中医药随机对照试验报告质量评价

Assessing the Quality of Reporting of Randomized Controlled Trials in Traditional Chinese Medicine

目的应用CONSORT声明修订版和Jadad评分标准等综合评价1999～2004年发表在中国大陆的中医药随机对照试验（RCT）的报告质量。方法选择《中国中西医结合杂志》等13种中医药期刊，根据Cochrane手检指南手检发表于1999～2004年的所有文献。所有评价人员均接受中国Cochrane中心的培训。采用CONSORT声明修订版、Jadad评分标准和其它补充评价方法综合评价随机对照试验的报告质量。如果有争议采取讨论和仲裁方式解决。结果《中国中西医结合杂志》等13种中医药期刊在1999～2004年共发表7422篇RCT。RCT发表数和所占百分比逐年增加，1999～2004年RCT百分比分别是18．6％、23．9％、27．5％、28．8％、33．0％和35．6％。RCTIadad评分为1．03±0．61，其中有1个RCT5分，14个RCT4分，102个RCT3分。从1999～2004年Jadad评分分别为0．85±0．53（n=746）、0．82±0．63（n=941）、0．90±0．61（n=1243）、1．03±0．60（n=1325）、1．12±0．58（n=1533）和1．20±0．62（n=1634）。尽管ladad评分逐年提高但速度非常缓慢。纵观所有的RCT，我们发现有39．4％（11．82±5．78）CONSORT声明修订报告完整，一些有关RCT的重要方法学如样本含量估算（1．1％）、随机序列产生（7．9％）、分配隐藏（0．3％）、随机分配的实施（0．0％）、意向性治疗分析（0．0％）等均未完整报告。结论1999～2004年中国大陆中医药RCT报告质量逐年提高但仍然不理想。我们期待中医药CONSORT声明（the CONSORT for traditional Chinese medicine）的建立。

Objective To assess the quality of reporting of randomized controlled trials（RCTs） on traditional Chinese medicine（TCM） in China from 1999 to 2004 by CONSORT statement and ladad scale. Methods We randomly selected 13 journals of TCM including Chinese Journal of Integrated Chinese and Western Medicine, ect using stratified sampling from about 100 journals of TCM in China's Mainland, and all issues of selected iournals published from 1999 to 2004 were hand-searched according to the hand-search guideline developed by Cochrane Collaboration. All reviewers were trained in the method of evaluating RCTs. A comprehensive quality assessment of each RCT was completed using methods including the revised consolidated standards of reporting trials （CONSORT） checklist and ladad scale. Disagreements were resolved by consensus. Results A total of 7422 RCTs were identified, and the percentage of RCTs was significantly increased by 18.6%, 23.9%, 27.5%, 28.8%, 33.0% and 35.6% from 1999 to 2004. The mean Jadad score was 1.03 ± 0.61 in all trials with 1 RCT with 5 points, 14 with 4 points, and 102 with 3 points, from 1999 to 2004, the mean Jadad score was 0.85±0.53 （n=746）, 0.82±0.63 （n=941）, 0.90±0.61 （n=1 243）, 1.03± 0.60 （n=1 325）, 1.12±0.58 （n=1 533） and 1.20±0.62 （n=1 634） respectively, which was improved continuously but slowly. 39.4% of the items in CONSORT, which was equivalent to 11.82 （standard deviation=5.78） of a total of 30 items, were reported across those trials. Some important methodological components of RCTs such as sample size calculation （1.1%）, randomization sequence （7.9%）, allocation concealment （0.3%）, implementation of the random allocation sequence （0.0%） , analysis of intention to treat （0.0%）, were incompletely reported. Conclusion Our study suggests that the quality of reporting has been improved but still in poor status, which would urgently promote the establishment of the CONSORT for TCM.