002 Hypnosedatives for Anxiety Insomnia Muscle Spasm
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Transcript of 002 Hypnosedatives for Anxiety Insomnia Muscle Spasm
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ReportNo:0610002R3
TransportAccidentCommission&WorkSafeVictoriaEvidenceService
Hypnosedativesforanxiety,insomniaandmusclespasmEvidenceMapMay2010EmmaDonoghue,DrissAitOuakrim
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EXECUTIVESUMMARYTheaimofthisworkistoprovideanevidencemapoftheexistinghighlevelstudies(systematicreviewsandevidencebasedguidelines)onthebenefitsandharmsofhypnosedativesforanxiety, insomniaandmusclespasm.Thedrugsincludedunderthetitleofhypnosedativeswere: benzodiazepines:alprazolam,bromazepam,clobazam,diazepam,flunitrazepam,lorazepam,midazolam,
nitrazepam,oxazepam,temazepam,triazolam nonbenzodiazpinehypnotics:zolpidem,zopiclone
Searches ofMedline and Embase, and the internet yielded 1,943 potentially relevant studies. Screeningagainstinclusionandexclusioncriteriaresultedinatotalof41relevantstudies(34systematicreviews[SRs]and7evidencebasedguidelines[EBGs]).Thenumbersofstudiesidentifiedforeachindicationwereasfollows:Anxiety: 18SRs,5EBGsInsomnia: 17SRs,2EBGsMuscleSpasm:1SR,0EBGsOneSRwasabouttheuseofhypnosedativesforallthreeindications.AllotherEBGsandSRswereaboutoneindicationonly.
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BACKGROUNDSedativesareaclassofpsychoactivedrugscommonlyprescribedastreatmentforsleepdisorders,anxietyandavarietyof relatedconditions. Inorder todevelopandupdatepolicies for theiruse inpatientswiththeseconditions, theHealthServicesGroupof theTransportAccidentCommissionandWorkSafeVictoria(TAC/WSV)requestedamapoftheavailablehigh levelevidenceexamining thebenefitsandharmsoftheuseofsedativesinanxiety,insomniaandmusclespasm.The term hypnosedatives refers to benzodiazepines, benzodiazepine derivatives, and a group of nonbenzodiazepinehypnoticdrugs(referredtoasZdrugs),thatincludeszolpidemandzopiclone.Benzodiazepines have been widely used in clinical practice since their introduction in the 1950s andcontinue tobeoneof themost consumed andhighlyprescribed classofdrugs available. Their rangeofactionsedative/hypnotic,anxiolytic,anticonvulsantandmusclerelaxantcombinedwithlowtoxicityandcostgainedthempopularityamongphysiciansandpatients.(1)The Zdrugsarehypnoticswith similarpharmacology tobenzodiazepines.Theyhavebeenpromotedasbeing safer than benzodiazepines and inmany countries they are themostwidely prescribed drugs forinsomnia.(2)Sincetheearly1980sstudieshaveregularlypointedouttherisksandadverseeffectsrelatedto longtermuseofbenzodiazepinesandotherhypnotics.(3)Theaimofthiswork istoprovideanevidencemapoftheexistinghighlevelstudies(systematicreviewsandevidencebasedguidelines)onthebenefitsandharmsofhypnosedativesforanxiety,insomniaandmusclespasm.
THEQUESTIONTheresearchquestionsinitiallyposedwere: Inwhatconditionsaresedatives(benzodiazepineandnonbenzodiazepine)indicated? Whatistheeffectivenessofsedativesintheseconditions? Whatistheeffectofsedativesonfunction,qualityoflife,returntowork,othermedicationuse? Inwhatconditions/patienttypesshouldsedativesnotbeused,usedshorttermonlyorusedwith
caution? Whatrisksareassociatedwiththeuseofsedatives?
There isnowelldefined,universallyaccepteddefinitionofwhatasedative is,noradefinitive listofdrugsthatareconsideredsedatives.Drugsthatpeoplemightrefertoassedativescanfallundermanydifferentdrugclassessuchassedatives,hypnotics,antianxietyagents,orcomplementarymedicines,dependingontheorganizationclassifyingthedrugs.Suchabroadlistofdrugs,combinedwithopenscopeonconditionsforwhichtheyareindicatedmeantthattheresearchquestionsinitiallyposedwouldbeunfeasible.Afterfurtherdiscussion,thescopeofthequestionwasnarrowedfromsedativestohypnosedatives,whichcomprisesbenzodiazepinesandselectednonbenzodiazepinehypnoticagents.Thedrugschosenwere the
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benzodiazepines listed in MIMS as either antianxiety agents or sedatives, hypnotics, and two nonbenzodiazepinehypnotics:zolpidemandzopiclone(seeTable1).Thequestionwasfurtherrefinedtoincludethreespecificindications: Whatistheeffectivenessofhypnosedativesinanxiety? Whatistheeffectivenessofhypnosedativesininsomnia? Whatistheeffectivenessofhypnosedativesinmusclespasm? Whataretherisksassociatedwithhypnosedativeuseintheseconditions?Table1.ListofincludedhypnosedativesBenzodiazepines NonbenzodiazepineHypnoticsAlprazolamBromazepamClobazamDiazepamFlunitrazepamLorazepamMidazolamNitrazepamOxazepamTemazepamTriazolam
ZolpidemZopiclone
METHODSTheSearchSearches of Medline and Embase, and the internet were conducted to identify systematic reviews andevidencebasedclinicalpracticeguidelines(seeAppendix1forfurtherdetail).InclusionandexclusioncriteriaSearchresultswerescreenedbytworeviewersaccordingtopredetermined inclusionandexclusioncriteria(seeAppendix1).Forastudytobe included,at leastoneofthehypnosedativeshadtobespecified inthesearchstrategytoensurethatallreferencesaboutthatdrugweresought.Wherean includeddrugwasnotthe focusofthestudy,butresultsofthedrugasacomparatorwerereported,thestudywasexcluded.DataextractionForincludedstudies,thefollowingdatawasextracted Studytype(systematicrevieworevidencebasedguideline) Hypnosedativesexamined Indication Whetherthestudywasaboutbenefits,harmsorboth
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The extracted data was tabulated in evidence maps to allow determination of the volume of existingevidence,andidentifythegaps.
