Quality Requirements for Real-World Studies of Traditional Chinese Medicine

Evidence-based Medicine (EBM) was introduced in China in 1996 [1]; since then Chinese investigators have tried to conduct randomized controlled trials (RCTs) of TCM following EBM standards. For example, during 2007 and 2012 a total of 1341 clinical trial articles, including 387 articles on complex TCM interventions (decoctions, acupuncture, moxibustion, and massage), were published in the two main TCM journals, Chinese Journal of Integrated Traditional and Western Medicine and Journal of Traditional Chinese Medicine [2]. However, most RCTs of TCM were not consistent with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. In a review of 3159 RCTs of TCM published before 2009, only12%, 7%, and 19% of the articles in Chinese journals followed adequate methods of randomization, allocation, and blinding, respectively, compared with 25%, 26%, and 60% of those in English journals [3]. Other aspects of poor methodological quality included small sample size, lack of rationale for interventional components, lack of long-term outcomes, lack of compliance data, ambiguous component interaction, incomplete follow-up information, failure to quantitatively report the efficacy, and failure to include data on baseline characteristics or all side effects' profiles [1-3].