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Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development |
Zhaoxiang Bian1(), Baoyan Liu2, David Moher3, Taixiang Wu4, Youping Li4, Hongcai Shang5, Chungwah Cheng1 |
1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China; 2. China Academy of Chinese Medical Sciences, Beijing 100700, China; 3. Chalmers Research Group, Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada; 4. Department of Clinical Epidemiology, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China; 5. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China |
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Abstract The reporting standards for randomized controlled trials were first published in 1996 by a group of scientists under the name “CONSORT,” which means consolidated standards of reporting trials. Revisions followed in 2001 and 2010. A draft of the CONSORT for traditional Chinese medicine (TCM) was published in both Chinese and English in 2007. After publication of the draft, comments were solicited from the medical community. Some papers did raise concerns about which items should be included in the CONSORT for TCM such as the rationale of the trial design, intervention, outcome assessment, and adverse events. We have now reached the next step which is the finalization of the CONSORT for TCM. Three tasks remain. First, the major changes in CONSORT statement 2010 should be integrated into the CONSORT for TCM. Second, Chinese drugs from minerals and animals should be included in the guidelines. Finally, agreement must be reached among the working groups. Once the draft is finalized, wide dissemination and co-publication will be considered.
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Keywords
CONSORT for TCM
reporting standards
future development
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Corresponding Author(s):
Bian Zhaoxiang,Email:bzxiang@hkbu.edu.hk
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Issue Date: 05 June 2011
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1 |
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, G?tzsche PC, Lang T, CONSORT group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134(8): 663–694 pmid:11304107
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Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152(11): 726–732 pmid:20335313
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The CONSORT Group. Extensions of the CONSORT Statement. http://www.consort-statement.org
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Bian ZX, Li YP, Moher D, Dagenais S, Liu L, Wu TX, Miao JX, Kwan AK, Song L. Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology. J Chin Integr Med ( Zhong Xi Yi Jie He Xue Bao) 2006; 4(2): 120–129 (in Chinese) doi: 10.3736/jcim20060204 pmid:16529686
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Bian ZX, Moher D, Dagenais S, Li YP, Liu L, Wu TX, Miao JX. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design. J Chin Integr Med (Zhong Xi Yi Jie He Xue Bao) 2006; 4(2): 130–136 (in Chinese) doi: 10.3736/jcim20060205 pmid:16529687
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Bian ZX, Moher D, Dagenais S, Li YP, Wu TX, Liu L, Miao JX, Song L, Zhang HM. Improving the quality of randomized controlled trials in Chinese herbal medicine, part IV: applying a revised CONSORT checklist to measure reporting quality. J Chin Integr Med (Zhong Xi Yi Jie He Xue Bao) 2006; 4(3): 233–242 (in Chinese) doi: 10.3736/jcim20060303 pmid:16696907
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12 |
Wu TX, Li YP, Bian ZX, Chen KJ, Shang BL, Shang HC, Moher D. Consolidated standards for reporting trials of traditional Chinese medicine (CONSORT for TCM). Chin J Evid Based Med (Zhong Guo Xun Zheng Yi Xue Za Zhi) 2007; 7(8): 601–605 (in Chinese)
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Wu TX, Li YP, Bian ZX, Chen KJ, Shang BL, Shang HC, Moher D. Consolidated standards for reporting trials of traditional Chinese medicine (CONSORT for TCM). Chin J Evid Based Med (Zhong Guo Xun Zheng Yi Xue Za Zhi) 2007; 7(8): 625–630
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MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med 2001; 9(4): 246–249 doi: 10.1054/ctim.2001.0488 pmid:12184354
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MacPherson H, Altman DG, Hammerschlag R, Li YD, Wu TX, White A, Moher D. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. PLoS Med 2010; 7(6): e1000261 doi: 10.1371/journal.pmed.1000261 pmid:20543992
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Cheng CW, Bian ZX, Li YP, Moher D, Wu TX, Dagenais S, Li J, Li TQ. How to explain the methodological rationale of randomized controlled trial on traditional Chinese medicine. Chin J Evid Based Med ( Zhong Guo Xun Zheng Yi Xue Za Zhi) 2008; (3):152–154 (in Chinese)
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Bian ZX, Moher D, Li YP, Wu TX, Dagenais S, Cheng CW, Li J, Li TQ. Precise reporting of traditional Chinese medicine interventions in randomized controlled trials. J Chin Integr Med (Zhong Xi Yi Jie He Xue Bao) 2008; 6(7): 661–667 (in Chinese) doi: 10.3736/jcim20080701 pmid:18601844
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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 (in Chinese) doi: 10.3736/jcim20080801 pmid:18664342
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Cheng CW, Bian ZX, Li YP, Moher D, Wu TX, Dagenais S, Li J, Li TQ. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. J Chin Integr Med (Zhong Xi Yi Jie He Xue Bao) 2008; 6(9): 881–886 (in Chinese) doi: 10.3736/jcim20080901 pmid:18782527
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