Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews.
Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews.
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DOI：
10.1186/1745-6215-12-122
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发表时间：
2011-05-13
期刊：
影响因子：
2.5
通讯作者：
Shang L
中科院分区：
文献类型：
--
作者：
He J;Du L;Liu G;Fu J;He X;Yu J;Shang L
随机对照试验（RCTs）的质量较差，往往会夸大效果估计，导致错误或误导性的结论。本研究的目的是评估随机化方法、分配隐藏和盲法在中医随机对照试验中的质量，讨论当前中医随机对照试验中存在的问题，并提出质量改进建议。我们检索了中国生物医学数据库（Chinese Biomedical Database, 1978 - July 31, 2009）和Cochrane Library (Issue 2, 2009)，根据纳入/排除标准收集中医系统评价和荟萃分析，从中可以识别出rct。质量评价包括随机化方法、分配隐藏和盲法是否足够。采用不同的干预措施，对发表在不同期刊（国内外）的不同类型疾病进行分层分析。采用SPSS 15.0软件进行统计分析。共纳入3159篇rct，其中中文期刊发表2580篇，外文期刊发表579篇。有381项（12%）随机对照试验采用了适当的随机化方法；207项（7%）随机对照试验采用了适当的分配隐藏，601项（19%）采用了适当的盲法；有130项（4%）随机对照试验采用了适当的随机化方法和分配隐藏；只有100项（3%）随机对照试验采用了适当的随机化方法、分配隐藏和盲法。在国外期刊上发表的rct中，适当的随机化方法、分配隐藏和盲法所占比例较大（分别为25%、26%和60%），且随年份增加，而在中国期刊上发表的rct中，只有适当的随机化方法随时间而增加。非药物干预（主要是针灸）rct的质量高于药物干预rct。在药物干预方面，所列药品质量高于其他药品。所有纳入的所有类型疾病的随机对照试验的质量普遍较差，没有发现规模大、质量高的研究。目前中医药随机对照试验的质量普遍较差，特别是在中文期刊上发表的。今后，中医药随机对照试验研究人员应更加重视实验设计和方法学质量，接受相关培训，运用CONSORT（综合报告试验标准）声明提高报告质量，以提高中医药临床研究质量，保证结论的真实性和可靠性。
Randomized controlled trials (RCTs) which are of poor quality tend to exaggerate the effect estimate and lead to wrong or misleading conclusions. The aim of this study is to assess the quality of randomization methods, allocation concealment and blinding within traditional Chinese medicine (TCM) RCTs, discuss issues identified for current TCM RCTs, and provide suggestions for quality improvement. We searched Chinese Biomedical Database (CBM, 1978 to July 31, 2009) and the Cochrane Library (Issue 2, 2009) to collect TCM systematic reviews and meta-analyses according to inclusion/exclusion criteria, from which RCTs could be identified. The quality assessment involved whether the randomization methods, allocation concealment and blinding were adequate or not based the study reported. Stratified analyses were conducted of different types of diseases published in different journals (both Chinese and foreign) using different interventions. SPSS 15.0 software was used for statistic analyses. A total of 3159 RCTs were included, of which 2580 were published in Chinese journals and 579 in foreign journals. There were 381 (12%) RCTs which used adequate randomization methods; 207 (7%) RCTs which used adequate allocation concealment and 601 (19%) which used adequate blinding; there were 130 (4%) RCTs which both used adequate randomization methods and allocation concealment; and there were only 100 (3%) RCTs which used adequate randomization methods, allocation concealment, as well as blinding. In the RCTs published in foreign journals, the adequate randomization methods, allocation concealment and blinding accounted for a relatively large proportion (25%, 26%, and 60%, respectively) and increased with years, while in the RCTs published in Chinese journals, only the adequate randomization methods improved over time. The quality of non-drug intervention (chiefly acupuncture) RCTs was higher than that of drug intervention RCTs. In drug intervention, the quality of listed drugs is higher than the others. The quality of all included RCTs of all types of diseases was generally poor and no studies that were large in size and of high quality were found. The quality of the current TCM RCTs as judged by their publications is generally poor, especially those published in Chinese journals. In future, researchers of TCM RCTs should attach more importance to experimental design and methodological quality, receive relevant training, and improve reporting quality using the Consolidated Standards of Reporting Trials (CONSORT) statement, so as to improve the quality of TCM clinical research and ensure truth and reliability of conclusions.
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影响因子：
2.5
作者：
Hopewell S;Altman DG;Moher D;Schulz KF
通讯作者：
Schulz KF
中医药随机对照试验报告质量：对中国大陆13种随机期刊的调查
影响因子：
3.2
作者：
Wang, Gang;Mao, Bing;Li, Ting-Qian
通讯作者：
Li, Ting-Qian
影响因子：
168.9
作者：
Moher, D;Pham, B;Klassen, TP
通讯作者：
Klassen, TP
影响因子：
120.7
作者：
Begg, C;Cho, M;Stroup, DF
通讯作者：
Stroup, DF
影响因子：
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作者：
Kunz, R;Oxman, AD
通讯作者：
Oxman, AD