibilitycriteriaforcentersandthose performingtheinterventions.

4.b Settingsandlocationswherethedatawerecollected Interventions 5 Theinterventionsforeachgroupwithsufficientdetailsto

allowreplication,includinghowandwhentheywere actuallyadministered

Precisedetailsofboththeexperimentaltreatmentand comparator-seeTable1fordetails

Outcomes 6.a Completelydefinedpre-specifiedprimaryandsecondary outcomemeasures,includinghowandwhentheywere assessed

6.b Anychangestotrialoutcomesafterthetrialcommenced withreasons

Samplesize 7.a Howsamplesizewasdetermined Whenapplicable,detailsofwhetherandhowthe clusteringbycareprovidersorcenterswasaddressed. 7.b Whenapplicable,explanationofanyinterimanalysesand

stoppingguidelines Randomization

Sequence generation

8.a Methodusedtogeneratetherandomallocationsequence Whenapplicable,howcareproviderswereallocatedto eachtrialgroup.

8.b Typeofrandomization;detailsofanyrestriction(e.g., blockingandblocksize)

Allocation concealment

9 Mechanismusedtoimplementtherandomallocation sequence(e.g.,sequentiallynumberedcontainers), describinganystepstakentoconcealthesequenceuntil interventionswereassigned

Implementation 10 Whogeneratedtherandomallocationsequence,who enrolledparticipants,andwhoassignedparticipantsto interventions

Blinding 11.a Ifdone,whowasblindedafterassignmenttointerventions (e.g.participants,careproviders,thoseassessing outcomes)andhow

Whetherornotthoseadministeringco-interventionswere blindedtogroupassignment.Ifblinded,methodof blindinganddescriptionofthesimilarityofinterventions. 11.b Ifrelevant,descriptionofthesimilarityofinterventions

Statisticalmethods 12.a Statisticalmethodsusedtocomparegroupsforprimary andsecondaryoutcomes

Whenapplicable,detailsofwhetherandhowthe clusteringbycareprovidersorcenterswasaddressed. 12.b Methodsforadditionalanalyses,suchassubgroup

analysesandadjustedanalyses RESULTS

Participantflow(A diagramisstrongly recommended)

13.a Foreachgroup,thenumbersofparticipantswhowere randomlyassigned,receivedintendedtreatment,andwere analyzedfortheprimaryoutcome

Thenumberofcareprovidersorcentersperformingthe interventionineachgroupandthenumberofpatients treatedbyeachcareproviderorineachcenter. 13.b Foreachgroup,lossesandexclusionsafterrandomization,

togetherwithreasons Implementationof

intervention

Detailsoftheexperimentaltreatmentandcomparatoras theywereimplemented.

Recruitment 14.a Datesdefiningtheperiodsofrecruitmentandfollow-up 14.b Whythetrialendedorwasstopped

Baselinedata 15 ATableshowingbaselinedemographicandclinical characteristicsforeachgroup

Whenapplicable,adescriptionofcareproviders(case volume,qualification,expertise,etc.)andcenters(volume) ineachgroup.

Numbersanalyzed 16 Foreachgroup,numberofparticipants(denominator) includedineachanalysisandwhethertheanalysiswasby originalassignedgroups

Outcomesand estimation

17.a Foreachprimaryandsecondaryoutcome,resultsforeach group,andtheestimatedeffectsizeanditsprecision(e.g., 95%confidenceinterval)

17.b Forbinaryoutcomes,presentationofbothabsoluteand relativeeffectsizesisrecommended

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Table2(Continued)

Section/Topic Item# CONSORT2010Statementa_:_Checklist_item_[10]_._Describe: _Additional_items_from_the_{Non-pharmacological}_Trials

ExtensiontoCONSORT[14].Add:

Harms 19 Allimportantharmsorunintendedeffectsineachgroup; forspecificguidanceseeCONSORTforHarms[60] DISCUSSION

Limitations 20 Triallimitations,addressingsourcesofpotentialbias, imprecision,and,ifrelevant,multiplicityofanalyses Generalizability 21 Generalizability(externalvalidity,applicability)ofthetrial

findings

Generalizability(externalvalidity)ofthetrialfindings accordingtotheintervention,comparators,patientsand careprovidersandcentersinvolvedinthetrial. Interpretation 22 Interpretationconsistentwithresults,balancingbenefits

andharms,andconsideringotherrelevantevidence

Inaddition,takeintoaccountthechoiceofthecomparator, lackoforpartialblinding,unequalexpertiseofcare providersorcentersineachgroup.

OTHER INFORMATION

Registration 23 Registrationnumberandnameoftrialregistry Protocol 24 Wherethefulltrialprotocolcanbeaccessed,ifavailable Funding 25 Sourcesoffundingandothersupport(e.g.,supplyof

drugs);roleoffunders

a_We_strongly_recommend_reading_this_Statement_in_conjunction_with_the_CONSORT₂₀₁₀_explanation_and_elaboration_[11]_for_important_{clarifications}_on_all_the_items.

