中医药防治胆石症随机对照试验的质量评价

目的评价中医药防治胆石症随机对照试验的方法学和报告质量。方法计算机检索CNKI（1994～2007）、CBM（1978—2007）、CMCC（1994～2007）、VIP（1989～2007））、MEDLINE（1966～2007．4）、Cochrane图书馆（2006年第4期）。全面收集与中医药防治胆石症有关的临床试验，纳入凡文中有“随机”字样或“随机分组”、“随机对照”的以胆石症为目标疾病的研究，按照Cochrane协作网推荐的评价方法对纳入研究进行方法学质量评价，按照CONSORT for TCM清单项目进行研究报告质量评价。结果共纳入17篇文献，其中随机对照试验16个，半随机对照试验1个。评价结果显示，纳入文献方法学质量较低，均为C级；CONSORT for TCM评价最高18分。所有纳入研究的报告质量均低。结论以往的中医药防治胆石症的随机对照试验存在不同程度的方法学质量缺陷，使得其结论存在选择性偏倚、实施偏倚、测量偏倚以及减员偏倚的高度可能性。而较低的报告质量又会严重影响读者对研究结果真实性、重要性及实用性的正确理解和评价。因此期待设计严谨、实施科学、报告完整的大样本高质量的随机对照试验出现。

Quality Evaluation of Randomized Controlled Trials Involvring Traditional Chinese Medicine for Cholelithiasis

Objective To evaluate the methodological and reporting quality of randomized controlled trials involving traditional Chinese medicine in the treatment of cholel ithiasis.Methods We searched CNKI(1994 to 2007),CMCC(1994 to 2007),VIP(1989 to 2007),MEDLINE(1966 to April 2007)and The Cochrane Library(Issue 4, 2006).Data from randomized controlled trials(RCTs)and quasi-RCTs were extracted by two reviewers independently. The methodological qual ity of included trials was assessed by using the qual ity assessment criteria recommended by The Cochrane Collaboration,and the reporting quali ty was assessed by using the CONSORT for TCM checkli st. Results Seventeen studies including 16 RCTs and one quasi-RCT were included.The methodological and reporting qualities of included studies were generally low.All studies were graded C.The highest score evaluated by the CONSORT for TCM checklist was 18.Conclusion The quality of RCTs and quasi-RCTs involving traditional Chinese medicine for cholelithiasis is generally low,with a high risk of biases.The reporting of these trials is also incomplete,which would affect a reader's understanding and evaluation of the validity,importance and applicability of the study results.Therefore,new randomized controlled trials of high quality are required to provide reliable evidence.