Tolerability of an extract of European mistletoe among immuno compromised and healthy individuals

Context European mistletoe (Viscum album L) has been used parenterally for more than 80 years as an anticancer medication with significant immunomodul ating action. Since 1984, clinical experience with a Viscum album extract ( Viscum album Quercus Frischsaft (Qu FrF]) among HIV-positive patients has s uggested that it inhibits HIV disease progression. Objective To determine the toxicity profile and biochemical effects of a Vi scum album extract. Design A dose-escalating phase I/II study. Patients 32 HIV-positive and 9 healthy participants. Intervention Standardized for its lectin and viscotoxin content, the extrac t was administered subcutaneously twice weekly in gradually increasing dose s for 2 to 17 weeks per nose increase. Doses of 0.01 mg to 10.0 mg were adm inistered Main Outcome Measures Adverse events, hematology, and biochemistry. Results No severe side effects were found During gradual dose escalation, m ore adverse events occurred at the lower dose range. The hazard rate of sys temic adverse events was highest among HIV-positive patients. Drug-related adverse events were flu-like symptoms and transient exacerbations of gingiv itis, fever, and eosinophilia. An increase of serum? urea nitrogen and seru m creatinine levels occurred as did a slight decrease in total protein caus ed by a minor fall in albumin concentrations. Dose dependence was apparent for inflammation and fever, which may or may not have been side effects of the preparation. Conclusions Viscum album Qu FrF can be administered safely to HIV-positive patients. It induces immunomodulation in HIV-positive ann healthy individua ls and may inhibit the progression of HIV disease.