首页 | 本学科首页   官方微博 | 高级检索  
检索        

提高中草药随机对照试验的质量Ⅳ:采用修改后的CONSORT条目评价临床随机对照试验报告的质量
引用本文:卞兆祥,David MOHER,Simon DAGENAIS,李幼平,吴泰相,刘良,缪江霞,宋丽,张慧敏.提高中草药随机对照试验的质量Ⅳ:采用修改后的CONSORT条目评价临床随机对照试验报告的质量[J].中西医结合学报,2006,4(3):233-242.
作者姓名:卞兆祥  David MOHER  Simon DAGENAIS  李幼平  吴泰相  刘良  缪江霞  宋丽  张慧敏
作者单位:1. 香港浸会大学中医药学院,香港
2. 加拿大东安大略省研究所儿童医院,加拿大 渥太华
3. 四川大学华西医院中国循证医学中心,四川 成都 610041
4. 香港中文大学中医学院,香港
摘    要:目的:以Cochrane图书馆中有关中草药治疗2型糖尿病系统评价中的66个临床随机对照试验为基础,分析在中草药临床随机对照试验研究报告中存在的问题,以及如何提高临床随机对照试验报告的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的纳入随机对照试验最多的系统评价—中草药治疗2型糖尿病系统评价,共包含66个临床随机对照试验。以原有的CONSORT条目为基础,增加有关中医药方面的5项内容,即中医证型、组方依据、复方组成、制剂类型及质量控制。修订后的CONSORT评估表共包含63项条目,并以此为标准评估66篇临床随机对照试验报告的质量。结果:按修改后的CONSORT条目,66篇临床随机对照试验的总体报告率为19%~44%,中位数32%(标准差8%)。结论:中草药临床随机对照试验报告的总体质量较低。建议:以CONSORT条目为基础,进行中草药临床随机对照试验报告规范化的研究。同时建议中医药类杂志的编辑要求作者按照规范格式发表临床研究报告。

关 键 词:随机对照试验  中草药  方法学  质量评估  报告
文章编号:1672-1977(2006)03-0233-10
收稿时间:2005-12-07
修稿时间:2005年12月7日

Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅳ: applying a revised CONSORT checklist to measure reporting quality
Zhao-Xiang BIAN,David MOHER,Simon DAGENAIS,You-Ping LI,Tai-Xiang WU,Liang LIU,Jiang-Xia MIAO,Lisa SONG,Hui-Min ZHANG.Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅳ: applying a revised CONSORT checklist to measure reporting quality[J].Journal of Chinese Integrative Medicine,2006,4(3):233-242.
Authors:Zhao-Xiang BIAN  David MOHER  Simon DAGENAIS  You-Ping LI  Tai-Xiang WU  Liang LIU  Jiang-Xia MIAO  Lisa SONG  Hui-Min ZHANG
Institution:School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. bzxiang@hkbu.edu.hk
Abstract:Objective: To discuss the quality of reporting in randomized controlled trials(RCTs) of Chinese herbal medicine(CHM),and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area.Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM.A revised CONSORT checklist designed for CHM clinical studies was implemented.The revised CONSORT checklist contained 63 items,including the following new items added specifically for CHM:(1)"syndrome of disease" based on Chinese medicine theories;(2)rationale of CHM formula;(3) formula composition;((4) preparation) form of CHM;(5) quality control of CHM. Results: The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%,with a median score of 32%(standard deviation 8%).Conclusion: The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor,reflecting the need for improvements in reporting future clinical trials in this area.Recommendations: To improve the quality of reporting of RCTs of CHM,we recommend adopting a revised CONSORT checklist that includes items specific to CHM.We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication.
Keywords:randomized controlled trial  Chinese herbal medicine  methodology  quality assessment  reporting  
本文献已被 CNKI 维普 万方数据 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号