Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅰ: clinical trial design and methodology
Zhao-Xiang BIAN 1, You-Ping LI 2, David MOHER 3, Simon DAGENAIS 3, Liang LIU 1, Tai-Xiang WU 2, Jiang-Xia MIAO 4, Andrew K. L. KWAN 1, Lisa SONG 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)
Objective: To discuss the quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) with respect to design and methodology, and provide suggestions for further improvement in future clinical trials. Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs). Results: The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6%) trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6%) trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8%) of trials were open-label, while only 13.2% used blinding. Almost half (45.5%) administered the CHM intervention as a tea or decoction. Only one trial (0.6%) reported a sample size calculation, and a single trial (0.6%) discussed quality control of the CHM intervention. Conclusion: The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. Recommendations: (1) Investigator conducting RCTs should have formal training about clinical trial design; (2) A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3) Conducting pilot studies prior to RCTs may help improve their design; (4) Registration of clinical trials and publishing their protocols prior to enrolment may reduce publication bias and solicit peer reviews of the proposed design; (5) Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.
【CateGory Index】： R285.6