RESULTSThesearchreturned1,943results.Afterscreening,atotalof41relevantreferenceswereidentified,whichincluded34SystematicReviews(SRs)and7evidencebasedguidelines(EBGs)(seeFigure1).Figure1.screeningofsearchresultsforinclusion
Studiesidentified 1,943
Titlesand/orabstractsreviewed 1,670 Excluded
Fulltextretrieved 273 Fulltextreviewed 232 Excluded
TOTALINCLUDED 41 TOTALEXCLUDED 1,902
TotalSR 34 TotalEBG 7
Therewere18SRsand5EBGsonhypnosedativesforanxiety;17SRsand2EBGsforinsomnia;and1SRformusclespasm.TherewerenoEBGsonhypnosedativesformusclespasm(Table2).Oneofthestudieswasasystematic reviewofhypnosedatives forall three indications.Allotherguidelinesand systematic reviewswereaboutoneindicationonly.Table2.EvidencemapforeachindicationIndication SystematicReviews EvidenceBasedGuidelines
Anxiety 18 5Insomnia 17 2
Musclespasm 1 0
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ThenumberofSRsandEBGsforeachdrugbyindicationarepresentedinTable3andmoredetailedinformationisincludedinTables48.AreferencelistofincludedstudiesispresentedinAppendix2.Table3.Evidencemapforeachdrugbyindication
ANXIETY INSOMNIA MUSCLESPASM TOTAL*DRUG SR EBG SR EBG SR EBG SR EBG
Benzodiazepines** 14 5 10 1 1 0 23 6
Alprazolam 16 2 2 0 1 0 17 2
Bromazepam 10 1 0 0 0 0 10 1
Clobazam 4 0 0 0 0 0 4 0
Diazepam 11 2 5 1 1 0 15 3
Flunitrazepam 2 0 5 0 0 0 7 0
Lorazepam 8 2 5 0 0 0 13 2
Midazolam 2 0 4 0 0 0 6 0
Nitrazepam 2 0 7 1 0 0 9 1
Oxazepam 4 0 2 0 0 0 6 0
Temazepam 2 0 11 2 0 0 13 2
Triazolam 4 0 10 1 1 0 13 1
Zolpidem 0 0 14 2 0 0 14 2
Zopiclone 1 0 8 1 0 0 9 1*totalreferstothetotalnumberofSRsorEBGsforeachdrug,thisfiguremaydifferfromthesumoftherow,asoneSRwasrelevanttoallthreeindications.**papersthatreportedresultsormaderecommendationsaboutbenzodiazepinesasagroup
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Table4.Includedsystematicreviewsofhypnosedativesforanxiety
STUDYBlanco2003p427
Blanco2003p29
Busto1998
Cox1992p175
Cox1992p300
Furukawa2001
Gould1997
Hidalgo2007
Inada2003
Ipser2006
Ipser2008
Kaplan2005
Mahe2000
Martin2007
Mitte2005
Robinson2007
Watanabe2009
Wetherell2005
INDICATIONS SAD SAD
anxiety,insomnia,'musclerelaxant' PDA
PDA,OCD,GAD
anxietyassociatedwithmajordepression GAD GAD anxiety
treatmentresistantanxietydisorders SAD
anxietydisorders GAD GAD GAD SAD
panicdisorder
geriatricanxietydisorders
OUTCOMES B&H B H B B B&H B B B B&HB&H B&H B B B B&H B&H B
BENZODIAZEPINESBenzodiazepines* X X X X X X X X X X X X X XAlprazolam X X X X X X X X X X X X X X X XBromazepam X X X X X X X X X XClobazam X X X XDiazepam X X X X X X X X X X XFlunitrazepam X XLorazepam X X X X X X X XMidazolam X XNitrazepam X XOxazepam X X X XTemazepam X XTriazolam X X X XOtherBenzos** X X X X X X X X X X X XNONBENZODIAZEPINEHYPNOTICSZolpidem Zopiclone X Other*** X X
*papersthatreferredtobenzodiazepinesasagroup**Otherbenzodiazepinesincludedinsomeofthesesystematicreviewswere:adinazolam,bentazepam,camazepam,chlordiazepoxide,clonazepam,clorazepate,clotiazepam,cloxazolam,estazolam,flurazepam,flutoprazepam,halazepam,ketazolam,loflazepate,lormetazepam,medazepam,metaclazepam,mexazolam,nordazepam,prazepam,propazepam,quazepam,tofisopam***Theothernonbenzodiazepinehypnoticsincludedinsomeofthesesystematicreviewswas:alpidem
KEY:INDICATIONSGAD:generalizedanxietydisorderOCD:obsessivecompulsivedisorderPDA:panicdisorderwithagoraphobiaSAD:socialanxietydisorder
OUTCOMESB:benefitsH:harmsB&H:bothbenefitsandharms
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Table5.IncludedevidencebasedguidelinesofhypnosedativesforanxietySOURCE AACAP2007 Andrews2003
MotorAccidentAuthorityofNSW2003
NICE 2004Author:McIntosh2004
GACendorsedguidelinesAuthor:Swinson2006
TITLE
PracticeParameterfortheAssessmentandTreatmentofChildrenandAdolescentsWithAnxietyDisorders
AustralianandNewZealandclinicalpracticeguidelinesforthetreatmentofPanicdisorderandagoraphobia
Anxietyfollowingmotorvehicleaccidents.AGuidelines&technicalreport
ClinicalGuidelinesfortheManagementofanxiety(panicdisorder,withorwithoutagoraphobia,andgeneralisedanxietydisorder) ManagementofAnxietyDisorders
OUTCOMES Benefits&Harms Benefits&Harms Benefits&Harms Benefits&Harms Benefits&HarmsBENZODIAZEPINESBenzodiazepines* X X X X XAlprazolam X XBromazepam XClobazam Diazepam X XFlunitrazepam Lorazepam X XMidazolam Nitrazepam Oxazepam Temazepam Triazolam OtherBenzos** X XNONBENZODIAZEPINEHYPNOTICSZolpidemZopiclone
*papersthatreferredtobenzodiazepinesasagroup**Otherbenzodiazepinesincludedinsomeofthesesystematicreviewswere:adinazolam,andclonazepam
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Table6.Includedsystematicreviewsofhypnosedativesforinsomnia
