Review Article of Journal of Herbal Medicine Research
On Clinical Development of Traditional Chinese Herbal Medicine
Qianqian Lin1* and Shein-Chung Chow2
1Qianqian Lin’ Ling’s Acupuncture,Orlando, Florida
2Duke University School of Medicine, Durham, North Carolina
In recent years, the slowdown of new drug development has resulted in search for alternative medicines such as traditional Chinese herbal medicine (TCM) that can treat critical and/or life-threatening diseases in the medical community and pharmaceutical industry. Although the development of promising traditional Chinese herbal medicine has great potential, it has been challenged regarding how to effectively and scientifically develop and evaluate a promising TCM under investigation due to the fact that there are some fundamental differences between a Western medicine and a TCM. This article provides a comprehensive review of critical issues that are commonly encountered during the development of a TCM. These issues include, but are not limited to, variation (or consistency) in raw materials, component-to-component interactions, animal studies, matching placebo and calibration of study endpoints in clinical trials, packaging insert, and transition from experience-based to evidence-based clinical practice and investigation.
Keywords: Chinese herbal medicine; Test for consistency; Flexible dose; Matching placebo; Evidence-based clinical investigation; Global dynamic balance or harmony;