Phlogenzym® versus Diclofenac in the treatment of activated osteoarthritis of the knee. A double-blind prospective randomized study
Singer F., Singer
C., Oberleitner H.
Sonderkrankenanstalt
für Rheumatologie, Orthopädie und Neurologie der PVArb, Laab im Walde,
Austria.
Int. J. Immunotherapy 2001, Vol. XVII, No. 2/3/4, pp. 135-141- ISSN 0255-9625
218 K/375 (19-05-3)
Summary: The aim of this study
was to compare the short-term efficacy and tolerability of an oral enzyme
therapy (Phlogenzym®) 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 2 7 days. Thirty-one patients were
included in the Phlogenzym® 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 (0°), 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® 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® 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® 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.