Sham Acupressure Controls Used in Randomized Controlled Trials

40 Pages·2015·1.1 MB·English

RESEARCHARTICLE
Sham Acupressure Controls Used in
Randomized Controlled Trials: A Systematic
Review and Critique
Jing-YuTan1,2,LornaK.P.Suen1,TaoWang3,AlexanderMolassiotis1*
1 SchoolofNursing,TheHongKongPolytechnicUniversity,HungHom,Kowloon,HongKongSAR,China,
2 SchoolofNursing,FujianUniversityofTraditionalChineseMedicine,Fuzhou,Fujian,China,3 The
SecondAffiliatedPeople’sHospital,FujianUniversityofTraditionalChineseMedicine,Fuzhou,Fujian,China
* [email protected]
Abstract
Objectives
Toexplorethecommonlyutilizedshamacupressureproceduresinexistingacupressuretri-
als,andtoassesswhetherdifferenttypesofshaminterventionsyielddifferenttherapeutic
outcomes,and,asfaraspossible,toidentifydirectionsforthefuturedevelopmentofan
adequateshamacupressuremethod.
OPENACCESS
Citation:TanJ-Y,SuenLKP,WangT,MolassiotisA Methods
(2015)ShamAcupressureControlsUsedin
Randomizedcontrolledtrialscomparingtrueacupressurewithshaminterventionswere
RandomizedControlledTrials:ASystematicReview
andCritique.PLoSONE10(7):e0132989. included.Thirteenelectronicdatabaseswereadoptedtolocaterelevantstudiesfromincep-
doi:10.1371/journal.pone.0132989 tiontoJuly3,2014.Meanwhile,eightChinesejournalsoncomplementaryandalternative
Editor:NguyenTienHuy,InstituteofTropical medicineweremanuallysearchedtolocateeligiblearticles.Inaddition,eligiblestudies
Medicine(NEKKEN),NagasakiUniversity,JAPAN listedinthereferencelistsoftheincludedpapersandotherrelatedsystematicreviewson
Received:January22,2015 acupressurewerealsoscreenedtofurthersearchanypotentiallyeligibletrials.Methodolog-
icalqualityoftheincludedstudieswasevaluatedusingtheriskofbiasassessmenttool
Accepted:June23,2015
developedbytheCochraneBackReviewGroup.Descriptiveanalysiswasadoptedtosum-
Published:July15,2015
marizethetherapeuticoutcomes.
Copyright:©2015Tanetal.Thisisanopenaccess
articledistributedunderthetermsoftheCreative
CommonsAttributionLicense,whichpermits Results
unrestricteduse,distribution,andreproductioninany
Sixty-sixstudieswith7265participantswereincluded.Methodologicalqualityofthe
medium,providedtheoriginalauthorandsourceare
credited. includedtrialswasgenerallysatisfactory.Sixtypesofshamacupressureapproacheswere
identifiedand“non-acupoint”stimulationwasthemostfrequentlyutilizedshampointwhile
DataAvailabilityStatement:Allrelevantdataare
withinthepaperanditsSupportingInformationfiles. anacupressuredevicewasthemostcommonlyusedapproachforadministeringsham
treatments.Acupressuretherapywasabeneficialapproachinmanagingavarietyofhealth
Funding:Theseauthorshavenosupportorfunding
toreport. problemsandthetherapeuticeffectwasfoundtobemoreeffectiveinthetrueacupressure
groupsthanthatintheshamcomparativegroups.Noclearassociationcouldbeidentified
CompetingInterests:Theauthorshavedeclared
thatnocompetinginterestsexist. betweendifferentshamacupressuremodalitiesandthereportedtreatmentoutcomes.
PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 1/40
ShamAcupressureControlsUsedinRandomizedControlledTrials
Conclusions
Agreatdiversityofshamacupressurecontrolshavebeenusedinclinicalpracticeand
research.Asolidconclusionwhetherdifferentshamalternativesarerelatedtodifferent
treatmentoutcomescannotbederivedbecauseofsignificantclinicalheterogeneityamong
theanalyzedtrials.Non-acupointsaregenerallyrecommendedbutthedefinitelocations
shouldbeidentifiedwithcaution.Forstudiesusingsingleshamacupointsonhandsorlegs,
itissuggestedtoapplyidenticalacupressuredevicesonthesameacupointasintheactive
interventionwithoutanystimulation.Whileforstudiesonpain,stimulationofshamacu-
pointsshouldbeavoided.
