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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:Gingkobiloba◼C:◼O:Effect4Searchter

ms&Strategy◼Keyword:Gingko,Alzheimer’sdisease◼Database:PubMed◼Searchstrategy:Gingko:1414A.D.:50043GingkoandA.D.:1

34+English,Chinese,Human,Abstract:67++ClinicalTrial,Meta-analysis,RCT:155OxfordCentreforEBMLevelsofEvidence(2001-5)◼1a:SR(withho

mogeneity)ofRCTs.◼1b:IndividualRCT(withnarrowconfidenceinterval).◼2a:SR(withhomogeneity)ofcohortstudi

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

b:Individualcase-controlstudy.◼4:Case-series(poorqualitycohortandcase-controlstudies).◼5:Expertopinionwithoute

xplicitcriticalappraisal,orbasedonphysiology,benchresearchor“firstprinciples”6Ginkgobilobaanddonepezil:acomparisoninth

etreatmentofAlzheimer'sdementiainarandomizedplacebo-controlleddouble-blindstudyEurJNeurol2006Level:Ib☺◼24-we

ekrandomized,placebo-controlled,double-blindstudy.◼Aged50-80years,mildtomoderatedementia◼Ginkgobiloba(160mgdailydose),donepezil(5mgdailydose),o

rplacebogroup.◼NoevidenceofrelevantdifferencesintheefficacyofEGb761anddonepezilinthetreatmentofmildtomoderateAlzheimer'sdementia,sotheuseofboths

ubstancescanbejustified.7Arandomized,double-blind,placebo-controlledtrialoftwodosesofGinkgobilobaextractindementiaoftheAlzheimer'stype.Cur

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

eAlzheimer'stypescoring10to24onMMSEandlessthan4onthemodifiedHachinskiIschemicScore.◼26-weektreatmentwithGbE

atdailydosesof120mgor240mgorplacebo◼ThetrialdidnotshowefficacyofGbE,however,thelackofdeclineoftheplacebopa

tientsmayhavecompromisedthesensitivityofthetrialtodetectatreatmenteffect.◼Thus,thestudyremainsinconclusivewithrespecttotheeffi

cacyofGbE.8ThesituationofpatientswithdementiamayberectifiedbyGinkgobiloba.Resultsofahealthservicesresearchs

tudyconcerningtheabilityofpatientswithdementia,qualityoflifeofthenursingfamilymembersandtotaltreatmentcostsMMVF

ortschrMed2005Level:IIb(?)☺◼Non-randomised,two-armedcohortstudywithanopendesign◼683slightlyormoderatelydementedpatien

ts,etween65and80years.◼Quality-of-lifeofcare-takingrelatives(p<0.001)intheGinkgo-cohort.◼Barthel-Indexi

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

otreatmenthasavalidplaceincaretakingstructureofhealthservices.◼Gingkoattributestoahigherqualityoflifeforbothcare-t

akersandpatients,theprogressionofdiseaseissloweddownandtreatmentcostsarelower.9Ginkgobilobacomparedwithcholinesteraseinhibitorsinthetre

atmentofdementia:areviewbasedonmeta-analysesbytheCochranecollaboration.DementGeriatCognDisord2004Level:

Ia◼CochraneCollaborationmeta-analysesofginkgo,donepezil,rivastigmineandgalantamineinpatientswithdementia.◼6monthsoftreatment◼Trialdataforc

holinesteraseinhibitorsweremoreconsistentthanthoseforginkgo,particularlyregardingpatientpopulationsandoutcomemeasures.◼Significantbenefitsoncogni

tionvs.placebowereseenwithdonepezil,5and10mg,rivastigmine,6-12mg,andgalantamine,16and24mg.◼Significantbenefitvs.placebowithginkgowas

seenonlywhenalldoseswerepooled.Similarproportionsofpatientsdiscontinuedtreatmentwithginkgoandplacebo.◼Cholinesteraseinhibitorswerealsowel

ltolerated,althoughasignificantlygreaterproportionofpatientsreceivingactivetreatmentdiscontinuedvs.placebowithsomedoses.10Ginkgo

bilobaextractEGb761indementia:intent-to-treatanalysesofa24-week,multi-center,double-blind,placebo-controlled,randomizedtrial.Ph

armacopsychiatry2003Level:Ib☺◼GinkgobilobaspecialextractEGb761(240mg/day)inoutpatientswithpre-senileandsenilep

rimarydegenerativedementiaoftheAlzheimertype(DAT)andmulti-infarctdementia(MID)ofmildtomoderateseverity.◼Double-

blind,placebo-controlled,randomized,multi-centerstudy◼TheresultsofthisITTanalysissubstantiatetheoutcomespreviouslyobtainedwitharespondera

nalysisoftheper-protocolpopulationandconfirmthatEGb761improvescognitivefunctioninaclinicallyrelevantmannerinpatientssuffer