Ifrelevant,wealsorecommendreadingCONSORTextensionsforclusterrandomizedtrials[61],noninferiorityandequivalencetrials[62],herbalinterventions[63],and pragmatictrials[16].Moreover,additionalextensionsareforthcoming.Forthoseandalsoforup-to-datereferencesrelevanttothischecklist,see http://www.consort-statement.org.

acupuncturesocieties.Thefinalinterventionstrategieswere definedbytheabovementionedthreespecialiststogetherwith thestudyteamandsubsequentlywerecommunicatedtothe externaladvisors[27].

3.4. Item1c

Extenttowhichtreatmentwasvaried.

Theextent towhich the treatmentwasindividualised, both betweenpatientsandbetweenpractitioners,shouldbedescribed. Trialprotocolschooseoneofthreebroadlevelsofindividualisation, rangingfromnoneatall(allpatientsreceivingthesametreatment atallsessions),throughpartiallyindividualisedtreatments(e.g.use ofafixedsetofpointstobecombinedwithasetofpointstobe usedflexibly),tofullyindividualisedtreatmentprotocolswithin whicheachpatientreceivesauniqueandevolvingdiagnosisand treatment.Additionally,thepractitionersmayhavetoapplya stan-dardisedtheoreticalframework,ormaybeallowedtoapplytheir own.Many stylesofacupuncture,whetherbasedontraditional theoriesorWesternizedconceptssuchastriggerpoints,are indi-vidualisedinroutinepractice.Trialsthataremorepragmatic[28]

intheiraim,anddesignedtoreplicateroutinesettingsandpatient groups,havemoreofanemphasisonfullyindividualised treat-ment.Insuchcasesstandardisationmayconsistofaprotocolthat instructspractitionerstoprovidetreatmentsastheynormallydo. Trialsthataremoreexplanatory(mechanistic)intheiraimtendto needatighterdefinitionofspecificcomponentsinorderto min-imisevariationacrosstreatments.

3.4.1.1. Examples.

(i)Eachpatientreceivedindividualisedacupuncturetreatments thatfocusedonspecificneedsandsymptomsthatthe indi-vidualwasexperiencing. Therationaleforthis intervention wastotestacupunctureasitistypicallyperformedinpractice. Pointselectionwasbasedonthegeneralprinciplesof acupunc-tureandTraditionalChineseMedicine(ref).Thetreatmentwas modifiedoverthecourseofthestudytoaccommodatethe indi-vidual’schangingpatternofpain,sleep,orotherhealthissues

[29]

(ii)Theverumpointsconsistedofobligatorypointsandadditional pointsindividuallychosenbythephysiciansonthebasisof tra-ditionalChinesemedicinediagnosisforsyndromes(including tonguediagnosis),acupuncturechannelsrelatedtothe indi-vidualheadachearea,andAhShipoints(locusdolendipoints)

[30].

(iii)Theacupunctureprotocolwasbasedontheconceptof ade-quacy of treatment, (ref) survey results, (ref) a consensus workshop, and recommendations from traditional Chinese protocols.Wedidnotallowmoxibustion,cupping,herbs,or electroacupuncture.Foreachindividualisedtreatmentsession betweensixand10 acupuncturepointsfrom16commonly usedlocalanddistalpointswereselected.Localpointswere Sp9,Sp10,St34,St35,St36,Xiyan,Gb34,andtriggerpoints. DistalpointswereLI4,TH5,Sp6,Liv3,St44,Ki3,BI60,and Gb41[31].

3.5. STRICTAitem2:detailsofneedling

3.6. Item2a

Numberofneedleinsertionspersubjectpersession(meanand rangewhererelevant).

Itisrecommendedthatthereportingofthisitemshouldinclude atotalofneedleinsertionspersubjectpersession.Thisitemis rele-vanttoalldesignsofrandomizedcontrolledtrials,frompragmatic toexplanatory.Formoreexplanatorydesignswhereaformulaof pointsisprescribed, thenumberofneedle insertionsshouldbe reportedasasimpletotal.Formorepragmaticdesigns,with indi-vidualisedtreatments, themeanand range shouldbereported. Clearly,fulldetailsofindividualisedtreatmentcannotbereported ineverysectionofItem2below.However,eachitemshouldbe consideredandasmuchinformationgivenaspossible.

3.6.1.1. Examples.

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pertreatment(range6–12).See(table)forvariationsbetween practitioners[32].

(ii)Disposablestainlesssteelneedles(0.2×50mm,Seirin)were

inserted intothe skinover thetrigger point toa depth of 10–30mm, appropriate tothe muscletargeted, attempting toelicitalocalmuscleresponseusingthe“sparrowpecking” technique.Afterthelocaltwitchresponsewaselicitedora rea-sonableattemptmade,theneedlewasretainedforafurther tenminutes.Themeannumberofinsertionswas3.3[33]. (iii)Intherealacupuncturegroup,theacupuncturepointsHegu

(LI4),Jiache(St6),Xiaguan(St7)andYifeng(SJ17)wereused unilaterallyonthetoothextractionside[34].

3.7. Item2b

Names (or location if no standard name) of points used (uni/bilateral).