STUDYBain2006
Buscemi2007
Busto1998
Dundar2004
Glass2005
Grad1995
Hajak2003
Holbrook2000
Holm2000
Joya2009
Krystal2007
Nowell1997
Smith2002
Soldatos1999
SwainstonHarrison2005
VanLiempt2006
Verster2006
INDICATIONSchronicinsom
chronicinsom
anxiety,insom,musclespasm insom insom insom insom insom insom insom insom
chronic,primaryinsom insom insom insom
disordedsleepinPTSD insom
OUTCOMES B&H B&H H B&H B&H B&H H B&H B&H H B B B H B&H B HBENZODIAZEPINESBenzodiazepines* X X X X X X X X X XAlprazolam X XBromazepamClobazamDiazepam X X X X XFlunitrazepam X X X X XLorazepam X X X X XMidazolam X X X XNitrazepam X X X X X X XOxazepam X XTemazepam X X X X X X X X X X XTriazolam X X X X X X X X X XOtherBenzos** X X X X X X X X X X X X XNONBENZODIAZEPINEHYPNOTICSZolpidem X X X X X X X X X X X X X XZopiclone X X X X X X X XOther*** X X X X X X
*papersthatreferredtobenzodiazepinesasagroup**Otherbenzodiazepinesincludedinsomeofthesesystematicreviewswere:chlordiazepoxide,clonazepam,estazolam,flurazepam,loprazolam,lormetazepam,quazepam***Othernonbenzodiazepinehypnoticsincludedinsomeofthesesystematicreviewswere:Eszopiclone,zaleplon
KEY:INDICATIONSInsom:insomniaPTSD:posttraumaticstressdisorder
OUTCOMESB:benefitsH:harmsB&H:bothbenefitsandharms
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Table7.IncludedevidencebasedguidelinesofhypnosedativesforinsomniaSOURCE Bloom2009 NICE2004
TITLEEvidenceBasedRecommendationsfortheAssessmentandManagementofSleepdisordersinolderpersons
Guidanceontheuseofzaleplon,zolpidemandzopliconefortheshorttermmanagementofinsomnia.London:NationalInstituteforClinicalExcellence
OUTCOMES Benefits&Harms Benefits&HarmsBENZODIAZEPINESBenzodiazepines* XAlprazolam Bromazepam Clobazam Diazepam XFlunitrazepam Lorazepam Midazolam Nitrazepam XOxazepam Temazepam X XTriazolam X OtherBenzos** X XNONBENZODIAZEPINEHYPNOTICSZolpidem X XZopiclone XOther*** X X
*papersthatreferredtobenzodiazepinesasagroup**Otherbenzodiazepinesincludedinsomeofthesesystematicreviewswere:estazolam,flurazepam,lormetazepam,quazepam***Theothernonbenzodiazepinehypnoticincludedinoneguidelinewas:zaleplon
KEY:INDICATIONSInsom:insomniaPTSD:posttraumaticstressdisorder
OUTCOMESB:benefitsH:harmsB&H:bothbenefitsandharms
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Table8.IncludedsystematicreviewsofhypnosedativesformusclespasmSTUDY Busto1998
INDICATIONS anxiety,insomnia,musclespasmOUTCOMES HarmsBENZODIAZEPINESBenzodiazepines* XAlprazolam XBromazepamClobazamDiazepam XFlunitrazepamLorazepamMidazolamNitrazepamOxazepamTemazepamTriazolam XNONBENZODIAZEPINEHYPNOTICSZolpidemZopiclone
*papersthatreferredtobenzodiazepinesasagroup
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DISCUSSIONThebenzodiazepineslistedintheresearchquestionarethoselicensedforuseinAustraliaandlistedinMIMsas either antianxiety agents or sedatives, hypnotics. Many studies identified included various otherbenzodiazepines.StudiesfromtheUKorUSoften includedonlythosebenzodiazepines licensedforuse inthat country. This should be kept in mind when looking at recommendations or reported results ofbenzodiazepines,asthelistofdrugsthatdifferentauthorsarereferringtoarenotlikelytobethesame.TheSRsidentifiedgenerallyfocusedonthedrug/sinquestionforaparticularindication,whereastheEBGsfocused on the indication as a whole, including other material such as diagnosis, prevention and nonpharmacologicalmanagement.Noqualityappraisalhasbeendoneonanyoftheincludedstudies.
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DISCLAIMERThe information in this report is a summaryof that availableand isprimarilydesigned to give readers astartingpointtoconsidercurrentlyavailableresearchevidence.Whilstappreciablecarehasbeentaken inthepreparationofthematerialsincludedinthispublication,theauthorsandtheNationalTraumaResearchInstitutedonotwarranttheaccuracyofthisdocumentanddenyanyrepresentation,impliedorexpressed,concerningtheefficacy,appropriatenessorsuitabilityofanytreatmentorproduct.InviewofthepossibilityofhumanerrororadvancesofmedicalknowledgetheauthorsandtheNationalTraumaResearchInstitutecannot anddonotwarrant that the information contained in thesepages is in every aspect accurateorcomplete.Accordingly,theyarenotandwillnotbeheldresponsibleorliableforanyerrorsoromissionsthatmaybefoundinthispublication.Youarethereforeencouragedtoconsultothersourcesinordertoconfirmthe informationcontained inthispublicationand, intheeventthatmedicaltreatment isrequired,totakeprofessionalexpertadvicefromalegallyqualifiedandappropriatelyexperiencedmedicalpractitioner.
