CONSORT extension for Traditional Chinese Medicine Formula 2017: recommendations, explanation and elaboration

摘要

Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine (TCM) interventions. The general reporting quality of randomized clinical trials (RCTs) of CHM formulas is disappointing although there are CONSORT (Consolidated Standards of Reporting Trials) Statement extensions for herbal medicinal interventions and acupuncture interventions. A group of TCM clinical experts, methodologists, epidemiologists and editors has developed CONSORT–CHM Formulas through a comprehensive process including publication of the CONSORT–CHM Formulas (Draft), 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 sub-item, Keywords was added to facilitate the indexation 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 upon and the explanation of Harms of CHM formulas is revised. Illustrative examples and explanations are also provided. We hope that CONSORT–CHM Formulas 2017 can improve the reporting quality of RCTs of CHM formulas.