Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment

Erik W Baars; Gunver S Kienle; Peter Heusser; Peter A Pedersen; Herman A van Wietmarschen; Helmut Kiene; Tido von Schoen-Angerer; Harald J Hamre

doi:10.1177/21649561211073079

Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment

Glob Adv Health Med. 2022 Mar 8:11:21649561211073079. doi: 10.1177/21649561211073079. eCollection 2022.

Authors

Erik W Baars^{1

2

3}, Gunver S Kienle^{1

4

5

6}, Peter Heusser^{1

5}, Peter A Pedersen^{1

7}, Herman A van Wietmarschen^{1

2}, Helmut Kiene^{4

5}, Tido von Schoen-Angerer⁸, Harald J Hamre^{1

4

5}

Affiliations

¹ ESCAMP, European Scientific Cooperative on Anthroposophic Medicinal Products, Freiburg, Germany.
² Department Nutrition & Health, Louis Bolk Institute, Driebergen, The Netherlands.
³ Faculty of Healthcare, University of Applied Sciences Leiden, Leiden, The Netherlands.
⁴ Institute for Applied Epistemology and Medical Methodology, Witten/Herdecke University, Freiburg, Germany.
⁵ Faculty of Health, Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany.
⁶ Faculty of Medicine, Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Freiburg, Germany.
⁷ Independent Pharmaceutical Consultant, Søborg, Denmark.
⁸ ARCIM Institute, Filderstadt, Germany.

Abstract

Background: Regulatory assessment of anthroposophic medicinal products (AMPs) can be challenging due to their specific features.

Objective: The aim of this paper is therefore to provide adequate scientific information on AMPs for regulatory purposes.

Methods: A literature review was executed with database searches in PubMed, Cinahl, Merkurstab, Anthromedics, and https://iaap-pharma.org/. Search terms were: anthroposophic medicinal products, anthroposophic medicines, anthroposophic pharmacy. There was no language restriction; searches were executed from onset until June 11, 2020. In addition, experts were invited to suggest relevant literature.

Results: Eighty-seven of 660 identified publications were included. The system of anthroposophic medicine (AM) with its conceptual background and various aspects of AMPs was described: definition, pharmaceutical properties, an example of AMP development, use in clinical practice, similarities with and differences to conventional medicinal products, societal aspects, scientific and regulatory assessment.

Conclusion: AMPs are part of the integrative whole medical system of AM. AMPs are manufactured according to Good Manufacturing Practice and national drug regulations and have an excellent safety status; the limited available evidence suggests clinical benefits. Current drug regulation of AMPs in the EU and most European countries does not take the special properties of AMPs into account. Future research should focus on appropriate methodologies for the evaluation of effects of AMPs as part of the AM whole medical system, the scientific quality of its non-atomistic holistic ontological position, and the integration of AM and conventional medicine in clinical practice. Future policies should focus on appropriate ways of addressing regulatory challenges to AMPs.

Keywords: anthroposophic medicinal products; conceptualization; drug regulation; integrative medicine; literature review; whole medical system.