Introduction
Randomizedcontrolledtrial(RCT)isoneofthecommonlyusedexperimentalmethodsfor
testingtheeffectivenessofanintervention[1].Todistinguishthespecificeffectofatherapeutic
approachfromthenon-specificeffect,aplacebocontrolisusuallyemployed[2].Placebois
definedas“anytherapyorcomponentoftherapyusedforitsnonspecific,psychological,or
psychophysiologicaleffect,orthatisusedforitspresumedspecificeffect,butiswithoutspecific
activityfortheconditionbeingtreated”[3](p.371).Aplacebointerventioniscommonlyused
inexperimentaldrugstudieswherethe“placebodrug”isidenticaltotheactiveagentwithout
anyspecificpharmacologicalactivityagainstthedisease.Theoretically,placebocomparisons
shouldbeindistinguishablefromthetrueintervention,andmostimportantly,shouldbeinert,
whichmeansonlycreatenon-specificphysiologicalandpsychologicalchanges[4].However,
anadequateplacebodesignbecomesdifficulttoimplementwhenastudyisadoptingcomplex
non-pharmacologicalinterventionssuchasphysiotherapy,acupunctureoracupressure,etc.
Multiplemechanismsinvolvedinthesetypesoftreatmentsmakeitcomplicatedtodevelopan
appropriateplacebocontrolgroup.
Acupressurehasbeenwidelyappliedindealingwithavarietyofhealthissuesglobally.In
additiontothespecifictherapeuticeffects,stimulationattheacupointsisalsobelievedtogen-
eratesomenon-specificeffects,inbothphysiologicalandpsychologicalaspects[5].Placebo
controlsadoptedinacupressuretrialsareusuallyreferredtoas“shaminterventions”,which
indicatefakedacupressureapproaches.Varioustypesofshamacupressurehavebeenreported
intheliteraturewhichmainlydifferinthreeaspects,theselectedacupoints,theacupressure
approach,andtheacupressureintensity.Acupointsadoptedinshamprocedurescommonly
includenon-acupoints,trueacupointsastheactiveacupressuregroup,andnon-therapeutic
acupoints.Non-acupointsgenerallyrefertoineffectivebodypointswhichcannotbefoundon
establishedacupuncture-pointcharts,whilenon-therapeuticacupointsmeansirrelevanttrue
acupointsconsideredtobeineffectiveforthetargetedhealthproblem[2,6].
Shamproceduresusedinacupuncturehavereceivedconsiderableattentioninresearch.A
numberofRCTsandsystematicreviewshavebeenconductedtoinvestigatethespecifictreat-
menteffectofacupunctureinawiderangeofdisorders,especiallyinpainmanagement,and
haveyieldedcontradictoryresults.Someofthemsupportedthespecificbenefitofacupuncture
[5,7–9],whileothersarguedthattheeffectsoftrueacupunctureweresimilartothatinthe
shamintervention[10–12],andconsequentlyreachedtheconclusionthattheso-calledtreat-
menteffectofacupuncturemaybeonlyanon-specificphysiologicaleffectand/oraplacebo
effect.However,beforedevelopingsuchconclusions,thosestudiesmusthaveaprecondition
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ShamAcupressureControlsUsedinRandomizedControlledTrials
thattheemployedshamprocedureisinert.Similarsituationswerealsodetectedinstudiesof
acupressure.Despitethesignificantamountsofresearchonacupressureduringthepast
decades,itisstilluncertainwhichtypeofshamacupressureisthemostadequatedesign,andto
ourknowledge,nostudyhasbeenconductedsofartosummarizethefrequentlyusedsham
acupressuremodalitiesandtoexploretheirstrengthsanddrawbacks.Hence,theaimsofthis
studyaretoidentifythecommonlyutilizedshamproceduresinexistingacupressuretrials,to
assesswhetherdifferenttypesofshaminterventionyielddifferenttherapeuticoutcomes,and,
ifpossible,toidentifydirectionsforthefuturedevelopmentofanadequateshamacupressure
mode.
Methods
Thisstudyisasystematicreviewoftheliterature(S1File).Areviewprotocolwascreatedby
thefirstauthoranditwasapprovedbytwoexpertswithexperienceinacupressurebeforethe
commencementofthestudy(S2File).
DataSourcesandSearchStrategies
Bothelectronicandmanualsearcheswereusedtolocaterelevantstudies.Thirteenelectronic
databaseswereaccessedincludingPubMed,EMBase,CochraneCentralRegisterofControlled
Trials(CENTRAL),CINAHL,AlliedandComplementaryMedicine(AMED),PsycINFO,
ThomsonReutersWebofScience,ScienceDirect,ForeignMedicalJournalService(FMJS),
ChinaNationalKnowledgeInfrastructure(CNKI),WanFangData,ChineseScientificJournal
Database(CQVIP)andChineseBiomedicalLiteratureDatabase(CBM),frominceptiontoJuly
3,2014.Therewasnolanguagerestrictionsetforelectronicsearches.Meanwhile,eightChinese
journalsoncomplementaryandalternativemedicine(issuespublishedwithinthelatestthree
years)weremanuallysearchedtopossiblyidentifysomelatestpublicationswhichwerestillnot
includedintheonlinedatabases.Inaddition,eligiblestudieslistedinthereferencelistsofthe
includedpapersandotherrelatedsystematicreviewsonacupressurewerealsoscreenedtofur-
thersearchanypotentiallyeligibletrials.Literaturesearcheswereperformedindependentlyby
tworeviewerswithChinesemedicinebackground(JYTandTW).Meshterms,entryterms,
keywordsandfreewordssuchas“acupressure”,“acupress(cid:1)”,“wristband(cid:1)”“shiatsu”and“chih
ya”wereusedinthesearchingstrategies.FourselectedEnglishandChinesesearchstrategies
arelistedinS1Table.
