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Journal of Chinese Integrative Medicine: 2008; 6(8): 771-775
DOI: 10.3736/jcim20080801
Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine
1. Zhao-xiang BIAN (School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China E-mail: bzxiang@hkbu.edu.hk)
2. David MOHER (Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada )
3. You-ping LI (Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China )
4. Tai-xiang WU (Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China )
5. Simon DAGENAIS (Division of Orthopaedic Surgery and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada )
6. Chung-wah CHENG (School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China )
7. Jing LI (Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China )
8. Ting-qian LI (Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China )

Abstract: Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

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Please cite this article as:
Bian ZX, Moher D, Li YP, Wu TX, Dagenais S, Cheng CW, Li J, Li TQ. Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine. J Chin Integr Med / Zhong Xi Yi Jie He Xue Bao. 2008; 6(8): 771-775.
References:
1Reeve-Irving Research Centre. Anatomy 101: human research.http://www.reeve.uci.edu/anatomy/research.php#5.
2Wu 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. Chinese.
3Wu 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.  .
4Liu JP. Evidence-based medicine approach and traditional Chinese medicine therapeutic evaluation[J].Shou Du Yi Ke Da Xue Xue Bao, 2007, 28(2): 212-215. Chinese with abstract in English.
5Cheng CW, Bian ZX, Li YP, et al. CONSORT serial 1: How to explain the methodological rationale of randomized controlled trials of traditional Chinese medicine?[J].Zhongguo Xun Zheng Yi Xue Za Zhi, 2008, 8(3): 152-154. Chinese.
6Good PI. A manager's guide to the design and conduct of clinical trials[M]. 2nd ed. New Jersey: John Wiley & Sons, Inc, 2006.  .
7Ministry of Health of the People's Republic of China. Guidelines of clinical research on Chinese new herbal medicines[M]. Beijing: Medical Science and Technology Publishing House of China, 1993. Chinese.
8State Administration of Traditional Chinese Medicine. Diagnostic and therapeutic effect evaluation criteria of diseases and syndromes in traditional Chinese medicine[M]. Nanjing: Nanjing University Press, 1994. Chinese.

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