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Journal of Chinese Integrative Medicine ›› 2006, Vol. 4 ›› Issue (2): 130-136.doi: 10.3736/jcim20060205

• Review • Previous Articles     Next Articles

Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅱ: Control group design

Zhao-xiang Bian1, You-ping Li2, David Moher3, Simon Dagenais3, Liang Liu1, Tai-xiang Wu2, Jiang-xia Miao4, Andrew K.L. Kwan1, Lisa Song1   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    3. Chalmers Research Group, Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    4. School of Chinese Medicine, Chinese University of Hong Kong, Hong Kong SAR, China
  • Online:2006-03-20 Published:2006-03-15

Objective

To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area.

Methods

A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis.

Results

Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug.

Conclusion

A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. Recommendations: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.

Key words: Randomized controlled trial, Chinese herbal medicine, Methodology, Quality assessment

CLC Number: 

  • R-3

"

Study design Quantity of RCTs (%)
CHM+conventional drug vs conventional drug 27 (40.9%)
CHM vs conventional drug 24 (36.4%)
CHM vs placebo 5 (7.6%)
CHM+conventional drug vs placebo+conventional drug 3 (4.5%)
CHM vs conventional drug vs other CHM 3 (4.5%)
CHM vs no treatment 1 (1.5%)
CHM+placebo vs conventional drug+placebo 1 (1.5%)
CHM vs CHM+conventional drug vs conventional drug vs placebo 1 (1.5%)
CHM vs conventional drug vs CHM+conventional drug 1 (1.5%)
Total 66 (100%)
[1] Su S. Atlas of Meteria Medica(1 st)[M]. Hefei: Anhui Science & Technology Publishing House,1995,(1 st):
[2] PREVENTION of whooping-cough by vaccination. a Medical Research Council investigation[J]. BMJ, 1951,( 4721):1463-1471
[3] Medical Research Council Streptomycin in Tuberculosis Trials Committee.Streptomycin treatment for pulmonary tuberculosis[J].BMJ, 1948, ii(): 769-782
[4] Shanghai collaborative group of clinical research on Buxux harlandii. Analysis of the effect of Buxux harlandii on coronary heart disease by double blind method. Report of 110 cases[J]. J Tradit Chin Med, 1983,24(5):37-40
[5] Freedman B . Equipoise and the ethics of clinical research[J]. N Engl J Med, 1987,317(3):141-145
doi: 10.1056/NEJM198707163170304 pmid: 3600702
[6] Bian ZX, Li YP, Moher D , et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅰ: clinical design and methodology[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(2):120-129
[7] .[ OTHER].Liu JP, Zhang M, Wang WY , et al. Chinese herbal medicines for type 2 diabetes mellitus. The Cochrane Database of Systematic Reviews, 2002, 3. . Chinese herbal medicines for type 2 diabetes mellitus. The Cochrane Database of Systematic Reviews, 2002, 3. 2005-10-08.
[8] Hill AB . Medical ethics and controlled trials[J]. BMJ, 1963,( 5337):1043-1049
doi: 10.1136/bmj.1.5337.1043 pmid: 2123937
[9] Rothman KJ, Michels KB . The continuing unethical use of placebo controls[J]. N Engl J Med, 1994,331(6):394-398
[10] Declaration of Helsinki Ⅳ ( 1992). The Nazi doctors and the Nuremberg Code: human rights in human experimentation(1 st)[M]. New York: Oxford University Press, 1995,( 1 st):339-342
[11] .[ Guidance for industry: E 10 choice of control group and related issues in clinical trials. 2001. , 2005-10-08.
[12] Weijer C, Shapiro SH, Cranley Glass K . For and against: clinical equipoise and not the uncertainty principle is the moral underpinning of the randomized controlled trial[J]. BMJ, 2000,321(7263):756-758
[13] Mann H , Djulbegovic B . Choosing a control intervention for a randomised clinical trial[J].Med Res Methodol, 2003, 3 7
[14] 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
[15] Melnikow J, Kiefe C . Patient compliance and medical research: issues in methodology[J]. J Gen Intern Med, 1994,9(2):96-105
[16] Vermeire E, Wens J, Van Royen P , et al. Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus[J]. Cochrane Database of Syst Rev , 2005, 18(2):CD003638
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