Abstract
Safety of drugs is a common concern, regardless of traditional Chinese medicine or Western medicine. Historical experiences tell us that ignored drug safety evaluation would lead to serious consequences. Although Chinese medicine has been used for thousands of years, reevaluation of the safety is still very important. The criteria for safety of Chinese herbal medicines should be the same as those for chemical drugs. Many Chinese herbal medicines have a long history of traditional use. However, many of them do not possess proven safety and efficacy by today’s standards. Well- designed randomized controlled trials and comprehensive pre-clinical toxicological studies were not done. Although the lack of such evidence does not absolutely count against the efficacy and safety of Chinese herbs, laboratory and clinical investigations are still needed before the herbs could be considered safe. This paper reviews the evaluation on the safety of Traditional Chinese Medicine.
Highlights
IntroductionMore than 40 major drug disasters happened in the world. Such incidents alerted people of all levels about the importance of drug safety
The Need for Safety EvaluationIn the last century, more than 40 major drug disasters happened in the world
In the situations of traditional Chinese medicine, the history has been over 3000 years, and has been generally considered safe; the safety data derived from scientific tests remain very limited
Summary
More than 40 major drug disasters happened in the world. Such incidents alerted people of all levels about the importance of drug safety. The result was 8000 to 10,000 babies were born with congenital malformations [1,2,3] Such disasters caused by chemical drugs made clinicians and authorities realize the importance of drug safety before promotion. In the situations of traditional Chinese medicine, the history has been over 3000 years, and has been generally considered safe; the safety data derived from scientific tests remain very limited. Many commonly used Chinese herbs are already known to be highly toxic, such as Strychnos, Radix Aconiti, Radix Aconiti Kusnezoffii, Fructus Crotonis, Sheeploitered Azalea etc. Others such as Rhizoma Arisaematis, Rhizoma Pinelliae, Realgar, Rhizoma Polygoni Cuspidati, and Radix Sophorae Tonkinensis are moderately toxic; while many others are mildly toxic.
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