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Acupuncture for migraine prophylaxis (Review)
Linde K, Allais G, Brinkhaus B, ManheimerE, Vickers A, White AR
ThisisareprintofaCochranereview,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochraneLibrary
2009,Issue1
http://www.thecochranelibrary.com
Acupunctureformigraineprophylaxis(Review)
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Figure3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Figure6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Analysis1.1.Comparison1Acupuncturevs.noacupuncture,Outcome1Response. . . . . . . . . . . . 69
Analysis1.2.Comparison1Acupuncturevs.noacupuncture,Outcome2Headachefrequency(variousmeasures). . 71
Analysis1.3.Comparison1Acupuncturevs.noacupuncture,Outcome3Migraineattacks. . . . . . . . . . 74
Analysis1.4.Comparison1Acupuncturevs.noacupuncture,Outcome4Migrainedays. . . . . . . . . . . 76
Analysis1.5.Comparison1Acupuncturevs.noacupuncture,Outcome5Headachedays. . . . . . . . . . 78
Analysis1.6.Comparison1Acupuncturevs.noacupuncture,Outcome6Headacheintensity. . . . . . . . . 80
Analysis1.7.Comparison1Acupuncturevs.noacupuncture,Outcome7Analgesicuse. . . . . . . . . . . 82
Analysis1.8.Comparison1Acupuncturevs.noacupuncture,Outcome8Headachescores. . . . . . . . . . 85
Analysis2.1.Comparison2Acupuncturevs.shaminterventions,Outcome1Response. . . . . . . . . . . 88
Analysis2.2.Comparison2Acupuncturevs.shaminterventions,Outcome2Headachefrequency(variousmeasures). 93
Analysis2.3.Comparison2Acupuncturevs.shaminterventions,Outcome3Migraineattacks. . . . . . . . . 97
Analysis2.4.Comparison2Acupuncturevs.shaminterventions,Outcome4Migrainedays. . . . . . . . . . 100
Analysis2.5.Comparison2Acupuncturevs.shaminterventions,Outcome5Headachedays. . . . . . . . . 104
Analysis2.6.Comparison2Acupuncturevs.shaminterventions,Outcome6Headacheintensity. . . . . . . . 107
Analysis2.7.Comparison2Acupuncturevs.shaminterventions,Outcome7Analgesicuse. . . . . . . . . . 109
Analysis2.8.Comparison2Acupuncturevs.shaminterventions,Outcome8Headachescores. . . . . . . . . 114
Analysis2.9.Comparison2Acupuncturevs.shaminterventions,Outcome9Response(forfunnelplot). . . . . 117
Analysis2.10.Comparison2Acupuncturevs.shaminterventions,Outcome10Response(higherqualitystudies). . 119
Analysis2.11.Comparison2Acupuncturevs.shaminterventions,Outcome11Headachefrequency(variousmeasures-
forfunnelplot). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Analysis2.12.Comparison2Acupuncturevs.shaminterventions,Outcome12Headachefrequency(variousmeasures-
higherqualitystudies). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Analysis3.1.Comparison3Acupuncturevs.drugtreatment,Outcome1Response. . . . . . . . . . . . . 123
Analysis3.2.Comparison3Acupuncturevs.drugtreatment,Outcome2Headachefrequency(variousmeasures). . 125
Analysis3.3.Comparison3Acupuncturevs.drugtreatment,Outcome3Migraineattacks. . . . . . . . . . 128
Analysis3.4.Comparison3Acupuncturevs.drugtreatment,Outcome4Migrainedays. . . . . . . . . . . 130
Analysis3.5.Comparison3Acupuncturevs.drugtreatment,Outcome5Headachedays. . . . . . . . . . . 133
Analysis3.6.Comparison3Acupuncturevs.drugtreatment,Outcome6Headacheintensity. . . . . . . . . 135
Analysis3.7.Comparison3Acupuncturevs.drugtreatment,Outcome7Analgesicuse. . . . . . . . . . . 137
Analysis3.8.Comparison3Acupuncturevs.drugtreatment,Outcome8Headachescores. . . . . . . . . . 140
Analysis3.9.Comparison3Acupuncturevs.drugtreatment,Outcome9Numberofpatientsreportingadverseeffects. 142
Acupunctureformigraineprophylaxis(Review) i
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Analysis3.10.Comparison3Acupuncturevs.drugtreatment,Outcome10Numberofpatientsdroppingoutdueto
adverseeffects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Analysis4.2.Comparison4Acupuncturevs.othertherapy,Outcome2Headachefrequency(variousmeasures). . . 143
Analysis4.7.Comparison4Acupuncturevs.othertherapy,Outcome7Analgesicuse. . . . . . . . . . . . 146
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
WHAT’SNEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Acupunctureformigraineprophylaxis(Review) ii
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
[InterventionReview]
Acupuncture for migraine prophylaxis
KlausLinde1,GianniAllais2,BennoBrinkhaus3,EricManheimer4,AndrewVickers5,AdrianRWhite6
1CentreforComplementaryMedicineResearch,DepartmentofInternalMedicineII,TechnischeUniversitaetMuenchen,Munich,
Germany.2Women’sHeadacheCenterandServiceforAcupunctureinGynecologyandObstetrics,DepartmentofGynecologyand
Obstetrics,UniversityofTorino,Torino,Italy.3InstituteforSocialMedicine,EpidemiologyandHealthEconomy,CharitéUniversity
Hospital,Berlin,Germany.4CenterforIntegrativeMedicine,UniversityofMarylandSchoolofMedicine,Baltimore,USA.5Integrative
Medicine Service,Memorial Sloan-KetteringCancerCenter,NewYork,USA.6DepartmentofGeneralPracticeandPrimaryCare,
PeninsulaMedicalSchool,Plymouth,UK
Contactaddress:KlausLinde,CentreforComplementaryMedicineResearch,DepartmentofInternalMedicineII,TechnischeUni-
versitaetMuenchen,Wolfgangstr.8,Munich,81667,[email protected].(Editorialgroup:CochranePain,
PalliativeandSupportiveCareGroup.)
