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Sham Acupressure Controls Used in Randomized Controlled Trials PDF

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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 PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 2/40 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 PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 3/40 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 PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 4/40 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), PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 5/40 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. PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 6/40 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) PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 7/40 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) PLOSONE|DOI:10.1371/journal.pone.0132989 July15,2015 8/40 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

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Randomized controlled trials comparing true acupressure with sham established acupuncture-point charts, while non-therapeutic acupoints . auricular acupressure studies (n = 11), and were articles published in Arabic/Farsi (n
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