Review Article Adverse Events of Auricular Therapy: A Systematic Review - Hindawi

21 Pages·2015·1.4 MB·English

Hindawi Publishing Corporation
Evidence-Based Complementary and Alternative Medicine
Volume 2014, Article ID 506758, 20 pages
http://dx.doi.org/10.1155/2014/506758
Review Article
Adverse Events of Auricular Therapy: A Systematic Review
Jing-YuTan,1AlexanderMolassiotis,1TaoWang,2andLornaK.P.Suen1
1SchoolofNursing,TheHongKongPolytechnicUniversity,HungHom,Kowloon,HongKong
2TheSecondAffiliatedPeople’sHospital,FujianUniversityofTraditionalChineseMedicine,No.13HudongRoad,
GulouDistrict,Fuzhou350003,China
CorrespondenceshouldbeaddressedtoLornaK.P.Suen;[email protected]
Received24June2014;Revised26August2014;Accepted27August2014;Published10November2014
AcademicEditor:Byung-CheulShin
Copyright©2014Jing-YuTanetal.ThisisanopenaccessarticledistributedundertheCreativeCommonsAttributionLicense,
whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.
Theaimofthisstudywastosystematicallyevaluatetheliteratureonadverseeventsassociatedwithauriculartherapy(AT).Case
reports,caseseries,surveys,andalltypesofclinicaltrialsreportingadverseeventsofATwereincluded.Relevantarticleswere
mainlyretrievedfrom13electronicdatabasesandsevenChinesejournalsoncomplementarymedicine.AT-relatedadverseevents
werereportedin32randomizedcontrolledtrials,fiveuncontrolledclinicaltrials,fourcasereports,andtwocontrolledclinicaltrials.
Forauricularacupuncture,themostfrequentlyreportedadverseeventsweretendernessorpainatinsertion,dizziness,localdis-
comfort,minorbleedingandnausea,andsoforth.Forauricularacupressure,localskinirritationanddiscomfort,mildtendernessor
pain,anddizzinesswerecommonlyreported.Skinirritation,localdiscomfort,andpainweredetectedinauricularelectroacupunc-
ture,andminorinfectionwasidentifiedinauricularbloodlettingtherapy.Mostoftheseeventsweretransient,mild,andtolerable,
andnoseriousadverseeventswereidentified.OurfindingsprovidepreliminaryevidencethatATisarelativelysafeapproach.
Consideringthepatient’ssafety,prospectiveorretrospectivesurveysareneededinfutureresearchtogatherpractitioner-reported
andpatient-reportedadverseeventsonAT,andthequalityofadverseeventsreportinginfutureATtrialsshouldbeimproved.
1.Introduction TheWHOrecognizesATasamicroacupuncturesystem
that can produce a positive impact on regulating the whole
Being one of the most popular complementary therapeutic
bodyfunction[5],anditstherapeuticeffecthasbeeninves-
approaches, auricular therapy (AT) is defined as “a health
tigated in a wide range of health problems in both oriental
care modality whereby the external surface of the ear, or
andwesterncountries.Clinicaltrialsandsystematicreviews
auricle, is stimulated to alleviate pathological conditions in
haveshownthatATcanbeapromisingmodalityinrelieving
other parts of the body” [1]. The earliest record of AT can
preoperative anxiety [6], psychosomatic disorders [7], and
trace back to 500 to 300 B.C. in ancient China, where the
various types of pain [8], managing hypertension [9] and
Yellow Emperor’s Inner Canon (Huangdi Neijing) described
cocaine dependence [10], and controlling obesity [11]. The
that the ear is not isolated but intimately connected with
wideuseofATinclinicalpracticerequirescontinualsafety
the five viscera and the six bowels [2]. The modern system
evaluation. It is said that the popularity of AT is partially
ofATwasdevelopedbytheFrenchneurologistPaulNogier
attributedtoitsconvenienceandsafety,andinsomeoriental
in the late 1950s, and it is recognized that the outer ear has
a somatotopic arrangement with an inverted fetus pattern countries,ATisusuallyconductedbyhealthcareprofession-
andeachinternalorganiscorrespondingtoasensitivepoint alsonlywithATshort-termtrainingorevenbyunqualified
located in the auricle [3]. AT could produce a therapeutic practitionerswithoutanyexperienceinperformingAT[12].