CochraneDatabaseofSystematicReviews,Issue1,2009(Statusinthisissue:Newsearchforstudiescompleted,conclusionschanged)
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
DOI:10.1002/14651858.CD001218.pub2
Thisversionfirstpublishedonline:21January2009inIssue1,2009.
Lastassessedasup-to-date: 14April2008.(Helpdocument-DatesandStatusesexplained)
This recordshouldbecited as: LindeK,AllaisG,BrinkhausB,ManheimerE,VickersA,WhiteAR.Acupunctureformigraine
prophylaxis.CochraneDatabaseofSystematicReviews2009,Issue1.Art.No.:CD001218.DOI:10.1002/14651858.CD001218.pub2.
ABSTRACT
Background
Acupuncture isoftenusedformigraine prophylaxisbut itseffectivenessisstillcontroversial.Thisreview (alongwith acompanion
reviewon’Acupuncturefortension-typeheadache’)representsanupdatedversionofaCochranerevieworiginallypublishedinIssue
1,2001,ofTheCochraneLibrary.
Objectives
Toinvestigatewhetheracupunctureisa)moreeffectivethannoprophylactictreatment/routinecareonly;b)moreeffectivethan’sham’
(placebo)acupuncture;andc)aseffectiveasotherinterventionsinreducingheadachefrequencyinpatientswithmigraine.
Searchstrategy
TheCochranePain,Palliative&SupportiveCareTrialsRegister,CENTRAL,MEDLINE,EMBASEandtheCochraneComplementary
MedicineFieldTrialsRegisterweresearchedtoJanuary2008.
Selectioncriteria
Weincludedrandomizedtrialswithapost-randomizationobservationperiodofatleast8weeksthatcomparedtheclinicaleffectsofan
acupunctureinterventionwithacontrol(noprophylactictreatmentorroutinecareonly),ashamacupunctureinterventionoranother
interventioninpatientswithmigraine.
Datacollectionandanalysis
Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias
andqualityoftheacupunctureintervention.Outcomesextractedincludedresponse(outcomeofprimaryinterest),migraineattacks,
migrainedays,headachedaysandanalgesicuse.Pooledeffectsizeestimateswerecalculatedusingarandom-effectsmodel.
Mainresults
Acupunctureformigraineprophylaxis(Review) 1
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Twenty-twotrialswith4419participants(mean201,median42,range27to1715)mettheinclusioncriteria.Sixtrials(including
twolargetrialswith401and1715patients)comparedacupuncture tonoprophylactictreatmentorroutinecareonly.After3to4
monthspatientsreceivingacupuncturehadhigherresponseratesandfewerheadaches.Theonlystudywithlong-termfollowupsawno
evidencethateffectsdissipatedupto9monthsaftercessationoftreatment.Fourteentrialscompareda’true’acupunctureintervention
withavarietyofshaminterventions.Pooledanalysesdidnotshowastatisticallysignificantsuperiorityfortrueacupunctureforany
outcomeinanyofthetimewindows,buttheresultsofsingletrialsvariedconsiderably.Fourtrialscomparedacupuncturetoproven
prophylacticdrugtreatment.Overallinthesetrialsacupuncturewasassociatedwithslightlybetteroutcomesandfeweradverseeffects
thanprophylacticdrugtreatment.Twosmalllow-qualitytrialscomparingacupuncturewithrelaxation(aloneorincombinationwith
massage)couldnotbeinterpretedreliably.
Authors’conclusions
In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but
insufficient.Now,with12additionaltrials,thereisconsistentevidencethatacupunctureprovidesadditionalbenefittotreatmentof
acutemigraineattacksonlyortoroutinecare.Thereisnoevidenceforaneffectof’true’acupunctureovershaminterventions,though
thisisdifficulttointerpret,asexactpointlocationcouldbeoflimitedimportance.Availablestudiessuggestthatacupuncture isat
leastaseffectiveas,orpossiblymoreeffectivethan,prophylacticdrugtreatment,andhasfeweradverseeffects.Acupunctureshouldbe
consideredatreatmentoptionforpatientswillingtoundergothistreatment.
