Hindawi Evidence-Based Complementary and Alternative Medicine Volume 2017, Article ID 6383649, 14 pages https://doi.org/10.1155/2017/6383649 Review Article Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Li-HuaYang,1Pei-BeiDuan,2Qing-MeiHou,1Shi-ZhengDu,3Jin-FangSun,4 Si-JuanMei,1andXiao-QingWang1 1DepartmentofOncology,HospitalAffiliatedtoNanjingUniversityofTraditionalChineseMedicine,155HanzhongRoad, GulouDistrict,Nanjing,Jiangsu210029,China 2DepartmentofNursing,HospitalAffiliatedtoNanjingUniversityofTraditionalChineseMedicine,155HanzhongRoad, GulouDistrict,Nanjing,Jiangsu210029,China 3SchoolofNursing,NanjingUniversityofTraditionalChineseMedicine,138XianlinRoad,QixiaDistrict,Nanjing, Jiangsu210046,China 4DepartmentofEpidemiologyandBiostatistics,SchoolofPublicHealth,SoutheastUniversity,87DingjiaqiaoRoad, GulouDistrict,Nanjing,Jiangsu210009,China CorrespondenceshouldbeaddressedtoPei-BeiDuan;[email protected] Received 20 February 2017; Revised 14 April 2017; Accepted 8 June 2017; Published 18 July 2017 AcademicEditor:MarutiRamGudavalli Copyright©2017Li-HuaYangetal.ThisisanopenaccessarticledistributedundertheCreativeCommonsAttributionLicense, whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited. Objectives.ToidentifytheefficacyofauricularacupressureonpainanddisabilityforchronicLBPbysystematicreview.Methods. AsearchofrandomizedcontrolledtrialswasconductedinfourEnglishmedicalelectronicdatabasesandthreeChinesedatabases. Tworeviewersindependentlyretrievedrelatedstudies,assessedthemethodologicalquality,andextracteddatawithastandardized dataform.Meta-analyseswereperformedusingalltime-pointsmeta-analysis.Results.Atotalof7trialsmettheinclusioncriteria, ofwhich4hadthelowriskofbias.Thefindingsofthisstudyshowedthat,fortheimmediateeffect,auricularacupressurehadlarge, significanteffectsinimprovingpainwithin12weeks.Asforthefollow-upeffect,thepooledestimatesalsoshowedpromisingeffect at4-weekfollow-upafter4-weekintervention(standardizedmeandifference=−1.13,95%CI(−1.70,−0.56),𝑃 < 0.001).But,for thedisabilitylevel,thetherapeuticeffectwasnotsignificant(meandifference=−1.99,95%CI(−4.93,0.95),𝑃=0.18).Noserious adverseeffectswererecorded.Conclusions.Theencouragingevidenceofthisstudyindicatesthatitisrecommendedtoprovide auricularacupressuretopatientswithchroniclowbackpain.However,amoreaccurateestimateoftheeffectwillrequirefurther rigorouslydesignedlarge-scaleRCTsonchronicLBPforimprovingpainanddisability. 1.Introduction “atthegloballevel,among291diseasesandinjuries,LBPhas beenthemainreasonfordisabilityandlabelledasthehighest Low back pain (LBP) is now a prevalent and burdensome causeofyearslivedwithdisability”[4].IntheUnitedStates, issueforbothindividualsandsociety,affectingapproximately chronicLBPhasresultedinhugenegativeeffectsonpeople’s 60%–80%oftheworld’spopulation,and20%ofthemhave well-beingandcosttosociety,asreflectedbyincreasedmed- developedintochronicsymptoms[1,2].Eighty-fivepercent icalcarecostsanddisability-relatedlossofproductivityand of patients in chronic LBP conditions have nonspecific wages[5,6].ThecontinuedhighprevalenceofLBPandseri- underlyingcausesorpathology[3].Besidespersistentpain, oussocioeconomicburdenrelatingtoLBPmayhighlightthe declined physical activity is one of the major complaints in requirementformoreeffective,safe,andlow-costpainman- patients with chronic LBP. According to the Global Burden agement.AsoneoftheseLBPmanagements,auriculotherapy ofDiseases,InjuriesandRiskFactorsStudy2010(GBD2010), (AT)mayplayanimportantrole[7–10]. 2 Evidence-BasedComplementaryandAlternativeMedicine Auricular therapy, as defined by Oleson, refers to “a AMED)andthreeChinesedatabases(CBMdisc,CNKI,and healthcare modality by stimulating the external surface of WanFang Data) were searched until March 18, 2016, with theeartoalleviatepathologicalconditionsinotherpartsof thefollowingMeshtermsandtextwords:(“auriculotherapy” the body” [11]. The French AT of Nogier and the Chinese OR “auricular therapy” OR “auricular point sticking” OR are currently two main lines of research that can explain “auricularpointtherapy”OR“auricularplastertherapy”OR the principles of AT. Dr. Paul Nogier first determined the “auricular pressing therapy” OR “ear point” OR “auricular somatotopicarrangementofearpointsastheinvertedfetus acupressure”OR“auraltherapy”OR“earacupressure”)AND in the 1950s and considered the auricular microsystem as (“low back pain” OR “backache” OR “lumbosacral”) AND ∗ reflexology of a neurological action [12, 13]. The Chinese (“randomized controlled trial” OR “random ”). Finally, a school theorizes that using AT to treat disease should root snowballsearchwasdone,inwhichreferencelistsofeligible intraditionalChinesemedicine(TCM)[12,14].InTCM,the RCTswerescreenedandcheckedforpotentialrelevantclini- vital energy (Qi) of the body circulates in the channels and calstudies.Non-Englisheligiblepublicationsweretranslated