effect for treating various types of disorders by stimulating However, this kind of intervention is not entirely risk-free,
the particular acupoint which corresponds to the targeted where adverse events, such as chest tightness, dizziness,
partofthebodyororgan[4].Variousmodalitiesareadopted perichondritis,andnausea,arealsoreportedintheliterature
inATpracticeincludingauricularacupuncture,acupressure, [13]; meanwhile, when applying AT to special populations
moxibustion,injection,andauricularbloodlettingtherapy. suchaspregnantwomenandimmunocompromisedpatients,
2 Evidence-BasedComplementaryandAlternativeMedicine
unwanted miscarriage and infection could have occurred ScientificJournalDatabase(CQVIP),andChineseBiomedi-
[13]. calLiteratureDatabase(CBM).Nolanguagerestrictionwas
The ear possesses abundant capillaries which make it appliedforelectronicsearch.Meanwhile,sevenChinesecore
highlyvulnerabletoskininflammationsandotherinfections journalsoncomplementarymedicine(JournalofIntegrative
[13].TominimizepotentialharmscausedbyAT,practitioners Medicine,ChineseAcupuncture&Moxibustion,ChinaJour-
needtostrictlyfollowstandardizedproceduresofATadmin- nalofTraditionalChineseMedicineandPharmacy,Journal
istration as well as fully understand the potential adverse of Traditional Chinese Medicine, Chinese Journal of Basic
eventsassociatedwithit.Itisimportanttoassessthesafety MedicineinTraditionalChineseMedicine,ChineseJournal
ofATinclinicalpractice.Unfortunately,differentfromother of Integrated Traditional and Western Medicine, Journal of
traditionaltherapiessuchasbodyacupuncture,moxibustion, BeijingUniversityofTraditionalChineseMedicine,andJour-
andcupping,whosesafetyiswellanalyzedinsurveysand/or nal of Nanjing University of Traditional Chinese Medicine,
systematic reviews [14–17], clinical evidence on the safety issueswithinthelatestthreeyears)weremanuallyretrieved
of AT has not been clearly established to date. Despite for further relevant articles. Reference lists of the included
the increasing number of studies in recent years reporting papers were also checked to identify any potential eligible
harm data associated with AT, their results have not been studies.Allsearcheswereconductedbytworeviewers(TanJY
systematicallysummarized.Uptonow,thereisnosystematic andWangT)independently.Meshterms,keywords,andfree
review to evaluate the adverse events associated with AT. wordssuchas“auriculotherapy,”“acupuncture,ear,”“adverse
∗ ∗ ∗
Therefore, the aim of this study was to evaluate the type event ,”“sideeffect ,”“adverseeffect ,”“adversehealthcare
∗ ∗
and frequency of AT-related adverse events, to identify any event,”“safe ,”and“risk ”wereusedinthesearchingstrate-
avoidable adverse events associated with nonstandardized gies. Table3 presents three main search strategies for this
ATprocedures,andtoproviderecommendationsforfuture review.
researchandpracticeinthisarea.
2.4.StudySelectionandDataExtraction. Studycharacteris-
2.Methods
ticsandoutcomedataofeachincludedarticlewereextracted
using the data extraction form, which included (1) first
A study protocol accompanied with a data extraction form
author, year of publication, study design, and setting; (2)
was formulated and critically reviewed by two experts who
participantcharacteristics(age,gender,samplesize,diagnos-
were familiar with AT and systematic reviews before the
tic criteria, and reason for AT); (3) AT protocol (type of
initiationofthestudy.
AT, practitioner, selected acupoints, type of AT equipment,
2.1. Definition of Adverse Events. In this study, an adverse and treatment duration); and (4) AT-related adverse events
event was defined as “an undesirable experience associated (type of adverse event, frequency, outcome, and causality).
withtheuseofamedicalproductinapatient”accordingto Study selection and data extraction were conducted by two
theUSFoodandDrugAdministration[18].Aseriousadverse reviewers independently, and disagreement was resolved
event was defined when the event led to serious outcomes throughdiscussion.
such as death, hospitalization, disability, and permanent
damageorasbeinglife-threatening[18].
2.5.OutcomeAssessment. TypeandfrequencyofAT-related
adverse events were the main outcomes of this study. The
2.2. Inclusion and Exclusion Criteria. Case reports, case likelihoodofcausalityandqualityofadverseeventsreporting
series,prospectiveandretrospectivesurveys,andalltypesof werealsojudgedbytworeviewersandcheckedbytwoexperts
clinicaltrials(randomizedcontrolledtrials,nonrandomized specializedinATandacupuncture.
controlledclinicaltrials,orotheruncontrolledclinicaltrials) For adverse events reported in case reports or case
reporting adverse events associated with AT in human series, the likelihood of causality was judged by the WHO-
subjects were included. Animal research, in vitro studies, Uppsala Monitoring Centre (UMC) System for Standardized
and review papers were excluded. Types of AT could be CaseCausalityAssessment[19].Thelikelihoodwasclassified
auricular acupuncture, auricular electroacupuncture, auric- intosixgradesincludingthefollowing:(1)certain:aplausible
ularacupressure,auricularmoxibustion,auricularinjection, time relationship that adverse events clearly occurred after
orauricularbloodlettingtherapy. receiving AT and disappeared after withdrawal, and these
events could not be explained by other health problems or
2.3. Data Sources and Searching Strategies. Relevant stud- interventions;(2)probable/likely:areasonabletimerelation-
ies were retrieved from three sources: electronic database, ship that the onset of symptoms was most likely related
manual search, and reference lists search for final included to AT and that was unlikely attributed to other health
studies. Electronic search was conducted in 13 databases problems or interventions; (3) possible: a reasonable time
(frominceptiontoMay8,2014)includingPubMed,EMBase, relationship that the onset of symptoms was most likely
CochraneCentralRegisterofControlledTrials(CENTRAL), related to AT but that could also be explained by other
CINAHL, PsycINFO, Allied and Complementary Medicine healthproblemsorinterventions,andtheinformationonAT
(AMED),ThomsonReutersWebofScience,ScienceDirect, withdrawal was lacking or unclear; (4) unlikely: there was
Foreign Medical Journal Service (FMJS), China National animprobabletimerelationshipbetweenATandtheadverse
KnowledgeInfrastructure(CNKI),WanFangData,Chinese event;(5)conditional/unclassified:eventoccurredbutmore
Evidence-BasedComplementaryandAlternativeMedicine 3
Records identified from databases and other sources (N=8015)
n
o
cati PubMed (n=4284); EMBase (n=1688); CENTRAL (n=158); CINAHL (n=163);
fi
nti AMED (n=16); PsycINFO (n=18); Web of Science (n=30); SD (n=7); FMJS (n=295);
e
Id CNKI (n=520); WanFang (n=747); VIP (n=50); CBM (n=34); Manual retrieval (n=5)
Duplicated records(N=1187)
g
n
ni
ee Browse title and abstract of each record(N=6828)
cr
S
Records excluded (N=6495)
Full-text articles assessed for eligibility (N=333)
bility Full-text articles excluded(N=290)
gi Review(n=28)
Eli Study protocol (n=5)
Conference abstract (n=22)
Nonauricular therapy study (n=34)
Adverse events not reported (n=201)
Full-text articles included for analysis(N=43)
d
de PubMed (n=15); EMBase (n=11); CENTRAL (n=2); CINAHL (n=1);
u
ncl AMED (n=0); PsycINFO (n=0); Web of Science (n=0); SD (n=0); FMJS (n=0);
I CNKI (n=10); WanFang (n=4); VIP (n=0); CBM (n=0); Manual retrieval (n=0)
Figure1:Flowchartofstudyselection.CENTRAL:CochraneCentralRegisterofControlledTrials,CINAHL:CumulativeIndextoNursing
andAlliedHealthLiterature;AMED:AlliedandComplementaryMedicine,SD:ScienceDirect,FMJS:ForeignMedicalJournalService,
CNKI: China National Knowledge Infrastructure, VIP: Chinese Scientific Journal Database, and CBM: Chinese Biomedical Literature
Database.
