Phlogenzym® versus diclofenac in the treatment of activated osteoarthritis of the knee.: A double-blind prospective randomized study

The aim of this study was to compare the short-term efficacy and tolerability of an oral enzyme therapy (Phlogenzym(R)) with the nonsteroidal antiinflammatory drug, diclofenac, in patients with active osteoarthritis of the knee. Sixty-three patients with active osteoarthritis of the knee were treated in a randomized, double blind, parallel group trial for 21 days. Thirty-one patients were included in the Phlogenzym(R) group and 32 patients were included in the diclofenac group. Efficacy was primarily evaluated by the Lequesne index and by using the visual analog scale (VAS) for pain at rest and in motion, In addition, overall assessment of efficacy and tolerability (both by patients and the physician), various laboratory parameters, range of motion without pain (00), circumference of the affected knee, self-judgment of impairment and therapy outcome were evaluated descriptively. Patients were evaluated at baseline, at weekly intervals throughout the study and at 4 weeks after discontinuing medication intake. All 63 patients were evaluated on an intent-to-treat data set. Statistical evaluation showed that in the main endpoints, the Lequesne index and VAS, the Phlogenzym(R) group was equivalent to the diclofenac group. The mean value of the Lequesne index decreased from 15.48 to 9.81 after 7 weeks in the Phlogenzym(R) group and from 15.81 to 10.83 after 7 weeks in the diclofenac group. In the statistical evaluation the lower band of the 95% confidence interval of the Mann-Whitney estimator was above 0.44, the limit for equivalence, at all times. The secondary criteria showed no significant differences. In the majority of patients, overall assessment of efficacy and tolerance were judged in both drug groups as very good or good. In conclusion, short-term evaluation indicates that Phlogenzym R as an oral enzyme formulation can be considered as an effective and safe alternative to nonsteroidal antiinflammatory drugs such as diclofenac in the treatment of active osteoarthritis of the knee.