Thepointdescriptionsintheseminalclassictexts,suchasthe HuangdiNeijing (Inner Canon ofthe Yellow Emperor) are rare andvague.Thedepictionofacupuncturepointsinrelationto pre-ciseanatomical structuresdatesbackonly100years. Sincethe mid1950s a process of standardisation hasbeen taking place, andtheacupuncturepointdescriptionsbasedonanatomical loca-tionsandproportionalcunmeasurementsystemshaveservedas ablueprintformanyWesterntranslations.Itshouldbenotedthat theselocationshavenotbeenuniversallyadopted.Giventhis his-toricalcontext,itremainsimportanttoknowwhichacupuncture pointshavebeenusedinclinicaltrials,withasaccurate descrip-tionsaspossibleofthelocationofthesepoints,andwhererelevant themethodusedtoidentifythepoints.

Thespecificpointlocationsusedintreatmentswhere standard-isedshouldbedescribedintermsofanacceptednomenclature(e.g. GB21)[35]orintermsofanatomicallocationwherethereisno acceptedname.Whethertheneedlesareinsertedunilaterallyor bilaterallyshouldbestated.Forprotocolswithpartially individu-alisedprescriptions,listanyprescribedessentialoroptionalpoints, anddescribe(inSection3)boththepointsusedateveryvisit,and allthepointsusedonanadhocbasis.Ifthelistisextensive,the mostcommonlyusedpoints(withpercentages)shouldbereported. Whereprotocolsspecifyusingfullyindividualisedpoint prescrip-tions,authorsshouldconsiderthebestwaytoreportthepoints used,forexample bylistingallpointsacrossallsubjects,orby identifyingthemostcommonlyusedpointsifthelistisextensive.

3.7.1.1. Examples.

(i)We based the acupuncture point selections on Traditional ChineseMedicine meridiantheorytotreat kneejointpain, knownasthe“Bi”syndrome.Thesepointsconsistedof5local points(Yanglinquan[gallbladdermeridianpoint34], Yinlin-quan[spleenmeridianpoint9],Zhusanli[stomachmeridian point36],Dubi[stomachmeridianpoint35],andextrapoint Xiyan)and4distalpoints(Kunlun[urinary–bladder,meridian point60],Xuanzhong[gallbladdermeridianpoint39], Sany-injiao[spleenmeridianpoint6],andTaixi[kidneymeridian point3])onmeridiansthattraversetheareaofpain(refs).The samepointsweretreatedforeachaffectedleg.Ifbothknees wereaffected,9needleswereinsertedineachleg[21]. (ii)TheVA(verumacupuncture)groupreceivedacupuncturewith

a 0.25×40-mm stainless steel needle (Asia Med, Munich,

Germany) at LI4, which is situated between the first two metacarpalbonesonthedorsalsideofbothhandsatthetop ofthemusclebelly(figureprovided)[36].

(iii)ThemostfrequentlytreatedlocalpointswereBl23,Bl25,Gb 30,DU4,Bl26,andtheextrapointHuatuojiaji(tableprovided) ...ThemostfrequentlytreateddistantpointswereBl40,Kid

3,Gb34,Bl60,SI3,andDU20.Inmostcases,8–12localpoints and4–6distantpointswereused.Physiciansusedadditional acupuncturepointsin565ofthetreatmentsessions.Themost frequentlyusedadditionallocalpointswereLi4,St40,Bl17, Sp6,andSt36[27].

3.8. Item2c

Depthofinsertion,basedonaspecifiedunitofmeasurement,or onaparticulartissuelevel.

ThedepthofinsertionshouldbeexpressedusingtheChinese measurementofthecun;intermsofanatomicaldepth,forexample, ofsubcutaneoustissue,fascia, muscleor periosteum;orin mil-limetres.Forsometrials,theprotocolmightspecifytheangleand directionofinsertionalongwithdepthofinsertion,inwhichcase theseshouldalsobereported.

3.8.1.1. Examples.

(i)All needle placements were performed by an experienced acupuncturistatapremarkeddepthof4mmfromthetipof theneedle[37].

(ii)Thedepthofneedleinsertionvariedwiththicknessoftheskin andsubcutaneousfattytissuesatthesiteoftheacupuncture points;itwasusually1–1.5cm[38].

(iii)Shallowandlightneedlingstimulation(1–2mm)usingfine needles (0.18–0.16mm) inserted with the aid of insertion tubeswasemphasized.Pointswereneedledata10◦_–20◦_angle

witha2-handneedlingtechnique,generallyinthedirectionof theflowofthechannel[39].

3.9. Item2d

Responsessought(e.g.,deqiormuscletwitchresponse).

Ifthestudyprotocolrequiresthatspecificresponsestoneedling beelicited,forexamplethedeqisensationintraditionalChinese acupuncture,themuscletwitchintriggerpointtreatmentor mus-cle contractionin electro-acupuncture, theseelicited responses shouldbereported.Whererelevant,theauthorsshould differen-tiatebetweentheresponsesrequiredintheprotocoland those actuallyobtained(whichshouldbereportedinSection3).

