2023+中国临床实践指南：针灸治疗膝骨关节炎（英文）.pdf

Received:18January2023Accepted:17March2023DOI:10.1111/jebm.12526G U I D E L I N EAcupuncturefortreatmentofkneeosteoarthritis:AclinicalpracticeguidelineXiaochaoLuo1,2,3JialiLiu1,2,3QianruiLi1,2,3,4JipingZhao5QiukuiHao6,7LingZhao8YemengChen9PengbinYin10,11LingLi1,2,3FanrongLiang8XinSun1,2,31ChineseEvidence-BasedMedicineCenter,CochraneChinaCenterandMAGICChinaCenter,WestChinaHospital,SichuanUniversity,Chengdu,China2NMPAKeyLaboratoryforRealWorldDataResearchandEvaluationinHainan,Chengdu,China3SichuanCenterofTechnologyInnovationforRealWorldData,Chengdu,China4DepartmentofNuclearMedicine,WestChinaHospital,SichuanUniversity,Chengdu,China5DepartmentofAcupunctureandMoxibustion,DongzhimenHospital,BeijingUniversityofChineseMedicine,Beijing,China6TheCenterofGerontologyandGeriatrics/NationalClinicalResearchCenterofGeriatrics,WestChinaHospital,SichuanUniversity,Chengdu,China7SchoolofRehabilitationScience,McMasterUniversity,Hamilton,Ontario,Canada8AcupunctureandTuinaSchool,ChengduUniversityofTraditionalChineseMedicine,Chengdu,China9NewYorkCollegeofTraditionalChineseMedicine,Mineola,NewYork10DepartmentofOrthopedics,ChinesePLAGeneralHospital,Beijing,China11NationalClinicalResearchCenterforOrthopedics,SportsMedicineandRehabilitation,Beijing,ChinaCorrespondenceXinSunandLingLi,ChineseEvidence-BasedMedicineCenter,CochraneChinaCenterandMAGICChinaCenter,WestChinaHospital,SichuanUniversity,Chengdu,China.Email:;FanrongLiang,AcupunctureandTuinaSchool,ChengduUniversityofTraditionalChineseMedicine,Chengdu,China.Email:FundinginformationNationalScienceFundforDistinguishedYoungScholars,Grant/AwardNumber:82225049;SichuanProvincialCentralGovernmentGuidesLocalScienceandTechnologyDevelopmentSpecialProject,Grant/AwardNumber:2022ZYD0127;FundamentalResearchFundsfortheCentralPublicWelfareResearchInstitutes,Grant/AwardNumber:2020YJSZX-3;InnovationTeamandTalentsCultivationProgramofNationalAdministrationofTraditionalChineseAbstractClinicalquestion:Isacupunctureeffectiveintreatingkneeosteoarthritis(KOA)?Current practice:Although increasingly usedin theclinical setting,acupuncture is notmentionedorweaklyrecommendedinguidelinesforthetreatmentofKOA.Recommendations:We suggest acupuncture rather than no treatment in adult KOA(weak recommendation,moderate certainty evidence),and acupuncture combinedwith nonsteroidal anti-inflammatory drugs(NSAIDs)rather than acupuncture alonewhen KOA symptoms are severe(weak recommendation,moderate certainty evi-dence),with duration of acupuncture for 48 weeks depending on KOA severityand treatment response(weak recommendation,moderate certainty evidence),anddiscussingwithpatientsinshareddecision-making.How this guidelinewas created:This rapid recommendation was developed followingthe Making GRADE the Irresistible Choice(MAGIC)methodological framework.First,theclinicalspecialistidentifiedthetopicofrecommendationanddemandforevidence.Then the independent evidence synthesis group performed a systematic review tosummarize available evidence and evaluate the evidence using the GRADE approach.2023ChineseCochraneCenter,WestChinaHospitalofSichuanUniversityandJohnWiley&SonsAustralia,Ltd.JEvidBasedMed.2023; AL.Medicine,Grant/AwardNumber:ZYYCXTD-D-202003Finally,the clinical specialist group produced recommendations for practice through aconsensusprocedure.The evidence:The linked systematic review and meta-analysis included 9422 KOApatients,61.1%of whom were women.The median mean age was 61.8 years.Com-pared with no treatment,acupuncture had beneficial effect on KOA in improving theWestern Ontario and McMaster Universities Osteoarthritis Index(WOMAC)totalscore(moderate certainty evidence),and WOMAC pain(very low certainty evidence),WOMAC stiffness(low certainty evidence),and WOMAC