中国大陆13种随机选取期刊的中医药随机对照试验报告质量：一项调查
The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.
作者信息
Wang Gang, Mao Bing, Xiong Ze-Yu, Fan Tao, Chen Xiao-Dong, Wang Lei, Liu Guan-Jian, Liu Jia, Guo Jia, Chang Jing, Wu Tai-Xiang, Li Ting-Qian
机构信息
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Ckengdu, People's Republic of China.
出版信息
Clin Ther. 2007 Jul;29(7):1456-67. doi: 10.1016/j.clinthera.2007.07.023.
BACKGROUND
The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials.
OBJECTIVE
This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004.
METHODS
Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus.
RESULTS
Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%).
CONCLUSION
The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.
背景
中医药随机对照试验（RCT）的数量在不断增加。然而，对这些试验报告质量的系统评估却很少。
目的
本研究旨在评估1999年至2004年中国大陆出版的中医期刊中RCT的报告质量。
方法
通过对中国大陆出版的约100种中医期刊进行分层抽样，随机选择了13种中医期刊。根据Cochrane中心的指南，对所选期刊1999年至2004年出版的所有期次进行手工检索。所有评审人员在中国循证医学中心接受了RCT评估培训。使用修改后的《试验报告统一标准》（CONSORT）清单（共30项）和Jadad量表对每个RCT进行全面质量评估。分歧通过协商一致解决。
结果
共识别出7422项RCT。在所研究的时间段内，已发表的RCT相对于所有类型已发表临床试验的比例显著增加，从1999年的18.6%增至2004年的35.9%（P<0.001）。总体Jadad评分均值（标准差）为1.03（0.61）。1项RCT的Jadad评分为5分；14项评分为4分；102项评分为3分。1999年（746项RCT）的Jadad评分均值（标准差）为0.85（0.53），2004年（1634项RCT）为1.20（0.62）。在所有试验中，修改后的CONSORT清单上39.4%的条目有报告，相当于30项条目中的11.82（5.78）项。RCT一些重要的方法学组成部分报告不完整，如样本量计算（1.1%的RCT有报告）、随机化序列（7.9%）、分配隐藏（0.3%）、随机分配序列的实施（0%）以及意向性分析（0%）。
结论
本研究结果表明，中医RCT的报告质量有所提高，但仍然较差。
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