CONFLICTOFINTERESTTheTAC/WSVEvidenceService isprovidedby theNationalTraumaResearch Institute.TheNTRIdoesnotacceptfundingfrompharmaceuticalorbiotechnologycompaniesorothercommercialentitieswithpotentialvestedinterestintheoutcomesofsystematicreviews.The TAC/WSV Health Services Group has engaged the NTRI for their objectivity and independence andrecognise thatanymaterialsdevelopedmustbe freeof influence frompartieswithvested interests.TheEvidenceServicehasfulleditorialcontrol.
REFERENCES1. AshtonH.Thediagnosisandmanagementofbenzodiazepinedependence.CurrentOpinioninPsychiatry.2005May;18(3):24955.2. OlsonLG.Hypnotichazards:adverseeffectsofzolpidemandotherzdrugs.AustralianPrescriber.2008;31(6):1469.3. TyrerP,MurphyS.Theplaceofbenzodiazepinesinpsychiatricpractice.BrJPsychiatry.1987Dec;151:71923.4. LiberatiA,AltmanDG,TetzlaffJ,MulrowC,GtzscheP,IoannidisJPA.andthePRISMAGroup.ThePRISMAstatementforreportingsystematicreviewsandmetaanalysesofstudiesthatevaluatehealthcareinterventions:Explanationandelaboration.PLoSMed.2009;6:e1000100.
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5. TheAGREECollaboration.TheAGREEInstrument.2010[updated2010;citedMarch2010];Availablefrom:www.agreecollaboration.org.
APPENDIX1:METHODSTAC/WSVstaffassistedinthedevelopmentofsearchtermsandinclusionexclusioncriteria.InclusionandexclusioncriteriaInclusionandexclusioncriteriawereestablishedapriori(TableA1.1)andwereappliedbytworeviewers.Anydiscrepancieswerediscussedandresolved.TableA1.1.InclusionandexclusioncriteriaPatient/population
Inclusion:patientswith: Anxiety(includinganxietydisorders) Insomnia,or MusclespasmAllagesExclusion:Conditionsoccurringinthecontextofcancer,StiffManSyndrome,Athetosis,Alcoholwithdrawal,Tetanus,Statusepilepticus,Allergytreatment(urticaria,pruritis),Spasticityduetouppermotorneuronlesion,Migraine,Dementia,Bipolardisorder,Schizophrenia,Psychosis,Neurodegenerativedisorders,Delirium,Borderlinepersonalitydisorder,Dyspnoea,Detoxificationorwithdrawalfrombenzodiazepineaddiction.Patientsreceivingsedativesforthefollowingpurposes:preoperativemedication,inductionofanaesthesia,sedationinintensivecareunit,asanantiemetic.
Intervention/indicator
Inclusion:Studieswherethefocusisatleastoneofthefollowinghypnosedatives:BenzodiazepinesAlprazolamBromazepamClobazamDiazepamFlunitrazepamLorazepamMidazolamNitrazepamOxazepamTemazepamTriazolamNonbenzodiazepineHypnoticsZolpidemZopicloneExclusion:Studieswheretheincludedhypnosedativeswereonlyreportedonasacomparator
Comparison/control
Inclusion:AnyExclusion:Nil
Outcomes Inclusion:Outcomesrelatedtoresolution orreductionofproblembeingtreated.Outcomes
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relatedtotheeffectoftreatmentonfunction(abilitytoconductdailyactivities),QOL,othermedicationuse,returntowork.AdverseeffectsExclusion:studiesonpharmacokinetics
Setting Inclusion:Allhealthcaresettingsnotontheexclusionlist(e.g.acute,primarycare,rehabilitation)Exclusion: Intensivecareunit Nursinghomes Palliativecare
Studydesign Inclusion:EvidencebasedguidelinesorSystematicreviewsExclusion:NonEBGs,nonsystematicreviews,randomisedcontrolledtrials,controlledclinicaltrials,cohortstudies,casecontrolstudies,caseseries,editorials,letters,commentaries.
Publicationdetails Inclusion:StudiesinEnglishandconductedonhumansExclusion:StudiesinlanguagesotherthanEnglishand/orconductedonanimals
Timeperiod Inclusion:AnypublicationdateExclusion:Nil
Forastudytobe included,at leastoneofthehypnosedativeshadtobespecified inthesearchstrategytoensurethatallreferencesaboutthatdrugweresought.Wherean includeddrugwasnotthe focusofthestudy,butresultsofthedrugasacomparatorwerereported,thestudywasexcluded.Reviewswereconsideredsystematic reviews if theymet items4and8on thePRISMAchecklist(4),whichinvolves:astatementoftheobjectivesofthereviewandthetypesofstudiesthatwillbeincluded,andthesearchstrategyinsufficientdetailthatitcouldberepeated.GuidelineswereconsideredtobeEvidenceBasedGuidelinesiftheymetAGREE(5)criteria8and12,whichinvolves: the search strategy in sufficient detail that it could be repeated, and an explicit link betweenrecommendationsandthesupportingevidence.DataextractionDataoncharacteristicsofthestudieswereextractedandsummarisedforevidencemapping.SearchstrategyAhighlysensitivesearch inMedlineandEmbaseasdetailedbelowwasundertakenforallthegenericandAustralianproductdrugnamestobereviewed.Afurtherhighlysensitivefilterforsynthesizedevidencewasappliedandtheresults limitedtothose inEnglish.The largerEmbaseyieldwasfurtherreducedby limitingtheresultstothethreeconditionsunderreview;anxiety,insomniaandmusclespasm.TableA1.2.DatabasesaccessedDatabasename Datescovered Datesearched RefsEmbase 1980to2010Week04 05/02/2010 1,444
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Medline 1950toJanuaryWeek32010 05/02/2010 595TOTAL 1,921
TableA1.3.SearchstrategiesusedDatabasename StrategyEmbase ES_Sedatives_Embase_withSRetcfilter
1.expAnxiety/2.(anxietyoranxious).ti,ab.3.or/124.exp"SleepInitiationandMaintenanceDisorders"/5.(insomniaorsleep*).ti,ab.6.or/457.expSpasm/8.((muscularormuscle*)adj5spasm*).ti,ab.9.or/7810.Alprazolam/11.(AlpraxorAlprazolamorKalmaorXanaxorXanaxorZamhexal).ti,ab.12.or/101113.Bromazepam/14.Lexotan.ti,ab.15.or/131416.(ClobazamorFrisium).ti,ab.17.Diazepam/18.(AntenexorDiazepamorDuceneorRanzepamorValiumorValpam).ti,ab.19.or/171820.Flunitrazepam/21.Hypnodorm.ti,ab.22.or/202123.Lorazepam/24.Ativan.ti,ab.25.or/232426.Midazolam/27.Hypnovel.ti,ab.28.or/262729.Nitrazepam/30.(AlodormorMogadon).ti,ab.31.or/293032.Oxazepam/33.(AlepamorMurelaxorSerepax).ti,ab.34.or/323335.Temazepam/36.(TemazepamorNormisonorTemazeorTemtabs).ti,ab.37.or/353638.Triazolam/39.Halcion.ti,ab.40.or/383941.(ZolpidemtartrateorDormizolorSomidemorStildemorStilnoxorZolpibellorZolpidem).ti,ab.42.(ZopicloneorImovaneorImrest).ti,ab.43.or/12,1516,19,22,25,28,31,34,37,404244.hypnosedative*.ti,ab.45.43or4446."review"/orreview.pt.orreview.ti.
