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ALTERNATIVETHERAPIESjulaug2011VOL.17NO.449MenopauseTraditionalChineseMedicinevsHormoneTherapyordiscontinueHTbecauseofperceivedris6smedicalcontraindica-tionsorageneralreluctancetouseunnaturalexogenoushormones.1011Concernsaboutthesafetyofestrogen-basedhormonereplacementtherapysuchasris6ofbreastcancercoronaryheartdiseaseandstro6e1213haveledtodemandsforotheroptionsandmanywomenarenowactivelysee6ingalternativeapproaches.HerbalmedicineandacupuncturehavebeenusedforcenturiesinChinatotreatmenopausalsymptomsandarestillpopular.ClinicaltrialsinChinahavemanifestedsigniJcantefJcacyofChineseherbalmedicineCHMli6ekunBaoWankBWinalleviatingmenopausalsymptomsinChinesewomen.14-18Alsomanyclinicaltri-alssuggestthepositiveeffectsofacupunctureindecreasingmeno-pause-relatedsymptoms.19-23ThisstudywasdesignedtoassesstheefJcacyofkBWwhichisamixtureofmanyChinesemedicinalherbsincomparisonwithtwootherstudygroupsHTandacupunctureplusCHMinrelievingthemenopausalsymptomsinChineseperi-andpostmenopausalwomen.ThewomenmettheChinesemedicinediagnosispatternof6idneyandliveryindeJciencyaccompaniedbyliveryanghyperac-tivityasadetermininginclusioncriterion.METHODSParticipantsThisclinicaltrialwascarriedoutduringa14-monthperiodbetweenJune2008andJuly2009atDongzhimenHospitalwhichisafJliatedwiththeBeijingUniversityofChineseMedicineandPe6ingUniversityPeopleHospital.Ninety-sevenChinesewomenwhowerereferredtotheclinicofgynecologyfortheirmenopause-relatedsymptomswerescreenedforinclusionandexclusioncriteria.Peri-orpostmenopausalwomenwhoshowedatleastthreeofthe11kuppermanIndexsymptomsx14hotKushesparesthesiathefeelingofx1cpinsandneedlesx1dononex19ss6ininsomnianervousnessmelan-choliavertigowea6nessarthralgiaormyalgiaheadachepalpita-tionsandformicationthesensationofinsectscrawlingonorunderonex19ss6inx14wereenteredintothestudyprovidedthattheywereatleast40yearsold.Perimenopausalwomenwereincludediftheyexhibitedmenstrualirregularitiesorariseintheleveloffollicle-stim-ulatinghormoneFSHgreaterthan10IUL.TheinclusioncriterionforChinesemedicinediagnosiswasthepatternof6idneyandliveryindeficiencyaccompaniedbyliveryanghyperactivity.Ax1credtonguewithoutfurx1dwaspresentinallpatients.TheChinesemedi-cinesyndromedifferentiationwasestablishedbyonlyoneChinesemedicinedoctorinordertoensureuniformdiagnosis.Thoseta6ingmedicationsthatinKuencedtherateofhotKushsystemicHTselec-tiveserotoninreupta6einhibitorswereincludedonlyafterawash-outperiodof8wee6s4wee6sforthoseta6inglocalestradiolE2preparations.Gynecologicalexaminationandlaboratorytestswerecarriedouttoscreenthepatientsforanyorganicdiseasesofthereproductivesystem.Patientswereas6edwhethertheywerecurrent-lyundermedicaltreatmentorsufferingfrombreastcancerorseriouscardiacrenalmetabolicendocrineorhepaticdisease.Aftertheapplicationofinclusionandexclusioncriteria25womenwereexcludedand72wereenteredintothestudyandrandomizedintothreegroups.Oftheincludedpatients57chosetocontinueduringthecourseoftreatmentbut15patientsdroppedout.Participantswererandomizedintothreeequalgroupsusingarandomizationchart.Randomizationassignmentswereplacedinatablevisibletobeassignedsequentially.Among57patientswhoremainedinthestudytotheend22wereintheCHMgroup20wereintheacupunc-tureplusCHMACUCHMgroupand15wereintheHTgroupFigure.Blindingwomentotheirtreatmentassignmentwasimpos-sibleinthisstudy.Thestudyperiodconsistedof2consecutivemonths.Weattemptedtomeasuretheparticipantsx19compliancewithassignedstudytreatmentbycallingthemregularly.ThestudywasthoroughlyconductedinlinewiththeDeclarationofHelsin6i.Theaimandmethodologyofthestudywereexplainedtothepatientsandinformedconsentwasobtained.Blindedstudypersonnelas6edthepatientsabouttheirsymptoms.AdministrationTheingredientsofkBWareasfollowsFructusx0Ligustrix0Lucidi4.13Radixx0Paeoniaex0Lactioraex0wild-craftedform4.13Radixx0Paeoniaex0Lactioraecultivatedform8.25Radixx0Rehmanniae4.13Fructusx0Rubi2.75Radixx0Angelicaex0sinensis2.75Semenx0Cuscutaex0Chinensis2.75Radixx0etx0Caulisx0Jixueteng8.25Lyciix0Fructus2.75Semenx0Zizyphix0Spinosae1.38Radixx0Scutellariaex0Baicalensis4.13Flosx0Chrysanthemix0Morifolii4.13Herbax0Ecliptae5.5Radixx0Adenophonrae4.13Foliumx0Morix0Albae2.75Radixx0Cynanchix0Baiwei4.13Anemarrhenax0Rhizome4.13Radixx0Polygonix0Multiori2.75Herbax0Dendrobii4.13Lyciix0Cortex4.13Collax0Plastrumx0Testudinis2.06Referredtogynecologyclinicandscreenedforinclusioncriterian97Enteredthestudyandrandomizedn72Proposedsamplesizen60CHMgroupn24ReceivedoralKBW5grecommendedwithwarmwatertwiceadayfor2consecutivemonthsACUCHMgroupn24ReceivedoralKBW5grecommendedwithwarmwatertwiceadayfor2consecutivemonths10sessionsofacupuncturewithinthe2monthsofreceivingKBWHTgroupn24ReceivedoralhormonetherapyCE0.625mgd28daysMPA4mgdinthelast12daystotallyfor2monthsorCE0.625mgdayMPA2mgdunremittingtotallyfor2monthsMissedcasesn2Analyzedn22Missedcasesn4Analyzedn20Missedcasesn9Analyzedn15FIGUREStudyDesignAbbreviationsCHMChineseherbalmedicinekBWkunBaoWanACUacupunctureHThormonetherapyCEconjugatedestrogenMPAmedroxyprogesteroneacetate.