Critical appraisal of clinical studies in Chinese herbal medicine

Journal of Chinese Integrative Medicine

Volumn 4, Issue 5, 2006, Pages 455-465

  Dagenais, Simon ^a,b   Tricco, Andrea C ^a,b   Bian, Zhao Xiang ^c   Huang, Wen Hua ^d   Moher, David ^a,b  

^a CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^b UNIVERSITY OF OTTAWA   (Canada)

^c HONG KONG BAPTIST UNIVERSITY   (Hong Kong)

^d SECOND MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

Chinese herbal medicine; CONSORT statement; Evidence based medicine; Randomized controlled trial; Research design

Indexed keywords

HEAVY METAL; HERBACEOUS AGENT; HERBICIDE; MYCOTOXIN; PESTICIDE; PLACEBO;

ACUPUNCTURE; ALLOPATRY; ALTERNATIVE MEDICINE; CHINESE MEDICINE; CLINICAL PRACTICE; CLINICAL TRIAL; CONSUMER; DIETARY INTAKE; EVIDENCE BASED MEDICINE; GOOD MANUFACTURING PRACTICE; HUMAN; LIFESTYLE; MEDICAL RESEARCH; METHODOLOGY; MOXIBUSTION; PERSONNEL MANAGEMENT; PHYSICIAN; QUALITY CONTROL; RATING SCALE; REVIEW;

EVIDENCE-BASED MEDICINE; HUMANS; MEDICINE, CHINESE TRADITIONAL; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 33748948247     PISSN: 16721977     EISSN: None     Source Type: Journal    
DOI: 10.3736/jcim20060504     Document Type: Review

References (38)

1. Kessler RC, Davis RB, Foster DF, et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Intern Med, 2001, 135(4): 262-268.
2. Tindle HA, Davis RB, Phillips RS, et al. Trends in use of complementary and alternative medicine by US adults: 1997-2002. Altern Ther Health Med, 2005, 11 (1): 42-49.
3. 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. JAMA, 1995, 273(5): 408-412.
4. Egger M, Juni P, Bartlett C, et al. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Health Technol Assess, 2003, 7(1): 1-6.
5. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312(7023): 71-72.
6. Meinert CL. Clinical trials: Design, conduct, and analysis. New York: Oxford University Press, 1986.
7. 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. Zhong Xi Yi Jie He Xue Bao, 2006, 4(2): 120-129.
8. Bian ZX, Moher D, Dagenais S, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design. Zhong Xi Yi Jie He Xue Bao, 2006, 4(2): 130-136.
9. Evans D. Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions. J Clin Nurs, 2003, 12(1): 77-84.
10. Hulley S, Cumming SR, Browner WS, et al. Designing clinical research. 2nd edition. Philadelphia: Lippincott Williams &. Wilkins, 2001.
11. Mulrow CD. The medical review article: state of the science. Ann Intern Med, 1987, 106(13):485-488.
12. Mulrow CD. Rationale for systematic reviews. BMJ, 1994, 309(6954): 597-599.
13. Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med, 1997, 126(5): 376-380.
14. AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Safety Health Care, 2003, 12(1): 18-23.
15. Gluud LL. Bias in clinical intervention research. Am J Epidemiol, 2006, 163(6): 493-501. Epub 2006 Jan 27.
16. Tsay MY, Yang YH. Bibliometric analysis of the literature of randomized controlled trials. J Med Libr Assoc, 2005, 93(4): 450-458.
17. Plint A, Moher D, Altman DG, et al. Does the CONSORT checklist improve the quality of reports of randomized controlled trials? A systematic review. Presented at the 5th International Congress on Peer Review and Biomedical Communication (Chicago, September 2005).
18. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276 (8): 637-639.
19. Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomized controlled trials: a systematic review. Med J Aust (in press).
20. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol, 2001, 1: 2. Epub 2001 Apr 20.
21. Freemantle N, Mason JM, Haines A, et al. CONSORT: an important step towards evidence-based health care. Consolidated Standards of Reporting Trials. Ann Intern Med, 1997, 126(1): 81-83.
22. Schulz KF. The quest for unbiased research: randomized clinical trials and the CONSORT reporting guidelines. Ann Neurol, 1997, 41(5): 569-573.
23. Huston P, Hoey J. CMAJ endorses the CONSORT statement. CONsolidation of Standards for Reporting Trials. CMAJ, 1996, 155(9): 1277-1282.
24. Davidoff F. News from the International Committee of Medical Journal Editors. Ann Intern Med 2000, 133 (3): 229-231.
25. Campbell MK, Elbourne DR, Altman DG, et al. CONSORT statement: extension to cluster randomised trials. BMJ, 2004, 328(7441): 702-708.
26. Piaggio G, Elbourne DR, Altman DG, et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA, 2006, 295(10): 1152-1160.
27. Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141 (10): 781-788.
28. Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med, 2006, 144(5): 364-367.
29. Moher D, Jadad AR, Tugwell P. Assessing the quality of randomized controlled trials. Current issues and future directions. Int J Technol Assess Health Care, 1996, 12(2): 195-208.
30. Moher D, Jadad AR, Nichol G, et al. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials, 1995, 16(1): 62-73.
31. Verhagen AP, de Vet HC, de Bie RA, et al. The art of quality assessment of RCTs included in systematic reviews. J Clin Epidemiol, 2001, 54(7): 651-654.
32. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
33. Pildal J, Chan AW, Hrobjartsson A, et al. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ, 2005, 330(7499): 1049. Epub 2005 Apr 7.
34. Juni P, Witschi A, Bloch R, et al. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA, 1999, 282(11): 1054-1060.
35. Emerson JD, Burdick E, Hoaglin DC, et al. An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Control Clin Trials, 1990, 11(5): 339-352.
36. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet, 1998, 352(9128): 609-613.
37. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions 4. 2. 5. 2005. http://www.cochrane.org/resources/handbook/ handbook.pdf.
38. Leung KSY, 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. Zhong Xi Yi Jie He Xue Bao, 2006, 4(3): 225-232.