collaterals,andimbalanceofaperson’sQimaycausedisease into English for further analysis and EndNote software was orillness.Stimulatingaspecificareaoftheauricularcartilage usedtomanagecitations. regulatesQi,activatestheenergypathways,andhasregulative effectsonthecorrespondingzang-fufunction[13,14].Means 2.2.SelectionofStudies. OnlyRCTswereselectedaseligible of stimulation on the auricular acupoints are either multi- studies.Further,theyshouldsatisfythefollowingcriteria. tudinous, including small acupuncture needles [15], Semen vaccariae (a type of plant seed) [16], magnetic pellets [17], P(Population).Studiesthatexaminedadults(≥18yearsold) and electroacupuncture [18], or applied directly to the skin suffering from chronic nonspecific LBP which lasted for liketranscutaneouselectricalnervestimulation(TENS)[19]. more than 3 months [27, 28] were reviewed. But those that Unlikeothermodels,thestimulationofS.vaccariaeormag- recruitedparticipantswithanyspecificpathologies(i.e.,with neticpelletstapedontheouterearisconductedbypressing inflammatory,malignantdiseaseorfracture)wereineligible. themwiththethumbandforefinger.Inthismodel,without anyinvasiveprocedure,auricularacupressure(AA)seemsto I(Intervention).StudiesofinterventionsthatadoptedAAas bemoreacceptedbypatients,andalso,relatedadverseevents experimentalstrategiesortheprimarymodalityinmanaging suchasinflammationoftheacupointsmayhavebeenreduced LBPwereincluded.Thetapedobjectscanbebotanicalplant [20]. seeds (i.e., S. vaccariae) or magnetic pellets. In particular, Recently, enthusiasm is growing for the role of AA in RCTs on the use of AA, which involve invasive techniques, managing chronic LBP. Lots of clinical trials have been such as auricular acupuncture, electroacupuncture stimula- performed,andtheresultshaveshownpromisingeffects[8, tion,anderjianbloodlettingmethod,wereexcluded. 21,22].Severalsystematicreviews(SR)ofauriculartherapy forpainmanagementhavebeenconducted[23,24],mainly C (Comparison). TheinterventiontobecomparedwithAA oncalculatingsummaryestimatesfromeligibletrialsatfinal wouldincludeanyofthefollowing:conventionalmodalities, time point (final time-point meta-analysis, FTM). In fact, notreatment,sham,orotherTCM. formanagementofchronicpain,durationoftreatmentisa keyfactorfortherapeuticoutcomes[24].Exploringalltime- O (Outcome). Each eligible trial should take pain intensity pointsmeta-analysis(ATM)ofrepeatedmeasurestocapture (e.g., Visual Analogue Scale, Numerical Rating Scale) and thetrendofeffectivenessofAAoverthetimeisinevitableand disability measured by validated instruments (e.g., Roland- necessary.Uptonow,twopublishedsystematicreviewshave Morris Disability Questionnaire [29]) as its primary out- studiedtimeeffects[25,26].Oneofthemisonthetopicoftra- comes. Other outcomes, such as total therapeutic effect on ditionalChinesemedicinetreatmentsforneckpainandlow chronicLBP(e.g.,fromtheStandardsforDiagnosisandCura- backpain[25].However,inthesectionofanalysesconsisting tiveEffectofChineseMedicalSymptomorClinicalGuideline of acupressure for LBP, RCTs adopted auricular pressing of New Drugs for TCM [30, 31]), would be considered as therapyoracupressureinthewholehumanbodyasexperi- secondaryindicators. mentalstrategieswereallfoundforfurtheranalysis.Theother one demonstrated the role of auriculotherapy in managing 2.3. Study Outline. First, seven electronic databases were chronicpain,butthisstudyinvolvedvarietiesofimplemen- searchedforrelevantstudies.Afterdeletingtheduplications, tationmodels(auricularacupuncture,auricularacupressure, one reviewer (Li-Hua Yang) selected potential relevance andauricularelectrostimulation),ratherthanusingauricular basedontitle,abstract,orkeywordsandtheotherreviewer pressingtherapyonly[26]. (Si-JuanMei)readarandomsamplingindependently.Then, Giventheseconditions,weaimedtoquantitativelyassess bothreviewers(Li-HuaYangandSi-JuanMei)reviewedthe the effects of AA for the management of chronic LBP from randomized controlled trials (RCTs) in terms of two major full texts of relevant studies. Finally, a snowball technique complaints:painanddisabilityasprimaryoutcome(s).And, was utilized to check for more eligible RCTs from the ifpossible,ATMwouldbeusedformeta-analysis. referencelistsofselectedarticles.Duringtheprocessesabove, disagreements between the two reviewers were resolved by 2.Methods usingaconsensusmethod. 