function(low certainty evi-dence)subscale scores.Compared with usual care,acupuncture improved WOMACstiffness subscale score(moderate certainty evidence).Subgroup analyses showeddifferent effects in the improvement of WOMAC total scores by different durationsof acupuncture and whether acupuncture combined with NSAIDs,but no differencebetweenmanualacupunctureandelectroacupuncturewasfound.Understanding the recommendations:Compared with no treatment,acupuncture issuggestedtoreducepain,stiffness,anddisfunctioninKOApatients,ultimatelyimprov-ingthepatientshealthstatus.Acupuncturecanbeusedasanalternativetherapywhenusual care is ineffective or there are adverse reactions so that patients can no longercontinue the treatment.Manual acupuncture or electroacupuncture is suggested for48 weeks to improve the health status of KOA.The patients values and preferencesshouldbeconsideredwhenselectingacupunctureforKOAtreatment.KEYWORDSacupuncture,clinicalpracticeguideline,kneeosteoarthritis,rapidrecommendation1INTRODUCTIONKnee osteoarthritis(KOA)is the most common arthritis degenerativedisease in adults,with a high level of disability and socioeconomicburden.1-3In 2019,there were 364.58 million patients with KOAworldwide,and more than two times that of 20 years ago.4Approxi-mately40%patientswithKOAexperiencephysicalfunctiondisability.5The years lived with disability of KOA are expected to increase asthe global population aging trend and more obese people.6The mosttroubling symptoms of KOA are pain and knee dysfunction,oftenaccompanied by stiffness,and later atrophy of the muscles around theknees.2,5The severity of KOA is manifested by more pain,dysfunctionand stiffness,as well as having a lower health-related quality of life.7KOA patients with more severe pain also have more functional limita-tions,and are more likely to choose more therapies,but the treatmentresultsareoftenunsatisfactory.8The mainly goal of KOA treatment is to alleviate pain anddisfunction.9-11Duetothelimitedbenefitsofmedication,treatmentofKOA has shifted to nonpharmacologic therapies,which are more likelyto provide long-term pain relief and functional recovery.2,12Oral non-steroidal anti-inflammatory drugs(NSAIDs)as the primary treatmentforKOAareoflimiteduseinpatientswithcoexistingconditionssuchasuppergastrointestinalbleeding,cardiovasculardiseaseandfrailty.1,9,13Otherdrugssuchasglucosamine,hyaluronicacid,andtramadolarenotwell supported for KOA.2,14-16Exercise and physical activity as typ-ical nonpharmacologic therapies are recommended by authoritativeguidelinestoalleviatepainanddysfunction,anddelaythedevelopmentof KOA.1,17-20However,the effects of exercise and physical activityare strongly influenced by patient compliance.21,22The most effectiveexercise program is to improve compliance to complete the therapeu-tic dose or add adjunctive interventions.23,24Since the nonadherenceof patients increases with exercise duration,it is necessary to seekadjuvanttherapies.25Acupuncture has been used as an adjunctive intervention for KOAin clinical setting and studied extensively.2628As a nondrug treat-ment of traditional Chinese medicine that regulates the balance ofQi(vital energy)and blood to conduct health conditions,29acupunc-ture can reduce knee inflammatory response and improve hyperal-gesia to relieve pain,as well as enhance muscle tone around theknee and slow cartilage degeneration to improve dysfunction.30,31A systematic review found that acupuncture might be the mostbeneficial physical therapy for pain relief in KOA patients.32Acupunc-ture is not mentioned,13,18conditionally recommended,1or weaklyrecommended17in the guidelines for treatment of KOA(Table 