datawereessentialforapropercausalityassessment;and(6) analysesonAT-relatedharms.Thequalityofeachitemwas
unassessable/unclassifiable: an adverse event was suggested judged as “adequate,” “partially adequate,” “inadequate,” or
by a report but cannot be judged due to insufficient or “notreported”accordingly[17].Itwasratedas“adequate”if
contradictoryinformation[19]. anitemwasproperlydescribedindetailinthearticleorin
For clinical trials, the quality of adverse events report- thestudyprotocol;“partiallyadequate”wasgivenifanitem
ing was assessed using the CONSORT for Harms Data was properly described but only in a brief format; when an
Recommendations [20, 21]. Seven items were employed for itemfailedtobeproperlydescribed,thequalitywasjudged
assessment[17,20,21]:(1)reportofdataonharmsinthetitle as “inadequate”; and “not reported” meant an item was not
orabstract;(2)reportofAT-relatedharmsintheintroduction described[17].
section; (3) prespecification of potential adverse events of
AT(clinicaland/orlaboratory);(4)specificationofapproach 3.Results
for collecting harm-related information; (5) description of
plansforpresentingandanalyzingadverseeventsofAT;(6) 3.1.CharacteristicsofAnalyzedStudies. Electronicandman-
descriptionofparticipantwithdrawalsduetoadverseevents ualsearchesyielded8015records.Aftercheckingbyreference
of AT; and (7) report of the particular denominators for managementsoftware,1187duplicatedrecordswereremoved,
4 Evidence-BasedComplementaryandAlternativeMedicine
and another 6495 were further excluded after browsing the and another was 43-year-old with dilated cardiomyopathy)
titles and abstracts. Full text of the remaining 333 records reported drowsiness and somnolence at the 12th and 15th
wasretrievedforeligibilityassessment,and290articleswere day, respectively,duringtheATtreatment.Theirsymptoms
finally excluded because they were reviews (𝑛 = 28), were disappearedimmediatelyafterremovingthetapedseedsand
studyprotocols(𝑛 = 5),wereconferenceabstracts(𝑛 = 22), reoccurred when seeds were taped again. Adverse events
and were non-AT interventions (𝑛 = 34), and the adverse describedinthesethreecaseswereassessedasprobably/likely
eventswerenotreported(𝑛=201).Therefore,43studies[22– relatedtoAT.InMa’sreport[25],a58-year-oldwomanwith
64]wereidentifiedforfinalanalysis.Theflowchartofstudy chronic diarrhea suffered from abdominal pain 30 minutes
selectionispresentedinFigure1. afterreceivingauricularacupressure,andthesymptomdis-
Theanalyzedstudiesincluded32randomizedcontrolled appeared immediately after removing the taped seeds. The
trials,fiveuncontrolledclinicaltrials,fourcasereports,and author described it as a rare event caused by AT and the
two nonrandomized controlled trials, with a total of 3396 causalitywasassessedaspossible.
participantsreceivingATtreatment.Sixstudieswerefromthe
United States, five from Taiwan, four from Germany, three
3.3.ClinicalStudies
from Hong Kong, two from Australia, two from Austria,
two from the United Kingdom, 15 from China, and one 3.3.1. Quality of Adverse Events Reporting. Table2 presents
each from Malaysia, Canada, Sweden, and Spain. Four AT AT-relatedadverseeventsreportedinclinicaltrials.Forthe
modalitieswereutilizedincludingauricularacupuncturein quality of adverse events reporting, the overall results were
18 studies [26–43], auricular acupressure in 21 studies [22– not optimal. Twenty studies adequately or partially ade-
25,44–60],auricularelectroacupunctureinthreestudies[61– quatelydescribedadverseeventsinthetitleand/orabstract
63],andauricularbloodlettingtherapyinonestudy[64].AT (51.3%), whereas there were only nine studies appropriately
was applied to deal with a variety of health problems such describing safety issues of AT in the introduction (23.1%).
as drug dependence, smoking cessation, pain, constipation, AT-relatedadverseeventswereseldomprespecified(17.9%),
insomnia,andobesity. and 16 studies properly described approaches for adverse
The clinical effectiveness of AT was descriptively sum- eventsdatacollectionsuchasinvestigatorobservation,ques-
marized from the included 34 controlled clinical trials tionnaire, or self-report (41.0%). Only six studies properly
(randomizedornonrandomized)[26–32,34–42,44–50,52– describedplansforpresentingandanalyzingadverseevents
56, 58–63], as the data synthesis was not available due to (15.4%). Twelve studies adequately or partially adequately
thesignificantclinicalheterogeneityinthetypesofdisease, reportedwhethertherewereanysubjectsthatwithdrewdue
AT protocols, and intervention durations among analyzed toadverseeventsofAT(30.8%),and13studiesappropriately
trials. Twenty-three studies reported significantly positive described the denominators for analyzing adverse events
effect of AT for the primary and/or secondary outcomes (33.3%).