InclusionandExclusionCriteria
RCTscomparingtrueacupressurewithashaminterventionwereincluded.Bothtrueand
shamacupressurecanbemanipulatedthrougheithermanualinterventionoracupressure
devices(e.g.,wristbandsorattachedacupressurebeads,etc.).Toeliminatetheeffectofelectri-
calstimulationonthetherapeuticoutcomesofacupressure,studiesonelectronicacupressure
deviceswereexcluded.Atthesametime,studiesonothermodalitiesofacupuncture-point
stimulationsuchasmanual/electronic/laseracupunctureandmoxibustion,aswellasallkinds
ofauriculartherapywereexcluded.StudiespublishedinlanguagesotherthanEnglishandChi-
nesewereexcluded.
MethodologicalQualityEvaluation
Methodologicalqualityoftheincludedstudieswasevaluatedusingtheriskofbiasassessment
tooldevelopedbytheCochraneBackReviewGroup[13].Thetoolcanbeviewedasanexten-
sionoftheoriginalcriteriarecommendedbytheCochraneHandbook.Itnotonlyincludesall
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ShamAcupressureControlsUsedinRandomizedControlledTrials
thenecessaryitemsdescribedinthelatestversionoftheCochraneriskofbiastool,butalso
providesmoredetailedcriteriaforassessing“incompleteoutcomedata”and“othersourcesof
potentialbias”.Thetoolconsistsof12itemsincluding:(1)“Wasthemethodofrandomization
adequate?”;(2)“Wasthetreatmentallocationconcealed?”;(3)“Wasthepatientblindedtothe
intervention?”;(4)“Wasthecareproviderblindedtotheintervention?”;(5)“Wastheoutcome
assessorblindedtotheintervention?”;(6)“Wasthedrop-outratedescribedandacceptable?”;
(7)“Wereallrandomizedparticipantsanalyzedinthegrouptowhichtheywereallocated?”;
(8)“Arereportsofthestudyfreeofsuggestionofselectiveoutcomereporting?”;(9)“Werethe
groupssimilaratbaselineregardingthemostimportantprognosticindicators?”;(10)“Were
co-interventionsavoidedorsimilar?”;(11)“Wasthecomplianceacceptableinallgroups?”and
(12)“Wasthetimingoftheoutcomeassessmentsimilarinallgroups?”[13].Eachitemcanbe
ratedasof“yes”,“no”or“unclear”where“yes”indicatesalowriskofbias[13].Importantly,
differentfromtheoriginalCochraneriskofbiascriteria,thetoolusedinthisstudycanprovide
anoverallmethodologicalqualityassessmentforasingletrial.Theoverallqualitycanbe
assessedas“lowriskofbias”whenatleastsixitemsarescoredas“yes”andnoseriousmethod-
ologicalflawsareidentified(e.g.80%dropoutratefoundinonestudyarm)[13].Inthisreview,
onlyRCTswithlowriskofbiaswereeligibleforfinalanalysis.
DataExtraction
Foreachoftheincludedstudies,thefollowingdatawasextractedindependentlybythesame
tworeviewers:(1)studygeneralinformation(firstauthor,yearofpublication,fullnameof
journal,countryoforigin,typeofstudydesign,andstudysetting);(2)participantcharacteris-
tics(age,gender,samplesize,dropoutrate,diagnosticcriteria,inclusionandexclusioncriteria,
andreasonforacupressure);(3)true/shamacupressureprotocols(practitioner,acupressure
equipment,selectedacupoints,treatmentdurationandnumberofsessions,andacupressure
intensityandfrequency,etc.);(4)mainoutcome(s)andresultsofthetherapeuticeffects;(5)
adverseeventsassociatedwithacupressure;and(6)assessmentofmethodologicalquality(12
itemsoftheriskofbiastoolplusexaminationofthecredibilityofblinding).Forstudiescom-
prisingmorethantwoactivetreatmentarms,onlydatafromtrueandshamacupressurearms
wereextractedforanalysis.Meanwhile,forstudiesincludinganothercontrolgroupwithstan-
dardmethodsofcare,datafromthestandardcarearmwerealsoextractedaccordingly.Dis-
agreementbetweenthetworeviewerswasresolvedbydiscussionorbyconsultingathird
reviewer(AM).
