Safety and immunological effects of Iscucin® Populi and Viscum Mali—A placebo-controlled study

Background Mistletoe preparations Iscucin ® Populi (IP) and Viscum Mali (VM, both WALA GmbH) are licensed in Germany as supportive cancer medication within the concept of Anthroposophical Medicine. Safety and immunological effects in humans of these preparations were for the first time investigated in this study. Methods A 3-armed randomized study in healthy volunteers was performed. The probands injected in increasing doses either IP (strength F, G and H, each for 4 weeks) or VM (strength D3, D2 and 2% each for 4 weeks) or placebo (isotonic solution) subcutaneously twice weekly for a total of 12 weeks. Clinical and safety controls were performed weekly. Immunological outcome parameters (differential blood count, lymphocyte differentiation, interleukin (IL)-6) were analysed every 4 weeks. Results A total of 71 probands were included (IP=30, VM=21, placebo=20), 69 finished the study regularly and were analysed. Application of IP strength G and H caused strong local reactions at the site of injection. In parallel they resulted in distinct eosinophilia ( p p Discussion and conclusion Eosinophilia as an effect of mistletoe-lectin (ML) containing mistletoe preparations is well known and was pronounced due to the high content of ML in IP strength G and H. Most of the probands did not tolerate the full dose of IP strength G and H due to local reactions. Repeated injections induced, however, a certain tolerance (smaller local reactions, less eosinophilia despite inreasing dosages), which was accompanied by induction of mistletoe lectin antibodies in all subjects receiving IP (data not shown). Therefore, IP strength G and H should in general be used only after pretreatment with lower dosages. For the first time there was an increase of T-helper cells during application of mistletoe preparations in a placebo-controlled study. This could be beneficial for the treatment of immunosuppressed cancer patients. Eosinophils play a role in host response against cancer and eosinophilia correlates with a better prognosis in a variety of cancer types. Whether eosinophilia during treatment with IP has a clinical benefit for cancer patients has to be further investigated. Both mistletoe preparations have been shown to be safe. VM induces only mild local reactions and is used as mild counter stimulant in patients with painful osteoarthritis.