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1實證醫學個案討論急診內科何英豪醫師95-10-182Q:一位76歲的男性患有輕度阿茲海默症，但未服用任何藥物。他的兒子帶他來門診就診，想要了解銀杏治療失智症的療效。3PICO◼P:Alzheimer’sdisease◼I:G

ingkobiloba◼C:◼O:Effect4Searchterms&Strategy◼Keyword:Gingko,Alzheimer’sdisease◼Database:PubMed◼Searchstrategy:Gingko:1414A.D.:50043Gingk

oandA.D.:134+English,Chinese,Human,Abstract:67++ClinicalTrial,Meta-analysis,RCT:155OxfordCentreforEBMLevelsofEvide

nce(2001-5)◼1a:SR(withhomogeneity)ofRCTs.◼1b:IndividualRCT(withnarrowconfidenceinterval).◼2a:SR(withhomogeneity)ofcoho

rtstudies◼2b:Individualcohortstudy(lowqualityRCT;<80%follow-up)◼3a:SR(withhomogeneity)ofcase-controlstudies.◼3b:Individualc

ase-controlstudy.◼4:Case-series(poorqualitycohortandcase-controlstudies).◼5:Expertopinionwithoutexplicitcriticalappraisal,orbasedonphy

siology,benchresearchor“firstprinciples”6Ginkgobilobaanddonepezil:acomparisoninthetreatmentofAlzheimer'sdementiainarandomizedplacebo-c

ontrolleddouble-blindstudyEurJNeurol2006Level:Ib☺◼24-weekrandomized,placebo-controlled,double-blindstudy.◼Aged50-80yea

rs,mildtomoderatedementia◼Ginkgobiloba(160mgdailydose),donepezil(5mgdailydose),orplacebogroup.◼Noevidenceofrelevantdiff

erencesintheefficacyofEGb761anddonepezilinthetreatmentofmildtomoderateAlzheimer'sdementia,sotheuseofbothsubstancescanbejustified.7Arand

omized,double-blind,placebo-controlledtrialoftwodosesofGinkgobilobaextractindementiaoftheAlzheimer'stype.CurrAlzheime

r’sRes.2005Level:Ib◼Randomized,placebo-controlled,double-blind,parallel-group,multicentertrial◼513outpatientswithun

complicateddementiaoftheAlzheimer'stypescoring10to24onMMSEandlessthan4onthemodifiedHachinskiIschemicScore.◼26-weektreatme

ntwithGbEatdailydosesof120mgor240mgorplacebo◼ThetrialdidnotshowefficacyofGbE,however,thelackofdeclineof

theplacebopatientsmayhavecompromisedthesensitivityofthetrialtodetectatreatmenteffect.◼Thus,thestudyremainsinconclusivewithrespecttothe

efficacyofGbE.8ThesituationofpatientswithdementiamayberectifiedbyGinkgobiloba.Resultsofahealthservicesresearchstudyconcerningtheabilityofpatien

tswithdementia,qualityoflifeofthenursingfamilymembersandtotaltreatmentcostsMMVFortschrMed2005Level:IIb(?)☺◼Non-randomised,two-armedcohorts

tudywithanopendesign◼683slightlyormoderatelydementedpatients,etween65and80years.◼Quality-of-lifeofcare-takingrelatives(p<0.001)intheGinkgo-cohort

.◼Barthel-IndexintheGinkgo-cohort(p<or=0,001).◼3.614,75eurointhestandard-cohort,3.031,78eurointheGinkgo-cohort(p=0.067).◼Ginkgotreatmenthasa

validplaceincaretakingstructureofhealthservices.◼Gingkoattributestoahigherqualityoflifeforbothcare-takersandpatients,t

heprogressionofdiseaseissloweddownandtreatmentcostsarelower.9Ginkgobilobacomparedwithcholinesteraseinhibitorsinthetreatmentofdementia:arevie