ClassificationofShamAcupressureMethods
Aftergoingthroughalloftheshamacupressureprotocolsoftheincludedstudiesaswellas
reviewingtheshamcontrolclassificationsforbodyandauricularacupunctureinprevious
studies[2,14,15],shammethodsinthisstudywereclassifiedintosixtypeswhicharedescribed
inTable1.
DataAnalysis
Aquantitativesynthesisofthemainoutcomeswasoriginallyproposedinthestudyprotocol.
However,aprecisemeta-analysiswasdeemedimpossibleduetothesignificantclinicalhetero-
geneityidentifiedinthehealthconditions,patientcharacteristics,interventionprotocolsand
outcomemeasuresamongstudies.Asubgroupmeta-analysisforthesamehealthconditions
withineachshamacupressuretypewasalsoconsideredbutfinallyabandonedforthereasons
thatclinicalheterogeneitywasstillconsiderablewithineachshammodality,andthenumberof
trialsinsomeshamtypeswasinsufficientfordatasynthesis.Toprovideanexploratoryanalysis
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ShamAcupressureControlsUsedinRandomizedControlledTrials
Table1. ClassificationofShamAcupressureMethods.
TypesofSham Description
Methods
Type1 ShamAcupressureatNon-acupointsbyManualPressure
Type2 ShamAcupressureatNon-acupointsbyEmployingAcupressureDevices
Type3 Pseudo-interventionattheSameAcupointsasTrueTreatmentArmbyManual
Light-Touch
Type4 Pseudo-interventionattheSameAcupointsasTrueTreatmentArmbyusing
PlaceboDevices
Type5 ManualAcupressureatNon-Therapeutic(Irrelevant)Acupoints
Type6 ShamAcupressureatNon-Therapeutic(Irrelevant)AcupointsbyAdopting
AcupressureDevices
doi:10.1371/journal.pone.0132989.t001
ofthestudyoutcomes,responderrateandresponderrateratio(responderrateintrueacupres-
suregroup/responderrateinshamgroup)foreachstudypresentingdichotomousdatawere
calculated,andariskratio(RR)with95%confidenceinterval(CI)wasusedtopresentthe
responderrateratio.Descriptiveanalysiswasalsousedtosummarizethetherapeuticoutcomes
ofacupressure,forboththeoveralleffectandthesubgroupeffectbyeachshamalternative.
Theoverallassessmentwastoinvestigatewhethertrueacupressureissuperiortoshamcom-
parisonswhilethesubgroupanalysiswasusedtoassesswhetherdifferenttypesofshammeth-
odscouldinducedifferenttherapeuticeffects.
Resultsofthetreatmenteffectforeachmainoutcomeineachindividualstudywere
extractedbytworeviewersaccordingtothefollowingvotecounts[2]:“++”:trueacupressureis
significantlybetterthanshamcontrolforthemainoutcome;“+”:trendofthemainoutcomein
favoroftrueacupressurebutwithoutstatisticalsignificance;“0”:nodifferencebetweentrue
andshamacupressure;“−”:trendofthemainoutcomeinfavorofshamacupressurebutwith-
outstatisticalsignificance;and“−−”:shaminterventionissignificantlybetterthantrueacu-
pressureforthemainoutcome.Forstudiesreportingmultiplemainoutcomes,allsuch
outcomeswereincludedforanalysis.Forstudiesnotindicatingthemainoutcomes,allvari-
ableswithbetween-groupcomparisonwereextractedaccordingly.
Inaddition,subgroupdescriptiveanalysesfordifferenttypesofhealthproblems,interven-
tiondurationandfrequencyaswellasacupressureintensitywerealsoconsideredwhendata
wereavailable.Basedontheanalyzedtrials,lengthoftreatmentwascategorizedinto
“extremelyshort-term”(lessthanonehour),“short-term”(morethanonehourbutlessthan
oneday),“mid-term”(morethanonedaybutlessthanoneweek),and“long-term”(more
thanoneweek).Forstudiesonpostoperativeissue(e.g.nausea,vomitingandpain,etc.)which
employedmultipleassessmenttimepoints,postoperativedatawithinthefirst24hourswere
abstractedforanalysis.Thechi-squaretestwasusedtoassessthedifferenceindropoutrates
betweenthetrueandshamacupressurearms.
