Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology.

@article{citeulike:2504159, abstract = {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 enrollment 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.}, address = {School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. bzxiang@hkbu.edu.hk}, author = {Bian, Z. X. and Li, Y. P. and Moher, D. and Dagenais, S. and Liu, L. and Wu, T. X. and Miao, J. X. and Kwan, A. K. and Song, L. }, citeulike-article-id = {2504159}, issn = {1672-1977}, journal = {Zhong Xi Yi Jie He Xue Bao}, keywords = {cam}, month = {March}, number = {2}, pages = {120--129}, posted-at = {2008-03-10 19:06:55}, priority = {2}, title = {Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/16529686}, volume = {4}, year = {2006} }

TY - JOUR ID - citeulike:2504159 L3 - citeulike-article-id:2504159 TI - Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology. JF - Zhong Xi Yi Jie He Xue Bao VL - 4 IS - 2 SP - 120 EP - 129 AD - School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. bzxiang@hkbu.edu.hk SN - 1672-1977 N2 - 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 enrollment 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. KW - cam AU - Bian, ZX AU - Li, YP AU - Moher, D AU - Dagenais, S AU - Liu, L AU - Wu, TX AU - Miao, JX AU - Kwan, AK AU - Song, L PY - 2006/03// UR - http://view.ncbi.nlm.nih.gov/pubmed/16529686 ER -