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47.(systematicorevidence$ormethodol$orquantitativ$oranalys$orassessment$).ti,sh,ab.48.46and4749.MetaAnalysis/50.metaanalysis.mp.51."systematicreview"/52.(metaanaly$ormetanaly$ormetaanaly$ormetaanaly$).mp.53.((systematic$orevidence$ormethodol$orquantitativ$)adj5(review$orsurvey$oroverview$)).ti,ab,sh.54.((pool$orcombinedorcombining)adj2(dataortrialsorstudiesorresults)).ti,ab.55.or/485456.exppracticeguideline/57.(clinicaladj3guideline*).ti,ab.58.or/555759.45and5860.3and5961.6and5962.9and5963.60or61or62Englisharticlesonly
Medline ES_Sedatives_Medline_withSRetcfilter1."review"/orreview.pt.orreview.ti.2.(systematicorevidence$ormethodol$orquantitativ$oranalys$orassessment$).ti,sh,ab.3.1and24.metaanalysis.pt.5.MetaAnalysis/6."systematicreview*".ti,ab.7.(metaanaly$ormetanaly$ormetaanaly$ormetaanaly$).mp.8.((systematic$orevidence$ormethodol$orquantitativ$)adj5(review$orsurvey$oroverview$)).ti,ab,sh.9.((pool$orcombinedorcombining)adj2(dataortrialsorstudiesorresults)).ti,ab.10.practiceguideline/11.(clinicaladj3guideline*).ti,ab.12.or/31113.Alprazolam/14.(AlpraxorAlprazolamorKalmaorXanaxorXanaxorZamhexal).ti,ab.15.or/131416.Bromazepam/17.Lexotan.ti,ab.18.or/161719.(ClobazamorFrisium).ti,ab.20.Diazepam/21.(AntenexorDiazepamorDuceneorRanzepamorValiumorValpam).ti,ab.22.or/202123.Flunitrazepam/24.Hypnodorm.ti,ab.25.or/232426.Lorazepam/27.Ativan.ti,ab.28.or/262729.Midazolam/30.Hypnovel.ti,ab.31.or/2930
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32.Nitrazepam/33.(AlodormorMogadon).ti,ab.34.or/323335.Oxazepam/36.(AlepamorMurelaxorSerepax).ti,ab.37.or/353638.Temazepam/39.(TemazepamorNormisonorTemazeorTemtabs).ti,ab.40.or/383941.Triazolam/42.Halcion.ti,ab.43.or/414244.(ZolpidemtartrateorDormizolorSomidemorStildemorStilnoxorZolpibellorZolpidem).ti,ab.45.(ZopicloneorImovaneorImrest).ti,ab.46.or/15,1819,22,25,28,31,34,37,40,434547.hypnosedative*.ti,ab.48.46or4749.12and48Englisharticlesonly
GuidelinesearchesManyclinicalpracticeguidelinesarepublishedas standalonedocumentson the internet,rather thanasarticles inpeerreviewed journals.Additional searchmethodsareneeded to identifyguidelinespublishedoutside the health literature. Guidelines can be found by searching the internet as a whole, searchingrelevantwebsites,andsearchingelectronichealthdatabases.Anevidencebasedguidelineisdifferenttoasystematicreviewinthatasystematicreviewusuallyattemptsto answer one clinical question, whereas a guideline may encompass many clinical questions, and thecorrespondingsystematicreviews.WebsitesearchestoidentifyrelevantevidencebasedguidelinesThe reviewers were aware of websites of guideline clearinghouses, guideline developers, centres ofevidencebased practice, Australian government health services and websites of specific relevance (eg.accidentcompensationgroups)knowntocontainevidencebasedresources.The 17websitespreviously identified by the review team (9 guideline services, 2Australian governmentwebsitesand1centreofevidencebasedpractice,and5otheraccidentcommissionwebsites)weresearchedforrelevantEBGs.DetailsofwebsitessearchedcanbefoundinTableA1.4.Whereaninternalsearchenginewasavailable,websitesweresearchedusingthesearchstringsdetailedinthetablebelow. Ifnosearchenginewasavailable, listsofEBGs,publicationsorotherresources identifiedonthesitewerescannedforrelevantdocuments.InternetsearchestoidentifyrelevantevidencebasedguidelinesandsystematicreviewsThe systematic searchmethodologywouldnormally includea strategywith relevant terms in theGoogleAdvancedSearchfunction.However,theGoogleadvancedsearchscreendidnothavethecapacitytoallowasearchwhichencompassedallthepossiblenamesduetothesizeandcomplexityofthetopic(13drugsfor3 indications).Sample testswithabbreviatednameoptionsdidnot suggest thatanypossibleyieldwouldrepaythetimespentinattemptingthenumeroussearchesthatwouldberequired.