Results
CharacteristicsoftheIncludedStudies
Atotalof5225itemswerelocated.Amongthose2283duplicatedarticleswereexcludedafter
screeningbythereferencemanagementsoftwareNoteExpress.Atotalof2694recordswere
subsequentlyremovedbycheckingtitlesandabstracts.Fortheremaining248items,full-texts
wereaccessedforevaluatingeligibility,amongwhich,160werefurtherremovedbecausethey
failedtoincludeashamcontrolgroup(n=92),wereconferenceproceedings(n=32),were
auricularacupressurestudies(n=11),andwerearticlespublishedinArabic/Farsi(n=21),
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ShamAcupressureControlsUsedinRandomizedControlledTrials
Fig1.FlowChartofStudySelection.CENTRAL:CochraneCentralRegisterofControlledTrials,CINAHL:CumulativeIndextoNursingandAlliedHealth
Literature,AMED:AlliedandComplementaryMedicine,FMJS:ForeignMedicalJournalService,CNKI:ChinaNationalKnowledgeInfrastructure,CQVIP:
ChineseScientificJournalDatabase,CBM:ChineseBiomedicalLiteratureDatabase
doi:10.1371/journal.pone.0132989.g001
Korean(n=3)andFrench(n=1).Theremaining88articleswerefurtheradoptedformethod-
ologicalqualityevaluation,ofwhich,22withhighriskofbiaswereremoved(S2Table)and66
studies[16–81]werefinallyincludedforanalysis.Fig1showstheflowchartofthestudy
selection.
Theincludedstudiescomprised7265subjects,withanaveragesamplesizeof110patients
perstudy.Thesestudieswerepublishedbetween1991and2015andwereconductedin18dif-
ferentcountriesorregions.Ofwhich,13studiesoriginatedfromIran,12fromtheUnited
States,tenfromTaiwan,fivefromSweden,fourfromtheUnitedKingdom,threefromAustria,
threefromSouthKorea,threefromCanada,twofromItaly,twofromIreland,twofromIndia,
andoneeachfromHongKong,Denmark,Australia,Turkey,Pakistan,PolandandNorway.
Morethanhalfwerecarriedoutinhospitalsormedicalcenters.Acupressurewasusedtodeal
withavarietyofhealthproblemsincludingnauseaandvomiting,laborpain,primarydysme-
norrhea,sleepdisturbance,postoperativegastrointestinaldysfunction,andanxiety,etc.Char-
acteristicsoftheincludedstudiescanbeseeninTable2.
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ShamAcupressureControlsUsedinRandomizedControlledTrials
Table2. CharacteristicsoftheIncludedStudies.
Study&Setting(s) Condition(s) Sample Intervention&Control MainOutcome(s) Therapeutic Acupressure-
Size& Groups Effectsof relatedAEs
Dropout Acupressure*
(N/n)
Type1—ShamAcupressureatNon-Acupoints:ManualAcupressure
Tangetal.2014 Cancer-related Total:57/ TAG1:Manual Fatigue(Tang +1 NotReported2
[16],Pulmonary Fatigue 12,TAG1: AcupressureatTrue FatigueRatingScale)
WardsofAMedical 24/8,TAG Acupoints,TAG2:
Center,Taiwan 2:17/2, ManualAcupressureat
SAG:16/2 TrueAcupoints
+EssentialOils,SAG:
ManualAcupressureat
Non-Acupoints
Atrianetal.2013 Primary Total:67/ TAG:Manual PainIntensity(VAS) 0 NoAEsFoundin
[17],Dormitoriesof Dysmenorrhea 8,TAG: AcupressureatTrue theStudy
KashanUniversityof 33/6,SAG: Acupoints,SAG:
MedicalSciences, 34/2 ManualAcupressureat
Iran Non-Acupoints
Sehhatie-Shafaie LaborPainin Total:84/ TAG:Manual PainIntensity(Visual ++ NotReported2
etal.2013[18],The Nulliparous 0,TAG: AcupressureatTrue PainScale)
PublicHospitalsof Women 42/0,SAG: Acupoints,SAG:
Ardebil,Iran 42/0 ManualAcupressureat
Non-Acupoints
Chaoetal.2013 Postoperative Total:66/ TAG:Manual FrequencyofBowel ++(ForBowel NotReported2
[19],AnUrban Gastrointestinal 6,TAG: AcupressureatTrue Sounds,Timetothe Sounds,Flatus
MedicalCenterin Function 30,SAG: Acupoints+Routine FirstFlatusPassage Passage,and
Taipei,Taiwan 30 Care,SAG:Manual andDefecation,and LiquidIntake),+
