From Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong Special Administrative Region, People's Republic of China; Chinese Cochrane Centre and Chinese Evidence-Based Medicine Centre, Sichuan University, Sichuan, People's Republic of China; Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
Ann Intern Med. 2017 Jun 27;167(2):112-121. doi: 10.7326/M16-2977. Print 2017 Jul 18.
Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine (TCM) interventions. The general reporting quality of randomized controlled trials (RCTs) of CHM formulas is disappointing, although CONSORT (Consolidated Standards of Reporting Trials) Statement extensions for herbal medicinal interventions and acupuncture interventions are available. A group of TCM clinical experts, methodologists, epidemiologists, and editors has developed this CONSORT Extension for CHM Formulas (CONSORT-CHM Formulas 2017) through a comprehensive process, including publication of the draft version, solicitation of comments, revision, and finalization. The CONSORT 2010 Statement was extended by introducing the idea of TCM Pattern and the features of CHM formulas. One new checklist subitem, keywords, was added to facilitate indexing and data searching. Seven of the 25 CONSORT checklist items, namely title and abstract, background and objectives, participants, interventions, outcomes, generalizability, and interpretation, are now elaborated, and the explanation of harms specific to CHM formulas is revised. Illustrative examples and explanations are also provided. The group hopes that CONSORT-CHM Formulas 2017 can improve the reporting quality of RCTs of CHM formulas.
中草药（CHM）方剂是中医药（TCM）干预的主要组成部分。尽管有草药和针灸干预的 CONSORT（临床试验报告标准）声明扩展，但 CHM 方剂的随机对照试验（RCT）的总体报告质量令人失望。一组中医临床专家、方法学家、流行病学家和编辑通过全面的过程制定了这个 CONSORT 扩展用于 CHM 方剂（CONSORT-CHM 方剂 2017），包括发布草案、征求意见、修订和定稿。通过引入中医模式的概念和 CHM 方剂的特点，对 CONSORT 2010 声明进行了扩展。添加了一个新的清单子项“关键词”，以方便索引和数据搜索。现在详细阐述了 CONSORT 清单中的 25 个项目中的 7 个，即标题和摘要、背景和目标、参与者、干预措施、结果、普遍性和解释，并且修订了针对 CHM 方剂的特定危害的解释。还提供了说明性示例和解释。该小组希望 CONSORT-CHM 方剂 2017 能够提高 CHM 方剂 RCT 的报告质量。
