School of Chinese Medicine
Precise reporting of traditional Chinese medicine interventions in randomized controlled trials
Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/ formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2)The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.
Chinese herbal drugs, Clinical research, Evidence-based medicine, Randomized controlled trials, Traditional Chinese medicine
Source Publication Title
Journal of Integrative Medicine (JIM) = 中西医结合学报
Link to Publisher's Edition
Bian, Zhao-Xiang, David Moher, You-Ping Li, Tai-Xiang Wu, Simon Dagenais, Chung-Wah Cheng, Jing Li, and Ting-Qian Li. "Precise reporting of traditional Chinese medicine interventions in randomized controlled trials." Journal of Integrative Medicine (JIM) = 中西医结合学报 6.7 (2008): 661-667.