2.1. Selection Strategy. With no time limit, four English 2.4.QualityCriticalAppraisal. Tworeviewers(Li-HuaYang databases (PubMed, Embase, the Cochrane Library, and andSi-JuanMei)independentlyassessedthemethodological Evidence-BasedComplementaryandAlternativeMedicine 3 qualityusingtheCochraneriskofbiastoolforRCTsrecom- used [33]. Otherwise, a random-effect model would be mendedbyCochranehandbook[32].TheCochraneCollab- appliedtopoolthedataifthetrialsareclinicallyhomogenous oration’sriskofbiastoolconsistsofsixitems(randomization, enough,andthensensitivityanalysiswouldbeconductedto allocationconcealment,blinding,incompleteoutcomedata, identify the sources for contributing heterogeneity. Or they selective outcome reporting, and other potential sources of would be synthesized with qualitative analysis rather than bias).Eachitemwasscoredas“met,”“unmet,”or“unclear.” quantitativeassessment.WhenasufficientnumberofRCTs Because AA may not be double-blinded, in our review, we wereavailable,afunnelplotwouldbeconstructedtoexamine consideredsingle-blindingofoutcomeassessorsas“met”for potentialpublicationbias. blinding. Two summary statistics were used for meta-analysis of BasedonCochranehandbook,wedividedthequalityof painintensity,themeandifference(MD)andthestandard- RCTsintothreelevels(A,B,andC).“A”indicatedthatallor izedmeandifference(SMD).Ifthepainscoresweremeasured mostofthesixcriteriaweremet,whichstandsforthelowrisk bythesamescale,MDwouldbeusedinmeta-analysis.But ofbias.ForonecandidateRCT,ifoneormorecriteriawere if they were measured by different scales, SMD would be partlymet,Blevelwouldberatedrepresentingunclearriskof applied. According to Cochrane handbook and Warsi et al. bias.Butifoneormorecriteriawerenotmet,“C”reflecting [32,34],amagnitudeeffectsize(SMD)of<0.2,0.2∼0.5,and the high risk of bias would be defined. Given that the high >0.5was,respectively,definedassmall,moderate,andlarge riskofbiaswouldgreatlyreducethecredibilityoftheresults, effect. For dichotomous data, we calculated a relative risk articlesratedasClevelwouldbeeliminated. (RR)andcorresponding95%ConfidenceInterval(CI). Two reviewers (Li-Hua Yang and Si-Juan Mei) scored eachRCTseparately,withathirdreviewer(PBD)actingasan 3.Results arbiter when any disagreements occurred. If study contents were insufficient to determine the risk of bias, the corre- 3.1. Search Process. We identified 85 potentially relevant spondingauthorofthestudywouldbecontactedforfurther records in total. After removing the duplicates, 66 records information. were retrieved for evaluation according to title/abstract. Excludedontitleandabstractwere40references,leaving26 2.5.ExtractionofData. Tworeviewers(Li-HuaYangandSi- articlesrequestedforfulltexts.With1studyunavailable,25 JuanMei)independentlyextractedthedatausingastandard- recordswithfulltextsweresubsequentlyevaluatedaccording ized data form. Pieces of information about characteristics tothecriteria.Atthisstage,18recordswereexcludedforvari- of the participants (e.g., sample size, age, sex, and specific ousreasonspresentedinFigure1.Meanwhile,noarticleswere conditionsofparticipants),interventionprotocol(e.g.,taped selectedbasedonsnowballsearch.Therefore,inourreview, objects, selected ear points, acupoint detection, detailed 7 articles that met the inclusion criteria were passed on to instructions of manual pressing, duration of AA, follow- qualitycriticalappraisal[20,35–40]. up,andthecontrolintervention),andtherapeuticoutcomes (including main outcome measure and the results, adverse 3.2.CriticalAppraisalofQuality. Of7studies,wedefined4 events) were all recorded. Any disagreements between two RCTsasAqualitylevel[20,37–39]and3RCTsasBquality reviewerswereresolvedbyconsensusandwetriedtocontact level according to the Cochrane risk of bias tool [35, 36, studyauthorsoftheRCTstosupplythemissingdata. 40]. Disagreements between the two reviewers were solved Forcontinuousdataonpainintensity,thechangesfrom afterconsensusmeeting.Theriskofbiasassessmentofeach baseline of most eligible studies expressed with means and includedtrialisdescribedinTable1. standarddeviations(SD)couldbeextractedfromtheoriginal or calculated according to methods recommended by the 3.3. Characteristics of EligibleRCTs Includedfor Analysis. A Cochrane handbook. So we would use the differences in totalof7studiesmettheinclusioncriteriaandwerepassed change score for meta-analysis in order to make the results morecredible. on to analysis. Table 2 contains the information of their characteristics.AllRCTswerefromUSA(3)[37–39],Hong 2.6. Quantitative Synthesis of Data. Meta-analysis was KongSpecialAdministrativeRegionofthePeople’sRepublic accomplishedusingsoftwareRevMan(version5.2).ATMof of China (1) [20], and mainland of China (3) [35, 36, 40], repeatedmeasureswouldbeappliedtoanalyzethetrendof respectively.Six(6)wereinEnglish[20,35–39],andonewas effectiveness of AA on chronic LBP over time. And in our inChinese[40].Thedatesofpublicationfortheincluded7 review,datawereanalyzedaccordingtothedurationofAA studiesrangedfrom2007to2015.Participantsinfourofthe andfollow-up,whichwerecategorizedasshort-term(upto sevenstudiesweremiddle-agedpatients(2)ortheelderly(2). 