Liu Xue-Ting, Zhang Xin, Wen Shu, Peng Le, Hong Qi, Kang Deying
Department of Evidence-based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu, China.
J Evid Based Med. 2015 Nov;8(4):192-208. doi: 10.1111/jebm.12173.
To examine the reporting characteristics and key methodological factors of randomized controlled trials (RCTs) in the field of traditional Chinese medicine and assess whether use of the Consolidated Standards of Reporting Trials (CONSORT) statement is associated with improvement in the quality of reports of RCTs.
RCTs published in two major traditional Chinese medicine journals were retrieved and were systematically reviewed. Of those journals, one adopted the CONSORT statement (Journal of Chinese Integrative Medicine (JCIM)) and one did not (Chinese Journal of Integrative Medicine (CJIM)). Items within the CONSORT 2001 and the CONSORT 2010 statements were taken to develop a 63-item coding manual. The Jadad scale was also used to assess methodological quality of RCTs. Two observers assessed the reporting of reports and extracted data independently. P < 0.05 was considered statistically significant. SPSS was used for all analyses.
A total of 76 RCTs were included for the analysis (38 from JCIM and 38 from CJIM). Significant improvements both in the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) over time were observed in adopter journal (JCIM) (P = 0.001). Overall CONSORT score of studies published during 2010 to 2011 (post-CONSORT) increased 15.30 averagely with 95%CI 8.34 to 22.26 (P = 0.001). Of those, items addressed on reporting of methodological quality were different significantly too. JCIM had more 1.30 items addressed than CJIM in average (95% CI 0.52 to 2.08, P = 0.003). In the multivariate analysis regression, the page length and CONSORT-promoting status have statistically significant associated with the (P = 0.001 and P = 0.040, respectively).
Although a large room needs to improve the reporting of randomized clinical trials in traditional Chinese medicine, the impact for improvement of reporting of TCM RCTs has been proven in some extent.
研究中医药领域随机对照试验（RCT）的报告特征和关键方法学因素，并评估采用《报告试验的统一标准》（CONSORT）声明是否与RCT报告质量的提高相关。
检索并系统评价发表于两种主要中医药期刊的RCT。其中一种期刊采用CONSORT声明（《中国中西医结合杂志》（JCIM）），另一种未采用（《中西医结合学报》（CJIM））。采用CONSORT 2001和CONSORT 2010声明中的条目制定一份63项编码手册。Jadad量表也用于评估RCT的方法学质量。两名观察者独立评估报告情况并提取数据。P<0.05被认为具有统计学意义。所有分析均使用SPSS。
共纳入76项RCT进行分析（38项来自JCIM，38项来自CJIM）。在采用该声明的期刊（JCIM）中，观察到随着时间推移，报告的整体质量（CONSORT评分）和方法学条目的报告（Jadad量表）均有显著改善（P = 0.001）。2010年至2011年期间发表的研究（CONSORT之后）的总体CONSORT评分平均提高了15.30，95%CI为8.34至22.26（P = 0.001）。其中，关于方法学质量报告的条目也有显著差异。JCIM平均比CJIM多涉及1.30个条目（95%CI为0.52至2.08，P = 0.003）。在多变量分析回归中，页面长度和促进CONSORT声明使用的状态与（P分别为0.001和0.040）具有统计学显著相关性。
尽管中医药领域随机临床试验的报告仍有很大改进空间，但在一定程度上已证明对改善中医药RCT报告有影响。