PLAIN LANGUAGE SUMMARY
Acupunctureformigraineprophylaxis
Migrainepatientssufferfromrecurrentattacksofmostlyone-sided,severeheadache.Acupunctureisatherapyinwhichthinneedles
areinsertedintotheskinatdefinedpoints;itoriginatesfromChina.Acupunctureisusedinmanycountriesformigraineprophylaxis
-thatis,toreducethefrequencyandintensityofmigraineattacks.
We reviewed 22 trials which investigated whether acupuncture is effective in the prophylaxis of migraine. Six trials investigating
whetheraddingacupuncturetobasiccare(whichusuallyinvolvesonlytreatingacuteheadaches)foundthatthosepatientswhoreceived
acupuncturehadfewerheadaches.Fourteentrialscomparedtrueacupuncturewithinadequateorfakeacupunctureinterventionsin
whichneedleswereeitherinsertedatincorrectpointsordidnotpenetratetheskin.Inthesetrialsbothgroupshadfewerheadaches
thanbeforetreatment,buttherewasnodifferencebetweentheeffectsofthetwotreatments.Inthefourtrialsinwhichacupuncture
wascomparedtoaprovenprophylacticdrugtreatment,patientsreceivingacupuncturetendedtoreportmoreimprovementandfewer
sideeffects.Collectively,thestudiessuggestthatmigrainepatientsbenefitfromacupuncture,althoughthecorrectplacementofneedles
seemstobelessrelevantthanisusuallythoughtbyacupuncturists.
Acupunctureformigraineprophylaxis(Review) 2
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
BACKGROUND Multiplestudieshaveshownthatacupuncturehasshort-termef-
fectsonavarietyofphysiologicalvariablesrelevanttoanalgesia(
Bäcker2004;Endres2007).However,itisuncleartowhatextent
Descriptionofthecondition
theseobservationsfromexperimentalsettingsarerelevanttothe
Migraineisadisorderwithrecurrentheadachesmanifestinginat- long-term effectsreportedby practitioners. It is assumed that a
tackslasting4to72hours.Typicalcharacteristicsoftheheadache variablecombinationofperipheraleffects;spinalandsupraspinal
are unilateral location, pulsating quality, moderate or severe in- mechanisms;andcortical,psychologicalor’placebo’mechanisms
tensity, aggravation by routine physical activity and association contributetotheclinicaleffectsinroutinecare(Carlsson2002).
withnauseaand/orphotophobiaandphonophobia(IHS2004). Whilethereislittledoubt thatacupuncture interventions cause
Epidemiologicalstudieshaveconsistentlyshownthatmigraineis neurophysiologicalchangesintheorganism,thetraditionalcon-
acommon disorder with a1-yearprevalenceof around 10% to cepts of acupuncture involving specifically located points on a
12%andalifetimeprevalenceofbetween15%and20%(Oleson systemof’channels’calledmeridiansarecontroversial(Kaptchuk
2007).InEurope,theeconomiccostofmigraineisestimatedat27 2002).
billionEuroperyear(Andlin-Sobocki2005).Mostmigrainepa-
tientscanbeadequatelytreatedwithtreatmentofacuteheadaches
Whyitisimportanttodothisreview
alone,butarelevantminorityneedprophylacticinterventions,as
theirattacksareeithertoofrequentorareinsufficientlycontrolled Asin many other clinical areas, the findings of controlledtrials
by acute therapy. Several drugs, such as propranolol, metopro- ofacupunctureformigraineandotherheadacheshavenotbeen
lol, flunarizine, valproic acid and topiramate, have been shown conclusiveinthepast.In1999wepublishedafirstversionofour
to effectivelyreduce attack frequency in some patients (Dodick reviewonacupunctureforidiopathicheadache(Melchart1999),
2007).However,allthesedrugsareassociatedwithadverseeffects. and in 2001 we published an updated version in The Cochrane
Dropoutratesinmostclinicaltrialsarehigh,suggestingthatthe Library(Melchart2001).Inour2001update,weconcludedthat
drugsarenotwellacceptedbypatients.Thereissome evidence “overall,theexistingevidencesupportsthevalueofacupuncture
thatbehavioralinterventionssuchasrelaxationorbiofeedbackare forthetreatmentofidiopathic headaches.However,thequality
beneficial(Holroyd1990;Nestoriuc2007),butadditionaleffec- andtheamountofevidencearenotfullyconvincing.”Inrecent
tive,low-risktreatmentsareclearlydesirable. yearsseveralrigorous,largetrialshavebeenundertaken.Dueto
theincreasingnumberofstudies,andforclinicalreasons,wede-
cidedtosplitourpreviousreviewonidiopathicheadacheintotwo
Descriptionoftheintervention
separate reviews on migraine and tension-type headache (Linde
Acupunctureinthecontextofthisreviewisdefinedastheneedling 2009)forthepresentupdate.
