ABSTRACT
OBJECTIVE: To examine the characteristics of the evidence-based clinical literatures regarding the Chinese patent medicines on the National Essential Medicine List of China (2009 Edition) so as to lay a foundation for the establishment of an evidence-based pharmaceutical review system for the Chinese patent medicines oriented at treating TCM-syndromes. METHODS: The evidence-based literatures on Chinese patent medicines were categorized, and their characteristics were analyzed concerning the distribution of the literatures according to the five levels of evidence, the concentration of the diseases under treatment, and chronological changes; in accordance with the Drug Registration Regulation, the differences among these literatures were explored. RESULTS: With regard to the literatures on some Chinese patent medicines, there were a large proportion of randomized controlled trials (RCTs), with a rapid increase in the number of the literatures in recent years and a clear focus on certain diseases. By contrast, some other Chinese patent medicines had a high proportion of before-after studies and empirical introductions as well as a low concentration of diseases under treatment. CONCLUSION: The Chinese patent medicines can be divided into two categories, namely, the modern branch and the traditional branch. While the disease-oriented evidence-based review system can be applied to the evaluation of the literatures on some patent medicines in the modern branch, it does not fit the traditional branch. Therefore, in order to reflect the characteristics of the Chinese patent medicines, a TCM-syndrome-oriented evidence-based review system has to be established. Copyright 2012 by the Chinese Pharmaceutical Association.