01a Introducing anthroposophic medicine
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Browsing 01a Introducing anthroposophic medicine by Author "van Wietmarschen, Herman"
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Publication Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment(2022) Baars, Erik W.; Kienle, Gunver S.; Heusser, Peter; Pedersen, Peter A.; van Wietmarschen, Herman; Kiene, Helmut; von Schoen-Angerer, Tido; Hamre, Harald J.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, drug regulation, conceptualization, integrative medicine, whole medical system, literature review
Citation: Baars, E. W., Kienle, G. S., Heusser, P., Pedersen, P. A., Wietmarschen, H. A. van, Kiene, H., von Schoen-Angerer, T., & Hamre, H. J. (2022). Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment. Global Advances in Health and Medicine, 11, 21649561211073080. https://doi.org/10.1177/21649561211073079
Publication Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases(2021) Jong, Miek C.; van Wietmarschen, Herman; Glockmann, Anja; Baars, Erik W.; Hamre, Harald J.Background Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide.
Objective To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs).
Patients and Methods Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold.
Results In the period 2010–2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (1.9%) were classified as serious. The frequency of ADRs for all AMPs was 1.50 per million MDADs. For serious ADRs the frequency was 0.03 per million MDADs. ADRs were more frequently reported with parenteral AMP administration (injections) than with oral or local administration (18.85 vs. 0.59 vs. 1.61 ADRs per million MDADs, respectively; p < 0.0001). The large majority of users (91.9%) had recovered or were recovering from the ADRs and there were no reports with a fatal outcome. Most frequently reported ADR symptom was injection site inflammation for parenteral AMPs (4.66 ADRs per million MDADs), nausea for oral AMPs (0.03 ADRs per million MDADs), and eye irritation for locally administered AMPs (0.23 ADRs per million MDADs).
Conclusions In this retrolective safety analysis of pharmacovigilance data, the frequency of ADRs to AMPs was 1.50 per million MDADs. Notably, the ADR frequency in this study based on spontaneous reporting is not directly comparable to frequencies in prospective clinical studies nor to frequencies based on other measures of patient exposure than MDADs.
Citation: Jong, M. C., van Wietmarschen, H., Glockmann, A., Baars, E. W., & Hamre, H. J. (2021). Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases. Drugs - Real World Outcomes, 8(4), 589–601. https://doi.org/10.1007/s40801-021-00262-7