Abstract
Traditional Chinese medicine (TCM) is currently considered a complementary or alternative
medical system in most Western countries and has been increasingly accepted worldwide.
More and more clinical trials on TCM have been conducted internationally, and scientists
worldwide are becoming increasingly interested in the evaluation of clinical efficacy
of TCM based on clinical trials. This paper reviews the situation of clinical trials
on TCM in the past decade, including systematic reviews about clinical trials either
focusing on the treatment of disease with TCM approaches or focusing on one herbal
product, conduction of clinical trials on TCM either with randomization and controlled
methods or general observation. Some general issues on the conduct of clinical trials
on TCM, such as randomization, control, quality of life (QOL), patient reported outcomes
(PROs) and biomarkers, quality control, safety evaluation and case studies, are discussed,
and accordingly some suggestions are proposed.
Key words
traditional Chinese medicine - clinical trials - systematic review
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Prof. Hongxin Cao, MD
TCM Clinical Research Department
China Academy of Chinese Medical Sciences
Beijing 100700
People's Republic of China
Phone: +86 10 64 01 44 11-22 05
Fax: +86 10 64 03 26 59
Email: caohongxin898@hotmail.com
Prof. Aiping Lu, MD
Disease and TCM Pattern Correlation Research Department
China Academy of Chinese Medical Sciences
Beijing 100700
People's Republic of China
Phone: +86 10 64 06 76 11
Fax: +86 10 84 03 28 81
Email: lap64067611@126.com