《中国中西医结合杂志》发表随机对照试验报告的质量评价

Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement

目的调查《中国中西医结合杂志》发表的随机对照试验(RCT)报告的方法学质量。方法手工检索《中国中西医结合杂志》1999～2004年刊载的RCT,采用CONSORT标准修订版和自拟其它评价指标对所有RCT进行质量评价。结果共检索了6卷72期2765篇已发表的文献,其中RCT1288篇,占临床试验类文献(1874篇)的68.73%。该1288篇RCTs中,描述了随机方法的有630篇(48.92%),与1999年以前相比,其差异有统计学意义(P<0.001),但采用安慰剂对照仅有21篇(1.63%),描述了终点指标者有114篇(8.85%),进行了样本量估算者有7篇(0.55%),无一篇描述随机分配,采用盲法的有54篇(4.20%)、对具体P值进行了描述的有9篇(0.70%)、无一篇报道随机试验流程图,描述了依从性的有2篇(0.16%),报告阴性结果的有1篇(0.08%),进行了辅助分析的有33篇(2.57%),采用多中心试验的有10篇(0.78%),进行了伦理学审批者为零,报道了患者知情同意者有3篇(0.24%),进行了致谢的有3篇(0.24%),描述了中医证型的有163篇(12.66%),采用了干预措施质量控制标准的有2篇(0.15%),采用模拟方法的有8篇(0.63%),描述了中医证候疗效指标的有258篇(20.04%),以上调查项目的质量评分均偏低。结论随着循证医学理念的深入和中国生物医学杂志编辑的重视,中医药临床试验报告质量已有提高,但与目前国际公认的CONSORT标准比较尚有差距。

Objective To explore the quality of the reporting of randomized controlled trials （RCTs） published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004. Methods A manual search was performed and the 22 checklists of CONSORT statement and other self-established criteria were applied. Results Six volumes and 72 issues were checked. There were 1 874 clinical trials of which 1288 （68.73%） RCTs were identified in 2 765 articles. Randomization methods were described in 630 （48.92%） RCTs which showed there was more significant difference than the RCTs published in 1998 （P〈0.001）.In the 1288 RCTs, placebo control was reported only in 21 trials （1.63%） and endpoint measurements were reported in 114 trials （8.85%）. Seven trials （0.55%） mentioned the estimation of sample size. None mentioned randomization concealment. Blinding was reported in 54 trials （4.2%） and P value was reported in 9 trials （0.70%）.Flow chart was not mentioned in any trials. Compliance was reported in 2 trials （0.16%）, and only one trial （0.08%） reported negative results. Ancillary analysis was used in 33 trials （2.57%）. 10 trials are multi-centre RCTs. None of the trials reported the approval of ethics committee. Informed consent was reported in 3 trials （0.24%）. Acknowledgements were mentioned in 3 trials （0.24%）. Syndrome types defined by traditional Chinese medicine （TCM） were reported in 163 trials （12.66%）. The criteria of intervention quality control was mentioned in 2 trials （0.15%）. Double dummy was used in 8 trials （0.63%） and outcome measurement of TCM was reported in 258 trials （20.04%）. All Items reported in RCTs were of low quality. Conclusions The quality of reporting of RCTs published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004 has been improved, but it does not meet the CONSORT statement.