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TableA1.4.WebsitessearchedtoidentifyrelevantguidelinesGuidelineServices NationalInstituteofClinicalStudies.ClinicalPracticeGuidelinesPortalhttp://www.clinicalguidelines.gov.au/
Therapeuticguidelinespsychotropicversion6(2008)http://www.clinicalguidelines.gov.au/browse.php?treePath=F.D001520.D004644.D001007&pageType=2&fldglrID=466&TherapeuticguidelinesRespiratoryversion4(2009)http://www.clinicalguidelines.gov.au/search.php?pageType=2&fldglrID=1600&Myhandsshake:Classificationandtreatmentoftremorhttp://www.racgp.org.au/afp/200909/200909sirisena.pdf
Webpagereviewed:GuidelinePortal,Browsebycondition
NationalHealthandMedicalResearchCouncil(NHMRC)www.nhmrc.gov.au AustralianGuidelinesfortheTreatmentofAdultswithAcuteStressDisorderandPosttraumaticStressDisorder
http://www.nhmrc.gov.au/publications/synopses/mh13syn.htm
Webpagereviewed:Guidelines,health
NationalInstituteforHealthandClinicalExcellenceUK(NICE)www.nice.org.uk
Anxiety:managementofanxiety(panicdisorder,withorwithoutagoraphobia,andgeneralisedanxietydisorder)inadultsinprimary,secondaryandcommunitycare.http://guidance.nice.org.uk/CG22
Insomnianewerhypnoticdrugs:Zaleplon,zolpidemand
Webpagereviewed:Ourguidance,healthtopic,MentalhealthandbehaviouralconditionsWebpagereviewed:Ourguidance,healthtopic,Musculoskeletal
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zopicloneforthemanagementofinsomniahttp://guidance.nice.org.uk/TA77
NewZealandGuidelineGroup(NZGG)www.nzgg.org.nz
IdentificationofCommonMentalDisordersandManagementofDepressioninPrimaryCarehttp://www.nzgg.org.nz/guidelines/dsp_guideline_popup.cfm?guidelineCatID=8&guidelineID=152
Webpagereviewed:GuidelinesandReports
ScottishIntercollegiateGuidelinesNetwork(SIGN)www.sign.ac.uk
Earlymanagementofpatientswithaheadinjuryhttp://www.sign.ac.uk/guidelines/fulltext/110/index.html
Webpagereviewed:GuidelinesMentalHealthWebpagereviewed:GuidelinesOther
GuidelinesInternationalNetworkwww.gin.net
Australianguidelinesforthetreatmentofadultswithacutestressdisorderandposttraumaticstressdisorder(MH13)http://www.gin.net/membership/members/nhmrcaunationalhealthandmedicalresearch/guidelines/australianguidelinesforthetreatmentofadultsEffectivenessofnasalcontinuouspositiveairwaypressure(nCPAP)inobstructivesleepapnoeainadults(HPR21,HPR22)http://www.gin.net/membership/members/nhmrcaunationalhealthandmedicalresearch/guidelines/effectivenessofnasalcontinuouspositiveairway
Webpagereviewed::InternationalGuidelineLibrary(membersonly)Searchedbykeywords:sedative,sedatives*,anxiety,sleepORinsomnia,muscle,spasm,AlprazolamORbromazepamORclobazamORdiazepamORflunitrazepamORlorazepamORmidazolamORnitrazepamORoxazepamORtemazepamORtriazolamORzolpidemORzopiclone
GuidelinesAdvisoryCommitteewww.gacguidelines.ca
Anxietyhttp://www.gacguidelines.ca/index.cfm?ACT=topics&Summary_ID=233&Topic_ID=24
Webpagereviewed:Listalltopicsandsummaries
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NationalGuidelineClearinghouseUS(NGC)(1) searchedon07/02/1013Resultstotal
www.guidelines.gov
Guidelinesforthemanagementofseveretraumaticbraininjury.Anesthetics,analgesics,andsedatives.http://www.guidelines.gov/summary/summary.aspx?doc_id=10999&nbr=005779&string=%28Alprazolam+OR+Bromazepam+OR+Clobazam+OR+Frisium+OR+Diazepam+OR+Flunitrazepam+OR++Lorazepam+OR+Midazolam+OR+Nitrazepam+OR+Oxazepam+OR+Temazepam+OR+Triazolam+OR+Zopiclone+or+Imovane+or+Imrest%29Guidanceontheuseofzaleplon,zolpidemandzopiclonefortheshorttermmanagementofinsomnia.http://www.guidelines.gov/summary/summary.aspx?doc_id=8641&nbr=004814&string=%28Alprazolam+OR+Bromazepam+OR+Clobazam+OR+Frisium+OR+Diazepam+OR+Flunitrazepam+OR++Lorazepam+OR+Midazolam+OR+Nitrazepam+OR+Oxazepam+OR+Temazepam+OR+Triazolam+OR+Zopiclone+or+Imovane+or+Imrest%29
Searchedby:Keyword:(AlprazolamORBromazepamORClobazamORFrisiumORDiazepamORFlunitrazepamORLorazepamORMidazolamORNitrazepamOROxazepamORTemazepamORTriazolamORZopicloneorImovaneorImrest)Disease/Condition:(traumaORspinalORspineORbrainORanxietyORsleepORinsomniaORmuscleORmuscular))
TRIPDatabase(1) searchedon07/02/101,780ResultstotalEvidenceBasedSynopses81SystematicReviews114Guidelines:Aus.&NZ12Canada5
AdultConditionedInsomnia:DiagnosistoManagement(CPDaccess)RecommendationsfortheSafeTransferofPatientswithBrainInjury2006http://www.aagbi.org/publications/guidelines/docs/brain_injury.pdfEvidencebasedtreatmentforthepharmacologicaltreatmentofanxietydisordersNationalLibraryofGuidelines(UK)2006(CPDaccess)
Searchedby:Drugnames
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UK58USA8Other4