ofspecificpointsofthebody.Itisone ofthemostwidelyused
complementarytherapiesinmanycountries(Bodeker2005).For
example,accordingtoapopulation-basedsurveyintheyear2002
intheUnitedStates,4.1%ofrespondentsreportedlifetimeuseof
OBJECTIVES
acupuncture, and1.1% recentuse (Burke2006).A similarsur-
veyinGermanyperformedinthesameyearfoundthat8.7%of Weaimedtoinvestigatewhetheracupunctureisa)moreeffective
adultsbetween18and69yearsofagehadreceivedacupuncture thannoprophylactictreatment/routinecareonly;b)moreeffective
treatment in the previous 12 months (Härtel 2004). Acupunc- than ’sham’ (placebo) acupuncture; and c) as effective as other
turewasoriginallydevelopedaspartofChinesemedicinewherein interventionsinreducingthefrequencyofheadachesinpatients
thepurposeoftreatmentistobringthepatientbacktothestate withmigraine.
ofequilibriumpostulatedtoexistpriortoillness(Endres2007).
Some acupuncture practitioners have dispensed with thesecon-
ceptsandunderstandacupunctureintermsofconventionalneu-
METHODS
rophysiology.Acupunctureisoftenusedtotreatheadache,espe-
ciallymigraine.Forexample,9.9%oftheacupunctureusersinthe
U.S.surveymentionedabovestatedthattheyhadbeentreatedfor Criteriaforconsideringstudiesforthisreview
migraineorotherheadaches(Burke2006).Practitionerstypically
Typesofstudies
claimthatashortcourseoftreatment,suchas12sessionsovera
3-month period,canhavealong-termimpactonthefrequency We included controlled trials in which allocation to treatment
andintensityofheadacheepisodes. was explicitlyrandomized, andin whichpatients werefollowed
up for at least 8 weeks after randomization. Trials in which a
clearlyinappropriatemethodofrandomization(forexample,open
Howtheinterventionmightwork
alternation)wasusedwereexcluded.
Acupunctureformigraineprophylaxis(Review) 3
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Typesofparticipants • CochraneComplementaryMedicineFieldTrialsReg-
Studyparticipantshadtobediagnosedwithmigraine.Studiesfo- ister;
cusing on migraine but including patients with additional ten- • CochraneCentralRegisterofControlledTrials(CEN-
sion-typeheadachewereincluded.Studiesincludingpatientswith TRAL;Issue1,2000);
headachesofvarioustypes(forexample,somepatientswithmi- • individualtrialcollectionsandprivatedatabases;
graine, some with tension-type headache)were includedonly if • bibliographiesofreviewarticlesandincludedstudies.
findingsformigrainepatientswerepresentedseparatelyorifmore
Thesearchtermsusedfortheelectronicdatabaseswere’(acupunc-
than90%ofpatientssufferedfrommigraine.
tureoracupressure)’and’(headacheormigraine)’.Intheyearsfol-
Typesofinterventions lowingpublicationofthe2001review,thefirstauthorsregularly
The treatments considered had to involve needle insertion at checkedPubMedandCENTRALusingthesamesearchterms.
acupuncturepoints,painpointsortriggerpoints,andhadtobe Forthepresentupdate,detailedsearchstrategiesweredeveloped
describedasacupuncture.Studiesinvestigatingothermethodsof foreachdatabasesearched(seeAppendix1).Thesewerebasedon
stimulatingacupuncturepointswithoutneedleinsertion(forex- the search strategy developedfor MEDLINE, revised appropri-
ample,laserstimulationortranscutaneouselectricalstimulation) atelyforeachdatabase.TheMEDLINEsearchstrategycombined
wereexcluded. asubjectsearchstrategywithphases1and2oftheCochraneSen-
Controlinterventionsconsideredwere: sitiveSearchStrategyforRCTs(aspublishedinAppendix5b2of
theCochraneHandbookforSystematicReviewsofInterventions,
• no treatment other than treatment of acute migraine
version4.26(updatedSept2006)). Detailedstrategiesforeach
attacksorroutinecare(whichtypicallyincludestreat-
databasesearchedareprovidedinAppendix1.
mentofacuteattacks,butmightalsoincludeothertreat-
Thefollowingdatabasesweresearchedforthisupdate:
ments;however,trialsnormallyrequirethatnonewex-
perimentalorstandardizedtreatmentbeinitiateddur- • CochranePain,Palliative&SupportiveCareTrialsReg-
ingthetrialperiod); istertoJanuary2008;
• sham interventions (interventions mimicking ’true’ • CochraneCentralRegisterofControlledTrials(CEN-
acupuncture/true treatment, but deviating in at least TRAL;Issue4,2007);
one aspectconsidered importantby acupuncture the- • MEDLINEupdatedtoJanuary2008;
ory,suchasskinpenetrationorcorrectpointlocation); • EMBASEupdatedtoJanuary2008;
• other treatment (drugs, relaxation, physical therapies, • CochraneComplementaryMedicineFieldTrialsReg-
etc.). isterupdatedtoJanuary2008.