ingfromdementia.11ResponsepatternsofEGb761inAlzheimer'sdisease:influenceofneuropsychologicalprofiles.Pharmacopsychi

atry2003Level:Ib☺◼52-week,randomized,double-blind,placebo-controlledstudywith120mgEGb761basedoncut-offpointsappliedtoAlzheimer'sDisease.◼Retrospecti

veanalysisofoverallefficacyindicatedthataquantitativetreatmenteffectfavorabletoEGb761couldbeobservedincognitiveperformance(p=0.04)andsocialfunctionin

g(p=0.02).12AssociationofAlzheimer'sdiseaseonsetwithginkgobilobaandothersymptomaticcognitivetreatmentsinapopulation

ofwomenaged75yearsandolderfromtheEPIDOSstudy.JGerontolABiolSciMedSci.2003Level:Ib☺◼PeripheralC4Atreatment(cerebralandp

eripheralvasotherapeutics)andespeciallyGinkgobilobaextractsareprescribedformemoryimpairment,inelderlypatients.◼Case-

controlstudyof1462community-dwellingelderlywomenagedover75years.◼69womenwithAlzheimer-typedementiawerecomparedwith3

45pairedwomenwhosecognitivefunctionremainednormal.◼7-yearfollow-upperiod.◼AmultivariateanalysisshowedthatfewerwomenwhodevelopedAlzheimer'sdementiah

adbeenprescribedC4Atreatment(includingEGb761)foratleast2years(oddsratio=0.31,95%confidenceinterval=0.12-0.82,p=.018).◼Theseresu

ltssuggestthatC4AtreatmentmayreducetheriskofdevelopingAlzheimer'sdementiainelderlywomen.13Influenceoftheseverityofcogn

itiveimpairmentontheeffectoftheGnkgobilobaextractEGb761inAlzheimer'sdisease.Neuropsychobiology2002Level:Ib☺◼52-week,randomized,double-blind,plac

ebo-controlled,parallel-group,multicenterstudywith120mgofEGb,usingcutoffpointsof23and14forMMSEscore.◼TreatmenteffectfavorabletoEG

bcouldbeobservedwithrespecttocognitiveperformance(p=0.02)andsocialfunctioning(p=0.001)regardlessofthestageofdementia,whethermildormoderatel

ysevere.◼Improvementinthegroupofpatientswithverymildtomildcognitiveimpairment.◼Inmoreseveredementia,themeanEGbeffectshou

ldbeconsideredmoreintermsofstabilizationorslowingdownofworsening,ascomparedtothegreaterdeteriorationobser

vedwithplacebo14CholinesteraseinhibitorsandGingkoextracts--aretheycomparableinthetreatmentofdementia?Comparisonofpublishedplacebo-c

ontrolledefficacystudiesofatleastsixmonths'duration.Phytomedicine2000Level:Ia(?)☺◼Theefficacyoffourcholinesteraseinhibitors(

tacrine,donepezil,rivastigmine,metrifonate)andGinkgospecialextractEGb761inAlzheimer'sdiseasewerecompared.◼Measuredonthe

ADAS-Cogscale◼Efficacyinthedelayofsymptomprogressionorthedifferenceinresponseratebetweenactivesubsta

nceandplacebo,showednomajordifferencesbetweenthefourcholinesteraseinhibitorsandtheGinkgospecialextract

.◼Onlytacrineexhibitedahighdropoutrateduetoadversedrugreactions.◼Second-generationcholinesteraseinhibitors(donepezil,rivastigmine,metrifon

ate)andGinkgospecialextractEGb761shouldbeconsideredequallyeffectiveinthetreatmentofmildtomoderateAlzheimer'sdementia.15Theefficacyofginkgof

orelderlypeoplewithdementiaandage-associatedmemoryimpairment:newresultsofarandomizedclinicaltrial.JAmGeriatSoc2000Level:Ib◼A24-week,randomized,doub

le-blind,placebo-controlled,parallel-group,multicentertrial.◼214olderpersonswithdementia(eitherAlzheimer'sdementiaorvasculardem

entia;mildtomoderatedegree)orage-associatedmemoryimpairment.◼EGb761(2tabletsperday,totaldosageeither240(high

dose)or160(usualdose)mg/day)orplacebo(0mg/d).◼Intention-to-treatanalysisshowednoeffectoneachoftheoutcomemea

suresforparticipantswhowereassignedtoginkgo(n=79)comparedwithplacebo(n=44)fortheentire24-weekperiod.◼Nobeneficialeffectsofahigherdo

seoraprolongeddurationofginkgotreatmentwerefound.◼Ginkgoisnoteffectiveasatreatmentforolderpeoplewithmildtomoderatedementiaorage-associatedmemory

impairment.16A26-weekanalysisofadouble-blind,placebo-controlledtrialoftheginkgobilobaextractEGb761indementia.DementGeriatrCognDisord2000Level