3.9.1.1. Examples.

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areas,especiallythepulseandabdomen.Bycarefully assess-ingchangesinpalpatoryfindings,thetreatmentwasadjusted continuouslybasedonthepatient’sresponse.Beforeneedling, the“live”pointswereidentifiedbypalpation,thatis,subtle changesattheskinlevel,orupontouchorpressure,forthat particularpatient[39].

3.10. Item2e

Needlestimulation(e.g.manualorelectrical).

Needlestimulationtechniques,whereused,shouldbeclearly describedforallpoints.Formanualstimulation,suchtechniques includelifting,thrustingorrotatingtheneedletomanipulatethe deqisensation.Forelectricalstimulation,thecurrent,amplitude andfrequencysettingsshouldberecorded.

3.10.1.1. Examples.

(i)This mode of (manual) stimulation was provided via the acupuncture needles, which were placed in the premarked depthatthemarkedsites.Theneedlewasrotatedbyan expe-riencedacupuncturistwiththeindexfingerandthumbinan alternatingclockwiseandcounterclockwisefashionattherate ofthreetofiverotationspersecond[37].

(ii)Electrical stimulation was given tothe anterior partof the kneefor10minandthen10minfortheposteriorpartusing abattery-operated,four-channel,‘ASSuper4′

Electrostimula-tor(RDGMedical,SurreyUK)whichgeneratedlowfrequency, square-wave (2–10Hz) pulses of 1 millisecond duration for 10min(ref).Inbothgroups,theapparatuswasattachedto nee-dlesatthetwoXiyanpoints,SP9andGB34,andBL40andBL57. Electricalstimulationwasdeliveredat6Hzataconstant cur-rent.Voltagewassetataleveljustabovethepainthreshold

[38].

3.11. Item2f

Needleretentiontime.

Needleretentiontimesshouldbereportedaseitherastandard orameanandrange.Authorsshouldmakeitclearthattheyare reportingthetimeelapsedbetweentheinsertionandremovalof needles(retentiontime)anddistinguishitfromtreatmenttime, whichmayincludeotherproceduressuchashistorytaking, dis-cussionandpreparationfortreatment.

3.11.1.1. Examples.

(i)Eachparticipantwastreatedbilaterallyandhadatotalofsix needlesinsertedforthedurationofthetreatment.Adraining techniquewasusedandtheneedleswereleftforaperiodof 30min.Thepractitionerreturnedtocheckontheparticipant atregularintervalsduringtheintervention[40].

(ii)Needles were withdrawnimmediately for tonification, and retainedforupto20minfortheevenstechnique[23]. (iii)Therapistsallow25(min)–35(max)minutesbetween

inser-tionofthelastneedleandcessationoftreatmentandduring thattimetheyaretorevisittheneedlesasappropriate[41]. (iv)ThepatientsingroupAweredryneedledforafewseconds.

Fortriggerpointinactivationbydryneedling...itisespecially

importantnottoapplytoostrongastimulusbecausethismay produceaflare-upofthepatient’ssymptoms[42].

3.12. Item2g

Needletype(diameter,length,andmanufacturerormaterial).

Detailsshouldbegivenofthetypesofneedlesused,including thediameterandlengthaswellasthemanufacturerand/orthe material.Thisinformationisofimportancesincetheeffectof dif-ferentmetalsorneedlesizesonthebodyisnotknown.Fortrials usingavarietyofdifferenttypesofneedles,therangesofdiameters andlengthsaswellastypesofmaterialshouldbereported.

3.12.1.1. Examples.

(i)Seirin36gauge2.5in.longunusedsterileL-typeneedleswere usedforthestudy[37].

(ii)TheVA(verumacupuncture)groupreceivedacupuncturewith a 0.25×40-mm stainless steel needle (Asia Med, Munich,

Germany)atLI4[36].

4. STRICTAitem3:treatmentregimen

4.1. Item3a

Numberoftreatmentsessions.

Theplannednumberof sessionsandfrequency oftreatment shouldbeclearlydocumented.Theactualnumberoftreatments receivedbyparticipantsshouldbereportedinSection3.Ifthere isvariationbetweenpatients,thenthemeanandrangeshouldbe reported.

4.1.1.1. Examples.

(i)The true acupuncture (experimental) group underwent 26 weeksofgraduallytaperingtreatmentaccordingtothe follow-ingschedule:8weeksof2treatmentsperweekfollowedby2 weeksof1treatmentperweek,4weeksof1treatmentevery otherweek,and12weeksof1treatmentpermonth[21]. (ii)In all groups, participants were asked to attend treatment

sessionstwiceweeklyfor12weeks(24treatments).We con-sideredparticipantswhoattended80%ormore(≥19of24)of

acupuncturesessionstohavecompletedafullcourseof treat-ment[43].

4.2. Item3b

Frequencyanddurationoftreatmentsessions.

Thefrequencyanddurationofsessionsshouldbedocumented, withmeanandrangetobereportedwherethereisvariationacross patients.Anyvariationinfrequencyoftreatment(forexampleif subjectsaretobetreatedtwiceweeklyinthefirsttwoweeksthen onceaweekforthenextsixweeks)shouldbeclearlyreported.