www.tripdatabase.com
ImplementingandensuringSafeSedationPracticeforhealthcareproceduresinadults.ReportofanIntercollegiateWorkingPartychairedbytheRoyalCollegeofAnaesthetistshttp://www.rcoa.ac.uk/docs/safesedationpractice.pdf
AustralianGovernmentWebsitescontainingGuidelinesAustralianGovernmentDepartmentofHealthandAgeingwww.health.gov.au
Webpagereviewed:HealthProfessionalsTreatments&TechniquesGuidelines
NSWHealthwww.health.nsw.gov.au Webpagereviewed:Publications&ResourcesPolicyDirectivesandGuidelines
CentresofEvidenceBasedPracticeWebsitesWACentreforEvidenceBasedNursingandMidwiferyhttp://wacebnm.curtin.edu.au
Webpagereviewed:ResourcesReports,GuidelinesandArticle
OtherAccidentCommissionsMotorAccidentsAuthorityNSWwww.maa.nsw.gov.au/
http://www.maa.nsw.gov.au/default.aspx?MenuID=170
MAASGuidelines
MASGuidelines
MedicalAssessmentGuidelines1October2008(2.1mb)
MedicalAssessmentGuidelinesMay2006 (77kb)(MSWordversion 929kb)
Webpagereviewed:Publications&ReportsMAAGuidelinesGuidesforProfessionals
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CARSGuidelines
ClaimsAssessmentGuidelines1October2008(AmendedOctober12009) (260kb)
ClaimsAssessmentGuidelinesMay2006 (77kb)(MSWordversion 929kb)
InjuryManagementGuidelines
Guidesforprofessionals Guidesforinjuredpeople
AccidentCompensationCorporationwww.acc.co.nz/index.htm
Treatmentprofileshttp://www.acc.co.nz/forproviders/clinicalbestpractice/PRV00053
Webpagereviewed::ForProvidersClinicalBestPracticePublishedClinicalGuidelines
WorkSafeVICwww.workcover.vic.gov.au
Webpagereviewed:Safety&Prevention;HealthandSafetyTopics
WorkCoverNSWwww.workcover.nsw.gov.au
Webpagereviewed:Publications
WorkCoverWAwww.workcover.wa.gov.au
Webpagereviewed:PublicationsPublicationsforhealthproviders
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APPENDIX2:INCLUDEDSTUDIESListofincludedsystematicreviews1. BainKT.Managementofchronicinsomniainelderlypersons.AmericanJournalGeriatric
Pharmacotherapy.2006Jun;4(2):16892.2. BlancoC,RazaMS,SchneierFR,LiebowitzMR.Theevidencebasedpharmacologicaltreatment
ofsocialanxietydisorder.InternationalJournalofNeuropsychopharmacology.2003Dec;6(4):42742.
3. BlancoC,SchneierFR,SchmidtA,BlancoJerezCR,MarshallRD,SanchezLacayA,etal.Pharmacologicaltreatmentofsocialanxietydisorder:Ametaanalysis.DepressionandAnxiety.2003;18(1):2940.
4. BuscemiN,VandermeerB,FriesenC,BialyL,TubmanM,OspinaM,etal.Theefficacyandsafetyofdrugtreatmentsforchronicinsomniainadults:AmetaanalysisofRCTs.JournalofGeneralInternalMedicine.2007Sep;22(9):133550.
5. BustoUE,PainT,LanctotKL,EinarsonTR,NaranjoCA.Assessmentoftheriskoftherapeuticdosebenzodiazepinewithdrawalreactionswithmetaanalysis.CanadianJournalofClinicalPharmacology.1998Sep;5(3):1618.
6. CoxBJ,EndlerNS,LeePS,SwinsonRP.Ametaanalysisoftreatmentsforpanicdisorderwithagoraphobia:Imipramine,alprazolam,andinvivoexposure.JournalofBehaviorTherapyandExperimentalPsychiatry.1992;23(3):17582.
7. CoxBJ,SwinsonRP,LeePS.Metaanalysisofanxietydisordertreatmentstudies[7].JournalofClinicalPsychopharmacology.1992;12(4):3001.
8. DundarY,BolandA,StroblJ,DoddS,HaycoxA,BagustA,etal.Newerhypnoticdrugsfortheshorttermmanagementofinsomnia:Asystematicreviewandeconomicevaluation.HealthTechnologyAssessment.2004Jun;8(24):iii68.
9. FurukawaTA,StreinerDL,YoungLT.Antidepressantplusbenzodiazepineformajordepression.CochraneDatabaseofSystematicReviews.2001(2):CD001026.
10. GlassJ,LanctotKL,HerrmannN,SprouleBA,BustoUE.Sedativehypnoticsinolderpeoplewithinsomnia:Metaanalysisofrisksandbenefits.BritishMedicalJournal.200519;331(7526):116973.
11. GouldRA,OttoMW,PollackMH,YapL.Cognitivebehavioralandpharmacologicaltreatmentofgeneralizedanxietydisorder:Apreliminarymetaanalysis.BehaviorTherapy.1997Mar;28(2):285305.
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12. GradRM.Benzodiazepinesforinsomniaincommunitydwellingelderly:Areviewofbenefitandrisk.JournalofFamilyPractice.1995;41(5):47381.
13. HajakG,MullerWE,WittchenHU,PittrowD,KirchW.Abuseanddependencepotentialforthenonbenzodiazepinehypnoticszolpidemandzopiclone:Areviewofcasereportsandepidemiologicaldata.Addiction.2003Oct;98(10):13718.
14. HidalgoRB,TuplerLA,DavidsonJRT.Aneffectsizeanalysisofpharmacologictreatmentsforgeneralizedanxietydisorder.JournalofPsychopharmacology.2007Nov;21(8):86472.
15. HolbrookAM,CrowtherR,LotterA,ChengC,KingD.Metaanalysisofbenzodiazepineuseinthetreatmentofinsomnia.CanadianMedicalAssociationJournal.[Review].200025;162(2):22533.
16. HolmKJ,GoaKL.Zolpidem:Anupdateofitspharmacology,therapeuticefficacyandtolerabilityinthetreatmentofinsomia.Drugs.2000;59(4):86589.
