Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation 英文参考文献.docVIP

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Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation 英文参考文献.doc

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Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation 英文参考文献

Joksi?etal.HarmReductionJournal2011,8:25 /content/8/1/25 RESEARCH OpenAccess Randomized,placebo-controlled,double-blind trialofSwedishsnusforsmokingreductionand cessation GordanaJoksi?1,VeraSpasojevi?-Ti?ma1,RuzaAnti?2,RobertNilsson2andLarsERutqvist3* Abstract Background:EpidemiologicalstudiessuggestthatsmokelesstobaccointheformofSwedishsnushasbeenused bymanysmokersinScandinaviatoquitsmoking,buttheefficacyofsnushassofarnotbeenevaluatedin controlledclinicaltrials. Methods:Weconductedarandomized,double-blind,placebo-controlled,clinicaltrialaimedatassessingthe efficacyofsnustohelpadultcigarettesmokersinSerbiatosubstantiallyreduce,and,eventually,completelystop smoking.Thestudyenrolled319healthysmokersaged20-65yearsattwooccupationalhealthcentersinBelgrade, Serbia.Mostofthem(81%)expressedaninteresttoquitratherthanjustreducetheirsmoking.Studyproducts wereusedadlibitumthroughoutthe48-weekstudyperiod.Themainstudyobjectiveduringthefirst24weeks wassmokingreduction.Theprimaryend-pointwasdefinedasabiologicallyverifiedreductionof≥50%inthe averagenumberofsmokedcigarettesperdayduringweek21-24comparedtobaseline.Duringweek25-48 participantswereactivelyinstructedtostopsmokingcompletely.Outcomemeasuresofbiologicallyverified, completesmokingcessationincluded1-weekpointprevalenceratesatclinicalvisitsafter12,24,36,and48weeks, aswellas4-,12-and24-weekcontinuedcessationratesattheweek36and48visits. Results:Attheweek24visit,theproportionofparticipantswhoachievedtheprotocoldefinitionofa≥50% smokingreductionwassimilarinthetwotreatmentgroups.However,theproportionthatreportedmoreextreme reductions(≥75%)wasstatisticallysignificantlyhigherinthesnusgroupthanintheplacebogroup(p0.01).The resultsforbiologicallyverifiedcompletecessationsuggestedthatparticipantsinthesnusgroupweremorelikely toquitsmokingcompletelythanthecontrols;theoddsratio(snusversusplacebo)fortheprotocolestimatesof cessationvariedbetween1.9to3.4,buttheseratioswereofborderlinesignificancewithp-valuesrangingfrom 0.04-0.10.Snuswaswellto