betweengroups,whileeightstudiesonlydetectedfavorable
changes within the AT groups. Of the controlled clinical 3.3.2.AuricularAcupuncture-RelatedAdverseEvents. Auric-
trials that employed auricular acupuncture, 93.8% (15/16) ular acupuncture-related adverse events were reported in
stated positive outcomes of AT between or within groups, 18 clinical studies [26–43] with a total of 1753 participants
whereas it was 93.3% (14/15) in studies using auricular receivingAT(Table2).Durationoftreatmentvariedamong
acupressure,respectively.Twooutofthreetrialsonauricular studiesand10studiesofferedATformorethanthreeweeks.
electroacupunctureshowed clinical effectiveness of AT. The Themostfrequentlyreportedadverseeventsweretenderness
majority(30studies)describedthepersonwhoadministered or pain at the needling site, dizziness, discomfort at the
AT including acupuncturist, TCM practitioner, physician, needlingsite, localbleeding, nausea,headache, andinflam-
psychiatrist,therapist,andnurse.Theselectionofacupoints mation at insertion. Most of these events were transient,
fortreatmentwasbasedonthetargetedhealthproblembut minor,andtolerable.
shenmen was the most commonly referred acupoint which Eleven studies reported 134 cases complaining of local
wasusedin35studiesfortreatingvarioustypesofdisorders. painandtendernessattheneedlingsite.ATwasperformed
by acupuncturist in eight studies [27, 31, 32, 34–36, 38, 39],
3.2.CaseReports. Table1presentsAT-relatedadverseevents by psychiatrist and nurse in two studies [37, 41], and by
reported in case reports. Four cases were located and the physiotherapistinonestudy[28].Forty-threecaseswithdrew
reported adverse events were dizziness in one case [22], duetopainbutthemajoritycouldtolerateATandcompleted
somnolence in two cases [23, 24], and abdominal pain in thetreatment.Twostudies[32,35]didnottakeanymeasures
onecase[25].Noseriousadverseeventswereidentified.All todecreaseadverseeventsandsymptomsgraduallydeclined,
casesweretreatedwithauricularacupressureusingvaccaria and one study [41] stopped AT temporarily or reduced
seeds, whereas only two [22, 23] specified the practitioner treatmentfrequenciestodealwithlocalpain.
whoadministeredAT(aphysician). Twenty-fivecasesineightstudiesreportedminorbleed-
In Ye’s report [22], a 48-year-old woman with consti- ing at insertion. AT was administered by an acupuncturist
pation experienced dizziness five minutes after receiving infivestudies[27,35,38,40,42],bypsychiatristandnurse
auricular acupressure. The symptom gradually disappeared in two studies [37, 41], and by physiotherapist in one study
afterremovingthetapedseeds.Intwootherreports[23,24], [28].Bleedingoftenhappenedduringinsertingand/orwith-
two men (one was 41-year-old with lumbar muscle strain, drawingtheneedleandstoppedsoonwithoutanytreatment.
Evidence-BasedComplementaryandAlternativeMedicine 5
Table1:Adverseeventsassociatedwithauriculartherapyreportedincasereports. AgeTypeofAT∗StudyandsettingReasonforATPractitionerSelectedacupointsAEsandseverityOutcomesCausality(gender)(methodandduration)Shenmen,kidney,Method:auricularacupressureRecoveryYe,2014[22],liver,spleen,usingauricularplasterwithEvent(s):dizzinessafterChinesePLAGeneral48(female)ConstipationPhysicianstomach,temple,Probable/likelyvaccariaseedsSeverity:notreportedremovingHospital,Beijing,Chinasubcortex,Duration:notreportedtapedseedsforehead,occiputMethod:auricularacupressureusingauricularplasterwithRecoveryYuandXie,2010[23],Heart,liver,spleen,LumbarmusclevaccariaseedsEvent(s):somnolenceafter41(male)PhysicianProbable/likelyTedaHospital,Tianjin,occiput,shenmen,strainDuration:threedaysperSeverity:notreportedremovingChinasympathetictreatment,4treatmentsintapedseedstotal(12days)Method:auricularacupressureHuoetal.,2000[24],usingauricularplasterwithHeart,liver,lung,RecoveryChinesePLA546Dilatedvaccariaseedsshenmen,spleen,Event(s):somnolenceafter43(male)NotreportedProbable/likelyHospital,Xinjiang,cardiomyopathyDuration:threedayspersympathetic,Severity:notreportedremovingChinatreatment,5treatmentsinocciputtapedseedstotal(15days)Largeintestine,Ma,1992[25],Method:auricularacupressureRecoverysmallintestine,Event(s):abdominalNingyangTCMusingauricularplasterwithafter58(female)ChronicdiarrheaNotreportedshenmen,liver,painPossibleHospital,Shandong,vaccariaseedsremovingsympathetic,Severity:severeChinaDuration:30minutestapedseedsspleen AT:auriculartherapy,AE:adverseevent,PLA:People’sLiberationArmy,andTCM:traditionalChinesemedicine.∗TheWHO-UppsalaMonitoringCentre(UMC)SystemforStandardizedCaseCausalityAssessment:certain—aplausibletimerelationshipthatadverseeventsclearlyoccurredafterreceivingATanddisappearedafterwithdrawal,andtheseeventscouldnotbeexplainedbyotherhealthproblemsorinterventions;probable/likely—areasonabletimerelationshipthattheonsetofsymptomswasmostlikelyrelatedtoATandthatwasunlikelyattributedtootherhealthproblemsorinterventions;possible—areasonabletimerelationshipthattheonsetofsymptomswasmostlikelyrelatedtoATbutthatcouldalsobeexplainedbyotherhealthproblemsorinterventions,andtheinformationatwithdrawalwaslackingorunclear;unlikely—therewasanimprobabletimerelationshipbetweenATandtheadverseevent;conditional/unclassified—eventoccurredbutmoredatawereessentialforapropercausalityassessment;unassessable/unclassifiable—anadverseeventwassuggestedbyareportbutcannotbejudgedduetoinsufficientorcontradictoryinformation.
