Li Ming, Zhou Boyang, Zhou Lihong, Li Linfeng
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, 95 Yong'an Road, Xicheng District, Beijing 100050, China.
Evid Based Complement Alternat Med. 2020 Sep 14;2020:2949125. doi: 10.1155/2020/2949125. eCollection 2020.
Chinese patent medicine (CPM) has been widely used to treat eczema in mainland China for decades. This study aims to investigate circulating CPM for eczema in mainland China and to evaluate the reporting quality of randomized controlled trials (RCTs) of them by using the CONSORT-CHM formulas 2017 (Consolidated Standards of Reporting Trials for Chinese herbal medicine formulas 2017).
Circulating CPM with the indication for eczema was selected by searching three drug databases and confirmed by contacting the manufacturers. RCTs for the treatment of eczema with CPM were selected in four Chinese literature databases and four English literature databases from their inception to August 31, 2019. The reporting quality of included RCTs was assessed based on the CONSORT-CHM formulas 2017. A univariate analysis was conducted to identify the factors associated with the reporting quality.
A total of 70 circulating CPMs had the indication for eczema. Among them, 21 CPMs with 144 RCTs reached the eligible criteria. The mean overall quality score (OQS) of 144 RCTs was 19.85 ± 2.73, which was much less than the maximum score of 38. Of the 38 items, 12 items were reported in over 70% of the trials, 6 items were reported in 50%-70% of the trials, and 16 items were reported in less than 50% of the trials. Publication after 2015 ( < 0.001) and the first author from a university hospital (=0.010) were associated with the better reporting quality.
There are a lot of circulating CPMs with the indication for eczema in mainland China, but both the quantity and the reporting quality of RCTs regarding those CPMs are suboptimal. It is necessary that authors and journal editors learn and adhere to the CONSORT-CHM formulas 2017 to enhance the reporting quality of RCTs for the treatment of eczema with CPM.
几十年来，中成药在中国内地被广泛用于治疗湿疹。本研究旨在调查中国内地治疗湿疹的流通中成药，并使用2017年CONSORT-CHM公式（2017年中药方剂报告试验统一标准）评估其随机对照试验（RCT）的报告质量。
通过检索三个药品数据库筛选出有湿疹适应证的流通中成药，并与制造商联系进行确认。从四个中文文献数据库和四个英文文献数据库中选取自建库至2019年8月31日期间使用中成药治疗湿疹的RCT。根据2017年CONSORT-CHM公式评估纳入RCT的报告质量。进行单因素分析以确定与报告质量相关的因素。
共有70种流通中成药有湿疹适应证。其中，21种中成药及144项RCT符合纳入标准。144项RCT的平均总体质量得分（OQS）为19.85±2.73，远低于最高分值38分。在38项条目中，超过70%的试验报告了12项，50%-70%的试验报告了6项，少于50%的试验报告了16项。2015年后发表（<0.001）以及第一作者来自大学医院（=0.010）与更好的报告质量相关。
中国内地有很多有湿疹适应证的流通中成药，但关于这些中成药的RCT数量和报告质量均不理想。作者和期刊编辑有必要学习并遵守2017年CONSORT-CHM公式，以提高中成药治疗湿疹RCT的报告质量。
