Advertisement

Frontiers of Medicine

, Volume 5, Issue 2, pp 171–177 | Cite as

Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development

  • Zhaoxiang Bian
  • Baoyan Liu
  • David Moher
  • Taixiang Wu
  • Youping Li
  • Hongcai Shang
  • Chungwah Cheng
Review

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.

Keywords

CONSORT for TCM reporting standards future development 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T, CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134(8): 663–694PubMedGoogle Scholar
  2. 2.
    Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA 1994; 272(2): 125–128PubMedCrossRefGoogle Scholar
  3. 3.
    Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet 2001; 3 57(9263): 1191–1194PubMedCrossRefGoogle Scholar
  4. 4.
    Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996; 276(8): 637–639PubMedCrossRefGoogle Scholar
  5. 5.
    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): 726–732PubMedGoogle Scholar
  6. 6.
    Cals JW, van Amelsvoort LG, Kotz D, Spigt MG. CONSORT 2010 Statement-unfinished update? J Clin Epidemiol 2011 Jan 3; DOI:10.1016/j.jclinepi.2010.10.007Google Scholar
  7. 7.
    Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-andafter evaluation. JAMA 2001; 285(15): 1992–1995PubMedCrossRefGoogle Scholar
  8. 8.
    CONSORT Group. Extensions of the CONSORT Statement. http://www.consort-statement.org
  9. 9.
    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)CrossRefGoogle Scholar
  10. 10.
    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)CrossRefGoogle Scholar
  11. 11.
    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)CrossRefGoogle Scholar
  12. 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)Google Scholar
  13. 13.
    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): 625–630Google Scholar
  14. 14.
    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): 246–249PubMedCrossRefGoogle Scholar
  15. 15.
    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): e1000261PubMedCrossRefGoogle Scholar
  16. 16.
    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 (Zhongguo Xun Zheng Yi Xue Za Zhi) 2008; (3): 152–154 (in Chinese)Google Scholar
  17. 17.
    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)CrossRefGoogle Scholar
  18. 18.
    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)CrossRefGoogle Scholar
  19. 19.
    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)CrossRefGoogle Scholar

Copyright information

© Higher Education Press and Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  • Zhaoxiang Bian
    • 1
  • Baoyan Liu
    • 2
  • David Moher
    • 3
  • Taixiang Wu
    • 4
  • Youping Li
    • 4
  • Hongcai Shang
    • 5
  • Chungwah Cheng
    • 1
  1. 1.School of Chinese MedicineHong Kong Baptist UniversityHong KongChina
  2. 2.China Academy of Chinese Medical SciencesBeijingChina
  3. 3.Chalmers Research GroupChildren’s Hospital of Eastern Ontario Research InstituteOttawaCanada
  4. 4.Department of Clinical Epidemiology, Chinese Evidence-based Medicine Center, West China HospitalSichuan UniversityChengduChina
  5. 5.Tianjin University of Traditional Chinese MedicineTianjinChina

Personalised recommendations