Introduction Herbal medicinal products play an important role in the treatment of a whole range
of gastrointestinal ailments, including constipation. Clinical studies and many years
of experience have proven the effectiveness of the extracts of a number of herbal
drugs that have a group of ingredients in common, the anthraquinone derivatives. The
genotoxic safety of these drugs has been repeatedly discussed over the last years
[1]
[2].
Objective Additional data on the genotoxic potential are therefore desirable, for allowing
assessments of the therapeutic safety of these drugs, using the Ames test according
to the genotoxicity guideline of HMPC.
Methods Extracts from Aloes folii succus siccatus, Rhamni pushianae cortex, Frangulae cortex,
Rhei radix, Sennae fructus and Sennae folium drugs were tested in the Ames test.
Results The extracts did not show a mutagenic effect, even not in the highest concentrations
according to the OECD guidance.
Discussion The data add to the evidence from the published literature, which was evaluated according
to the PRISMA statement, and support therapeutic safety when used according to the
instructions in the resp. HMPC monographs.
Acknowledgements We thank Kooperation Phytopharmaka GBR, Bonn, Germany for its support of the project,
and study course head PD Dr. Heike Franke and study course coordinator M. Sc. Adelgunde
Graefe for making it possible to conduct this work as a thesis at the postgradual
study course in toxicology (PGS Toxikologie) at Leipzig University, Leipzig, Germany.