提高中草药随机对照试验的质量ⅱ：对照组设计

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1、提高中草药随机对照试验的质量Ⅱ：对照组设计作者：卞兆祥，李幼平，刘良，吴泰相，缪江霞【关键词】中草药［摘要］目的：如何选择对照组是临床随机对照试验设计的关键环节之一。通过对Cochrane图书馆发表的关于中草药治疗2型糖尿病系统评价中所包含的66个临床试验进行对照组设计的评价分析，探讨如何提高中草药临床试验中对照组设计的质量。方法：　　AnotherobservationontheRCTsofCHMfortype2diabetesmellitusostended.Thedifficultymydesignmaybeuseful.Thismethodcallsforparti

2、cipantsinboththecontrolandinterventiongroupstorecEIveaplaceboinadditiontoaplacebooractiveintervention.Forexample,participantsreceivinganactivedecoctionforeplacebotabletinadditiontoaninertteaorcapsule,theprescribedtreatmentregimeninclinicaltrials,therebydecreasingtheirefficacy［15］.Effortsto

3、improveortofacilitateadherenceofpeopleentremendationsdidnotshoentregimeninaRCT,thismaybiasitsresultsparedtothecontrolgroup.　　4.3Notreatmentcontrol　　InRCTsentcontrolgroup,participantsarerandomlyassignedtoatestinterventionornointervention.Themaindifferencebetustbemindfulofthesameethicalconsi

4、derationsasthosethatapplytoaplacebocontrolgroup.　　4.4Multiplecontrols　　Studiesultiplecontrolgroups,biningactivecontrol,placebocontrol,and/ornotreatmentcontrol,areincreasinglymoninRCTs.Theconsiderationsforselectingthistypeofcontrolarethesameasthoseoutlinedforeachtypeofcontrolgroupdiscusseda

5、bove.Houstconsidertheconsequencesofthisstudydesign.Theseincludetheneedtoenrollmoreparticipantsineachgroupinordertomaintainappropriatestatisticalpoplementamoreplexprotocol.Thisdesignentailstheneedtoscreenandrecruitadditionalparticipants,provideadditionalresourcesforinvestigatortrainingandin

6、terventions,alloe,moredatacollectionandanalysis,etc.Investigatorsshouldcarefullylyallocatedtoplaceboortestintervention,thendiscontinuethatinterventiontominimizecarryovereffects(termedainimizessamplesizesandresources.Thisdesignisbestusedinstable,chronicconditions,andmayhavebeenappropriatefo

7、rsomeoftheRCTsofCHMfortype2diabetes.　　5LIMITATIONS　　ThemainlimitationofthisstudyisthatresultsareapplicableonlytothoseRCTsofCHMfortype2diabetesmellitusidentifiedforqualityassessment.ThoughthesestudiesarebelievedtobeformarepresentativesampleofRCTsofCHM,resultsma