Efficacy and tolerability of an oral enzyme therapy in the treatment of painful acute superficial thrombophlebitis

AIM: In a double-blind, randomized, placebo-controlled multicenter clinical study, efficacy and tolerability of an oral enzyme therapy were investigated in patients with acute superficial thrombophlebitis of the legs. METHODS: 159 patients were included; 79 patients were treated in the active drug group, 77 patients in the placebo group for a maximum of 14 ± 2 days. The dosage was 4 enteric coated tablets (Wobenzym® N, Mucos Pharma, Germany) three times daily. Additionally, all patients got a pair of pressure stockings. The main endpoint was the reduction of the spontaneous pain until day 7 which had to amount to at least 4 score points on the Visual Rating Analogue Scale (VRAS) at baseline. RESULTS: On day 7 of treatment, a significantly better pain reduction was observed in the active drug group as compared to placebo (p = 0.0071). The secondary criterion, the response rates (reduction of the pain scores to 0 or 1), were 77.0% under active drug versus 58.1% under placebo at the end of the treatment (p = 0.011). 8 further criteria were investigated. These symptoms as well as the final global assessments of efficacy showed significant differences between the groups in favor of the enzyme therapy. CONCLUSIONS: This study confirmed the clinical efficacy and good tolerability of an oral enzyme therapy in the treatment of acute superficial thrombophlebitis, proofing the antiinflammatory, anti-edematous and analgesic effects of this therapy.