17. InadaT,NozakiS,InagakiA,FurukawaTA.Efficacyofdiazepamasanantianxietyagent:Metaanalysisofdoubleblind,randomizedcontrolledtrialscarriedoutinJapan.HumanPsychopharmacology.2003Aug;18(6):4837.
18. IpserJC,CareyP,DhansayY,FakierN,SeedatS,SteinDJ.Pharmacotherapyaugmentationstrategiesintreatmentresistantanxietydisorders.CochraneDatabaseofSystematicReviews.2006;(4)(CD005473).
19. IpserJC,KariukiCM,SteinDJ.Pharmacotherapyforsocialanxietydisorder:Asystematicreview.ExpertReviewofNeurotherapeutics.2008Feb;8(2):23557.
20. JoyaFL,KripkeDF,LovingRT,DawsonA,KlineLE.Metaanalysesofhypnoticsandinfections:eszopiclone,ramelteon,zaleplon,andzolpidem.JournalofClinicalSleepMedicine.2009Aug15;5(4):37783.
21. KaplanEM,DuPontRL.Benzodiazepinesandanxietydisorders:Areviewforthepracticingphysician.CurrentMedicalResearchandOpinion.2005;21(6)(pp941950)(2947).
22. KrystalAD.Treatingthehealth,qualityoflife,andfunctionalimpairmentsininsomnia.JournalofClinicalSleepMedicine.200715;3(1):6372.
23. MaheV,BaloghA.Longtermpharmacologicaltreatmentofgeneralizedanxietydisorder.InternationalClinicalPsychopharmacology.2000;15(2):99105.
24. MartinJLR,SainzPardoM,FurukawaTA,MartinSanchezE,SeoaneT,GalanC.Review:Benzodiazepinesingeneralizedanxietydisorder:Heterogeneityofoutcomesbasedonasystematicreviewandmetaanalysisofclinicaltrials.JournalofPsychopharmacology.2007Sep;21(7):77482.
25. MitteK,NoackP,SteilR,HautzingerM.Ametaanalyticreviewoftheefficacyofdrugtreatmentingeneralizedanxietydisorder.JournalofClinicalPsychopharmacology.2005Apr;25(2):14150.
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26. NowellPD,MazumdarS,BuysseDJ,DewMA,ReynoldsICF,KupferDJ.Benzodiazepinesandzolpidemforchronicinsomnia:Ametaanalysisoftreatmentefficacy.JournaloftheAmericanMedicalAssociation.199724;278(24):21707.
27. RobinsonHM,HoodSD.SocialanxietydisorderAreviewofpharmacologicaltreatments.CurrentPsychiatryReviews.2007May;3(2):95122.
28. SmithMT,PerlisML,ParkA,SmithMS,PenningtonJ,GilesDE,etal.Comparativemetaanalysisofpharmacotherapyandbehaviortherapyforpersistentinsomnia.AmericanJournalofPsychiatry.2002Jan;159(1):511.
29. SoldatosCR,DikeosDG,WhiteheadA.Toleranceandreboundinsomniawithrapidlyeliminatedhypnotics:Ametaanalysisofsleeplaboratorystudies.InternationalClinicalPsychopharmacology.1999;14(5):287303.
30. SwainstonHarrisonT,KeatingGM.Zolpidem:areviewofitsuseinthemanagementofinsomnia.CNSDrugs.2005;19(1):6589.
31. VanLiemptS,VermettenE,GeuzeE,WestenbergHGM.Pharmacotherapyfordisorderedsleepinposttraumaticstressdisorder:Asystematicreview.InternationalClinicalPsychopharmacology.2006Jul;21(4):193202.
32. VersterJC,VeldhuijzenDS,PatatA,OlivierB,VolkertsER.Hypnoticsanddrivingsafety:metaanalysesofrandomizedcontrolledtrialsapplyingtheontheroaddrivingtest.CurrDrugSaf.2006Jan;1(1):6371.
33. WatanabeN,ChurchillR,FurukawaTA.Combinedpsychotherapyplusbenzodiazepinesforpanicdisorder.CochraneDatabaseofSystematicReviews.2009;(1)(CD005335).
34. WetherellJL,LenzeEJ,StanleyMA.Evidencebasedtreatmentofgeriatricanxietydisorders.PsychiatricClinicsofNorthAmerica.2005Dec;28(4):87196.
Listofincludedevidencebasedguidelines1. AndrewsG.AustralianandNewZealandclinicalpracticeguidelinesforthetreatmentofpanic
disorderandagoraphobia.AustralianandNewZealandJournalofPsychiatry.2003Dec;37(6):64156.
2. AACAP.Practiceparameterfortheassessmentandtreatmentofchildrenandadolescentswithanxietydisorders.JournaloftheAmericanAcademyofChildandAdolescentPsychiatry.2007Feb;46(2):26783.
3. BloomHG,AhmedI,AlessiCA,AncoliIsraelS,BuysseDJ,KrygerMH,etal.Evidencebasedrecommendationsfortheassessmentandmanagementofsleepdisordersinolderpersons:Supplement.JournaloftheAmericanGeriatricsSociety.2009May;57(5):76189.
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4. MAAMACoN.Guidelinesforthemanagementofanxietyfollowingmotorvehicleaccidents.2003.
5. McIntoshACA,TurnbullN,EsmondeL,DennisP,EatockJ,FeetamC,HagueJ,HughesI,KellyJ,KoskyN,LearG,OwensL,RatcliffeJ,SalkovskisPClinicalGuidelinesandEvidenceReviewforPanicDisorderandGeneralisedAnxietyDisorder''.2004.
6. NationalInstituteofHealthandClinicalExcellence.Guidanceontheuseofzaleplon,zolpidemandzopiclonefortheshorttermmanagementofinsomnia:TechnologyAppraisal77.NICE;April2004[updatedApril2004;citedMay2010];Availablefrom:www.nice.org.uk/TA077guidance.
7. SwinsonRP.Clinicalpracticeguidelines:managementofanxietydisorders.Citation:CanJPsychiatry.2006;51(2):1S92S.