4weeks),long-term(12weeks),orfollow-up(about4weeks Studiesvariedinsamplesize.AlleligibleRCTs,withsize afterintervention). ranging from 19 to 74, totally allocated 369 adult patients Ineachmeta-analysis,thedegreeofheterogeneityamong with chronic LBP or lumbar muscle strain. Of these RCTs, studieswasestimatedbyusingthe𝜒2statisticsand𝐼2testwith fourstudiescomparedAAwithplacebocontrol[20,37–39] a𝑃value<0.10and𝐼2 >50%ofstatisticalsignificance.Ifthe and another three used Tai Chi exercise [35]/conventional data was measured without significant heterogeneity (𝐼2 < medicine [36]/walking training of lunge twist [40] as com- 50% and a 𝑃 value > 0.10), a fixed-effect model would be parison. 4 Evidence-BasedComplementaryandAlternativeMedicine Publications identified for retrieval (n=85) Englishn=57 Chinesen=28 Excluded due to duplication (n=19) Articles retrieved for more detailed evaluation according to title/abstract (n=66) Excluded (n=40) Design: 12 (i) Review: 9 (ii) Experience summary: 2 (iii) Case reports: 1 Subject: 25 (i) Sample: 17 (ii) Intervention: 8 Duplicate publication: 3 Articles requested for full texts (n=26) Excluded due to unavailable full text (n=1) Articles with full texts for further evaluation according to the inclusion criteria (n=25) Excluded (n=18) Design: 2 (i) Commentary: 1 (ii) Quasi-experiment: 1 Subject: 10 (i) Sample: 1 (ii) Intervention: 9 Outcome indicators: 4 Duplicate publication: 2 0 articles added by snowball Studies passed on to quality critical appraisal (n=7) Eligible RCTs included for analysis (n=7) Figure1:Studyflowdiagram. Table1:Methodologicalqualityofallincludedstudies. Random Allocation Incomplete Selective Studies Blinding Otherbias Qualitylevel allocation concealment outcome reporting Luetal.2015 + ? − − − + B Suenetal.2007 ? ? + + + + A Wang2015 + − − − + + B Xiaetal.2011 ? − − − + + B Yehetal.2013 + + + + − + A Yehetal.2014 + + + + + + A Yehetal.2015 + + + + + + A “+”=criteria“met”;“−”=criteria“unmet”;“?”=criteria“unclear.” 3.4.ContentandImplementationofAA thenumberofmainearpointsselectedinalleligiblestudies ranged from 4 to 7. As for the adjunct part, only 2 RCTs 3.4.1. Selection and Number of Ear Points in AA. Generally, claimed that adjunct ear points were selected according to auricular acupoints selected for treatment consist of two syndrome differentiation [35, 40]. As a unique diagnostic types:themainpartandtheadjunct.AspresentedinTable3, method, differentiation of syndrome (Bian Zheng) in TCM Evidence-BasedComplementaryandAlternativeMedicine 5 Table2:DataextractionofrandomizedcontrolledtrialsonAAforchronicLBP. Diagnosticcriteriaforchronic Studies Participants Controlintervention LBP/syndromedifferentiation Middle-agedandelderlypatients withthechroniclumbarmuscle TaiChiexercise,respectively,in Luetal.2015,China/Henan strain(𝑛=74),E:37(27M,10F), Yes/NM morningandatnight,about45 MA:49.39±5.90yr,C:37(26M, minutespertime 11F),MA:48.77±6.36yr TheelderlysufferingfromLBP Suenetal.2007, (𝑛=60),E:30(2M,28F),MA: AAwiththeseedsofSemen China/HongKong 82.13±6.87yr,C:30(30F),MA: Yes/NM vaccariae 81.23±6.21yr Middle-agedandelderlypatients Thewalkingtrainingoflunge withthechroniclumbarmuscle Wang2015,China/Henan strain(𝑛=58),E:29(22M,7F), Yes/NM twist,respectively,inmorning MA:47.4±6.0yr,C:29(21M, andatnight,about15minutes 8F),MA:46.6±6.4yr pertime Outpatientswithlumbarstrain Xiaetal.2011, (𝑛=60),E:30(13M,17F),MA: ApplingGuTongTieGao(1-2 China/Shenzhen 29.25±10.36yr,C:30(11M, Yes/NM plasters/day,2weeksintotal) 19F),MA:28.52±10.28yr Treatedwithauricular Patientswithchroniclowback pain(𝑛=19),E:10(2M,8F), acupressurewhereearpoints Yehetal.2013,USA MA:45.4±21.8yr,C:9(2M, Yes/NM werenotcorrelatedwithCLBP 7F),MA:49.8±14.4yr (mouth,stomach,duodenum, andkidney) Treatedwithauricular Olderpatientswithchroniclow backpain(𝑛=37),E:19(4M, acupressurewhereearpoints Yehetal.2014,USA 15F),MA:70.6±4.67yr,C:18 Yes/NM werenotcorrelatedwithCLBP (7M,11F),MA:76.7±7.00yr (mouth,stomach,duodenum, andeye) Treatedwithauricular Patientswithchroniclowback pain(𝑛=61),E:30(10M,20F), acupressurewhereearpoints Yehetal.2015,USA MA:60.97±17.44yr,C:31(10M, Yes/NM werenotcorrelatedwithCLBP 21F),MA:65.61±16.04yr (mouth,stomach,duodenum, internalear,andtonsil) AA,auricularacupressure;LBP,lowbackpain;E,experimentalgroup;C,controlgroup;M,male;F,female;MA,meanage;yr,year;NM,notmentioned. aims to analyze and recognize the syndrome of disease locations of auricular points, as is known, among the 93 for subsequent treatment decision. However, in the 2 RCTs auricularacupuncturepointsoftheinternationalstandardof referring to selection of adjunct ear points, there was no auricularacupuncturepoints(AAPs)developedbytheWorld further information described on types of syndrome. Both Federation of Acupuncture-Moxibustion Societies (WFAS), of them reported that 2 to 3 adjunct acupoints were added 34 (36.6%) were based on the nomenclature and locations asrequired.InfourRCTs[20,35,36,40],theAAtreatment ofNogier,twenty-one(22.6%)werebasedontheanatomical was given to only one ear each time, with two ears treated terminologyofthesurfaceoftheauricle,andtheremaining alternately. While