Herbal Medicinal Products – Ethical considerations towards a better representation in medical guidelines

Medical guidelines play an increasing role in therapy, and more and more herbal medicinal products are included (e.g. [ 1 ] [ 2 ]). Still, while e.g. the evidence of NSAIDs has been originally only characterized in pain after tooth extraction, they are now established for a broad range of pain syndromes, while herbal medicinal products (HMPs), despite having, based on their tradition of use and their pharmacology, an equally broad field of application, tend to be only considered in guidelines when a study in the specific pain syndrome is available. A similarly narrow approach can be observed for adjuvant therapies in oncological patients. For a recommendation of respective HMPs to additional syndromes, accordingly for each of them an own randomized placebo controlled clinical trial (RCT) would be needed, while ethical considerations tend to support a reduction of the number of RTCs to a minimum [ 3 ]. Concepts to extrapolate clincal evidence to adjacent patient groups where searched and assessed. A guideline recently issued by ICH, the guideline on the extrapolation of clinical data from adult to pediatric patients (E11A) [ 4 ] [ 5 ] could be a model. There, in the benefit-risk assessment of an extrapolation, three questions are raised: How similar is (1) the disease, (2) the pharmacology of the drug, and (3) the response to therapy, considering the similarity between the two patient groups as a continuum. Transferring this systematic approach from the pediatric extrapolation also to the extrapolation of the evidence on HMPs between other patient groups could make these products with their often favorable benefit to risk ratio available for additional patient groups, without the need of additional, ethically sometimes questionable RCTs. Acknowledgements Many thanks to K. Kraft, Rostock, and K. Goldner, Berlin, for encouraging exchange. Publication History Article published online: 05 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany