Mucos Pharma GmbH & Co. KG

This randomized, double-blind, placebo-controlled, and comparator-controlled trial evaluated the safety and efficacy of an enzyme combination, as Wobenzym, in adults with moderate-to-severe osteoarthritis (OA) of the knee. Adults (n=150) received Wobenzym, diclofenac (a nonsteroidal anti-inflammatory drug, NSAID), or placebo for 12 weeks. Improvement in pain scores (Lequesne Functional Index) did not differ between subjects treated with Wobenzym or diclofenac, and both treatment groups improved compared to placebo (P<0.05). Reduction in total WOMAC scores (secondary outcome measure) did not differ between Wobenzym and diclofenac, although only diclofenac emerged as different from placebo (P<0.05). The median number of rescue medication (paracetamol) tablets consumed was less in the Wobenzym group compared to placebo (P<0.05), while there was no difference between diclofenac and placebo. Adverse events were similar in frequency in Wobenzym and placebo groups (7.2% and 9.1% of subjects, resp.) and higher in diclofenac group (15.6%). Wobenzym is comparable to the NSAID diclofenac in relieving pain and increasing function in adults with moderate-to-severe painful knee OA and reduces reliance on analgesic medication. Wobenzym is associated with fewer adverse events and, therefore, may be appropriate for long-term use.

Oral hydrolytic enzymes in combination with rutoside have been applied in MS patients for more than 20 yr.We investigated whether immunol. alterations in MS patients are influenced by enzyme treatment.We determined the phenotypes of specific lymphocytic antigens in 12 patients with relapsing-remitting MS, who were known to be under long-term treatment with oral hydrolytic enzymes (Phlogenzym).Matched untreated (i.e., only treated for symptoms) MS patients (n=18) and healthy volunteers (n=10) served as controls.For phenotyping, the following lymphocytic antigens were measured: CD4, CD8, CD3, CD2, CD19, CD56, CD14, CD45, CD45RA, CD45RO, CD25, CD54 and HLA-DR.Tests were carried out with a panel of different fluorescence-conjugated murine monoclonal antibodies and subsequent two color flow-cytometry.Data is expressed as percentage gated cells.Symptomatically treated patients had increased CD4, CD19, CD2 and CD45RO, CD54 and CD56.These changes were influenced by hydrolytic enzymes in the following manner: CD8 was markedly decreased; CD4, CD2, CD25, CD-45-RO, CD-45RA, CD56 slightly decreased.Furthermore, a statistically significant decrease was found for CD45 and CD54.From these results the conclusion can be drawn that pos. clin. findings in MS patients under oral hydrolytic enzymes are causatively linked to a decrease in inflammatory activity.

In an open, randomized, clin. pilot trial, four groups with 20 hepatitis C patients each were treated with either "liver support" therapy, with established medications (one group with ribavirin, one group with α-interferon), or with a novel oral test drug, Phlogenzym, a combination of hydrolytic enzymes with the flavonoid rutosid.The liver transaminases, AST, ALT, and S-γ-GT markedly improved over the period of three months in the three drug groups, but only marginally in the liver support group.The best results were found with Phlogenzym, which was even superior to ribavirin and α-interferon.The tolerance of the oral enzymes was excellent.Further clin. trials with longer observation times, greater numbers of patients, double-blind and partly placebo-controlled, are under way.