Possible genotoxicity of drugs used in Chinese medicine and the implications for treatment of pregnant mothers (Article)
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Offenbacher Str. 5, Berlin, Germany
Abstract
Among the various risks that have to be taken into consideration when drugs are used for the treatment of pregnant mothers is that of genotoxicity. Of course, the problem is not significant to pregnant mothers alone, but it is particularly critical for this group of patients as well as for those undergoing fertility treatment. Hitherto, the world of Traditional Chinese Medicine has hardly been aware of this risk at all, although there is a significant amount of data available, mostly in Chinese publications. With regard to one particular medicinal, namely Rhizoma Coptidis (Huanglian), an extensive study conducted in Taiwan provided evidence that children of mothers who had taken this drug during pregnancy tended to develop tumours when they reached the age of 14.9 years on average. However, data taken from epidemiological studies on humans or from long-term carcinogenicity studies on animals, which represent the "gold standard", are the exception in Chinese Medicine. As a rule, one is obliged to resort to in-vitro of in-vivo data from mutagenicity or genotoxicity studies in order to be able to assess the carcinogenic risk. These data can only be applied to a limited extent to therapeutic situations during pregnancy. The article presents data available from mutagenicity or genotoxicity studies of 30 drugs that are of relevance to treatments during pregnancy. The results are predominantly negative, partly contradictory and partly positive. It is to be noted that there is a hierarchy to be observed in test procedures. A positive genotoxicity test does not necessarily mean that there must be a significant carcinogenic risk. There are many foods that also contain substances which have been shown to have genotoxic or carcinogenic properties. Ideally, to assess the risk accurately, anti-mutagenic effects also need to be considered, and the risk must be clearly quantified. At present, however, in the field of Chinese Medicine the prerequisites for such assessments are missing. In the case of doubt, and this is particularly true with regard to treating patients who are pregnant, one must be guided by the principle of "safety first". For the 30medicinal drugs that are relevant to pregnancy, an estimation of the genotoxic risk is made. In addition, a list is given of the drugs that represent a particular genotoxic and/or carcinogenic risk and whose use is not to be recommended at all with patients who are pregnant. An estimation of this kind is to an extent subjective, it is liable to change and will have to be revised in one direction or another when further data becomes available. In Germany a work group, Arbeitsgruppe Sicherheit der Chinesischen Arzneitherapie in der Schwangerschaft (ASCAS) has been created to provide a judgement on the risks that Chinese medicinal drugs represent to pregnant mothers.
Author keywords
Carcinogenicity; Chinese herbal therapy; Genotoxicity; Mutagenicity; Pregnancy; Pregnancy risks
Indexed keywords
EMTREE drug terms: Chinese drug; Coptis rhizome extract
EMTREE medical terms: Article; carcinogenicity; Chinese medicine; drug safety; genotoxicity; health hazard; human; infertility therapy; mutagenicity; nonhuman; prenatal exposure; Taiwan
ISSN: 09302786 CODEN: CHMEFSource Type: Journal Original language: German
Document Type: Article
Publisher: Urban und Vogel GmbH
