ABSTRACT
Anecdotal reports and open pilot studies reporting the positive influence of oral hydrolytic enzymes (Wobenzym or Phlogenzym) on the course of multiple sclerosis (MS) have existed for nearly 20 years.1 The antiinflammatory and anti-oedematous effect of these compounds has been known since that time. Based on animal model investigations, the mode of action was initially attributed to the ability of these enzymes to eliminate pathogenic immune complexes.2 In the following years positive results were obtained in open studies with a small cohort of MS patients. Recent investigations in the murine experimental autoimmune encephalomyelitis (EAE) model have revealed a significant decrease in the number of autoreactive T cells and a reduction in interferon-γ (IFN-γ) producing cells when animals were treated with oral enzymes.3 Further results demonstrating the strong inhibition of autoantigen-induced proliferation in human T cells from patients with manifest diabetes mellitus and rheumatoid arthritis led to the conclusion that the beneficial effect of oral enzymes in autoimmune diseases is due to their immunomodulatory property restoring a disturbed T-helper type 1 and type 2 (Th1 and Th2) response.4,5
Encouraged by these findings we have initiated a 2-year multicentre, prospective, randomized, double-blind, placebo-controlled study to determine the efficacy, safety and tolerability of Phlogenzym in relapsing MS patients.