6 Evidence-BasedComplementaryandAlternativeMedicine
e e
at at
u u
QualityofAEs△Reporting (1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Adequate(7)Notreported (1)Adequate(2)Adequate(3)Notreported(4)Adequate(5)Adequate(6)Inadequate(7)Adequate (1)Adequate(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Inadequate(7)Partiallyadeq (1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Notreported(7)Notreported (1)Adequate(2)Partiallyadeq(3)Notreported(4)Notreported(5)Notreported(6)Adequate(7)Notreported
g)
n
altrials. AEs(numberofCases)ofATandoutcome Uncomfortableattheneedlingsite𝑛=1()Outcome:withdrawal 𝑛=17Lightheadache()𝑛=14Slightbleeding()𝑛=19Tinglingsensations()𝑛=17𝑛=19Pain()andnausea()𝑛=11Drowsiness()anddizziness𝑛=19()𝑛=15Drymouth()andslightfever𝑛=19()Outcome:notreportedPainandredness(notreported)Minorbleeding(notreported)Swellingaroundtheneedlingsite#𝑛=1()Outcome:(i)NR(forpain,redness,andbleedi(ii)Recovery(forswelling) Warmthorastrangefeelingatthe𝑛=26treatedearordizziness()Outcome:notreported 𝑛=1Dizziness()Outcome:withdrawal
e2:Adverseeventsassociatedwithauriculartherapyreportedinclinic Intervention(detailsofAT)andcontrolSelectedacupoints StudiesonauricularacupunctureIntervention(trueAT):(i)Method:auricularacupuncturewithspringTrueAT:shenmen,liver,×handleneedles(0.1615mm)kidney,sympathetic,(ii)Duration:twotreatmentsweekly(45hippocampusminutespertreatment)for8weeksShamAT:nonacupunctureControl1(shamAT):pointslocatedonthehelixofauricularacupunctureatnonacupuncturetheearpointsControl2:waiting-listcontrol Intervention(MMT+AT):(i)Method:auricularacupuncture(needles:×0.2512.55mm)Shenmen,sympathetic,kidney,(ii)Duration:threetreatmentsweekly(30liver,lungminutespertreatment)for8weeksControl:MMTonly Intervention(exercise+AT):(i)Method:auricularacupuncturewith×Shenmen,lumbarspine,SeirinPyonexearneedles(1.800.26mm)cushion(ii)Duration:onetreatment(48hours)weeklyfor6weeksControl:exerciseonly Intervention(trueAT):(i)Method:auricularacupuncture(needles:×TrueAT:relaxation,0.215mm)tranquilizer,mastercerebral(ii)Duration:twentyminutesuntilthestartShamAT:tonsil,finger,ofdentaltreatmentshoulderControl1(shamAT):auricularacupunctureatnonspecificpointsControl2:nointerventionIntervention(trueAT):(i)Method:auricularacupuncture(needles:2mmtipand10mmannular-shapedbody)(ii)Duration:threetreatmentsweeklyfor4Shenmen,stomach,hunger,weeksendocrineControl1:auricularstimulationusingmagneticpelletsControl2(shamAT):needleswiththetipsremoved
l
Tab ReasonforATandpractitioner R:PTSD-relatedinsomniaP:physician R:drugdependenceP:acupuncturist R:chroniclowbackpainP:physiotherapist R:stateanxietybeforedentaltreatmentP:investigatorwithadiplomaofacupuncture R:obesityP:acupuncturist
C, UK 29]
Study Priscoetal.,2013[26]𝑁=35RCT()DepartmentofVeteransAffairsMedicalCenter,WashingtonDUSA LuaandTalib,2013[27]𝑁=97RCT()ThreeMethadoneMaintenanceTreatment(MMT)Centers,Terengganu,Malaysia Hunteretal.,2012[28]𝑁=52RCT()PrimaryCare&AUniversityPopulation,NorthernIreland, Michalek-Saubereretal.,2012[𝑁=182RCT()OutpatientClinic,MedicalUniversityofVienna,Vienna,Austria Lienetal.,2012[30]𝑁=90RCT()TaipeiCityHospital,Taiwan
Evidence-BasedComplementaryandAlternativeMedicine 7
ate ate ate ateate
u u u uu
QualityofAEs△Reporting(1)Adequate(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Adequate(7)Notreported(1)Notreported(2)Notreported(3)Adequate(4)Adequate(5)Notreported(6)Notreported(7)Partiallyadeq(1)Adequate(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Adequate(7)Partiallyadeq(1)Notreported(2)Inadequate(3)Notreported(4)Partiallyadeq(5)Notreported(6)Inadequate(7)Notreported(1)Adequate(2)Notreported(3)Adequate(4)Adequate(5)Adequate(6)Inadequate(7)Adequate (1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Partiallyadeq(6)Partiallyadeq(7)Adequate
e
AEs(numberofCases)ofATandoutcome Minorinflammationattheneedlingsit𝑛=1()Mildtendernessattheneedlingsite𝑛=9()Outcome:notreported 𝑛=4Transienteartenderness()Outcome:resolvedspontaneously Transientexacerbationofvasomotor𝑛=2symptoms()Outcome:resolvedspontaneously(lastedonlyseconds) Experiencingpainfromneedles(notreported)Outcome:notreported 𝑛=1Hematoma()𝑛=24Feelingofresidualneedling()𝑛=50Tendernesssensation()𝑛=3Minorbleeding()𝑛=1Minorinfection()𝑛=2𝑛=4Nausea()anddizziness()Outcome:graduallydeclined𝑛=1Dizzinessandnausea()Painatinsertionandsleepdisturbance𝑛=1()Outcome:(i)Disappearedafterwithdrawaloftheneedles(fordizzinessandnausea)(ii)Notreported(forpainandsleepdisturbance)