Trials that only compared different forms of acupuncture were In addition to the formal searches, one of the reviewers (KL)
excluded. regularly checked (last search 15 April 2008) all new entries
Typesofoutcomemeasures in PubMed identified by a simple search combining acupunc-
Studieswereincludediftheyreportedatleastoneclinicaloutcome ture AND (migraine OR headache), checked available confer-
relatedtoheadache(forexample,response,frequency,paininten- enceabstractsandaskedresearchersinthefieldaboutnewstud-
ies. Ongoing or unpublished studies were identified by search-
sity,headachescores,analgesicuse).Trialsreportingonlyphysio-
ing threeclinical trialregistries (http://clinicaltrials.gov/, http://
logicalorlaboratoryparameterswereexcluded,asweretrialswith
outcome measurement periods of less than 8 weeks (from ran- www.anzctr.org.au/,andhttp://www.controlled-trials.com/mrct/;
domizationtofinalobservation). lastupdate15April2008).
Searchmethodsforidentificationofstudies Datacollectionandanalysis
(Seealso:Pain,Palliative&SupportiveCareGroupmethodsused Selectionofstudies
inreviews.)
All abstracts identified by the updated search were screened by
Forourpreviousversionsofthereviewonidiopathicheadache(
onereviewer(KL),whoexcludedthosethatwereclearlyirrelevant
Melchart1999;Melchart2001),weusedaverybroadsearchstrat-
(forexample,studiesfocusingonotherconditions,reviews,etc.).
egytoidentifyasmanyreferencesonacupunctureforheadaches
Fulltextsofallremainingreferenceswereobtainedandwereagain
aspossible,aswealsoaimedtoidentifynon-randomizedstudies
screenedtoexcludeclearlyirrelevantpapers.Allotherarticlesand
foranadditionalmethodologicalinvestigation(Linde2002).The
alltrialsincludedin our previous review of acupuncture for id-
sourcessearchedforthe2001versionofthereviewwere:
iopathicheadachewerethenformallycheckedbyatleasttwore-
• MEDLINE1966toApril2000; viewersforeligibilityaccordingtotheabove-mentionedselection
• EMBASE1989toApril2000; criteria.Disagreementswereresolvedbydiscussion.
Acupunctureformigraineprophylaxis(Review) 4
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Dataextraction Weconsideredtrialsashaving alowriskofbiasfor thisitemif
Information onpatients, methods,interventions, outcomes and theyreportedtheresultsofthemostrelevantheadacheoutcomes
resultswasextractedindependentlybyatleasttworeviewersusinga assessed(typicallyafrequencymeasure,intensity,analgesicuseand
speciallydesignedform.Inparticular,weextractedexactdiagnoses; response)forthemostrelevanttimepoints(endoftreatmentand,
headache classifications used; number and type of centers; age; ifdone,follow-up),andiftheoutcomesandtimepointsreported
sex;durationofdisease;numberofpatientsrandomized,treated madeitunlikelythatstudyinvestigatorshadpickedthemoutbe-
andanalyzed;numberof,andreasonsfordropouts;duration of causetheywereparticularlyfavorableorunfavorable.
baseline,treatmentandfollow-upperiods;detailsofacupuncture Trialsthatmetallcriteria,orallbutonecriterion,wereconsidered
treatments (such as selection of points; number, frequency and tobeofhigherquality.Sometrialshadbothblindedshamcontrol
durationofsessions;achievementofde-chi(anirradiatingfeeling groups and unblinded comparison groups receiving no prophy-
considered toindicate effectiveneedling);number, training and lactictreatmentordrugtreatment.Intheriskofbiastables,the
experienceofacupuncturists);anddetailsofcontrolinterventions ’Judgement’columnalwaysrelatestothecomparisonwithsham
(shamtechnique,typeanddosageofdrugs).Fordetailsregarding interventions. In the ’Description’ column, we also include the
methodologicalissuesandstudyresults,seebelow. assessmentfortheothercomparisongroup(s).Astheriskofbias
Wherenecessary,wesoughtadditionalinformationfromthefirst tabledoesnotincludea’notapplicable’option,theitem’incom-
orcorrespondingauthorsoftheincludedstudies. pletefollow-upoutcomedataaddressed(4to12monthsafterran-
domization)?’wasratedas’unclear’fortrialsthatdidnotfollow
Assessmentofriskofbiasinincludedstudies
patientslongerthan3months.
Fortheassessmentofstudyquality,thenewriskofbiasapproach
Assessmentoftheadequacyoftheacupuncture
forCochranereviewswasused(Higgins2008).Weusedthefol-
intervention
lowingsixseparatecriteria:
Wealsoattemptedtoprovideacrudeestimateofthequality of
• Adequatesequencegeneration;
acupuncture.Tworeviewers(mostlyGAandBB,or,fortrialsin
• Allocationconcealment;
whichoneofthesereviewerswasinvolved,AW)whoaretrained
• Blinding;
inacupunctureandhaveseveralyearsofpracticalexperiencean-
• Incomplete outcome data addressed (up to 3 months
sweredtwoquestions.First,theywereaskedhowtheywouldtreat
afterrandomization);
thepatientsincludedinthestudy.Answeroptionswere’exactlyor
• Incompletefollow-upoutcomedataaddressed(4to12
almostexactlythesameway’,’similarly’,’differently’,’completely
monthsafterrandomization);
differently’ or ’could not assess’ due to insufficient information
• Freeofselectivereporting.
