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Journal of Chinese Integrative Medicine ›› 2006, Vol. 4 ›› Issue (1): 1-64.doi: 10.3736/jcim20060101

• Editorial •     Next Articles

Methodological quality assessment of clinical trials in traditional Chinese medicine: The principles of evidence-based medicine

Jian-ping Liu   

  1. Evidence-based Chinese Medicine Center for Clinical Research and Evaluation, School of Preclinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Online:2006-01-20 Published:2006-01-15
  • Contact: Jian-ping Liu E-mail:jianping_l@hotmail .com

The quality of clinical trials in traditional Chinese medicine (TCM) was analyzed with respect to their methodology and outcome assessment according to the concepts of evidence-based medicine (EBM). It was suggested that the essential methodological principles of EBM should be applied in clinical trials of TCM, including randomization, control and blindness. The sample size estimation, optimal parameter selection for outcome assessment, compliance and intention-to-treat analysis are all important aspects of randomized controlled trials. To bring the benefits of EBM into clinical trials will improve the quality of research in TCM and also promote international co-operation and communications. It is necessary to establish an assessment system of clinical outcome for TCM on the basis of EBM in order to evaluate the efficacy and safety of TCM objectively and scientifically.

Key words: Medicine, Traditional Chinese, Evidence-based medicine, Clinical trials, Methodology

CLC Number: 

  • R2-05
[1] 刘建平 . 中医药研究随机对照试验质量的现状及对策[J]. 中国中西医结合杂志, 2003,23(1):62-64
[2] 詹思远, 唐金陵, 谢立亚 , 等. 中医药学术期刊随机对照临床试验文章评阅及建议[J]. 中国中西医结合杂志, 1999,19(9):568
doi: 10.7661/CJIM.1999.9.568
[3] Liu JP, Kjaergard LL, Gluud C . Misuse of randomization: a review of Chinese randomized trials of herbal medicines for chronic hepatitis B[J]. Am J Chin Med, 2002,30(1):173-176
[4] 刘建平 . 临床试验随机化的概念与方法[J]. 中国中西医结合杂志, 2003,23(4):244-246
[5] Schulz KF, Chalmers I, Hayes RJ , et al. Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995,273(5):408-412
[6] Jadad A. Randomized controlled trials(1st ed)[M]. London: BMJ Publishing Group, 1998,( 1st ed):1-9
[7] World Medical Association . Declaration of Helsinki: ethical principles for medical research involving human subjects[J]. JAMA, 2000,284(23):3043-3045
[8] 刘建平 . 中医药临床试验的对照与盲法设置[J]. 中国中西医结合杂志, 2003,23(10):789-791
doi: 10.7661/CJIM.2003.10.789
[9] Juni P, Altman DG, Egger M . Systematic reviews in health care: Assessing the quality of controlled clinical trials[J]. BMJ, 2001,323(7303):42-46
doi: 10.1136/bmj.323.7303.42 pmid: 11440947
[10] 刘建平 . 临床试验样本含量的计算[J]. 中国中西医结合杂志, 2003,23(7):536-538
doi: 10.7661/CJIM.2003.7.536
[11] 刘建平 . 临床试验效应的表达——指标及其意义[J]. 中国中西医结合杂志, 2004,24(8):677-679
[12] 刘建平 . 随机对照试验的依从性和意向性治疗分析[J]. 中国中西医结合杂志, 2003,23(12):884-886
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