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Traditional Chinese Medicine (TCM)
 
TCM formulations are perhaps the best-known botanical drugs to have been derived from empirical observations in humans over the millennia.  Unlike Western medicine that generally uses purified compounds and targets a single physiological endpoint, TCM compositions usually comprise multiple herbs and components that interact and act simultaneously through multiple molecular targets and cellular mechanisms.  The herbs in a typical TCM prescription are assigned roles: principal or imperial herb, ministerial herb, assistant herb, and servant herb.  These multiple herbs serve various functions; some may be responsible for efficacy while others may decrease toxicity or increase bioavailability.  The claimed indication of any given Chinese medicinal preparation is multiple rather than single.  This is not surprising since many phytochemical ingredients in a formulation can exert actions at multiple targets and biological pathways.  Today, mixtures of botanical extracts are widely used throughout the world for the management of disease and are gaining increased acceptance in the Western world.
 

The FDA monitors botanical products in the U.S. under the Dietary Supplement and Health Education Act (DSHEA).  Approximately one third of the U.S. population has tried some form of alternative medicine at least once.  The FDA has recently issued its industry guidelines for botanical product drugs.  However, there is, as yet, no FDA-approved botanical prescription drug in the U.S.
 
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