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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (7): 661-667.doi: 10.3736/jcim20080701

Special Issue: Traditional Chinese Medicine

• Editorial •     Next Articles

Precise reporting of traditional Chinese medicine interventions in randomized controlled trials

Zhao-xiang Bian1(), David Moher2, You-ping Li3, Tai-xiang Wu3, Simon Dangenais4, Chung-wah Cheng1, Jing Li3, Ting-qian Li3   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    3. Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    4. Division of Orthopaedic Surgery and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa Canada
  • Received:2008-05-05 Online:2008-07-20 Published:2008-07-15
  • Contact: BIAN Zhao-xiang E-mail:bzxiang@hkbu.edu.hk

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.

Key words: traditional Chinese medicine, Chinese herbal drugs, clinical research, randomized controlled trials, evidence-based medicine

CLC Number: 

  • R-3

"

分类 中药新药名称
类别1 未在国内上巿销售的从植物、动物、矿物等物质中提取的有效成分及其制剂
类别2 新发现药材及其制剂
类别3 现有药材的替代品
类别4 新发现中药材的作用及其制剂
类别5 未在国内上巿销售的从植物、动物、矿物等药材中提取的有效成分及其制剂
类别6 未在国内上巿销售的中药复方或原药材制剂
类别7 改变己上巿药品剂型的制剂
类别8 改变己上 巿中药药品剂量的制剂
类别9 仿制品
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