4.2.1.1. Examples.

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5. STRICTAitem4:othercomponentsoftreatment

5.1. Item4a

Detailsofotherinterventionsadministeredtotheacupuncture group(e.g.moxibustion,cupping,herbs,exercises,lifestyleadvice).

Additionalcomponentsoftreatmentrefertotheauxiliary tech-niques,prescribedself-treatmentandlifestyleadviceprovidedby thepractitioner.Alladditionalcomponents,whethercarriedout by thepractitioner or patient and whether integral or adjunc-tivetotheacupunctureneedling,shouldbedescribedclearly.For acupuncturerelatedinterventions,suchasmoxibustion or cup-ping,detailshouldbeprovidedequivalenttothatrecommended foracupunctureneedling.Iftheprotocolspecifiestheoptionsof prescribedself-helptreatmentssuchasqigongormuscle stretch-ingexercises,and/orlifestyleadvicesuchasdietarychangesbased onacupuncture-relateddiagnosticcriteria, then thesetoomust be reported. The frequency with which the advice was given, andparticipants’compliancewiththisadvice,shouldbereported. “Othercomponentsoftreatment”shouldbedistinguishedfrom “co-interventions”,thatisinterventionsthatareprovided addition-allytobothgroups,whichshouldbefullyreportedasdescribedin STRICTAItem(6b)below.

5.1.1.1. Examples.

(i)Inadditiontoneedling,moxibustionorthermalstimulation ofthe acupointswasusedformingvery finewoolof mug-wort(Artemisavulgaris)intominute,thread-sizepunks(oky ¯u) andplacingthemonathinlayerofanherbalcream(shiunko). Themoxawaslitwithanincensestickandtheprocesswas repeatedseveraltimesuntilwarmthwasfeltbythepatient

[39].

(ii)Followingapplicationofthestuds,patientswereinstructedto applypressuretothestudbymakingsmallcircularmovements withthefingersoftheoppositehand,2–3cyclespersecondfor 1–2minperpoint.Asistypicalforself-administered acupres-sure,patientswereencouragedtoapplyacupressurethisway onwaking,intheearlyafternoonandduringany exacerba-tionofsymptoms.Initialinstructionwasprovidedverbally,at whichtimepatientswereaskedtoconfirmtheir understand-ingbydemonstratingtheprocedure.Patientsalsoweregiven easy-to-readwrittenmaterialsdescribingtheacupressure pro-cedure[45].

(iii)Chinese herbal medicine was to be taken three times per day over a period of 6 weeks and parallel to acupuncture treatment...Allherbsusedinthepresentstudywereimported

fromChinabyasingleTCMherbalmedicineimportcompany (Sinores,Lueneberg,Germany)...Allherbswerepreparedin

dried,mincedpiecesandthensealedingenericpapersachets byapharmacistinordertorendertheherbalformulation non-identifiablefor patients...In additiontothebasicformula,

everypatientreceivedasecondadditionalformulatailoredto hisorherindividualTCMdiagnosis[46].

5.2. Item4b

Settingandcontextoftreatment,includinginstructionsto prac-titionersandinformationandexplanationstopatients.

Thesettingandcontextoftreatmentcanalsoprovideimportant additionalcomponentstotreatment[47].Contextincludes instruc-tionstopractitionersthatmightmodifytheirnormalpractice,for

example,prescribingorproscribingexplanationstopatientsabout theirdiagnosis. For patients, thecontext includes the informa-tiontheyhavebeengivenaboutthetrialthatmightbeexpected tomodifyoutcomes.Therefore,theinformationthatthepatient receivesregardingthetreatmentandcontrolinterventionshould bereported,includinganyrelevantwordingonconsentformsand informationleafletsdesignedtoinfluencebeliefsorexpectations. Forexample,describingashamacupuncturecontrolas“atypeof acupuncture”mayhavea differenteffectonoutcomethan say-ingitis“notacupuncture,butwillinvolveasimilarexperienceto acupuncture.”

5.2.1.1. Examples.

(i)Thefirstacupuncturistwasthe‘diagnosingacupuncturist’(DA), whomthepatientsawfortheinitialconsultation,andbefore andaftereachtreatment.Afullcasehistorywastakenbythe DA,togetherwithtongueandpulseexamination,toarriveatan individualdiagnosisinaccordancewiththeprinciplesofTCM, withanadditionallesseremphasisonFiveElement Acupunc-ture (refs). Althoughall patients in the study had IBS, this correspondedtoawiderangeofTCMpatterns,making individ-ualdiagnosisessential.Dietaryandlifestyleadvice(important in treatmentaccording toTCM principles) was given toall patientsbytheDA,whothenselectedacupuncturepoints.The second“treatingacupuncturist”(TA)openedthe randomiza-tionenvelope,andforthedurationofthestudyremainedthe onlyindividualawareoftreatmentallocation.TheTAcarried outthetreatment−eitheraccordingtoinstructionsissuedby

theDAorusingshampoints,dependingontherandomization

[48].