:IIa☺◼ITTanalysis:after26weekstreatmentwitha120-mgdose(40mgt.i.d.)ofEGb761(EGb).◼Double-blind,placebo-controlle

d,fixeddose,parallel-group,multicenterstudy.◼MildlytoseverelyimpairedAlzheimer'sdiseaseormulti-infarctdementia◼From309patient

s,244patients(76%forplaceboand73%forEGb).◼Placebogroupshowedastatisticallysignificantworseninginalldomainsofassessment◼EGbwasconsideredsli

ghtlyimprovedonthecognitiveassessmentandthedailylivingandsocialbehavior.◼MeantreatmentdifferencesfavoredEGbwith1.3and0.12points,r

espectively,ontheADAS-Cog(p=0.04)andtheGERRI(p=0.007).17Thepharmacologicaleffectsofginkgobiloba,aplantextract,onthebrainofdementiapatient

sincomparisonwithtacrine.PsychopharmacolBull1998Level:III☺◼EGbortacrine,possibleorprobableAlzheimer's,

open,uncontrolledtrial◼18subjectsanaverageageof67.4yearswithlighttomoderatedementia◼Randomlyasingleoral"Test-Dose"ofeither40mgoftacrineor

240mgofEGb2intwoseparatesessionswithin3-to7-dayintervals.◼Theresultsalsoshowedthat240mgofEGbhastypicalcognitiveactivatorCEEGprofiles(respon

ders)inmoresubjects(8of18)than40mgtacrine(3of18subjects).◼Becauseofthesmallsamplesize,wecouldnottestthehypothesisthatsubjectswhoshowed

cognitiveactivator-typepharmacologicalresponsetothefirstTest-DoseofEGbortacrinealsoexhibitmoretherape

uticeffects(comparedtononresponders)whendrugsareadministeredchronically.18ClinicalefficacyofGinkgobilobaspecialextractEGb761indementiaoft

heAlzheimertype.JPsychiatrRes1997Level:Ib☺◼240mg/dayofGinkgobilabospecialextractEGb761◼Double-blind,rando

mized,placebo-controlledin20outpatients,3months◼Psychometricconfirmationofefficacy(SKTtest)◼Psychopathological(Clinical

GlobalImpression)anddynamicfunctional(EEGfindings)levels◼EvidenceofeffectivenessofGinkgobilobaspecialextractEGb761inmildt

omoderatedementiaandoflocaleffectsinthecentralnervoussystem.19Aplacebo-controlled,double-blind,randomizedtrial

ofanextractofGinkgobilobafordementia.NorthAmericanEGbStudyGroup.JAMA1997Level:Ib☺◼A52-week,randomizeddouble-blind,placebo-c

ontrolled,parallel-group,multicenterstudy.◼MildlytoseverelydementedoutpatientswithAlzheimerdiseaseormulti-infarc

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

score1.4pointsbetterthantheplacebogroup(P=.04)andaGERRIscore0.14pointsbetterthantheplacebogroup(P=.004).◼EGbwassafe

andappearscapableofstabilizingandinasubstantialnumberofcases,improvingthecognitiveperformanceandthesocialfunctio

ningofdementedpatientsfor6monthsto1year.20ProofofefficacyoftheginkgobilobaspecialextractEGb761inoutpatientssufferingfrommildtomoderateprimarydege

nerativedementiaoftheAlzheimertypeormulti-infarctdementia.Pharmacopsychiatry1996Level:IIa☺◼GinkgobilobaspecialextractEGb

761inoutpatientswithdementiaoftheAlzheimertype(DAT)andmulti-infarctdementia(MID)◼Prospective,randomized,double

-blind,placebo-controlled,multi-centerstudy.◼156/216patientsintherandomized24-weektreatment◼Dailyoraldoseof240mgEGb761orplacebo.◼CGI,SKT,andNAB◼Thef

requencyoftherapyrespondersinthetwotreatmentgroupsdifferedsignificantlyinfavorofEGb761(p<0.005).◼Theclinicalefficacyofthe

ginkgobilobaspecialextractEGb761indementiaoftheAlzheimertypeandmulti-infarctdementiawasconfirmed.21TheefficacyofGinkgobilobaoncognitive

functioninAlzheimerdisease.ArchNeurol1998Level:Ia☺◼Meta-analysis,>50articlesidentified,Only4studies◼AD,ginkgoextract,randomizedplacebo-con

trolledanddouble-blindstudy◼212subjectsineachoftheplaceboandginkgotreatmentgroups.◼Overalltherewasasign

ificanteffectsizeof0.40(P<.0001).◼Thismodesteffectsizetranslatedintoa3%differenceintheADAS-Cog.◼Thereisasmallbutsignificanteffectof3-to6

-monthtreatmentwith120to240mgofG.bilobaextractonobjectivemeasuresofcognitivefunctioninAD.◼2casereportsofbl

eedingcomplications.