ued. Selectedacupoints Shenmen,stomach,hunger,endocrine TrueAT:shenmen,kidney,analgesiaShamAT:shoulder,wrist,extra-auricularpoint Shenmen,liver,lung,autonomic,kidney Notreported TrueAT:shenmen,lung,mouth,sympatheticShamAT:eye,elbow,shoulder,knee TrueAT:shenmen,lung,kneejointShamAT:nonacupuncturepointslocatedonthehelixipsilateraltothesiteofsurgery
n
Table2:Conti Intervention(detailsofAT)andcontrol Intervention(trueAT):(i)Method:auricularacupuncture(needles:2mmtipand10mmannular-shapedbody)(ii)Duration:twotreatmentsweekly(3dayspertreatment)for6weeksControl(shamAT):needleswiththetipsremovedIntervention(trueAT):(i)Method:auricularacupuncturewithSeirinPyonexearneedles(ii)Duration:oneweekControl1(shamAT):auricularacupunctureatnonspecificpointsControl2:notreatment Intervention(AT):(i)Method:auricularacupuncturewith0.20gsterilesingle-useneedles(ii)Duration:weeklytreatment(40minutes)for10weeksControl:notapplicable Intervention(AT+usualtreatment):(i)Method:auricularacupuncture(detailsnotdescribed)(ii)Duration:threetreatmentsweekly(45minutespertreatment)(lengthoftreatmentnotmentioned)Control:usualtreatment Intervention(trueAT):(i)Method:auricularacupuncturewith36gauge0.5inchear-piercingneedles(ii)Duration:weeklytreatmentfor8weeksControl(shamAT):auricularacupunctureatnonspecificpoints Intervention(trueAT+analgesia):(i)Method:auricularacupuncturewith×indwellingsteelneedles(0.221.5mm)(ii)Duration:insertedbeforesurgeryandkeptuntilthefollowingmorningControl(shamAT+analgesia):auricularacupunctureatnonacupuncturepoints
ReasonforATandpractitioner R:obesityP:acupuncturist R:pregnantwomenwithlowbackpainandposteriorpelvicpainP:acupuncturist R:hotflushesinprostatecancerpatientswithLHRHagonisttreatmentP:notreported R:womenwithconcurrentsubstanceuseproblemsandanxietyanddepressivesymptomsP:acupuncturist R:smokingcessationP:acupuncturist R:postoperativepainP:acupuncturist
Study Hsuetal.,2009[31]𝑁=60RCT()TaipeiHospital,Taiwan Wangetal.,2009[32]𝑁=159RCT()Yale-NewHavenHospital,NewHaven,USA Hardingetal.,2008[33]𝑁=60Non-RCT()JamesCookUniversityHospital,Middlesbrough,UK Courbassonetal.,2007[34]𝑁=305Non-RCT()TheJeanTweedCentre,Toronto,Ontario,Canada Wuetal.,2007[35]𝑁=131RCT()SmokingCessationClinics,TaipeiVeteransGeneralHospital,Taiwan Usichenkoetal.,2007[36]𝑁=120RCT()AmbulatoryOrthopedicSurgeryCenteroftheErnstMoritzArndtUniversity,Greifswald,Germany
8 Evidence-BasedComplementaryandAlternativeMedicine
QualityofAEs△Reporting(1)Notreported(2)Notreported(3)Notreported(4)Adequate(5)Partiallyadequate(6)Inadequate(7)Adequate (1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Inadequate(6)Adequate(7)Inadequate (1)Adequate(2)Adequate(3)Adequate(4)Adequate(5)Partiallyadequate(6)Inadequate(7)Adequate (1)Notreported(2)Notreported(3)Notreported(4)Adequate(5)Notreported(6)Inadequate(7)Notreported (1)Partiallyadequate(2)Inadequate(3)Partiallyadequate(4)Notreported(5)Notreported(6)Partiallyadequate(7)Notreported
AEs(numberofCases)ofATandoutcome 𝑛=6Painandmildbleeding()Outcome:notreported 𝑛=3Painattheneedlingsite()Minorbleedingattheneedlingsite𝑛=2()𝑛=1Headache()𝑛=2Hippainafterneedlewithdrawal()Outcome:(i)Onewithdrew,notreportedforanother2(forpain)(ii)Recoveryaftertreatment(forbleeding)(iii)Recoveryaftersurgery(forheadache)(iv)Notreported(forhippain) 𝑛=44Painatinsertion()Outcome:forty-twodroppedoutand2completedtreatmenteventhoughtheyfounditpainful Infrequentminorbleedinguponneedleremoval(notreported)Outcome:notreported Minorlocalbleeding(notreported)Localpain(notreported)Outcome:(i)Treatmentwasnotrequired(forbleeding)(ii)StoppedATtemporarilyorhadlessfrequenttreatments(forlocalpain)
ued. Selectedacupoints Shenmen,sympathetic,kidney,liver,lung TrueAT:shenmen,lung,thalamus,hipjointShamAT:nonacupuncturepointsontheauricularhelix TrueAT:shenmen,lung,liver,kidney,sympatheticShamAT:nonspecificpointsontheauricularhelix TrueAT:shenmen,lung,liver,kidney,sympatheticShamAT:nonacupuncturepointslocatedwithin5mmofthetruepoints Shenmen,lung,liver,kidney,sympathetic
n
