[Drug therapy of activated arthrosis. On the effectiveness of an enzyme mixture versus diclofenac].

Clinical efficacy of the antiphlogistic potency of enzymes (Wobenzym, 4 x 7 capsules/day) vs. Diclofenac-Na (2 x 50 mg capsules/day) on patients (n = 80) suffering from osteoarthritis of the knee in an acute phase was evaluated. The study design was double blind according to the GCP-guidelines. The treatment period lasted 28 days and was followed by a treatment-free controll-period of another 28 days. There was equal status of age, sex, duration and impact of osteoarthritis in both groups. The clinical parameters as pain at rest, on motion, on walking, at night and pain tenderness showed a significant improvement (p < 0.05) after the treatment period, with tendency to relapse in the following observation period. No significant difference between both treatment-groups could be seen. No changes in laboratory findings were observed. The global-assessment (physician's and patient's score) of efficacy and tolerability in both groups were mostly stated as "very good" and "good". Adverse events were reported as: Wobenzym: total 14 patients: gastrointestinal complaints (obstipation, vomiting, meteorism), allergic rash once and dizziness twice, 6 of these patients discontinued by that reasons. Diclofenac: total 11 patients: gastrointestinal complaints (epigastrical pain, upset stomach, meteorism), dizziness, 3 of these discontinued. All of these vanished after intake was stopped. Summarizing up it could be demonstrated that both evaluated drugs showed equal clinical potency. So it might be assumed that Wobenzym can be used as an alternative substance in treatment of acute painful osteoarthritis.