Phlogenzym® versus Diclofenac in the treatment of
activated osteoarthritis of the knee. A double-blind prospective
randomized study
Singer F.,
Singer C., Oberleitner H. Phlogenzym® versus Diclofenac
in the treatment of activated osteoarthritis of the knee. A
double-blind prospective randomized study. Int. J. Immunotherapy
2001, Vol. XVII, No. 2/3/4, pp. 135-141- ISSN 0255-9625. 218 K/375
(19-05-3)
Sonderkrankenanstalt für Rheumatologie, Orthopädie und Neurologie
der PVArb, Laab im Walde, Austria.
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.