wbasedonmeta-analysesbytheCochranecollaboration.DementGeriatCognDisord2004Level:Ia◼CochraneCollaborationmeta-analysesofginkgo,do

nepezil,rivastigmineandgalantamineinpatientswithdementia.◼6monthsoftreatment◼Trialdataforcholinesteraseinhibitorsweremoreconsistentthanthos

eforginkgo,particularlyregardingpatientpopulationsandoutcomemeasures.◼Significantbenefitsoncognitionvs.placeboweresee

nwithdonepezil,5and10mg,rivastigmine,6-12mg,andgalantamine,16and24mg.◼Significantbenefitvs.placebowithginkgowasseenonlywhenalldosesw

erepooled.Similarproportionsofpatientsdiscontinuedtreatmentwithginkgoandplacebo.◼Cholinesteraseinhibitorswerealsowell

tolerated,althoughasignificantlygreaterproportionofpatientsreceivingactivetreatmentdiscontinuedvs.placebowithsomedo

ses.10GinkgobilobaextractEGb761indementia:intent-to-treatanalysesofa24-week,multi-center,double-blind,pla

cebo-controlled,randomizedtrial.Pharmacopsychiatry2003Level:Ib☺◼GinkgobilobaspecialextractEGb761(240mg/day)inoutpatientswi

thpre-senileandsenileprimarydegenerativedementiaoftheAlzheimertype(DAT)andmulti-infarctdementia(MID)ofmildto

moderateseverity.◼Double-blind,placebo-controlled,randomized,multi-centerstudy◼TheresultsofthisITTanalys

issubstantiatetheoutcomespreviouslyobtainedwitharesponderanalysisoftheper-protocolpopulationandconfirmthatEGb761i

mprovescognitivefunctioninaclinicallyrelevantmannerinpatientssufferingfromdementia.11ResponsepatternsofE

Gb761inAlzheimer'sdisease:influenceofneuropsychologicalprofiles.Pharmacopsychiatry2003Level:Ib☺◼52-week,randomized,double-blind,placebo-co

ntrolledstudywith120mgEGb761basedoncut-offpointsappliedtoAlzheimer'sDisease.◼Retrospectiveanalysisofoverallefficacyindicatedthataquantitativetr

eatmenteffectfavorabletoEGb761couldbeobservedincognitiveperformance(p=0.04)andsocialfunctioning(p=0.02).12

AssociationofAlzheimer'sdiseaseonsetwithginkgobilobaandothersymptomaticcognitivetreatmentsinapopulationofwomenaged75yearsandolderfromtheEPIDOSstudy.

JGerontolABiolSciMedSci.2003Level:Ib☺◼PeripheralC4Atreatment(cerebralandperipheralvasotherapeutics)andespeciallyGinkgobiloba

extractsareprescribedformemoryimpairment,inelderlypatients.◼Case-controlstudyof1462community-dwellingelderlywomenagedover75

years.◼69womenwithAlzheimer-typedementiawerecomparedwith345pairedwomenwhosecognitivefunctionremainednormal.◼7-yearfollo

w-upperiod.◼AmultivariateanalysisshowedthatfewerwomenwhodevelopedAlzheimer'sdementiahadbeenprescribedC4Atreatment(includingEGb761)foratlea

st2years(oddsratio=0.31,95%confidenceinterval=0.12-0.82,p=.018).◼TheseresultssuggestthatC4Atreatmentmayreducetheriskofdevelo

pingAlzheimer'sdementiainelderlywomen.13InfluenceoftheseverityofcognitiveimpairmentontheeffectoftheGnkgobilobaextractEGb761inAlzheimer'sdisea

se.Neuropsychobiology2002Level:Ib☺◼52-week,randomized,double-blind,placebo-controlled,parallel-group,mul

ticenterstudywith120mgofEGb,usingcutoffpointsof23and14forMMSEscore.◼TreatmenteffectfavorabletoEGbcouldbeobservedwithrespecttocognitiveperfo

