CONTEXT: European mistletoe (Viscum album L) has been used parenterally for more than 80 years as an anticancer medication with significant immunomodulating action. Since 1984, clinical experience with a Viscum album extract (Viscum album Quercus Frischsaft [Qu FrF]) among HIV-positive patients has suggested that it inhibits HIV disease progression. OBJECTIVE: To determine the toxicity profile and biochemical effects of a Viscum 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 extract was administered subcutaneously twice weekly in gradually increasing doses for 2 to 17 weeks per dose increase. Doses of 0.01 mg to 10.0 mg were administered. MAIN OUTCOME MEASURES: Adverse events, hematology, and biochemistry. RESULTS: No severe side effects were found. During gradual dose escalation, more adverse events occurred at the lower dose range. The hazard rate of systemic adverse events was highest among HIV-positive patients. Drug-related adverse events were flu-like symptoms and transient exacerbations of gingivitis, fever, and eosinophilia. An increase of serum urea nitrogen and serum creatinine levels occurred, as did a slight decrease in total protein caused 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 and healthy individuals and may inhibit the progression of HIV disease.
CONTEXT: European mistletoe (Viscum album L) has been used parenterally for more than 80 years as an anticancer medication with significant immunomodulating action. Since 1984, clinical experience with a Viscum album extract (Viscum album Quercus Frischsaft [Qu FrF]) among HIV-positive patients has suggested that it inhibits HIV disease progression. OBJECTIVE: To determine the toxicity profile and biochemical effects of a Viscum 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 extract was administered subcutaneously twice weekly in gradually increasing doses for 2 to 17 weeks per dose increase. Doses of 0.01 mg to 10.0 mg were administered. MAIN OUTCOME MEASURES: Adverse events, hematology, and biochemistry. RESULTS: No severe side effects were found. During gradual dose escalation, more adverse events occurred at the lower dose range. The hazard rate of systemic adverse events was highest among HIV-positive patients. Drug-related adverse events were flu-like symptoms and transient exacerbations of gingivitis, fever, and eosinophilia. An increase of serum ureanitrogen and serum creatinine levels occurred, as did a slight decrease in total protein caused 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 and healthy individuals and may inhibit the progression of HIV disease.
Authors: Patrick J Mansky; Dawn B Wallerstedt; Timothy S Sannes; Jamie Stagl; Laura Lee Johnson; Marc R Blackman; Jean L Grem; Sandra M Swain; Brian P Monahan Journal: Evid Based Complement Alternat Med Date: 2013-10-27 Impact factor: 2.629