提高中草药随机对照试验的质量ⅰ：临床试验设计和方法学(1).docx

提高中草药随机对照试验的质量提高中草药随机对照试验的质量ⅠⅠ：临：临 床试验设计和方法学床试验设计和方法学(1)(1)作者：卞兆祥，李幼平，刘良，吴泰相，缪江霞，关家伦，宋丽 【关键词】,随机对照试验［摘要］目的：通过对中草药临床随机对照试验的设计及方法学进行质量评价，探讨如何提高中草药临床试验的质量方法：文献检索 XX 年 7 月前发表于 Cochrane 图书馆的中草药系统评价共 11 篇，包含 167 个中草药临床随机对照试验质量评价方法采用修订版 CONSORT 声明 9 项指标以及中草药剂型及质量控制标准指标结果：所有 167个临床试验都含有试验目的、方法、第 1 结局指标、统计学方法及中药剂型；其中 163（%）个临床试验说明了研究对象的纳入标准，只有 26（%）个临床试验说明了研究对象的排除标准；只有 14（%）个临床试验详细说明了随机序列的产生方法；4（%）个临床试验提及了随机分配隐藏；绝大部分的临床试验（%）属于开放性的，只有%的临床试验采用了盲法设计；只有 1 个临床试验在试验前进行了样本含量的计算；在中草药剂型方面，%的临床试验使用的是汤剂或中药茶包，只有 1 个临床试验提及了制剂的质量控制。

在 167 个临床试验中，所有质量评价指标的涉及率只有%结论：现阶段中草药临床随机对照试验的质量还很低建议：（1）试验设计者及实施者必须接受正规的临床试验基础知识的培训；（2）推荐采用临床试验设计流程图，逐一解决临床试验过程中的关键问题；（3）在方案正式实施前进行预试验，并根据预试验的结果对临床试验设计方案进行调整；（4）对临床试验设计的最终方案进行注册登记，并预先发表（最好是网上发表）临床试验设计方案；（5）广泛开展国际合作，特别是与对中医药研究感兴趣的国际知名学术研究机构进行合作，以提高中草药临床研究的质量［关键词］随机对照试验;中草药;方法学;质量评价ImprovingthequalityofrandomizedcontrolledtrialsinChineseherbalmedicine,partⅠ:clinicaltrialdesignandmethodologyABSTRACTObjective:TodiscussthequalityofrandomizedcontrolledtrialsinChineseherbalmedicinewithrespecttodesignandmethodology,andprovidesuggestionsforfurtherimprovementinfutureclinicaltrials.Methods:AsearchoftheCochraneLibrarywasconductedtoidentifyRCTsofCHMonlineinJulyXX.QualityoftheRCTswasassessedusinga11itemchecklistmodifiedfromtherevisedCONSORTstatement,with2itemsspecifictoCHM.Results:Thesearchyielded167RCTsthatwereselectedforassessment.Alltrialsincludedstatementsabouttheinterventions,objectives,primaryoutcomedesign,statisticalmethods,andherbpreparationform.Although163trialsreportedinclusioncriteria,exclusioncriteriawereonlyreportedin26trials.Fewerthan10%oftrialsclearlystatedtherandomallocationsequencegenerationmethods,andonly%mentionedallocationconcealment.Thevastmajorityoftrialswereopenlabel,whileonly%usedblinding.AlmosthalfadministeredtheCHMinterventionasatea or decoction.Onlyonetrialreportedasamplesizecalculation,andasingletrialdiscussedqualitycontroloftheCHMintervention.Conclusion:TheoverallmethodologicqualityofRCTsinCHMwaspoor.ItisessentialtoimprovethedesignoffutureRCTsinthisclinicalarea.Recommendations:InvestigatorconductingRCTsshouldhaveformaltrainingaboutclinicaltrialdesign;Aflowchartisrecommendedtoensurethatallessentialstepsofclinicaltrialdesignareincluded.ConductingpilotstudiespriortoRCTsmayhelpimprovetheirdesign;Registrationofclinicaltrialsandpublishingtheirprotocolspriortoenrolmentmayreducepublicationbiasandsolicitpeerreviewsoftheproposeddesign;CollaborationbetweenCHMinvestigatorsandtraditionalmedicineacademicresearchcentersinterestedinintegrativemedicinemayleadtoqualityimprovementofRCTsofCHM.KEYWORDSrandomizedcontrolledtrial;Chineseherbalmedicine;methodology;qualityassessment1INTRODUCTIONChineseherbalmedicineisbecomingincreasinglypopularinindustrializednationsasoneformof“alternative” or“complementary”medicine.Inordertobringitfullyintotheconventionalmedicalsystemsoftheworld―andtherebyutilizeitsconsiderablebenefits―evidenceofthesafetyandefficacyofherbsandherbalproductsarenecessary.Thequestionthenis“Wherecanonefindsuchevidence?”Bothrandomizedcontrolledtrialsandsystematicreviewsarecommonlythoughttoprovidethestrongestlevelofevidenceregardingtreatmentefficacyofcompetingtherapeuticinterventions.ThecredibilityoftheevidencetosupportatreatmentapproachsuchasCHMthereforedependsonthequalityofRCTs.Previousreports［1,2］haveshowedthatsystematicreviewsincomplementarymedicineinvolvingCHMlackhighqualityRCTstoprovideclearevidenceofefficacy.Infact,thequalityofRCTswithinterventionofCHMasamodalityhasbeenatopicofdiscussionforlongtime［3,4］,thoughnoevidencewasavailabletomakeadefinitivejudgmentonthetopic.If,assomemaysuspect,thequalityofRCTsregardingCHMisnotinfactsatisfactory,adiscussionmustthenfollowregardingrecommendationsforimprovingthissituation.WehavethereforeproposedafourpartseriesofarticleswhichfocusonthefourbasicelementsofRCTsinCHM:clinicaltrialdesignandmethodology,controlgroupdesign,qualitycontrolofCHMusedinRCTsandreportingformatofRCTsinCHM.（作者：3COME 未知本文来源于爬虫自动抓取，如有侵犯权益请联系 service@立即删除）。