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.
Bian
Zhao-xiang
ZX
Moher
David
D
Li
You-ping
YP
Wu
Tai-xiang
TX
Dagenais
Simon
S
Cheng
Chung-wah
CW
Li
Jing
J
Li
Ting-qian
TQ
D004365:Drugs, Chinese Herbal / Q000592:standards* / Q000627:therapeutic use; D019317:Evidence-Based Medicine; D008516:Medicine, Chinese Traditional / Q000592:standards*; D010506:Periodicals as Topic; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design
D004365:Drugs, Chinese Herbal