Assessment of the genotoxic safety of herbal drug preparations used for constipation

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.

Publication History

Article published online:
13 June 2022

• References

• 1 Eidgenössisches Departement des Innern EDI, Bundesamt für Lebensmittelsicherheit und Veterinärwesen BVL. Toxikologisches Gutachten, 21.04.2021
• 2 EFSA Journal 2018; 16(1): 5090