(onacupunctureoronthepatients).Second,theywereaskedto
Wedidnotincludetheitem’otherpotentialthreatstovalidity’in ratetheirdegreeofconfidencethatacupuncturewasappliedinan
aformalmanner,butnotedifrelevantflawsweredetected. appropriatemannerona100-mmvisualscale(with0%=com-
In a first step, information relevant for making a judgment on pleteabsence ofevidencethattheacupuncture wasappropriate,
acriterion was copiedfromthe original publication into anas- and100%=totalcertaintythattheacupuncturewasappropriate).
sessmenttable.Ifadditionalinformationfromstudyauthorswas Thelattermethodwasproposedbyamemberofthereviewteam
available,thiswasalsoenteredinthetable,alongwithanindica- (AW)and hasbeenusedin asystematicreview of clinical trials
tionthatthiswasunpublishedinformation.Atleasttworeviewers ofacupunctureforbackpain(Ernst1998).IntheCharacteristics
independentlymadeajudgmentwhethertheriskofbiasforeach ofincludedstudiestable,theacupuncturists’assessmentsaresum-
criterionwasconsideredlow,highorunclear.Disagreementswere marizedunder’Methods’(forexample,’similarly/70%’indicatesa
resolvedbydiscussion. trialwheretheacupuncturist-reviewerwouldtreat’similarly’and
Fortheoperationalizationofthefirstfivecriteria,wefollowedthe is’70%’confidentthatacupuncturewasappliedappropriately).
recommendationsoftheCochraneHandbookforSystematicRe- Comparisonsforanalysis
viewsofInterventions(Higgins2008).Forthe’selectivereporting’
Forthepurposesofsummarizingresults,theincludedtrialswere
item, we decidedto use a more liberal definition following dis-
categorizedaccordingtocontrolgroups:1)comparisonswithno
cussionwithtwopersons(JulianHigginsandPeterJüni)involved
acupuncture (acute treatmentonly or routine care); 2)compar-
inthedevelopmentoftheHandbookguidelines.Headachetrials
isonswithshamacupunctureinterventions;3)comparisonswith
typicallymeasureamultiplicityofheadacheoutcomesatseveral
prophylacticdrugtreatment;and4)comparisonswithothertreat-
timepointsusingdiaries,andthereisaplethoraofslightlydiffer-
ments.
entoutcomemeasurementmethods.Whileasingleprimaryend-
Outcomesforeffectsizeestimation
pointissometimespredefined,theoverallpatternofavarietyof
outcomes isnecessary togetaclinicallyinterpretable picture.If Wedefinedfourtimewindowsforwhichwetriedtoextractand
thestrictHandbookguidelineshadbeenapplied,almostalltrials analyzestudyfindings:
wouldhavebeenrated’unclear’forthe’selectivereporting’item. 1. Upto8weeks/2monthsafterrandomization;
Acupunctureformigraineprophylaxis(Review) 5
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
2. 3to4monthsafterrandomization; 7. Frequencyofanalgesicuse(anycontinuousorrankmea-
3. 5to6monthsafterrandomization;and suresavailable,extractionofmeansandstandarddevi-
4. Morethan6monthsafterrandomization. ations,calculationofstandardizedmeandifferences).
Inallincludedstudiesacupuncturetreatmentstartedimmediately Forcontinuousmeasuresweused,ifavailable,thedatafromin-
orverysoonafterrandomization. tention-to-treatanalyseswithmissingvaluesreplaced;otherwise,
Ifmorethanonedatapointwereavailableforagiventimewindow, weusedthepresenteddataonavailablecases.
we used: for the first time window, preferably data closest to 8 All these outcomes rely on patient reports, mainly collected in
weeks; for thesecond window, data closesttothe 4weeksafter headachediaries.
completionoftreatment(forexample,iftreatmentlasted8weeks, Posthocwedecidedalsotoextractthenumberofpatientsreport-
datafor weeks9to12); for thethirdwindow, data closestto6 ingadverseeffectsanddroppingoutduetoadverseeffectsforthe
months;andforthefourthwindow,dataclosestto12months. trialscomparingacupunctureandprophylacticdrugtreatment.