Table2:Conti Intervention(detailsofAT)andcontrol Intervention(AT+usualtreatment):(i)Method:auricularacupuncturewith×stainless-steelacupunctureneedles(0.20.15mm)(ii)Duration:dailytreatment(45minutes)for5consecutivedaysControl:aromatherapy+usualtreatment Intervention(trueAT+analgesia):(i)Method:auricularacupuncturewith×permanentpresssteelneedles(0.221.5mm)(ii)Duration:insertedtheeveningbeforesurgeryandkeptfor3daysaftersurgeryControl(shamAT+analgesia):auricularacupunctureatnonacupuncturepoints Intervention(trueAT):(i)Method:auricularacupuncturewith×stainless-steeldisposableneedles(0.220.13mm)(ii)Duration:atotalof14treatments(40minutespertreatment)for4weeksControl(shamAT):auricularacupunctureatnonspecificpointsIntervention1(trueacupuncture+education):(i)Method:auricularacupuncturewith36gauge0.5inchneedles(ii)Duration:fivetreatmentsweekly(30minutespertreatment)for4weeksIntervention2(trueacupuncture)Control(shamacupuncture+education):auricularacupunctureatnonacupuncturepoints Intervention(receivingATfor5ormoretimes):(i)Method:auricularacupuncturewithsteriledisposableneedles(ii)Duration:dailytreatment(20–40minutes)Control:receivingATfor4orfewertimes
ReasonforATandpractitioner R:alcoholwithdrawalP:psychiatristsormental-healthnurses R:postoperativepainP:acupuncturist R:druguseproblem,psychologicalsymptoms,andphysicaldiscomfortinprisoninmatesP:acupuncturist R:smokingcessationandcigaretteconsumptionP:acupuncturist R:substance-abuseproblemP:psychiatristandnurses
Study Kunzetal.,2007[37]𝑁=109RCT()ClinicofPsychiatryandPsychotherapyBethel,Bielefeld,Germany Usichenkoetal.,2005[38]𝑁=61RCT()DepartmentofAnesthesiologyandOrthopedicSurgery,UniversityofGreifswald,Germany Bermanetal.,2004[39]𝑁=158RCT()TwoMedium-SecurityInstitutions(Jails),Sweden Bieretal.,2002[40]𝑁=141RCT()Arizona,USA Gurevichetal.,1996[41]𝑁=77Non-RCT()NorthShoreUniversityHospitalatGlenCove,USA
Evidence-BasedComplementaryandAlternativeMedicine 9
uate uate uateuate uate uate
QualityofAEs△Reporting (1)Notreported(2)Inadequate(3)Partiallyadeq(4)Notreported(5)Notreported(6)Inadequate(7)Notreported (1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Inadequate(7)Notreported (1)Adequate(2)Adequate(3)Notreported(4)Adequate(5)Inadequate(6)Inadequate(7)Partiallyadeq (1)Partiallyadeq(2)Partiallyadeq(3)Adequate(4)Notreported(5)Inadequate(6)Adequate(7)Partiallyadeq (1)Adequate(2)Adequate(3)Notreported(4)Adequate(5)Inadequate(6)Adequate(7)Partiallyadeq
AEs(numberofCases)ofATandoutcome Slightbleedingatinsertion(notreported)Mildnauseaanddizziness(notreported)Outcome:reliefwhentheneedleswereremoved Dizziness,upperlimbnumbness,andminornausea(notreported)Outcome:disappearedafterremovingstimulationonacupoint“sympathetic” 𝑛=18Pressureulcersinthepinna()𝑛=8Worsenedsymptoms()Outcome:(i)Healedwithin10daysofremoval(forpressureulcers)(ii)Notreported(forworsenedsymptoms) 𝑛=27Minorlocalitchiness()𝑛=2Minordizziness()Outcome:(i)SpontaneouslysubsidedafterAT(25)and2withdrew(foritchiness)(ii)SpontaneouslysubsidedafterAT(1)and1withdrew(fordizziness) Mildtomoderatelocaldiscomfort𝑛=5()𝑛=1Slightheadacheanddizziness()Outcome:(i)AllAEswereresolvedwithoutanymedicalintervention(forboth)(ii)Onesubjectwithdrew(foreardiscomfort)
Table2:Continued. Intervention(detailsofAT)andcontrolSelectedacupoints Intervention(trueAT+supportservice):(i)Method:auricularacupuncturewithTrueAT:shenmen,lung,single-usedisposableneedleskidney,sympathetic(ii)Duration:twenty-onedays(20–45minutesShamAT:nonacupuncturepertreatment)pointslocatedclosetothetrueControl(shamAT+supportservice):pointsauricularacupunctureatnonacupuncturepoints Intervention(AT):(i)Method:auricularacupunctureformainLiver,gallbladder,stomach,pointsandauricularacupressureforadjunctduodenum,shenmen,points(detailswerenotdescribed)sympathetic,lung(ii)Duration:notreportedControl:notapplicable StudiesonauricularacupressureIntervention(trueAT):(i)Method:auricularacupressureusingMainacupoints:shenmen,auricularplasterwithvaccariaseedsthalamus(ii)Duration:weeklytreatment(seedskeptforAdjunctacupoints:not7days)for8weeksreportedControl(placeboAT):auricularacupressureusingauricularplasterwithinactiveblackplasticdiscsIntervention(trueAT):(i)Method:auricularacupressureusingauricularplasterwithmagneticpelletsLargeintestine,rectum,San(ii)Duration:tendaysJiao,spleen,lung,sympathetic,Control1(placeboAT):auricularacupressuresubcortexusingauricularplasterwithvaccariaseedsControl2(usualcare):auricularacupressureusingauricularplasteronly Intervention(trueAT):TrueAT:shenmen,lung,(i)Method:auricularacupressurewithmouth,extra,liverstainless-steelpress-pellettapesShamAT:helix2,shoulder,(ii)Duration:weeklytreatmentfor8weeksclavicle,occiput,toothControl(shamAT):auricularacupressureatnonspecificpoints