rmance(p=0.02)andsocialfunctioning(p=0.001)regardlessofthestageofdementia,whethermildormoderatelysevere.◼Improvementin

thegroupofpatientswithverymildtomildcognitiveimpairment.◼Inmoreseveredementia,themeanEGbeffectshouldbeconsidere

dmoreintermsofstabilizationorslowingdownofworsening,ascomparedtothegreaterdeteriorationobservedwithplacebo14CholinesteraseinhibitorsandGin

gkoextracts--aretheycomparableinthetreatmentofdementia?Comparisonofpublishedplacebo-controlledefficacystudiesofat

leastsixmonths'duration.Phytomedicine2000Level:Ia(?)☺◼Theefficacyoffourcholinesteraseinhibitors(tacrine,donepezil,rivastigmine,metrifonate)and

GinkgospecialextractEGb761inAlzheimer'sdiseasewerecompared.◼MeasuredontheADAS-Cogscale◼Efficacyinthedelayofsymptomprogressionort

hedifferenceinresponseratebetweenactivesubstanceandplacebo,showednomajordifferencesbetweenthefourcholinesteraseinhibitorsandtheGinkgospecial

extract.◼Onlytacrineexhibitedahighdropoutrateduetoadversedrugreactions.◼Second-generationcholinesteraseinhibitors(

donepezil,rivastigmine,metrifonate)andGinkgospecialextractEGb761shouldbeconsideredequallyeffectiveinthetreatmentofmildtomoder

ateAlzheimer'sdementia.15Theefficacyofginkgoforelderlypeoplewithdementiaandage-associatedmemoryimpairment:newresultsofaran

domizedclinicaltrial.JAmGeriatSoc2000Level:Ib◼A24-week,randomized,double-blind,placebo-controlled,parallel-group,multicentertrial.◼214older

personswithdementia(eitherAlzheimer'sdementiaorvasculardementia;mildtomoderatedegree)orage-associatedmemoryimpairment.◼EGb761(2tab

letsperday,totaldosageeither240(highdose)or160(usualdose)mg/day)orplacebo(0mg/d).◼Intention-to-treatanalysissho

wednoeffectoneachoftheoutcomemeasuresforparticipantswhowereassignedtoginkgo(n=79)comparedwithplacebo(n=44)fortheentire24-weekperiod.◼Nob

eneficialeffectsofahigherdoseoraprolongeddurationofginkgotreatmentwerefound.◼Ginkgoisnoteffectiveasatreatmentforolderpeoplewithmildtom

oderatedementiaorage-associatedmemoryimpairment.16A26-weekanalysisofadouble-blind,placebo-controlledtrialoftheginkgo

bilobaextractEGb761indementia.DementGeriatrCognDisord2000Level:IIa☺◼ITTanalysis:after26weekstreatment

witha120-mgdose(40mgt.i.d.)ofEGb761(EGb).◼Double-blind,placebo-controlled,fixeddose,parallel-group,multicenterstudy.◼Mildl

ytoseverelyimpairedAlzheimer'sdiseaseormulti-infarctdementia◼From309patients,244patients(76%forplaceboand73%forEGb).◼Placeb

ogroupshowedastatisticallysignificantworseninginalldomainsofassessment◼EGbwasconsideredslightlyimprovedonthe

cognitiveassessmentandthedailylivingandsocialbehavior.◼MeantreatmentdifferencesfavoredEGbwith1.3and0.12points,respectively,ontheADA

S-Cog(p=0.04)andtheGERRI(p=0.007).17Thepharmacologicaleffectsofginkgobiloba,aplantextract,onthebrainofdem

entiapatientsincomparisonwithtacrine.PsychopharmacolBull1998Level:III☺◼EGbortacrine,possibleorprobable

