Safety

A number of analyses of anthroposophic medicinal products and approaches have confirmed good safety.

Safety of Anthroposophic Medicinal Products

The safety of Anthroposophic Medicinal Products (AMPs) is well documented.

The medicine safety analysis from the Evaluation of Anthroposophic Medicine (EvaMed) , a prospective pharmacovigilance study in Germany, comprised 44,662 outpatients with altogether 311,731 prescriptions of AMP. Adverse reactions were rare (0.071% of prescriptions), serious adverse reactions were very rare (0.0003%). 

The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicentre study of 1631 outpatients. The incidence of confirmed adverse reactions was 3.0% of users and one adverse reaction per 382 patient-months of AMP use. No severe adverse reaction occurred. The lower rate of adverse reactions in EvaMed was likely related to a younger patient cohort.

Viscum album (mistletoe) extracts are among the most widely used complementary oncological treatments in Europe. Safety of Viscum album extracts has been assessed systematically in different reviews, as summarised by Kienle et al. Dose-dependent and harmless reactions such as local swelling, redness, itching and pain as well as flu-like symptoms are frequently reported. Mistletoe can occasionally cause pseudo-allergic or very rarely anaphylactic reactions. In a systematic review of Viscum album’s use in cancer care looking at 18 clinical trials with over 6,800 participants, only one adverse reaction was recorded, and allergic reaction was rare. 

Safety of non-pharmacological Anthroposophic Medicine interventions

The incidence of reported adverse reactions to anthroposophic arts therapies, Eurythmy therapy and Rhythmical Massage in the Anthroposophic Medicine Outcomes Study (AMOS) was 2.0% of users for any reaction; 0.4% for reactions of severe intensity; and 0.3% for reactions leading patients to stop their therapy; reactions were not assessed for causality. No severe adverse reaction occurred. 

IVAA Position on Safety

The safety of Anthroposophic Medicinal Products (AMPs) and other therapies has been demonstrated by a number of studies. The IVAA therefore calls on policy makers to:

1. Create an enabling policy environment for more widespread availability of AMPs
2. Support further research into safety and efficacy of AMPs and other anthroposophic approaches

Further Reading on Safety

1. Hamre HJ, et al., Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network. Drugs – Real World Outcomes, 2017. 
2. Hamre HJ, et al., Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study. Glob Adv Health Med, 2014. 
3. Kienle, G.S., H. Kiene, and H.U. Albonico, Anthroposophic Medicine: Effectiveness, Utility, Costs, Safety. 2006: Schattauer.