(ii)Patients were informed about acupuncture and minimal acupunctureinthestudyasfollows:“Inthisstudy,different typesofacupuncturewillbecompared.Onetypeissimilarto theacupuncturetreatmentusedinChina.Theothertypedoes notfollowtheseprinciples,buthasalsobeenassociatedwith positiveoutcomesinclinicalstudies”[27].

6. STRICTAitem5:practitionerbackground

6.1. Item5

Description of participating acupuncturists (qualification or professionalaffiliation,yearsinacupuncturepractice,other rele-vantexperience).

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6.1.1.1. Examples.

(i)Physicians had a median of 350h (range 140–2508h) of acupuncturetrainingbeforeparticipatinginthetrial;33(73%) hadtheB-Diploma.Seventeen(17;38%)trialphysicianstaught acupuncturein accreditedpostgraduate courses.The physi-cianshadusedacupunctureintheirpracticesforanaverageof 11years(median10,range0–25)andhadtreated346patients (range22–1200)withacupunctureintheyearbeforethetrial. Forty-onephysicians(92%)indicatedthattheyfrequentlyor alwaysmake a Chinesesyndromediagnosisbeforestarting treatment[27].

(ii)EightUS-trainedandlicensedacupuncturistswithamedian of10yearsofexperience(range4–18years)providedstudy treatmentsintheirprivateoffices.Oneinvestigatortrainedthe acupuncturistsinthestudyprocedurestoincreasetheir com-fortwithdeliveringall4treatmentsandmonitoredcompliance withtheprotocolthroughoutthestudy[43].

(iii)Ofthe11midwivesparticipatinginthestudy,sixhadbeen taughtacupunctureformidwivesattheNorwegianSchoolof Acupuncture/NFKA.Thesesixgaverealandfalseacupuncture, whereastheothers,whohadbeentrainedinacupunctureby thesix,wereallowedonlytogivefalseacupuncture[50].

7. STRICTAitem6:controlandcomparatorinterventions

7.1. Item6a

Rationaleforthecontrolorcomparatorinthecontextofthe researchquestion,withsourcesthatjustifythechoice(s).

Therationale for choiceof control or comparatorshouldbe presentedand justifiedinrelationtotheresearchquestionand themethodology.Instudiesinwhichagroupreceiving acupunc-tureiscomparedwithanothergroup,thecontrolorcomparator canbeshamacupuncture,usualcare,anactivetreatment,a wait-ing list or no treatment. Whereas ‘control’ is sometimes used for a group that receives no intervention, the term ‘compara-tor’maybemoreappropriateforanactiveintervention,suchas physiotherapy, for which the intended action of the compara-tor is expected to betherapeutic. If using an acupuncture-like control in a participant-blindedtrial then oneof the following terms:activeacupuncturecontrol;penetratingneedlecontrol;or non-penetratingshamneedlingcontrolmightbehelpful descrip-tors.Controlproceduresinvolvinginvasiveornon-invasivesham needlingtechniquesmaybetherapeuticallyactive,evoking neuro-physiologicaland/orlocalisedimmuneandcirculatoryresponses. Theextentthatshamacupunctureneedling,whetherpenetrating ornot,mightelicitacupuncture-specificphysiologicalmechanisms isnotknown,andisinpartaconsequenceofourlackofknowledge ofthemechanism(s)oftrueacupuncture.Therearealsovariations inassumptionsabouttheprecisionrequiredforpointlocation,as forsomecliniciansandinvestigators,acupuncturepointsare con-sideredas areasof reactivityrather thanpoints ofaction. Such assumptions havea bearingontheintegrity of theshamasan appropriatecontrol.Somenon-needlingcontrolprocedurescanbe assumedtobephysiologicallyinert,suchasaninactivated tran-scutaneouselectricalnervestimulation(TENS)machine;however, theseproceduresmaynothavethesametotalpsychophysiological credibilityasacupuncture,therebycompromisingthe interpreta-tionoftheresults.Sourcesthatledtothechoiceofcontrol,such asliteratureorexpertopinion,shouldalsobereportedand refer-enced.Theauthorshouldreferencepriorworkthatsupportsthe

useoftheselectedcomparator,suchasfromtheconclusionofa systematicrevieworfromanotherrandomizedcontrolledtrial.

7.1.1.1. Examples.

(i)‘Sham’acupuncturepointswerechosenfromthreedifferent areasonthebody(theanterior thighdistally,theposterior thigh,andthelateralaspectofthelowerback),whichdonot correspondtorecognisedacupuncturepointsandaredeemed tohavenotherapeuticvalue[48].

