Background. In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany. Methods. A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated. Results. Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5？cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies. Conclusion. The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe. 1. Introduction Effective treatment of cancer remains one of the biggest challenges to modern medicine. Due to conventional therapies such as chemotherapy and radiation often falling short of their goals, and to patient dissatisfaction concerning adverse effects associated with these treatments, complementary and alternative medicines (CAM) are becoming increasingly popular [1]. Anthroposophic medicine (AM), founded in the 1920s by Rudolf Steiner and Ita Wegman, is a person-centred medical approach which combines conventional medicine with the use of CAM remedies and specialised therapies, such as physical and artistic therapies [2]. AM uses an integrative approach to treat cancer, focusing not only on elimination of pathological entities (conventional therapies), but also activating salutogenetic resources by using European mistletoe extracts (Viscum album L.), and other therapies, with the aim of improving health related functions or preventing further disease [2]. Mistletoe therapy is amongst the most frequently used complementary treatments by cancer patients in Europe [3]. In 2003 more than 18
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