Adverse drug reactions to anthroposophic and homeopathic solutions for injection: a systematic evaluation of German pharmacovigilance databases
ABSTRACT PURPOSE: Medicinal solutions for injection are frequently applied in anthroposophic medicine and homeopathy. Despite their extensive use, there is little data published on the safety of these products. Therefore, we investigated the safety of anthroposophic and homeopathic solutions for injection through a systematic evaluation of adverse drug reactions (ADRs). METHODS: ADRs were extracted from the pharmacovigilance databases of eight German manufacturers. Analysed ADRs included case reports in humans only, (spontaneous) case reports from post-marketing surveillance, literature and clinical/safety trials. RESULTS: Between 2000 and 2009, in total, 303 million ampoules for injection were sold, and 486 case reports were identified, corresponding to a total number of 1180 ADRs. Of all case reports, 71.8% (349/486) included ADRs that were listed (e.g. stated in package leaflet), and 9.5% (46/486) of the reports were classified as serious. The most frequently reported ADRs were pruritus, followed by angioedema, diarrhoea and erythema. A total of 27.3% (322/1180) were localized reactions for example; application or injection site erythema, pain, swelling and inflammation. The overall reporting rate of ADRs associated with injections was less than 4 per 1 million sold ampoules and classified as very rare. CONCLUSIONS: Our systematic evaluation demonstrated that the reporting rate of ADRs associated with anthroposophic and homeopathic solutions for injection is very low. Most reported ADRs were listed, and one quarter consisted of local reactions. These findings suggest a low risk profile for solutions for injection as therapeutically applied in anthroposophic medicine and homeopathy. Copyright © 2012 John Wiley & Sons, Ltd.
SourceAvailable from: Harald Johan Hamre[Show abstract] [Hide abstract]
ABSTRACT: Anthroposophic treatment includes special artistic and physical therapies and special medications. We here report an update to a previously published study of anthroposophic treatment for chronic diseases, including more patients and a longer follow up. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational cohort study of anthroposophic treatment for chronic indications in routine outpatient settings in Germany. Anthroposophic treatment was associated with improvements of symptoms and quality of life. Previous follow-up-analyses have been performed after 24 months or, in subgroups of patients enrolled in the period 1999-2001, after 48 months. We conducted a 48-month follow-up analysis of all patients enrolled in AMOS in the period 1999-2005. 1,510 outpatients aged 1-75 years, starting anthroposophic treatment for chronic conditions in routine German outpatient settings, participated in a prospective cohort study. Main outcomes were Symptom Score (primary outcome, mean symptom severity on numerical rating scales), SF-36 Physical and Mental Component scores in adults, and disease-specific outcomes in the six most common diagnosis groups: asthma, anxiety disorders and migraine (numerical rating scales), depression (Center for Epidemiological Studies Depression Scale), attention deficit hyperactivity symptoms (FBB-HKS Total score), and low back pain (Hanover Functional Ability Questionnaire, Low Back Pain Rating Scale). Median disease duration at baseline was 3.5 years. From baseline to 48-month follow-up all ten outcomes improved significantly (p < 0.001 for all pre-post comparisons). Standardised Response Mean effect sizes were large (range 0.84-1.24 standard deviations) for seven comparisons, medium for two comparisons (SF-36 Mental Component: 0.60, Low Back Pain Rating Scale: 0.55), and small for one comparison (SF-36 Physical Component: 0.39). Symptom Score improved significantly with large effect sizes in adults and children, and in the four main anthroposophic therapy modality groups (art therapy, eurythmy therapy, rhythmical massage therapy, medical therapy). This 48-month follow-up analysis confirmed previous analyses from the AMOS study. Outpatients receiving anthroposophic treatment for chronic indications had sustained, clinically relevant improvements of symptoms and quality of life.BMC Research Notes 07/2013; 6(1):269. DOI:10.1186/1756-0500-6-269