(ii)Internationalguidelinessuggestthatthebestpackageofcare forthispatientgroupisonethatincludespatienteducation, adviceandexercise(ref)...Randomisedclinicaltrials

con-sistentlyshowthebenefitofexerciseforkneepaininolder adults (refs).Recentstudiesalsohighlighttheneedto pro-videadequateinstruction,feedbackandpracticeinorderto ensurethatthekeymusclegroupsaroundtheknee,suchasthe quadriceps,areactivated(ref).TheEuropeanLeagueAgainst Rheumatism(EULAR) recommendationshave recentlybeen updated and in particular,advocate exercise for kneepain relatedtoosteoarthritis(ref).Inlinewiththisevidencebase, thecurrenttrialwasdesignedsothatallparticipantsreceivea packageofcarewhichincludeseducation,advice,andexercise

[41].

(iii)Forthisstudyaspecial‘placeboneedle’wasdesignedby Stre-itberger.Theneedlebodyisnotfixedinsidethecopperhandle. Itstipisbluntandwhenittouchestheskin,asmallpricking sensationisfeltbythepatient,simulatingthepunctureofthe skin.Thehandleoftheneedlemovesovertheneedle,the nee-dleisshortened.Patients‘see’theneedlemovinginsidetheir body...Thisneedlewastestedin60volunteersandproved

tobesufficientlycredibletobeusedinourclinicaltrialasa control(ref)[51].

7.2. Item6b

Precise description of the control or comparator. If sham acupunctureoranyothertypeofacupuncture-likecontrolisused, providedetailsasforItems1–3above.

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7.2.1.1. Examples.

(i)Acupuncturistsinserted2needlesintotheshampointsinthe abdominal area, approximately3cm lateral toand slightly abovetheumbilicusbilaterally,andthenimmediatelyapplied 2 pieces of adhesive tape nextto theneedles. In addition, theytappedamock plasticneedleguidingtubeonthe sur-faceofeachofthe9truepointsinthelegtoproducesome discerniblesensationandthenimmediatelyappliedaneedle witha piece of adhesive tape tothedermal surface, with-outneedleinsertion,ofeachpointforatotalof20min.The shamacupunctureprocedurewasgivenonthesameschedule astheexperimentalgroupandusedthesameactiveneedle placements,exceptactualinsertiondidnotoccuratthese9 points.Althoughelectricalstimulationdidnotoccur,amock transelectricalstimulationunit(whichemitteda soundand possessedablinkinglight)wasattachedtotheshamneedles attheknee.Tofacilitateblinding,weusedscreensinboth treat-mentandshamgroupsthatwereplacedbelowtheabdomento preventparticipantsfromactuallyobservingthetrueorsham proceduresatthekneeareabuttoallowthemtoobservethe procedurebeingperformedintheabdomenarea[21]. (ii)In each session, at least 5 out of 10 predefined distant

nonacupuncturepoints(ref)wereneedledbilaterally(atleast 10needles)andsuperficiallyusingfineneedles(ie,minimal acupuncture).“DeQi”andmanualstimulationoftheneedles wereavoided.Allacupuncturistsreceivedoralinstructions,a videotape,andabrochurewithdetailedinformationonsham acupuncture[52].

(iii)Conservativetherapyinvolved10visitstopractitionerswith consultationandaprescriptionfordiclofenac,upto150mg/d, orrofecoxib,25mg/d,asneededuntilweek23[53].

(iv)Patientsreceivedthesametreatmentasinthestandardgroup but in addition did stabilising exercises modified because of thepregnancy (refs).Thetraining programme startedby emphasisingactivationandcontroloflocaldeeplumbopelvic muscles.Trainingofmoresuperficialmusclesindynamic exer-cisestoimprovemobility,strength,andendurancecapacity wasgraduallyincluded.Patientsreceivedtreatments individ-uallyforatotalofsixhoursduringsixweeks.Theyweretold tointegratetheexercisesindailyactivitiesandtoexercisein shortsessionsonseveraloccasionsduringtheday[54].

8. Discussion

This revised STRICTA Statement has been designed to help improvethereportingofinterventionsinclinicaltrialsof acupunc-ture,withtheintentionthatitwillhelpauthorsofacupuncture trials provide readers with a clear, accurate and transparent accountof theiracupuncture protocolsas wellas theircontrol and/orcomparatorprocedures.InadditiontorevisingtheSTRICTA checklist,we haveimprovedtheexplanationsofeach item and provided examples of good reporting. To enhance awareness, endorsementandadherence,therevisedSTRICTAStatementhas beendevelopedasanextensiontoCONSORT.Authorsofclinical trialsofacupunctureshouldusetheSTRICTArecommendationsfor theacupunctureintervention(Item5intheCONSORT2010 State-ment)inconjunctionwiththeother25itemsofthechecklistin themainCONSORTguidelines[10,11].TheextensiontoCONSORT fornon-pharmacologicalinterventionsisalsohighlyrelevantto acupuncturetrials[14,15].ThereareotherextensionstoCONSORT thatmayberelevant,dependingonthetypeoftrialdesign, includ-ingextensionsfor clustertrials,equivalenceand non-inferiority trials,andpragmatictrials,andthereportingofabstractsandof harms(e.g.adverseevents)associatedwiththeintervention.The

SummaryPoints

•TheStandardsforReportingInterventionsinClinicalTrials

of Acupuncture(STRICTA) werepublishedinfivejournals

in2001and2002.Theseguidelines,intheformofa

check-listandexplanationsforusebyauthorsandjournaleditors,

were designed to improve reporting of acupuncture

tri-als, particularlytheinterventions,thereby facilitatingtheir

interpretation and replication. Subsequent reviews of the

application and impact of STRICTA have highlighted the

valueofSTRICTA aswellasscopeforimprovementsand

revision.