1).Becausetheadverseeffectsofacupuncturearerareandacceptabletopatients,someguidelinesdonotopposeacupuncture.1,9Arecentlypublishedlargesamplerandomizedcontrolledtrial(RCT)foundthat4-weekmanualacupunctureimprovedtheWesternOntario 17565391,0,Downloaded from https:/ by CochraneChina,Wiley Online Library on 03/04/2023.See the Terms and Conditions(https:/ Wiley Online Library for rules of use;OA articles are governed by the applicable Creative Commons LicenseLUOET AL.3TABLE 1Majorguidelinesrecommendationsonacupunctureforkneeosteoarthritis.OrganizationandpublicationyearofguidelineStrengthofrecommendationSituationwhereacupunctureisrecommendedAmericanAcademyofOrthopaedicSurgeons20229LimitedrecommendationAcupuncturemayimprovepainandfunctioninpatientswithkneeosteoarthritis,butcompellingevidenceislacking.JointSurgeryBranchoftheChineseOrthopaedicAssociation202117WeakrecommendationAcupunctureissuggestedtoimprovepainandfunctionofosteoarthritiswithmoderateevidencelevel.USDepartmentofVeteransAffairs/USDepartmentofDefense202033NeitherfornoragainstInsufficientevidenceofacupuncturetorecommended.AmericanCollegeofRheumatology/ArthritisFoundation20191ConditionalrecommendationAcupunctureisconditionallyrecommendedforkneeosteoarthritisbasedonpatientvaluesandpreferences.EuropeanSocietyforClinicalandEconomicAspectsofOsteoporosis,OsteoarthritisandMusculoskeletalDiseases201918NorecommendationNotmentioned.OsteoarthritisResearchSocietyInternational201913NorecommendationNotmentioned.andMcMasterUniversitiesOsteoarthritisIndex(WOMAC)totalscoreand pain,stiffness,and function subgroup scores in weeks 4 and 16compared with no treatment.34An RCT published in 2021 foundthat electroacupuncture was more effective than manual acupunc-ture in improving pain,stiffness,and disfunction at the end of 8-weektreatment.35These two RCTs might change the clinical practice ofacupuncture for KOA.Triggered by these two RCTs,we thus con-ductedthisrapidrecommendationaimingtotranslateevidencequicklyand transparently for clinicians and their patients by evidence-basedrecommendationstoimprovethecareofKOA.362METHODSThis guideline report follows the Reporting Items for Practice Guide-lines in Healthcare(RIGHT)for acupuncture and the BMJ RapidRecommendations.37,382.1Who was involved in the guideline group?This guideline panel included a clinical specialist group,a methodol-ogist group,an evidence synthesis group,and a project coordinationgroup(Supplementary material).First,the clinical specialist group,composed of acupuncturists and orthopedists,identified the recom-mended topics and evidence needs based on clinical questions.Anindependent evidence synthesis group then searched and synthesizedthe evidence to support clinical decision-making.The level of evidencewas assessed according to the Grading of Recommendations,Assess-ment,Development,and Evaluation(GRADE)approach.Finally,theclinical specialist and methodologist groups produced recommenda-tions for clinical practice through a consensus procedure.This rapidrecommendation was developed following the Making GRADE theIrresistible Choice(MAGIC)methodological framework.All the mem-bers signed the Declaration of Interests and confirmed no financialconflictsofinterestbeforethefirstpanelmeeting.2.2What research did the guideline panelrequest and review?The first panel meeting confirmed the clinical question,participants(P),intervention(I),comparison(C),outcome(O),study design(S),and subgroup analyses.The clinical question was whether acupunc-ture is effective in treating KOA.The full information was linkedwith a systematic review conducted by an independent evidencesynthesis group.The linked systematic review summarized evidenceofRCTs on the benefits and harms of acupuncture for KOA.39The par-ticipants were adults with primary KOA.Acupuncture interventionwas manual acupuncture(i.e.,filiform needle)or