in the other 3 studies, during each week, 38(40.8%)werebasedonChineseAAPs[41].Accordingto bilateralauricularpointsweretreatedfor5days.Andprior this standard, we reviewed all auricular acupoints used for tothenexttreatmentthereare2daysleftwithouttapingthe treating chronic LBP in 7 included studies and found that earssoastorecovertheacupoint’ssensitivityandminimize 3RCTsweresimultaneouslybasedonthenomenclatureand theriskofanallergicreactiontothetape[37–39]. locationsofNogier,theanatomicalterminologyofthesurface Inallincludedstudies,15mainauricularacupointswere oftheauricle,andtheChineseauricularacupuncturepoints commonly used for treating chronic LBP. Shenmen (7/7) whichwerecloselycombinedwithclinicalpractice[37–39]. and subcortex (6/7) were the ear points of high-frequent Theremaining4wereonlybasedonthenomenclaturesystem use, which were considered primarily for alleviating pain, putforthbyNogierandtheChinese[20,35,36,40]. followed by lumbosacral region (5/7), liver (4/7), kidney (4/7),sympathetic(3/7),lowback(2/7),waist(2/7),popliteal 3.4.2. Use of Taped Objects and Acupoint Detection Tools in fossa (1/7), groove of spinal posterior (1/7), sciatic nerve AA. Six of the eligible studies used S. vaccariae as taped (1/7), urinary bladder (1/7), buttock (1/7), spleen (1/7), and objectsinAA[35–40].InadditiontoS.vaccariae,magnetic Ashi point (1/7), respectively. For the nomenclature and pelletswerealsocommonlyappliedinChina.Inourreview, 6 Evidence-BasedComplementaryandAlternativeMedicine h h -up M two M M mont mont M Duration/follow 12weeks(3-4days/session)/N 3weeks(3days/session)/atandfourweeks 12weeks(3-4days/session)/N 2weeks(3-4days/session)/N 4weeks(5days/session)/1 4weeks(5days/session)/1 4weeks(5days/session)/N ed. n o nti e m Usingearsalternately √ √ √ √ No No No ess;NM,not n ot h e e e or onAAforchronicLBP. Manualpressing 20min/dayforatotalof20cycles/timeperacupointuntildeqi Nomanualpressureexerted 20min/dayforatotalof20cycles/timeperacupointuntildeqi 3times/dayforatotalof3–5min/timeuntildeqi ≥3times/dayfor3min/timand3minuteswheneverexperiencingpain ≥3times/dayfor3min/timand3minuteswheneverexperiencingpain ≥3times/dayfor3min/timand3minuteswheneverexperiencingpain mbness,distention,heaviness, u zedcontrolledtrials pointdetection Probe Electronic Probe NM Electronic Electronic Electronic feelingsofsoreness,n domi Acu ective n bj a u r s Table3:Implementationof Selectedearpoints(number)Mainearpoints(M)andadjunctearpoints(A)M(7):liver,kidney,waist,lumbar,sacrum,cortex,andShenmenA(5):adrenalgland,poplitealspace,liver,lung,andspleenM(7):Shenmen,kidney,urinarybladder,lumbosacralvertebrae,buttock,liver,andspleenM(7):liver,kidney,waist,lumbar,sacrum,cortex,andShenmenA(5):adrenalgland,poplitealspace,liver,lung,andspleenM(6):Ashipoint,lumbosacralvertebrae,kidney,liver,Shenmen,andsubcortexM(4):Shenmen,sympathetic,nervoussubcortex,lowerbackM(7):Shenmen,sympathetic,nervoussubcortex,poplitealfossa,grooveofspinalposterior,sciaticnerve,lumbosacralM(4):Shenmen,sympathetic,nervoussubcortex,twozonesforlowerbackwhichlocatedonthefrontandbackoftheear vaccariae;Deqireferstopatient’s n e m C: Se s et V, Tapedobject SV magneticpellSV SV SV SV SV SV wbackpain;S o E: P,l B L e; ur ess Studies Luetal.2015 Suenetal.2007 Wang2015 Xiaetal.2011 Yehetal.2013 Yehetal.2014 Yehetal.2015 AA,auricularacupr Evidence-BasedComplementaryandAlternativeMedicine 7 onestudyusedAAtreatmentinbothexperimentalgroupand Among7RCTs,4articlesdidnothaveaplanforafollow- control group [20], but the participants in the intervention upvisit[35,36,38,40],andthefollow-upsofthe3RCTsare groupweretapedwithmagneticpelletswhilethoseincontrol from2weeksto1month[20,37,39]. groupweregivenS.vaccariae. Exploringandlocatingthehypersensitivespotshasbeen 3.4.5.ComplianceandAttritionRate. Thetherapeuticeffect oneofthekeypointsinauricularplastertherapy.FourRCTs ofAAcanbegreatlyaffectedbythequalityofmanualpressing usedanelectricalacupointfinderworkingontheprincipleof (i.e.,thetimeandfrequencyofseedpressing).However,only detectingdecreased-resistancepoints[20,37–39].Earpoints threearticlesreportedthecomplianceofparticipantstothe couldbeidentifiedwhentheelectricaldetectormadeasound instructionsofmanualpressing[37–39].FourRCTsreported indicatingthecorrespondinglocationonthebody.TwoRCTs theirattritionrateswhicharefrom9.5%to37.8%[36–39]. appliedaprobe[35,40]andtheremainingonedidnotreport theuseofdetectiontools[36]. 