【摘要】 目的应用CONSORT声明修订版和Jadad评分标准等评价《中国循证医学杂志》发表的中医药随机对照试验(RCT)的报告质量,并与前期调查结果进行比较,了解中医药RCT报告质量的改善情况。方法手工检索《中国循证医学杂志》2001～2008年刊载的中医药RCT,采用CONSORT标准修订版Jadad评分量表和自拟指标进行质量评价。结果共检索出RCT57篇,其中中医药RCT17篇。摘要、纳入/排除标准、干预措施的具体实施、随机化顺序产生、统计方法描述、基线描述、结果与估计及解释结果等CONSORT标准评价项目的报告率均达100%;随机化分配隐藏、随机化实施、流程图的使用及依从性等项目的报告率明显高于本课题组前期研究结果;仅3篇有了致谢(17.6%),有1篇未记录中医证型,采用模拟剂的仅有4篇(23.5%)。17篇RCT的Jadad总评分为4.35±1.11,有11篇评分达到5分(64.7%)。结论《中国循证医学杂志》2001～2008年发表的中医药RCT的报告质量高于本课题组前期对13种中医药期刊在1999～2004年发表的RCT质量。可见,随着CONSORT标准的不断完善和中医药CONSORT声明(CONSORT for traditional Chinese medicine,CONSORT for TCM)的发表,中医药RCT质量在提高,我们期待中医药临床试验报告规范不断完善。更多还原

【Abstract】 Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35 à1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.更多还原