Weextracteddataforthefollowingoutcomes:
Mainoutcomemeasure
1. Proportion of ’responders’. For trialsinvestigating the
Althoughweconsidermeasuressuchasnumberofmigrainedays
superiority of acupuncture compared to no acupunc-
tobepreferable-becausetheyaremoreinformativeandlesssub-
ture or sham intervention, we used, if available, the
ject to random variation - we decided to use the proportion of
numberofpatientswithanattackfrequencyreduction
respondersasthemainoutcomemeasuresimplybecausethiswas
of at least 50% and divided it by the number of pa-
mostoftenreportedinthestudiesinamannerthatallowedeffect
tients randomized to the respective group. In studies
sizecalculation.Wechosethe3-to4-monthtimewindowasthe
comparing acupuncture with drugtreatmentor other
primarymeasurebecausethisa)istypicallyclosetotheendofthe
therapies,weusedforthedenominatorthenumberof
treatmentcycle,andb)isatimepointforwhichoutcomedataare
patientsreceivinganadequateamountoftreatment.If
oftenavailable.
the number of responders regarding attack frequency
wasnotavailableweused,indescendingorderofpref- Meta-analysis
erence,thefollowingoutcomes:atleast50%reduction
Pooledrandom-effectsestimates,their95%confidenceintervals,
innumberofmigrainedays;atleast50%reductionin theChi2-testforheterogeneityandtheI2-statisticwerecalculated
numberofheadachedays;atleast50%headachescore foreachtimewindowforeachoftheoutcomeslistedabove.Given
reduction;andglobalassessmentbypatientsorphysi- thestrongclinicalheterogeneity,pooledeffectsizeestimatescanbe
cians.Wecalculatedresponderrateratios(relativerisk consideredtobeonlyverycrudeindicatorsoftheoverallevidence.
ofhavingaresponse)and95%confidenceintervalsas Forthisreasonwealsorefrainedfromcalculatingnumbersneeded
effectsizemeasures.
totreattobenefit(NNTBs).
2. Frequencyofmigraineattacks(meansandstandardde-
viations) per 4-week period. (Weighted) mean differ-
enceswerecalculatedaseffectsizemeasures.
3. Numberofmigrainedays(meansandstandarddevia-
tions)per4-weekperiod(weightedmeandifferences). RESULTS
4. Numberofheadachedays(meansandstandarddevia-
tions)per4-weekperiod(weightedmeandifferences).
Descriptionofstudies
5. Headachefrequency(meansandstandarddeviations).
Asmanystudiesonlyreportedeitherattacks,migraine See:Characteristicsofincludedstudies;Characteristicsofexcluded
days,headachedaysorabsolute orpercentreductions studies;Characteristicsofongoingstudies.
frombaselineforoneofthesemeasures,wedecidedalso Selectionprocess
toincludeameasurewherevariousfrequencymeasures
Inourpreviousreviewonidiopathicheadache(Melchart2001),
couldbeused.Asavailable,weused(indescendingor-
weevaluated26trialsthatincluded1151participantswithvarious
derofpreference)absolutevaluesfrom4-weekperiods,
typesofheadaches.Thesearchupdateidentifiedatotalof251new
other periods, differencesfrombaseline or percentage
references. Full reports for three migraine trials (Alecrim 2005;
changefrombaselinefor(again,indescendingorderof
Alecrim2008;Jena2008)thatwerereportedonlyasabstractsat
preference)migrainedays,migraineattacksorheadache
thetimeofcompletionoftheliteraturesearch(January2008)were
days.Duetothevariabilityofoutcomes,standardized
lateridentifiedthroughpersonalcontactswithstudyauthors.
meandifferenceswerecalculatedaseffectsizemeasures.
Most of the references identified by the search update were ex-
6. Headacheintensity(anymeasuresavailable,extraction
cluded at the first screening step by one reviewer, as they were
ofmeansandstandarddeviations,calculationofstan-
clearlyirrelevant.Themostfrequentreasonsforexclusionatthis
dardizedmeandifferences).
levelwere:articlewasarevieworacommentary;studiesofnon-
Acupunctureformigraineprophylaxis(Review) 6
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
headacheconditions;clearlynon-randomizeddesign;andinvesti- mationfromtheauthorsof16trials;however,formostoldertri-
gationofaninterventionwhichwasnottrueacupunctureinvolv- alstheamount of additional information wasvery limited.De-
ingskinpenetration. tailedadditionaldatarelevantforthecalculationofeffectsizemea-
A total of 70 full-text papers were then formally assessed by at sureswerereceivedforeighttrials(Alecrim2005;Alecrim2006;
leasttworeviewersforeligibility.Thirty-twostudiesreportedin33 Alecrim 2008; Diener 2006; Jena 2008; Linde K 2005; Streng
publicationsdidnotmeettheselectioncriteria(seeCharacteristics 2006;Vincent1989).