•To managethe revision process a collaboration between

theSTRICTAGroup,theCONSORTGroup,andtheChinese

Cochrane Centrewas developedin2008. Anexpertpanel

with47participantswasconvenedthatprovidedelectronic

feedbackonareviseddraftofthechecklist.Atasubsequent

face-to-facemeetinginFreiburg,agroupof21participants

furtherrevisedtheSTRICTAchecklistandplanned

dissemi-nation.

•_The_new_STRICTA_checklist,_which_is_an_official_extension_of

CONSORT,includessixitemsand17sub-items.Thesesetout

reportingguidelinesfortheacupuncturerationale,thedetails

of needling, the treatmentregimen, other componentsof

treatment, thepractitionerbackground,andthecontrolor

comparator interventions.In addition,and aspart of this

revisionprocess,theexplanationsforeachitemhavebeen

elaborated,andexamplesofgoodreportingforeachitem

areprovided.Inaddition,theword“controlled”inSTRICTA

isreplacedby“clinical”,toindicatethatSTRICTAis

applica-bletoabroadrangeofclinicalevaluationdesigns,including

uncontrolledoutcomestudiesandcasereports.

•ItisintendedthattherevisedSTRICTA,inconjunctionwith

boththemainCONSORTStatementandextensionfor

non-pharmacologictreatment,willraisethequalityofreporting

ofclinicaltrialsofacupuncture.

mostrecentversionsofallCONSORTguidancedocumentscanbe foundontheCONSORTwebsite(http://www.consort-statement. org).

A complete, accurateand transparent trial report facilitates dissemination,interpretation,translationandreplicability.There continuestobeaneedforbetterreportinggenerally,ashasbeen highlightedinarecentstudyofwhatismissingfromdescriptions oftreatmentsintrialsandreviews[55].Theauthorsfoundthat elementsoftheinterventionweremissinginhalfofthepublished articlesthattheyreviewed,givinginsufficientdetail,forexample, withpractitionersunabletousethetreatmentsasdescribedand researchersunabletoreplicatestudies.Thisfindingissimilarto thatfromareviewofauthorsofacupuncturetrials[12].Improved reportingreducesreaderambiguityininterpretation,islikelyto increasecredibilityandapplicationoftheresultsbyproviding bet-terevidenceonwhichtobasedecisionsonpatientcare.

Reportingguidelinesdohelpimprovethequalityofreporting randomizedtrials[56]althoughitisdifficulttoobservetheir max-imalbenefitbecausetoofewjournalsendorsereportingguidelines

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Acknowledgments

ThisrevisiontoSTRICTAhasbenefitedfromcontributionsfrom manypeople.Supportandadministrativehelpin managingthe process of revising STRICTAhas come from Anne Burton, Ann Hopton,SuzanneJenna,StephaniePrady,andTracyStuardi.The SteeringGroupcomprisedDougAltmanandDavidMoher (CON-SORT),HughMacPhersonandRichardHammerschlag(STRICTA), andLiYoupingandWuTaixiang(ChineseCochraneCentre).

Theinitialconsultationwithexperts,whichwaspilotedwith thehelpofMarkBovey,ValHopwoodandAdrianWhite,involveda panelconsistingof:JoyceAnastasi,StephenBirch,JoaoBosco, Clau-diaCitkovitz,RemyCoeytaux,MishaCohen,AgathaColbert,Helen Elden,ReginaldodeCarvalhoSilvaFilho,AlastairForbes,Nadine Foster,JoelGagnier,MarkGoldby,MaritaGronlund,RichardHarris, DominikIrnich,HeleneLangevin,LaoLixing,AnnaLee,Lee Hyang-sook,LeeMyeongsoo,LeeSanghoon,GeorgeLewith,KlausLinde, Liu Jianping, Ryan Milley, Scott Mist, Dieter Melchart, Albrecht Molsberger, Vitaly Napadow, Richard Niemtzow, Park Jongbae, MahmoodSaghaei,KoosnadiSaputra,RosaSchnyer,CharlesShang, KarenSherman,ShinByung-Cheul,CarolineSmith,Elisabet Stener-Victorin, Kien Trinh, Jorge Vas, Andrew Vickers, Peter White, ClaudiaWitt,HitoshiYamashita,ChristopherZaslawski.

TheSTRICTARevisionGroup,whoparticipatedinthe consensus-buildingworkshopinFreiburg,comprisedthesixmembersofthe SteeringGroupandStephenBirch,IsabelleBoutron,MarkBovey,Fei Yutong,JoelGagnier,SallyHopewell,ValHopwood,SusanneJena, KlausLinde,LiuJianping,KienTrinh,EmmaVeitch,AdrianWhite, andHitoshiYamashita.

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