ReasonforATandpractitioner R:heroinaddictionP:acupuncturist R:cholecystolithiasisP:TCMpractitioner R:chronicnonspecificspinalpainP:doctorsandnurseswithATtraining R:constipationP:notreported R:smokingcessationP:acupuncturist
e,
Study Washburnetal.,1993[42]𝑁=100RCT()TheBayview-HuntersPointFoundation,SanFrancisco,USA ZhangandFan,1986[43]𝑁=179Non-RCT()TCMAcademyofShanxiProvincChina Vasetal.,2014[44]𝑁=265RCT()TenPrimaryHealthcareCentres,Seville,Spain Lietal.,2014[45]𝑁=99RCT()ElderlyResidentialCareHome,HongKong Zhangetal.,2013[46]𝑁=43RCT()RMITUniversity,Australia
10 Evidence-BasedComplementaryandAlternativeMedicine
ate ate ate ateate
u u u uu
QualityofAEs△Reporting(1)Adequate(2)Partiallyadeq(3)Notreported(4)Adequate(5)Partiallyadeq(6)Inadequate(7)Inadequate(1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Inadequate(7)Notreported(1)Notreported(2)Notreported(3)Notreported(4)Partiallyadeq(5)Notreported(6)Inadequate(7)Notreported(1)Inadequate(2)Notreported(3)Notreported(4)Adequate(5)Notreported(6)Inadequate(7)Notreported(1)Notreported(2)Notreported(3)Notreported(4)Notreported(5)Notreported(6)Inadequate(7)Notreported(1)Adequate(2)Notreported(3)Partiallyadeq(4)Partiallyadeq(5)Notreported(6)Inadequate(7)Notreported
AEs(numberofCases)ofATandoutcome 𝑛=2Mildskinirritation()Outcome:noobviousdiscomfortandATcontinued 𝑛=3Localitchiness()Outcome:continuedtocompletethestudy Mild,tolerable,andshort-termitchiness𝑛=7oftheears()Outcomes:notreported 𝑛=2Localrednessatthetapedsite()Outcome:recoveryaftertreatment 𝑛=2Sensationofauriculartenderness()Outcome:notreported Obviouspainatthetapedsitewhen𝑛=5receivingATforthefirsttime()Outcome:completedthestudybyreducingpressingfrequencyandintensity
ued. Selectedacupoints Shenmen,liver,kidney,heel,lesseroccipitalnerve,greatauricularnerve TrueAT:Shenmen,sympathetic,cardia,stomach,digestivesubcortexShamAT:externalkneepoint,vision,shoulderjoint,eye Largeintestine,rectum,SanJiao,spleen,lung,sympathetic,subcortex Mainacupoints:shenmen,occiput,subcortex,sympatheticAdjunctacupoints:(basedonTCMsyndrome)heart,spleen,kidney,liver,stomach Shenmen,kidney,heart,brainstem,subcortex Ashipoint,kidney,liver,lumbosacralvertebrae,shenmen,subcortex
n
Table2:Conti Intervention(detailsofAT)andcontrol Intervention(AT+intravenousanalgesia):(i)Method:auricularacupressureusingauricularplasterwithvaccariaseeds(ii)Duration:onetreatment(5hoursaftersurgery),seedskeptfor3daysControl:intravenousanalgesiaonly Intervention(trueAT+standardcare):(i)Method:auricularacupressureusingauricularplasterwithplantseeds(ii)Duration:onetreatment,seedskeptfor7daysControl(shamAT+standardcare):auricularacupressureatnonspecificpoints Intervention(trueAT):(i)Method:auricularacupressureusingauricularplasterwithmagneticpellets(ii)Duration:threeweeksControl(placeboAT):auricularacupressureusingauricularplasterwithvaccariaseeds Intervention(AT):(i)Method:auricularacupressureusingauricularplasterwithmagneticpellets(ii)Duration:onetreatment,seedskeptfor7daysControl:standardizedmedication Intervention(AT):(i)Method:auricularacupressureusingauricularplasterwithmagneticpellets(ii)Duration:dailytreatment(everynightbeforesleep)for4weeksControl:notapplicable Intervention(AT+Chinesemedicineplaster):(i)Method:auricularacupressureusingauricularplasterwithvaccariaseeds(ii)Duration:twotreatmentsweeklyfor2weeksControl:Chinesemedicineplasteronly
ReasonforATandpractitioner R:postoperativepainP:notreported R:chemotherapy-inducednauseaandvomitingP:therapist R:constipationP:notreported R:severeinsomniaP:TCMpractitioner R:womenwithpostmenopausalinsomniaP:acupuncturist R:lowbackpaincausedbylumbarstrainP:notreported
a
han, Chin
Study Kong,2012[47]𝑁=60RCT()FoshanHospitalofTCM,FosChina Yehetal.,2012[48]𝑁=10RCT()ALargeChildren’sHospital,Taiwan Lietal.,2012[49]𝑁=39RCT()ElderlyResidentialCareHome,HongKong Jinetal.,2012[50]𝑁=80RCT()CangnanTCMHospitalofZhejiangProvince,Cangnan, Kungetal.,2011[51]𝑁=45Non-RCT()TaipeiVeteransGeneralHospital,Taiwan Xiaetal.,2011[52]𝑁=60RCT()BaoanHospitalAffiliatedtoSouthMedicalUniversity,Shenzhen,China