AcupressureatNon- TimetoOralLiquid (ForSolidIntake
Acupoints+Routine andSolidIntake andDefecation)
Care
McFaddenetal. StressReduction Total:109/ TAG:Manual StressResponses 0 NotReported2
2012[20],University NR,TAG: AcupressureatTrue (HeartRate,Heart
ofColoradoat 39/NR, Acupoints,SAG: RateVariability,Skin
Boulder,United SAG:40/ ManualAcupressureat Conductance
States NR, Non-Acupoints,CG:An Response,State
CG:30/NR AudioRelaxationCD AnxietyInventory,
andPsychological
StressMeasure)
Valieeetal.2012 Preoperative Total:70/ TAG:Manual PreoperativeAnxiety ++(ForAnxiety, NotReported2
[21],SurgeryWards, Anxiety 0,TAG: AcupressureatTrue (VAS),andVital RespiratoryRate,
HospitalofTehran 35/0,SAG: Acupoints,SAG: Signs(Blood andSystolicBlood
UniversityofMedical 35/0 ManualAcupressureat Pressure,HeartRate, Pressure),+(For
Science,Iran Non-Acupoints andRespiratoryRate) HeartRateand
DiastolicBlood
Pressure)
Radetal.2012[22], Nauseaand Total:85/ TAG:Manual IntensityofNausea ++ NoAEsFoundin
RouhaniHospitalof Vomitingin 5,TAG: AcupressureatTrue (VAS)andVomiting theStudy
BabolUniversityof Pregnancy 43/3,SAG: Acupoints,SAG: (Frequencyof
MedicalScience,Iran 42/2 ManualAcupressureat Vomiting)
Non-Acupoints
Changetal.2011 UrodynamicStress Total:81/ TAG:Manual PelvicMuscle ++,TAGwas NotReported2
[23],A Incontinence 4,TAG: AcupressureatTrue Strength SignificantlyBetter
UrogynecologyClinic 27/1,SAG: Acupoints+PelvicFloor (Perineometry thanSAGandCG;
ofQueenElizabeth 27/1,CG: MuscleTraining,SAG: throughMeasuring NoDifferencewas
Hospital,HongKong 27/2 ManualAcupressureat VaginalSqueeze Foundbetween
Non-Acupoints+Pelvic Pressure) SAGandCG
FloorMuscleTraining,
CG:PelvicFloorMuscle
Training
(Continued)
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ShamAcupressureControlsUsedinRandomizedControlledTrials
Table2. (Continued)
Study&Setting(s) Condition(s) Sample Intervention&Control MainOutcome(s) Therapeutic Acupressure-
Size& Groups Effectsof relatedAEs
Dropout Acupressure*
(N/n)
McFaddenetal. TraumaticBrain Total:42/ TAG:Manual CognitiveImpairment ++ NotReported2
2011[24],A Injury 0,TAG: AcupressureatTrue andStateofBeing
Communityin 21/0,SAG: Acupoints,SAG: followingTraumatic
Colorado,United 21/0 ManualAcupressureat BrainInjury
States Non-Acupoints
Kashefietal.2011 Women’sGeneral Total:86/ TAG:Manual Women’sGeneral ++ NoAEsFoundin
[25],Bojnoord Health 10,TAG: AcupressureatTrue Health(General theStudy
UniversityofMedical 43/6,SAG: Acupoints,SAG: HealthQuestionnaire)
Science,Iran 43/4 ManualAcupressureat
Non-Acupoints
Rezaetal.2010 Sleep Total:90/ TAG:Manual Self-ReportedSleep ++,TAGwas NotReported2
[26],KahrizakCharity Disturbances 13,TAG: AcupressureatTrue Habits(Pittsburgh SignificantlyBetter
NursingHome,Iran 30/5,SAG: Acupoints+Usual SleepQualityIndex) thanSAGandCG;
30/4,CG: Care,SAG:Manual TheSleepQuality
30/4 AcupressureatNon- inSAGwasBetter
Acupoints+Usual thanThatinCGbut
Care,CG:UsualCare Therewasno
Statistical
Significance
McFadden& Cardiovascular Total:16/ TAG:Manual HeartRateandBlood ++(ForHeart NotReported2
Hernández2010 FunctioninStroke 3,TAG:7/ AcupressureatTrue Pressure Rate),0(ForBlood
[27],Denver/Boulder Survivors 1,SAG:9/ Acupoints,SAG: Pressure)
Communityin 2 ManualAcupressureat
Colorado,United Non-Acupoints
States
Maaetal.2007[28], Symptomsand Total:49/ TAG:Manual DailySputum 0,TAGwasBetter NotReported2
Departmentof Health-Related 14,TAG: AcupressureatTrue Amounts,Effortsto thanCGRegarding
ThoracicMedicine, QualityofLifein 16/5,SAG: Acupoints+Standard cleanSecretions totheSGRQ