3.5.OutcomeAnalysis 3.4.3. Instructions of Manual Pressing. According to Li et 3.5.1.TheChronicBackPainIntensity al., as a taped object, S. vaccariae has been confirmed to TheImmediateEffectafterIntervention.In7RCTs,themost havenotherapeuticeffectwithoutexertingmanualpressure frequentlyusedscalesforchronicLBPwereVisualAnalogue [42].Therefore,demonstrationofmanualpressingtechnique Scale (VAS), Verbal Rating Scale (VRS), and the Brief Pain to participants is the most frequently used supplementary Inventoryshortform(BPI-sf)(Table4).Threeofthemwere modalityinAAtherapy.85.7%oftheRCTs(6/7)adoptedit allmeasuredonascaleof0to10,withhigherscoreindicating whiletheremainingonereportedthatparticipantsincontrol more severe pain intensity. Data of changes from baseline group(S.vaccariae)orexperimentalgroup(magneticpellets) were available or calculated. The result of meta-analysis were all reminded not to press on it in order to avoid a revealedthat,comparedwithcontrolgroup,AAgrouphada confoundingeffectduetophysicalpressure[20]. large,significanteffectinrelievingpainatallfinaltimepoints Theinstructionsonmanualpressingmainlyconsistedof [SMD=−0.65,95%CI(−0.87,−0.44),𝑃<0.001](Figure2). its frequency, duration, timing, and the intensity required. At 4 weeks and similar cases, there were 5 RCTs which FourofthesixRCTswithpressingimplementationsreported usedBPI-sf,VAS,andVRSaspainintensityscales[20,36– the frequencyand duration of pressing completely [36–39]. 39],andthedataofchangesfrombaselinewereavailableor Three of them claimed it should be done “not less than calculated. The result of meta-analysis revealed that, com- 3 times per day” and for “3 minutes per acupoint every paredwithcontrolgroup,AAgrouphadalarge,significant time”[37–39].Theotheronereportedthefrequencyshould effect in relieving pain at 4 weeks [SMD = −0.78, 95% CI be “3 times per day,” but the instruction on duration was (−1.22, −0.33), 𝑃 < 0.001] (Figure 3). Due to the obvious describedas“3–5minutesperacupointeverytime”instead statisticalheterogeneity,asensitivityanalysiswasperformed. of clarifying a specific length of time [36]. Two RCTs only AfterremovingthestudyofXiaetal.,the𝐼2valueobviously stated the durationof pressing withoutdaily frequency[35, decreased (from 61% to 0%) and the result was relatively 40]. Both of them emphasized that each selected acupoint stable,wherethecomparisonstillstatisticallyfavoredtheAA should be lightly kneaded 20 times and kneading should intervention [SMD = −0.97, 95% CI (−1.28, −0.65), 𝑃 < be kept for 20 minutes per time. Regarding the timing for 0.001](Figure4). manualpressing,onlythreestudiesmentioneditshouldbe At 12 weeks, there were 2 RCTs which used VAS and VRS as pain scales [35, 40], and the data of changes from done for 3 minutes whenever pain occurred in addition to baselinewerecalculated.Theresultofmeta-analysisrevealed routinefrequencyofpressure[37–39].Asfortheintensity,2 that, compared with control group, AA group had a large, RCTsconsideredpatient’ssubjectivefeelingsof“deqi”which significanteffectinrelievingpainat12weeks[SMD=−0.56, presented as soreness, numbness, distention, heaviness, or 95%CI(−0.91,−0.21),𝑃=0.002](Figure5). hotness and simultaneously stressed that the pressing force should be based on the patients’ tolerance [35, 40]. One The Follow-Up Effect after the Same Intervention Duration. RCTdeclaredthatmildpressurewasusedforinitialtherapy Duringthe4-weekfollow-upafter4-weekintervention,there and the following intensity should be tolerated by patients were 2 RCTs which used BPI-sf and VRS as pain intensity [36].Other3RCTsconsideredmoderatepressureassuitable scales[37,39],andthedataofchangesfrombaselinewerecal- intensitybuttheimplementationofmanualpressingwasnot culated.Theresultofmeta-analysisrevealedthat,compared describedspecifically[37–39]. withcontrolgroup,AAgrouphadalarge,significanteffectin relievingpainafter4-weekfollow-up[SMD=−1.13,95%CI 3.4.4.DurationandFollow-UpofAA. AlleligibleRCTsgave (−1.70,−0.56),𝑃<0.001](Figure6). the explicit information of intervention duration. Of these studies,thedurationofauricularplastertherapyrangedfrom 3.5.2. The Disability Level related to Chronic LBP. Only 3 2 weeks to 3 months. However, 71.4% (5/7) had a duration RCTsassessedtheimpactofbackpainonparticipants’daily ofinterventionsnotmorethan4weeks[20,36–39],among physical functioning [20, 37, 39]. Roland-Morris Disability which 4-week duration was the most common length (3/7, Questionnaire (RMDQ) disability scale was the most fre- 42.9%)[37–39]. quently used instrument for disability. Scores of RMDQ 8 Evidence-BasedComplementaryandAlternativeMedicine Adverseevents None NM NM 14hadmild,tolerable,andshort-termitchiness(E:6,C:8);5inEgroupfeltobviousbuttolerablepainoftheearsafteradoptingAA Bothgroupsexperienced𝑛sensitivity(=3),soreness𝑛𝑛(=4),discomfort(=4),𝑛=7itchingontheear(),andsleepdisturbance𝑛=2(),butallweretolerable Bothgroupsexperienced𝑛sensitivity(=3),soreness𝑛𝑛(=4),discomfort(=4),𝑛=7itchingontheear(),𝑛andsleepdisturbance(=2),butallweretolerable 11hadsorenessandtendernessoftheearand3hadirritationandsensitizationcausedbytheadhesivetape d;Rx,treatment;SFMPQ,Short-DisabilityQuestionnaire. e