electroacupuncture.Controlled therapies included no treatment(including blank controland sham-acupuncture)and usual care.NSAIDs,glucosamine,sodiumhyaluronate,exercise therapy,physiotherapy,and education were allconsidered as usual care.Primary outcome was WOMAC total score,andsecondoutcomesincludedWOMACpainscore,WOMACstiffnessscore,WOMACfunctionscore,theMOSitemshortformhealthsurvey(SF-36),andadversereactions.2.3How did the guideline panel formulate therecommendations?First,the guideline panel made a recommendation on whether to useacupuncture in KOA patients.The second was how long acupuncture 17565391,0,Downloaded from https:/ by CochraneChina,Wiley Online Library on 03/04/2023.See the Terms and Conditions(https:/ Wiley Online Library for rules of use;OA articles are governed by the applicable Creative Commons License4LUOET AL.should be used.As manual acupuncture and electroacupuncture arethe two most used acupuncture,the evidence synthesis group thenexplored whether the treatment effects of these two types were dif-ferent.Since NSAIDs are the first-line medical therapy for KOA,theguideline panel finally made a recommendation on whether acupunc-ture in addition to NSAIDs was more effective than acupuncturealone.To better translate the outcomes,minimal clinically important dif-ference(MCID)was used to determine the clinical importance of theimprovement for continuous outcome.MCIDs of WOMAC total score(rang:096 scores),WOMAC pain,WOMAC function,WOMAC stiff-ness,and SF-36 physical component summary(PCS)were 6.432,1.5,4.556,0.576,and 2,respectively,while of SF-36 mental componentsummary(MCS)wasnotavailable.40TheGRADEapproachwasusedtoevaluate the certainty of results from the main domains of risk of bias,inconsistency,indirectness,imprecision,and publication bias.41WealsousedtheGRADEapproachtodeveloprecommendationsandclas-sified the strength of them as“strong”or“weak,”taking into accountthe balance of benefits and harms,the certainty of evidence,andclinical feasibility.We reached consensus on all recommendations byreferringtotheresultsofthelinkedsystematicreview39andcombinedwithconsensusofexperts.2.4Values and preferencesFor KOA patients,there is a great difference in their willingness tochoose and accept acupuncture.For example,some patients do notchoose acupuncture because they are afraid of acupuncture or cannottolerate the pain of needling,and some patients choose acupuncturebecause they are recommended by other patients who benefit fromacupuncture.The guideline panel generated the recommendationswith a patient-centered perspective,although there was no direct evi-dence of the values and preferences of KOA patients for acupuncture.All panel members made these recommendations based on patientvalues and preference.In particular,members of the clinical spe-cialist group were asked to make recommendations based on theirknowledge of the value and preferences of KOA patients from clinicalwork.2.5The evidenceThe linked systematic review and meta-analysis39included 77 RCTsexploringthebenefitsandharmsofacupuncturein9422KOApatients,61.1%of whom were women.The median mean age was 61.8 years(range:42.772.4years).Electroacupunctureandmanualacupuncturewere used in 32 and 45 trials,respectively.The control treatmentsincluded no treatment and usual care in 54 and 29 trials,respectively.In studies with no treatment as a control group,acupuncture in 18/33(54.55%)trialswasusedasanadjunctivetreatmenttotheusualcare.Comparedwithnotreatment,acupunctureimprovedWOMACtotalscores(29 RCTs,4119 patients,MD=8.05,95%CI:10.14 to5.96,moderate certainty evidence),WOMAC pain(31 RCTs,4379patients,MD=1.52,95%CI:2.02 to 1.02,very low certainty evi-dence),WOMAC stiffness(22 RCTs,2683 patients,MD=0.76,95%CI:1.09 to 0.44,low c