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EffectivenessofAcupunctureasAdjunctiveTherapyinOsteoarthritisoftheKneeARandomized,ControlledTrialBrianM.Berman,MD;LixingLao,PhD;PatriciaLangenberg,PhD;WenLinLee,PhD;AdeleM.K.Gilpin,PhD;andMarcC.Hochberg,MDBackground:Evidenceontheefficacyofacupunctureforreduc-ingthepainanddysfunctionofosteoarthritisisequivocal.Objective:Todeterminewhetheracupunctureprovidesgreaterpainreliefandimprovedfunctioncomparedwithshamacupunc-tureoreducationinpatientswithosteoarthritisoftheknee.Design:Randomized,controlledtrial.Setting:Twooutpatientclinics(anintegrativemedicinefacilityandarheumatologyfacility)locatedinacademicteachinghospi-talsand1clinicaltrialsfacility.Patients:570patientswithosteoarthritisoftheknee(meanage[±SD],65.5±8.4years).Intervention:23trueacupuncturesessionsover26weeks.Con-trolsreceived6two-hoursessionsover12weeksor23shamacupuncturesessionsover26weeks.Measurements:PrimaryoutcomeswerechangesintheWes-ternOntarioandMcMasterUniversitiesOsteoarthritisIndex(WOMAC)painandfunctionscoresat8and26weeks.Secondaryoutcomeswerepatientglobalassessment,6-minutewalkdis-tance,andphysicalhealthscoresofthe36-ItemShort-FormHealthSurvey(SF-36).Results:ParticipantsinthetrueacupuncturegroupexperiencedgreaterimprovementinWOMACfunctionscoresthantheshamacupuncturegroupat8weeks(meandifference,2.9[95%CI,5.0to0.8];P0.01)butnotinWOMACpainscore(meandifference,0.5[CI,1.2to0.2];P0.18)orthepatientglobalassessment(meandifference,0.16[CI,0.02to0.34];P0.2).At26weeks,thetrueacupuncturegroupexperiencedsignificantlygreaterimprovementthantheshamgroupintheWOMACfunc-tionscore(meandifference,2.5[CI,4.7to0.4];P0.01),WOMACpainscore(meandifference,0.87[CI,1.58to0.16];P0.003),andpatientglobalassessment(meandifference,0.26[CI,0.07to0.45];P0.02).Limitations:At26weeks,43%oftheparticipantsintheedu-cationgroupand25%ineachofthetrueandshamacupuncturegroupswerenotavailableforanalysis.Conclusions:Acupunctureseemstoprovideimprovementinfunctionandpainreliefasanadjunctivetherapyforosteoarthritisofthekneewhencomparedwithcredibleshamacupunctureandeducationcontrolgroups.AnnInternMed.2004;141:901-910.(1,2).Painandfunctionallimitationaretheprimaryclinicalmanifestationsofosteoarthritisoftheknee.Cur-rentrecommendationsformanagingosteoarthritis,includ-ingguidelinespublishedbytheAmericanCollegeofRheu-matology(3)andEuropeanLeagueofAssociationsofRheumatology(4),focusonrelievingpainandstiffnessandmaintainingorimprovingphysicalfunctionasimpor-tantgoalsoftherapy.Nocurativetherapiesexistforosteo-arthritis;thus,bothpharmacologicandnonpharmacologicmanagementfocusoncontrollingpainandreducingfunc-tionallimitation(5).Nonpharmacologictherapy,whichincludespatienteducation,socialsupport,physicalandoc-cupationaltherapy,aerobicandresistiveexercises,andweightloss,isthecornerstoneofamultidisciplinaryap-proachtoosteoarthritispatientmanagement(3).Pharma-cologictherapiesincludenonopioidanalgesics(suchasacetaminophen),nonsteroidalanti-inflammatorydrugs(NSAIDs)(includingcyclooxygenase-2[COX-2]enzymeselectiveinhibitors),topicalanalgesics(capsaicincream),opioidanalgesics,andintra-articularsteroidandhyaluro-nateinjections.Often,theseagentsareusedincombina-tionforadditiveanalgesicefficacy(6).Pharmacologicman-agementofosteoarthritisisoftenineffective,andagentssuchasNSAIDsmaycauseunwantedanddangeroussideeffects(7,8).Complementaryandalternativemedicineisanotherapproachtotreatingosteoarthritis(9–12),particularlyinAsiansocieties(13).ManyU.S.patientswithosteoarthritisalsousecomplementaryandalternativemedicaltherapies(14).Asystematicreviewofacupunctureandkneeosteoar-thritis(15)identified7smallrandomized,controlledtrialspublishedinEnglish.Withinthemethodologiclimitationsofthestudies,theevidencesuggestedthatacupunctureseemedtoalleviatekneepainandfunctioncomparedwith“sham”acupuncturecontrols,although2trialscomparingacupuncturewithanactive,nonpharmacologictreatment(physicaltherapy)didnotindicatesuchaneffect(16,17).Beforeconductingourlarge-scaletrial,wecompletedbothapilotstudy(18)andarandomized,single-blindtrial(19)oftheeffectofacupunctureonosteoarthritisoftheknee.Participantsintheuncontrolledpilotstudy(n12)showedstatisticallysignificantimprovementinbothself-reportedpainandphysicalfunction,aswellasperformancemeasuresofphysicalfunctionafter8weeksofacupuncturetreatmentandat12-weekfollow-upascomparedwiththeirbaseline(18).Inourlargerrandomized,single-blindAnnalsofInternalMedicineArticle©2004AmericanCollegeofPhysicians901trial(n73),whichexaminedthebenefitofacupunctureaddedtostandardmanagementwithNSAIDs,theacu-puncturetreatmentgroupexperiencedstatisticallysignifi-cantimprovementsinself-reportedpainanddisabilityscorescomparedwithastandard-carecontrolgroupaslateas4weeksaftertheendoftreatment(19).However,thiseffectdiminishedwithin18weeks(26weeksafterthebe-ginningofthetrial)afterth