title: Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L.) in Cancer Patients.
abstract: 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.
authors.affiliation: Research Institute Havelhoehe, 14089 Berlin, Germany.
authors.forename: Megan L
authors.initials: ML
authors.lastname: Steele
authors.affiliation: Research Institute Havelhoehe, 14089 Berlin, Germany.
authors.forename: Jan
authors.identifier: 0000-0003-1269-5586
authors.initials: J
authors.lastname: Axtner
authors.affiliation: Research Institute Havelhoehe, 14089 Berlin, Germany.
authors.forename: Antje
authors.initials: A
authors.lastname: Happe
authors.affiliation: Research Institute Havelhoehe, 14089 Berlin, Germany ; Hospital Havelhoehe, 14089 Berlin, Germany ; Institute for Social Medicine, Epidemiology and Health Economics, Charité-University Medical Center, 10117 Berlin, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Kröz
authors.affiliation: Research Institute Havelhoehe, 14089 Berlin, Germany ; Hospital Havelhoehe, 14089 Berlin, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Matthes
authors.affiliation: Research Institute Havelhoehe, 14089 Berlin, Germany ; Hospital Havelhoehe, 14089 Berlin, Germany.
authors.forename: Friedemann
authors.initials: F
authors.lastname: Schad