Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network

Abstract

BackgroundThere is a need for data on the clinical safety of anthroposophic medicinal products (AMPs).ObjectivesThe main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.MethodsEvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. All physicians documented ADRs of Grades III–IV and serious ADRs, seven ‘prescriber physicians’ also documented non-serious ADRs of any intensity. Patients were eligible for this analysis if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit.ResultsA total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. Among patients of prescriber physicians, ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. In subgroup analyses according to age, specific AMPs or AMP groups, dosage forms, and concentrations (altogether 11 groups), the highest ADR frequency was 0.290% of prescriptions (for one specific AMP). Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.ConclusionIn this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.Electronic supplementary materialThe online version of this article (doi:10.1007/s40801-017-0118-5) contains supplementary material, which is available to authorized users.

Contributing to Global Health: Development of a Consensus-Based Whole Systems Research Strategy for Anthroposophic Medicine

“…With regard to safety, a variety of objectives and methods can provide information and have been used for investigations in AM: a key source for safety data are adverse events and tolerability assessed within clinical trials and studies. Another, much wider source for safety information is pharmacovigilance studies and health service research [59, 89]. Many side effects of interventions, also rare ones, are captured with case reports and reports from authorities [39].…”

“…The multimodal approach, applying several interventions (including conventional and other T&CM methods) in the same patient, depending on the condition. This addresses the complexity of chronic NCDs in particular and the frequent concomitant diseases.The large diversity of treatments: about 1000 medicinal products and medicinally used natural substances [59], as well as therapeutic approaches like nursing approaches, arts or movement therapies, and counseling. This by far exceeds the single-component efficacy testing with one or two clinical trials each.The limited number of patients “fitting into” the trials while accepting a standardized care allocated randomly and who are not already recruited by competing trials [60–62].…”

“…The large diversity of treatments: about 1000 medicinal products and medicinally used natural substances [59], as well as therapeutic approaches like nursing approaches, arts or movement therapies, and counseling. This by far exceeds the single-component efficacy testing with one or two clinical trials each.…”

The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies

“…Adverse reactions to homeopathic and anthroposophic MPs are infrequent and usually of mild to moderate severity, and anaphylactic reactions occur but are very rare [15, 57, 184].…”

Mapping Physicians’ Experiences with Medicinal Products from Whole Medical Systems: A Descriptive Analysis of the <b><i>Vademecum of Anthroposophic Medicines</i></b>

“…according to Good Manufacturing Practice and national drug regula-DOI: 10.1159/000507541 tions [8]. The available evidence suggests that AMPs are generally well tolerated, with infrequent adverse reactions of mostly mild to moderate severity [9,10].…”