ChangGung Bronchiectasis 17/6,CG: Care,SAG:Manual (SputumSelf- ActivityDomain,
MemorialHospital, Patients 16/3 AcupressureatNon- Assessment),Six- andSAGwasbetter
Taiwan Acupoints+Standard MinuteWalking thanCGinthe
Care,CG:Standard Distance,Breathing Improvementof
Care Difficulty,andQuality SputumSelf-
ofLife(SGRQ) Assessment
Shinetal.2007[29], Nausea,Vomiting, Total:66/ TAG:Manual DegreeofNausea ++,TheDegreeof NotReported2
TwoGeneral andKetonuria NR,TAG: AcupressureatTrue andVomiting(The Nauseaand
Hospitals,South LevelsinWomen 23/NR, Acupoints+Routine RhodesIndexof VomitinginTAG
Korea withHyperemesis SAG:21/ IntravenousTherapy, Nausea,Vomiting, wasStatistically
Gravidarum NR,CG: SAG:Manual andRetching),and LowerthanSAG
22/NR AcupressureatNon- DegreeofKetonuria andCG,andNo
Acupoints+Routine Differencewas
IntravenousTherapy, Foundbetween
CG:Routine SAGandCG
IntravenousTreatment
Bertalanffyetal. MotionSicknessin Total:100/ TAG:Manual NauseaIntensity ++ NotReported2
2004[30],Sitesof Patientswith 0,TAG: AcupressureatTrue (VAS)
Accident,Austria Trauma 50/0,SAG: Acupoints,SAG:
50/0 ManualAcupressureat
Non-Acupoints
Chenetal.2003 Gastrointestinal Total:41/ TAG:Manual Gastrointestinal ++ NotReported2
[31],AMid-Taiwan Motilityafter 0,TAG: AcupressureatTrue Motility
TeachingHospital, Surgery 21/0,SAG: Acupoints,SAG: (Multifunctional
Taiwan 20/0 ManualAcupressureat Stethoscope)
Non-Acupoints
(Continued)
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ShamAcupressureControlsUsedinRandomizedControlledTrials
Table2. (Continued)
Study&Setting(s) Condition(s) Sample Intervention&Control MainOutcome(s) Therapeutic Acupressure-
Size& Groups Effectsof relatedAEs
Dropout Acupressure*
(N/n)
Tsay&Chen2003 SleepQuality Total:105/ TAG:Manual SleepQuality 0,TAGwas NotReported2
[32],FourDialysis 7,TAG: AcupressureatTrue (PittsburghSleep SignificantlyBetter
CentersinMajor NR,SAG: Acupoints+Usual QualityIndex) thanCG;No
HospitalsinTaipei, NR,CG: Care,SAG:Manual Differencewas
Taiwan NR AcupressureatNon- Foundbetween
Acupoints+Usual SAGandCG
Care,CG:UsualCare
Koberetal.2002 Pre-Hospital Total:60/ TAG:Manual Pain(VAS),Anxiety Comparisons NotReported2
[33],Sitesof Analgesia 0,TAG: AcupressureatTrue (VAS),andHeart betweenGroups
Accident,Austria 19/0,SAG: Acupoints,SAG: Rate werenotPerformed
20/0,CG: ManualAcupressureat (orNotClearly
21/0 Non-Acupoints,CG:No Reported)
Acupressure
Belluominietal. Nauseaand Total:90/ TAG:Manual NauseaandVomiting ++(ForNausea),+ NotReported2
1994[34], Vomitingin 30,TAG: AcupressureatTrue (TheIndexof (ForVomiting)
Departmentof Pregnancy 46/16, Acupoints,SAG: Nausea,Vomiting,
Obstetricsand SAG:44/ ManualAcupressureat andRetching)
Gynecology, 14 Non-Acupoints
CaliforniaPacific
MedicalCenter,
UnitedStates
Type2—ShamAcupressureatNon-Acupoints:AcupressureBandsorOtherDevices
Adib-Hajbaghery& Postoperative Total:70/ TAG:Acupressureat SeverityofNausea ++(ForPain),0 NotReported2
Etri,2013[35],A Pain,Nausea,and 0,TAG: TrueAcupointsusing andPain(VAS),and (ForNausea),NA
GeneralSurgical Vomiting 35/0,SAG: AcupressureBand, SeverityofVomiting (ForVomiting)3
WardofAUniversity 35/0 SAG:Acupressureat (Frequencyof
Hospital,Iran Non-Acupointsusing Vomiting)
AcupressureBand
Alessandrinietal. AcuteVertigo Total:204/ TAG:Acupressureat SeverityofVertigo Comparisons NotReported2
2012[36], 0,TAG: TrueAcupointsusing andNeurovegetative betweenGroups
Otolaryngology 102/0, AcupressureBand, Symptoms(VAS) werenotPerformed
Department, SAG:102/ SAG:Acupressureat (orNotClearly
