Analysis of Safety Reporting in Clinical Trials on Herbal Medicine Published in Chinese Journals

Abstract

Abstract: Objective To evaluate the safety reporting in randomized clinical trials（RCT） on Chinese herbal medicine published between 2005 to 2009 and compare with the previous Results to find out whether there is any improve-ment. Methods Searched Journal of Traditional Chinese Medicine, Fujian Journal of Traditional Chinese Medicine and Journal of Chengdu University of Chinese Medicine for all the RCTs on herbal meidicne published in the recent 5 years, extracted data about safety reporting in method, result and discussion. Results In the three journals reviewed, only 37%（204/550）、38%（140/364）and 38%（29/76）respectively reported safety data, which did not demonstrate im-provement compared with the previous data from 15 years （over arching 25 years in total） as 40%（354/879）, 38%（173/452）, and 33%（40/123）, respectively. Conclusion The awareness of safety observation and reporting in herbal trials is still far away from their sufficient reporting.

Key words: Chinese herbal medicine, clinical trial, safety, Chinese journals, reporting

CLC Number:

R286

LI Xun, LI Xin-xue, LIU Zhi-jun, MA Li-xin, LIU Jian-ping. Analysis of Safety Reporting in Clinical Trials on Herbal Medicine Published in Chinese Journals[J]. Chinese Journal of Pharmacovigilance, 2010, 7(1): 20-24.

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