Alzheimer's,open,uncontrolledtrial◼18subjectsanaverageageof67.4yearswithlighttomoderatedementia◼Randomlyasingleoral"Test-Dose"ofeith

er40mgoftacrineor240mgofEGb2intwoseparatesessionswithin3-to7-dayintervals.◼Theresultsalsoshowedthat240mgofEGbhastypicalcognitiveactivatorCEEGprof

iles(responders)inmoresubjects(8of18)than40mgtacrine(3of18subjects).◼Becauseofthesmallsamplesize,wecouldnottestthehypothesisthatsubjectswhoshowedcogn

itiveactivator-typepharmacologicalresponsetothefirstTest-DoseofEGbortacrinealsoexhibitmoretherapeuticeffects(comparedtononresp

onders)whendrugsareadministeredchronically.18ClinicalefficacyofGinkgobilobaspecialextractEGb761indementiaofth

eAlzheimertype.JPsychiatrRes1997Level:Ib☺◼240mg/dayofGinkgobilabospecialextractEGb761◼Double-blind,randomized,placebo-controlledin20out

patients,3months◼Psychometricconfirmationofefficacy(SKTtest)◼Psychopathological(ClinicalGlobalImpression)anddynamicfunction

al(EEGfindings)levels◼EvidenceofeffectivenessofGinkgobilobaspecialextractEGb761inmildtomoderatedementiaandoflocaleffectsint

hecentralnervoussystem.19Aplacebo-controlled,double-blind,randomizedtrialofanextractofGinkgobilobafordementia.NorthAmericanEGbStudyGroup.

JAMA1997Level:Ib☺◼A52-week,randomizeddouble-blind,placebo-controlled,parallel-group,multicenterstudy.◼MildlytoseverelydementedoutpatientswithAlzhei

merdiseaseormulti-infarctdementia◼EGb(120mg/d)orplacebo.◼ADAS-Cog,GERRI,andCGIC.◼202/309patientsincludedinanintent-to-treatanalysis◼EGbgroup

hadanADAS-Cogscore1.4pointsbetterthantheplacebogroup(P=.04)andaGERRIscore0.14pointsbetterthantheplacebogrou

p(P=.004).◼EGbwassafeandappearscapableofstabilizingandinasubstantialnumberofcases,improvingthecognitiveperformanceandthesocialfunctioningofdemente

dpatientsfor6monthsto1year.20ProofofefficacyoftheginkgobilobaspecialextractEGb761inoutpatientssufferingfrommildtomoderateprimarydeg

enerativedementiaoftheAlzheimertypeormulti-infarctdementia.Pharmacopsychiatry1996Level:IIa☺◼GinkgobilobaspecialextractEGb761inoutp

atientswithdementiaoftheAlzheimertype(DAT)andmulti-infarctdementia(MID)◼Prospective,randomized,double-blind,placebo-co

ntrolled,multi-centerstudy.◼156/216patientsintherandomized24-weektreatment◼Dailyoraldoseof240mgEGb761orplacebo.◼CGI,S

KT,andNAB◼ThefrequencyoftherapyrespondersinthetwotreatmentgroupsdifferedsignificantlyinfavorofEGb761(p<0

.005).◼TheclinicalefficacyoftheginkgobilobaspecialextractEGb761indementiaoftheAlzheimertypeandmulti-infarctdementiawasconfirmed.21Theef

ficacyofGinkgobilobaoncognitivefunctioninAlzheimerdisease.ArchNeurol1998Level:Ia☺◼Meta-analysis,>50articles

identified,Only4studies◼AD,ginkgoextract,randomizedplacebo-controlledanddouble-blindstudy◼212subjectsineachoftheplaceboandgin

kgotreatmentgroups.◼Overalltherewasasignificanteffectsizeof0.40(P<.0001).◼Thismodesteffectsizetranslatedintoa3%differenceintheADAS-Cog.◼

Thereisasmallbutsignificanteffectof3-to6-monthtreatmentwith120to240mgofG.bilobaextractonobjectivemeasuresofcognitivefunc

tioninAD.◼2casereportsofbleedingcomplications.