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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
[1] Bian ZX, Li YP, Moher D , et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅰ: clinical trial design and methodology[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(2):120-129
doi: 10.3736/jcim20060204
卞兆祥, 李幼平 , Moher D, 等. 提高中草药随机对照试验的质量Ⅰ: 临床试验设计和方法学[J]. 中西医结合学报, 2006,4(2):120-129
doi: 10.3736/jcim20060204
[2] Bian ZX, Moher D, Dagenais S , et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅱ: control group design[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(2):130-136
卞兆祥 , Moher D, Dagenais S, 等. 提高中草药随机对照试验的质量Ⅱ:对照组设计[J]. 中西医结合学报, 2006,4(2):130-136
[3] Liang SX, Bian ZX, Moher D , et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅲ: quality control of Chinese herbal medicine used in randomized controlled trials[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(3):225-232
梁士贤, 卞兆祥 , Moher D, 等. 提高中草药随机对照试验的质量Ⅲ:中草药的质量控制[J]. 中西医结合学报, 2006,4(3):225-232
[4] Bian ZX, Moher D, Dagenais S , et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅳ: applying a revised CONSORT checklist to measure reporting quality[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(3):233-242
卞兆祥 , Moher D, Dagenais S, 等. 提高中草药随机对照试验的质量Ⅳ: 采用修改后的CONSORT条目评价临床随机对照试验报告的质量[J]. 中西医结合学报, 2006,4(3):233-242
[5] Moher D, Schulz KF, Altman DG . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. J Am Podiatr Med Assoc, 2001,91(8):437-442
doi: 10.7547/87507315-91-8-437
[6] Altman DG, Schulz KF, Moher D , et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Ann Intern Med, 2001,134(8):663-694
doi: 10.7326/0003-4819-134-8-200104170-00012 pmid: 11304107
[7] Plint AC, Moher D, Morrison A , et al.Does the CONSORT checklist improve the quality of reports of randomized controlled trials? A systematic review[J].Med J Aust, 2006, 185: 263-267
[8] Gagnier JJ, Boon H, Rochon P , et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement[J]. Ann Intern Med, 2006,144(5):364-367
doi: 10.7326/0003-4819-144-5-200603070-00013
[9] Wu TX, Li YP, Bian ZX , et al. Consolidated standards for reporting trials of traditional Chinese medicine(CONSORT for TCM)[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2007,7(8):601-605
doi: 10.3969/j.issn.1672-2531.2007.08.013
吴泰相, 李幼平, 卞兆祥 , 等. 中医药临床随机对照试验报告规范(征求意见稿)[J]. 中国循证医学杂志, 2007,7(8):601-605
doi: 10.3969/j.issn.1672-2531.2007.08.013
[10] Wu TX, Li YP, Bian ZX , et al. Consolidated standards for reporting trials of traditional Chinese medicine(CONSORT for TCM)[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2007,7(8):625-630
doi: 10.3969/j.issn.1672-2531.2007.08.013
吴泰相, 李幼平, 卞兆祥 , 等. 中医药临床随机对照试验报告规范(征求意见稿)[J]. 中国循证医学杂志, 2007,7(8):625-630
doi: 10.3969/j.issn.1672-2531.2007.08.013
[11] State Food and Drug Administration .
国家食品药品监督管理局 .
[12] Liu YF, Yu HM, Zhang C , et al. Effects of Quyu Xiaoban capsules on clinical outcomes and platelet activation and aggregation in patients with unstable angina pectoris[J]. J Altern Complement Med, 2007,13(3):571-576
doi: 10.1089/acm.2007.6226
[13] Li Z, Seeram NP, Lee R , et al. Plasma clearance of lovastatin versus Chinese red yeast rice in healthy volunteers[J]. J Altern Complement Med, 2005,11(6):1031-1038
doi: 10.1089/acm.2005.11.1031 pmid: 16398595
[14] Szapary PO, Wolfe ML, Bloedon LT , et al. Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial[J]. JAMA, 2003,290(6):765-772
doi: 10.1001/jama.290.6.765
[15] Dimpfel W, Kler A, Kriesl E , et al. Neurophysiological characterization of a functionally active drink containing extracts of ginkgo and ginseng by source density analysis of the human EEG[J]. Nutr Neurosci, 2006,9(5-6):213-224
doi: 10.1080/10284150601043713
[16] State Pharmacopoeia Commission. The Pharmacopoeia of People's Republic of China(2005 ed)[M]. Beijing: People's Medical Publishing House, 2005,( 2005 ed)
国家药典委员会. 中华人民共和国药典(2005年版)[M]. 北京: 人民卫生出版社, 2005,( 2005年版)
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