应用CONSORT标准评价中医药治疗肠易激综合征随机对照试验报告的质量  

Assessment of reporting quality of randomized controlled trials on treatment of irritable bowel syndrome by traditional Chinese medicine by using CONSORT statement

作　　者：范芳芳[1] 张红[1] 赵生俊[1] 孙奇[2] 

机构地区：[1]新疆医科大学附属中医医院药学部,木齐830000 [2]新疆医科大学附属中医医院医学研究设计与数据处理中心,新疆乌鲁木齐830000

出　　处：《中国医院药学杂志》2015年第4期339-343,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:应用CONSORT2010标准评价5种核心期刊近5年发表的中医药治疗肠易激综合征随机对照试验的报告质量。方法:电子检索中国知网(CNKI)、中文科技期刊数据库(VIP)、万方数据库2009年至2013年发表在5种核心期刊中医药治疗肠易激综合征的RCT。由2名研究者按照CONSORT2010标准对照检查清单制定统一的评价表对纳入的每篇文献进行分配,每一条目根据作者是否报告,给出"是"或"否"判断并进行分析。结果:共纳入18篇文献,在报告质量上均存在不同程度的问题,主要在文题、样本量、分配隐藏、实施、盲法、基线资料、辅助分析、危害、局限性、试验注册、试验方案及资助等方面。结论:能够达到CONSORT2010标准的高质量的中医药治疗肠易激综合征的随机对照试验很少,在接纳和运用其结果时应谨慎。OBJECTIVE To assess the quality of randomized controlled trials（RCT）on treatment of irritable bowel syndrome（IBS）with traditional Chinese medicine（TCM）reported in 5 core journals published between 2009 and 2013 by using CONSORT2010.METHODS Literatures were retrieved in Wanfang Database,CNKI,VIP Database of China published between 2009 and 2013 in china on randomized controlled trials（RCT）on treatment of irritable bowel syndrome（IBS）with TCM.The CONSORT checklist was applied to evaluate the reporting quality of all eligible articles by two independent authors after discussing and comprehending the items thoroughly.Each item was graded as＂yes＂or＂no＂depending on whether the authors had reported it or not.RESULTS We identified 18 RCT.All RCT had reporting quality with different levels of flaws in title,sample size,allocation concealment,implementation,blinding,baseline data,auxiliary analysis,harm,limitation,trial registration,protocol and funding,etc.CONCLUSION The reporting quality are poor in RCT on treatment of irritable bowel syndrome（IBS）with TCM in5 core journals published between2009 and2013.Therefore,the reporting quality of each individual RCT should be scrutinized before accepting and using its results.We suggest that authors should adhere to CONSORT statement in reporting RCT,and editorial departments may consider the CONSORT statement as guidelines and instructions for authors to draft manuscripts and reviewers to judge manuscripts.

关 键 词：肠易激综合征 CONSORT 随机对照试验 报告质量 

分 类 号：R242[医药卫生—中医临床基础]