ble4:TherapeuticoutcomesofrandomizedcontrolledtrialsonAAforchronicLBP. Mainresults<±±±(1)Significantdecrease,P0.05;E:pre-AA5.371.85,post-AA2.491.66;C:pre-Rx5.422.13,±post-Rx3.561.74<(2)Significantdifference,P0.05;E:91.89%versusC:81.08%<±±±(1)Significantimprovement,P0.001;E:pre-AA2.730.74,post-AA1.870.68;C:pre-Rx2.47±0.78,post-Rx2.270.58;significantdifferencebetweenbaselineandtheothertimepoints(therapy<±completed,2-weekfollow-up,4-weekfollow-up)inEgroup,P0.001,E:2-weekfollow-up,2.07±0.69,versus4-weekfollow-up,2.200.55<±±±(1)Significantdecrease,P0.05;E:pre-AA5.241.91,post-AA2.361.43;C:pre-Rx5.312.05,±<post-Rx3.521.76;significantimprovementinEandCwithingroups(P0.05)<(2)Significantdifference,P0.05;E:93.1%versusC:82.8%<±(1)Significantdifferenceafter3-dayand2-weektreatmentinPRI,P0.05;E:pre-AA13.765.49,±±±post-AA(3-day)10.924.95,post-AA(2-week)6.252.17;C:pre-Rx13.925.25,post-Rx(3-day)±±<12.984.87,post-AA(2-week)7.562.31;significantdifferenceafter3-daytreatmentinVAS,P±±±0.05;E:pre-AA5.792.06,post-AA(3-day)4.751.69;C:pre-Rx5.861.89,post-Rx(3-day)5.09±±<0.05;E:pre-AA3.821.21.51;significantdifferenceafter3-daytreatmentinPPI,P4,post-AA±±±(3-day)2.921.17;C:pre-Rx3.531.12,post-Rx(3-day)3.251.20 (1)Significantdecreasein“worstpain”betweenEandCatendofinterventionand1-month<±±±±follow-up,P0.01;E:pre-AA5.400.97,post-AA1.601.71,follow-up1.401.43;C:pre-Rx5.88±±1.89,post-Rx4.381.06,follow-up4.141.86;Thescoresof“averagepain”and“overallpainseverity”hadasimilarchangeinpattern>(2)Nosignificantdecreaseinphysicalfunctionwhichwasinexpecteddirection,P0.05;E:pre-AA±±±±±3.302.54,post-AA1.671.32,follow-up1.901.66;C:pre-Rx7.756.23,post-Rx7.006.74,±follow-up6.135.28 <(1)Significantdecreasein“worstpain”atendofinterventionand1-monthfollow-up,P0.01;E:±−−±−pre-AA7.322.03,post-AA(3.00),follow-up(3.16);C:pre-Rx7.281.90,post-Rx(0.33),−follow-up(0.06)−<±6.11,post-AA(2.95),(2)Significantdecreaseinphysicalfunction,P0.01;E:pre-AA11.11−±−−follow-up(2.63);C:pre-Rx14.114.57,post-Rx(0.11),follow-up(0.33) 𝑃<(1)Significantdecreasein“worstpain”betweenEandCatendofintervention,0.01;E:pre-AA±±±±6.901.85,post-AA3.813.12;C:pre-Rx7.131.87,post-Rx6.132.93;greatestreductionwas±±recordedin“averagepain”inEgroup:pre-AA6.871.82,post-AA2.852.54(2)Themeanscoreofworstpaindecreased30.0%afterthefirstdayofAA,reachedthelargestdecrease(50.08%)atday24,andeventuallysettledata47.67%reductionatday28;threesignificantchangesoccurred,respectively,atday1,day5,andday8(3)Totalpressingtime,averageminutesperpressing,andanalgesicusedevelopedastatisticallysignificantassociationwithworstpainintensity(each1-minuteincreaseinpressingtheseedssignificantlyreducedtheworstpainscoreby0.04;each1-minuteincreaseintotalamountoftimeinwhichtheseedswerepressedsignificantlyreducedaveragepainby0.05) AnalogueScale;E,experimentalgroup;C,controlgroup;VRS,VerbalRatingScale(VRS-Chinese);NM,notmentionAS,VisualAnalogueScale;PPI,presentpainintensity;BPI,BriefPainInventory(shortform);RMDQ,Roland-Morris Ta StudiesMainoutcomemeasure (1)Painintensity(VAS)Luetal.2015(2)Thetotaleffectiverate Suenetal.2007(1)Painintensity(VRS) (1)Painintensity(VAS)Wang2015(2)Thetotaleffectiverate (1)Painintensity(SFMPQ,Xiaetal.2011consistingofPRI,VAS,andPPI) (1)Painintensity(BPI,consistingofworstpain,averagepain,andoverallpainintensity)Yehetal.2013(2)Physicalfunctioning(RMDQ) (1)PainintensityYehetal.2014(2)Physicalfunctioning(RMDQ) (1)Painintensity(BPI,consistingofworstpain,averagepain,andoverallpainintensity)(2)ChangeovertimeindailyYehetal.2015worstpainintensity(3)Relationshipofseedpressingtime,frequency,andanalgesicusetopainintensitychange AA,auricularacupressure;LBP,lowbackpain;VAS,VisualFormMcGillPainQuestionnaire;PRI,painratingindex;V Evidence-BasedComplementaryandAlternativeMedicine 9 Auriculotherapy Control Std. mean difference Std. mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, fixed, 95% CI IV, fixed, 95% CI Lu et al. 2015 −2.88 1.76 37 −1.86 1.96 37 20.8% −0.54 [−1.01, −0.08] Suen et al. 2007 −0.86 0.71 30 −0.2 0.7 30 15.7% −0.92 [−1.46, −0.39] Wang 2015 −2.88 1.72 29 −1.79 1.92 29 16.2% −0.59 [−1.12, −0.06] Xia et al. 2011 −4.11 1.95 30 −4.05 1.75 30 17.5% −0.03 [−0.54, 0.47] Yeh et al. 2013 −3.8 1.49 10 −1.5 1.64 9 4.2% −1.41 [−2.44, −0.38] Yeh et al. 2014 −3 2.61 19 −0.33 2.58 18 9.5% −1.01 [−1.70, −0.32] Yeh et al. 2015 −3.1 2.68 30 −1 2.03 31 16.1% −0.87 [−1.40, −0.35] Total (95% CI) 185 184 100.0% −0.65 [−0.87, −0.44] Heterogeneity:2=10.79,df=6(P=0.10);I2=44% −2 −1 0 1 2 Test for overall effect:Z=6.06(P<0.00001) Favours Favours [experimental] [control] Figure2:ForestplotofpainreliefofAAatallfinaltimepoints. Auriculotherapy Control Std. mean difference Std. mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, random, 95% CI IV, random, 95% CI Suen et al. 2007 −0.86 0.71 30 −0.2 0.7 30 22.8% −0.92 [−1.46, −0.39] Xia et al. 2011 −4.11 1.95 30 −4.05 1.75 30 23.5% −0.03 [−0.54, 0.47] Yeh et al. 2013 −3.8 1.49 10 −1.5 1.64 9 12.0% −1.41 [−2.44, −0.38] Yeh et al. 2014 −3 2.61 19 −0.33 2.58 18 18.7% −1.01 [−1.70, −0.32] Yeh et al. 2015 −3.1 2.68 30 −1 2.03 31 23.0% −0.87 [−1.40, −0.35] Total (95% CI) 