中医药治疗慢性疲劳综合征随机对照试验的报告质量评价  

Quality Assessment of the Reporting of Randomized Controlled Trials of Traditional Chinese Medicine for Chronic Fatigue Syndrome

作　　者：沈进[1] 汤曦 邹锟[3] 

机构地区：[1]四川大学学报医学版编辑部,成都610041 [2]四川大学华西临床医学院 [3]四川大学华西医院循证医学与临床流行病学中心

出　　处：《中国循证医学杂志》2007年第5期385-391,共7页Chinese Journal of Evidence-based Medicine

摘　　要：目的评价中医药治疗慢性疲劳综合征(CFS)的随机对照试验(RCT)的报告质量。方法计算机检索Cochrane图书馆CENTRAL(2006年第4期),PubMed、EMbase、CBMdisc、CNKI和VIP(检索日期截至2007年2月5日),并手检相关文献的参考文献,采用CONSORT修订版辅以其它指标对所有纳入的RCT进行质量评价。结果最初检索到62篇相关文献,最终纳入38篇文献进行评价。结果显示,所有文题均不含“随机”字样,仅17篇文献采用了结构式摘要;所有纳入研究对试验实施的科学背景与原理的阐述,样本量的计算,分配隐藏,盲法,流程图,意向治疗分析及辅助分析的使用情况均未报告;研究者对诊断标准和纳入标准的理解存在偏差,大多选择了不恰当的对照干预措施,统计方法描述不清并存在错误,研究结果均为阳性,少有报告不良反应;讨论中所有研究均未参考前人的研究结果,对研究的局限性,对临床和科研的意义,以及外部真实性的描述均未涉及。结论目前有关中医药治疗慢性疲劳综合征的随机试验质量较差,在试验报告的各个环节都存在不同程度的缺陷。研究者和编辑需要联合起来,学习和运用循证医学,特别是其所倡导的透明公开的临床试验注册和CONSORT,以提高中医药临床试验的设计、实施和报告质量,推动中医药的现代化和国际化。Objectives To explore the quality of the reporting of randomized controlled trials （RCTs） of traditional Chinese medicine （TCM） for chronic fatigue syndrome （CFS）. Methods We searched the Cochrane Central Register of Controlled Clinical Trials （CENTRAL） （The Cochrane Library, Issue 4, 2006）, PubMed, EMbase, the Chinese Biomedical Database （CBMdisc）, VIPInformation, and China National Knowledge Infrastructure （CNKI） （from establishment to February 2007）. We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word ＂randomization＂ was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial＇s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine-especially the use of a transparent prospective clinical trial register and the CONSORT Statement-to improve the design, conduct and report TCM trials.

关 键 词：慢性疲劳综合征 随机对照试验 中医药 CONSORT 文献质量评价 

分 类 号：R259[医药卫生—中西医结合]