UniversityofRome 0 Non-Acupointsusing Reported)
“TorVergata”,Italy AcupressureBand
Soltanietal.2011 Postoperative Total:200/ TAG:Using Postoperative ++4 NotReported2
[37],FarabiHospital, Nauseaand 0,TAG: AcupressureWristBand NauseaandVomiting
Iran Vomiting 50/0,SAG atTrueAcupoints,SAG duringtheFirstTwo
1:50/0, 1:UsingAcupressure Hours(0–2Hours)
SAG2:50/ WristBandatNon- andtheFollowing22
0,SAG3: Acupoints,SAG2: Hours(2–24Hours)
50/0 UsingAcupressure afterSurgery
WristBandatNon-
Acupoints
+Metoclopramide,SAG
3:UsingAcupressure
WristBandatNon-
Acupoints
+Ondansetron
(Continued)
PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 9/40
ShamAcupressureControlsUsedinRandomizedControlledTrials
Table2. (Continued)
Study&Setting(s) Condition(s) Sample Intervention&Control MainOutcome(s) Therapeutic Acupressure-
Size& Groups Effectsof relatedAEs
Dropout Acupressure*
(N/n)
Baoetal.2011[38], PaininCancer Total:78/ TAG:Acupressureat PainIntensity(VAS) 0 MildandTransient
TheSidneyKimmel Patients 1,TAG: TrueAcupointsusing BruisingorARash
Comprehensive undergoingBone 38/1,SAG: MagneticAcupressure attheAcupressure
CancerCenterat MarrowAspiration 40/0 SuctionCups Site(n=10)
JohnsHopkins, andBiopsy +StandardLocal
UnitedStates (BMAB) Analgesics,SAG:
AcupressureatNon-
Acupointsusing
MagneticAcupressure
SuctionCups
+StandardLocal
Analgesics
Majholm&Møller Postoperative Total:134/ TAG:Acupressureat Postoperative 0 Redness(n=40),
2011[39], Nauseaand 22,TAG: TrueAcupointsusing Nauseaand/or Swelling(n=17),
Copenhagen Vomiting 67/8,SAG: AcupressureBand, Vomiting Tenderness
UniversityHospital, 67/14 SAG:Acupressureat (n=16),and
Denmark Non-Acupointsusing Paresthesias
AcupressureBand (n=4)
Sinhaetal.2011 Nauseaand Total:340/ TAG:Acupressureat IncidenceofNausea 0 Discomfortfrom
[40],ASingle Vomitingduring 11,TAG: TrueAcupointsusing and/orVomiting Band(n=25)
TertiaryMaternity Labourand 170/6, AcupressureBand,
Unit,Australia Delivery SAG:170/ SAG:Acupressureat
5 Non-Acupointsusing
PlaceboAcupressure
Band
Wangetal.2008 Pre-Procedural Total:52/ TAG:Acupressureat AnxietyLevel(State ++ NotReported2
[41],AHospital AnxietyandIntra- 0,TAG: TrueAcupointsusing AnxietyInventoryfor
(Detailsnot Procedural 26/0,SAG: AcupressureBeads, Children)
Described),United PropofolNeedsin 26/0 SAG:Acupressureat
States Children Non-Acupointsusing
Undergoing AcupressureBeads
Anesthesia
Turgutetal.2007 Postoperative Total:102/ TAG:Acupressureat Severityof ++ Erythemaand
[42],Departmentof Nauseaand 2,TAG: TrueAcupointsusing Postoperative Swellingofthe
Anesthesiology, Vomiting 51/1,SAG: AcupressureBand, NauseaandVomiting TreatedHand
AnkaraOncology 51/1 SAG:Acupressureat (n=1)
Hospital,Turkey Non-Acupointsusing
AcupressureBand
Heazelletal.2006 Nauseaand Total:80/ TAG:Acupressureat No.ofDaysof 0(ForNo.ofDays NoDiscomforts
[43],ASingle VomitinginEarly 0,TAG: TrueAcupointsusing HospitalStay,and ofHospitalStay),+ FoundintheStudy
SecondaryCare Pregnancy 40/0,SAG: AcupressureBand, No.ofPatientsWho +(ForNo.of
Center,United 40/0 SAG:Acupressureat Required≧4Daysin PatientsWho
Kingdom Non-Acupointsusing theHospital Required≧4Days
AcupressureBand intheHospital)
Wangetal.2005 Preoperative Total:61/ TAG:Acupressureat ParentalAnxiety ++ NotReported2
[44],AHospital ParentalAnxiety NR,TAG: TrueAcupointsusing (StateAnxiety
(Detailsnot 28/NR, AcupressureBeads, Inventory)
Described),United SAG:33/ SAG:Acupressureat
States NR Non-Acupointsusing
AcupressureBeads
(Continued)
PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 10/40