119 118 100.0% −0.78 [−1.22, −0.33] Heterogeneity:2=0.15;2=10.35,df=4(P=0.03);I2=61% −4 −2 0 2 4 Test for overall effect:Z=3.41(P=0.0006) Favours Favours [experimental][control] Figure3:ForestplotofpainreliefofAAat4weeks. Auriculotherapy Control Std. mean difference Std. mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, fixed, 95% CI IV, fixed, 95% CI Suen et al. 2007 −0.86 0.71 30 −0.2 0.7 30 34.5% −0.92 [−1.46, −0.39] Yeh et al. 2013 −3.8 1.49 10 −1.5 1.64 9 9.3% −1.41 [−2.44, −0.38] Yeh et al. 2014 −3 2.61 19 −0.33 2.58 18 20.8% −1.01 [−1.70, −0.32] Yeh et al. 2015 −3.1 2.68 30 −1 2.03 31 35.5% −0.87 [−1.40, −0.35] Total (95% CI) 89 88 100.0% −0.97 [−1.28, −0.65] Heterogeneity:2=0.85,df=3(P=0.84);I2=0% −2 −1 0 1 2 Favours Favours Test for overall effect:Z=6.05(P<0.00001) [experimental] [control] Figure4:Forestplotofsensitivityanalysis(painreliefofAAat4weeks). Auriculotherapy Control Std. mean difference Std. mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, fixed, 95% CI IV, fixed, 95% CI Lu et al. 2015 −2.88 1.76 37 −1.86 1.96 37 56.2% −0.54 [−1.01, −0.08] Wang 2015 −2.88 1.72 29 −1.79 1.92 29 43.8% −0.59 [−1.12, −0.06] Total (95% CI) 66 66 100.0% −0.56 [−0.91, −0.21] Heterogeneity:2=0.02,df=1(P=0.89);I2=0% −4 −2 0 2 4 Favours Favours Test for overall effect:Z=3.17(P=0.002) [experimental][control] Figure5:ForestplotofpainreliefofAAat12weeks. 10 Evidence-BasedComplementaryandAlternativeMedicine Auriculotherapy Control Std. mean difference Std. mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, fixed, 95% CI IV, fixed, 95% CI Yeh et al. 2013 −4 1.26 10 −1.74 1.88 9 31.2% −1.36 [−2.39, −0.34] Yeh et al. 2014 −3.16 2.98 19 −0.06 2.97 18 68.8% −1.02 [−1.71, −0.33] Total (95% CI) 29 27 100.0% −1.13 [−1.70, −0.56] −4 −2 0 2 4 Heterogeneity:2=0.30,df=1(P=0.58);I2=0% Favours Favours Test for overall effect:Z=3.86(P=0.0001) [experimental] [control] Figure6:ForestplotofpainreliefofAAat4-weekfollow-upafter4-weekintervention. Auriculotherapy Control Mean difference Mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, fixed, 95% CI IV, fixed, 95% CI Yeh et al. 2014 −2.95 6.32 19 −0.11 5.8 18 56.6% −2.84 [−6.75, 1.07] Yeh et al. 2013 −1.63 2.2 10 −0.75 6.5 9 43.4% −0.88 [−5.34, 3.58] Total (95% CI) 29 27 100.0% −1.99 [−4.93, 0.95] −10 −5 0 5 10 Heterogeneity:2=0.42,df=1(P=0.52);I2=0% Favours Favours Test for overall effect:Z=1.33(P=0.18) [experimental] [control] Figure7:ForestplotofeffectsofAAonLBP-relateddisabilityat4weeks. Auriculotherapy Control Mean difference Mean difference Study or subgroup Weight Mean SD Total Mean SD Total IV, fixed, 95% CI IV, fixed, 95% CI Yeh et al. 2014 −2.63 7.2 19 −0.33 6.9 18 44.2% −2.30 [−6.84, 2.24] Yeh et al. 2013 −1.4 2.23 10 −1.62 5.81 9 55.8% 0.22 [−3.82, 4.26] Total (95% CI) 29 27 100.0% −0.89 [−3.91, 2.13] Heterogeneity:2=0.66,df=1(P=0.42);I2=0% −20 −10 0 10 20 Favours Favours Test for overall effect:Z=0.58(P=0.56) [experimental] [control] Figure8:ForestplotofeffectsofAAonLBP-relateddisabilityat4-weekfollow-upafter4-weekintervention. ranged from 0 to 24, with higher scores indicating greater timewhentherapywascompleted,2-and4-weekfollow-up disability. periods. At4weeks,therewere2RCTswhichusedRMDQscale as disability instruments [37, 39], and the data of changes 3.5.3.TheEffectofAAforChronicLBP from baseline were calculated. The result of meta-analysis revealed that, compared with control group, AA group had The Improvement Rate of AA for LBP. According to the no statistically significant effect in reducing disability but a guidelines [30, 31], “improvement” criteria referred to the favorable trend at 4 weeks [MD = −1.99, 95% CI (−4.93, disappearance or obvious relieving of backache and the 0.95),𝑃=0.18](Figure7). related stiffness accompanied by freely moving the lower At4-weekfollow-upafter4-weekintervention,therewere back. Three RCTs used the “improvement” criteria for LBP 2 RCTs which used RMDQ as disability scale [37, 39], and [35, 36, 40]. And the number of improved cases could be thedataofchangesfrombaselinewerecalculated.Theresult available.Theresultofmeta-analysisrevealedthat,compared ofmeta-analysisrevealedthat,comparedwithcontrolgroup, with control group, AA group had a significant effect in AAdidnotreducedisabilitysignificantlyattheendof4-week managingLBP[RR = 1.61,95%CI(1.20,2.14),𝑃 = 0.001] follow-up [MD = −0.89, 95% CI (−3.91, 2.13), 𝑃 = 0.56] (Figure9). (Figure8). The remaining1study usedthemodifiedAberdeen low TheTotalEffectiveRateofAAforLBP.“Noeffect”wasdefined backpainscaletoassessdisability[20],andtheresultshowed as no improvement or even LBP or the stiffness associated that,comparedwithcontrolgroup,AAgroupdemonstrated with LBP getting worse and the number of total effective significantimprovementintheoveralldisabilitylevelatthe couldbecalculated[30,31].ThreeRCTsusedthecriteriaof
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