of excluded studies). Common reasons for exclusion included:
Designandcomparisons
studygrouphadnon-migraineheadacheorincludedmixedpain
populations without reporting data separately for the migraine All trials used parallel-group designs; no trial had a cross-over
subgroup(8trials);interventionsdidnotmeetourdefinitionof design. Eighteentrials had two groups (one acupuncture group
acupuncture (for example, laser acupuncture or transcutaneous andacontrolgroup),threetrialswerethree-armed(Diener2006;
electricalstimulationatacupuncturepoints;6trials);comparison Doerr-Proske1985;LindeK2005)andonetrialhadfourgroups
ofacupuncturewithlaseracupunctureorotheracupuncture-like (Facco 2008). Six trials included a group which either received
interventions (5 trials); and questionable random allocation (5 treatmentofacuteattacksonly(Doerr-Proske1985;Facco2008;
trials). LindeK2005;LindeM2000)or’routinecare’thatwasnotspec-
Twenty-two trials described in 37 publications (including pub- ifiedbyprotocol(Jena2008;Vickers2004),whiletheexperimen-
lishedprotocols, abstracts of trials otherwise not available at all talgroupreceivedacupunctureinaddition.Fourteentrialshada
ornotavailableinEnglishlanguage,papersreportingadditional shamcontrolgroup.Shamtechniquesvariedconsiderably.Inthree
aspectssuchastreatmentdetailsorcost-effectivenessanalyses)met trialsexisting acupuncture points considered inadequate for the
all selection criteria and were included in the review. The total treatmentofmigrainewereneedledsuperficially(Alecrim2005;
number of study participants was 4419. One large study (n = Alecrim 2006; Alecrim 2008); in five trials superficial needling
401)inwhich6%ofpatientssufferedfromtension-typeheadache ofnon-acupuncture pointsatvariabledistance fromtruepoints
only was included, as 94% patients had migraine as a primary wasused(Diener2006;LindeK2005;Vincent1989;Weinschütz
diagnosis(Vickers2004).Twostudieswithalargerproportionof 1993; Weinschütz 1994); and ina furthertwo trialsclose non-
patients with tension-type headache were also included because acupuncturepointswereneedledwithoutindicationofneedling
separatesubgroupdataformigrainepatientswereavailable(Jena depth(Baust1978;Henry1985).Intwotrials(Linde M2005;
2008; Wylie 1997). Patients included in these two studies who Facco2008)’placebo’needles(telescopeneedleswith blunttips
hadonlytension-typeheadachearenotincludedinthenumber notpenetratingtheskin)wereused.InLindeM2005thesewere
of patients and other figures below. Ten of the22 included tri- placedatthesamepredefinedpointsasinthetruetreatmentgroup.
als(Baust1978;Ceccherelli1992;Doerr-Proske1985;Dowson Facco2008hadtwoshamgroups:inonegrouptheplacebonee-
1985;Henry1985;Hesse1994;Vincent1989;Weinschütz1993; dleswere placedatcorrect, individualized points afterthe same
Weinschütz1994;Wylie1997)hadbeenincludedinourprevi- fullprocessofChinesediagnosisasinthetruetreatmentgroup.
ousreview;theremaining12trials(Alecrim2005;Alecrim2006; Inthesecondgroupplaceboneedleswereplacedatstandardized
Alecrim2008;Allais2002;Diener2006;Facco2008;Jena2008; pointswithoutthe’Chineseritual’(toinvestigatewhetherthedif-
Linde K 2005; Linde M 2000; Linde M 2005; Streng 2006; ferentinteractionandprocessaffectedoutcomes).Intheremain-
Vickers2004)arenew. ingtwotrials(Ceccherelli1992;Dowson1985)othershaminter-
Searchesintheclinicaltrialregistersidentifiedfourongoingtrials ventionswithoutskinpenetrationwereapplied.Fourtrialscom-
(Liang;Vas;Wang;Zheng;seeCharacteristicsofongoingstudies). paredacupuncturetoprophylacticdrugtreatmentwithmetopro-
lol(Hesse1994;Streng2006),flunarizine(Allais2002)orindivid-
Generalstudycharacteristics
ualizedtreatmentaccordingtoguidelines(Diener2006).Inthree
A total of 4419 migraine patients participated in the included ofthesetrialsparticipantswereunblinded,whileoneblindedtrial
studies.Themeannumberofpatientsineachtrialwas201,with usedadouble-dummyapproach(trueacupuncture+metoprolol
amedianof42. Thesmallesttrialincluded27patientsandthe placebo vs. metoprolol + sham acupuncture; Hesse 1994). One
largest 1715. Five trials had between 114 and 401 participants trialcomparedacupuncturetoaspecificrelaxationprogram(and
(Allais 2002; Facco 2008; Linde K 2005; Streng 2006; Vickers awaitinglist;Doerr-Proske1985),andonetoacombinationof
2004); the two largest trials had 960 (Diener 2006) and 1715 massageandrelaxation(Wylie1997).
participants(Jena2008).Fiveofthelargertrialsweremulticenter
Includedpatients
studies;allotherswereperformedinasinglecenter.The10older
trialsincludedinthepreviousversionofourreviewhadincluded Mosttrialsincludedpatientsdiagnosedashavingmigrainewithor
atotalof407migrainepatients. withoutaura,orreportedonlythattheyincludedpatientswithmi-
Eight trials originated from Germany, four fromthe UK, three graine.Onetrialwasrestrictedtowomenwithmigrainewithout
eachfromItalyandBrazil,twofromSwedenandoneeachfrom aura(Allais2002),onerecruitedonlywomenwithmenstruallyre-
Denmark and France. We were able to obtain additional infor- latedmigraine(LindeM2005)andathirdrecruitedonlypatients
Acupunctureformigraineprophylaxis(Review) 7
Copyright©2009TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.