Short-Term Treatment of Painful Osteoarthritis of the Knee with Oral Enzymes. A Randomised, Double-Blind Study versus Diclofenac
Klein G.1,2 and
Kullich W.2. Short-Term Treatment of Painful
Osteoarthritis of the Knee with Oral Enzymes. A Randomised,
Double-Blind Study versus Diclofenac. Clinical Drug Investigation,
2000, Vol. 19, No. 1, pp. 15-23 - ISSN 1173-2563. PZ 18 (4-03-1)
1 Rehabilitation Center for Rheumatic and Cardiovascular Diseases,
Saalfelden, Austria. 2 Ludwig Boltzmann Institute for Rehabilitation
of Internal Diseases, Saalfelden, Austria
Abstract
Objective:
To compare the short-term efficacy and tolerability of an oral
enzyme therapy with the NSAID diclofenac in patients with
symptomatic osteoarthritis of the knee (gonarthritis).
Methods: In a double-blind clinical trial, 73 patients with painful
gonarthritis were randomised to receive 3 weeks of treatment with an
oral enzyme preparation (Phlogenzym®) containing
bromelain, trypsin and rutin (n = 36), or the NSAID diclofenac (n =
37). Efficacy was primarily evaluated using the Lequesne index
(measuring pain and function of the affected knee). Other
investigations included assessment of pain symptoms using a visual
analogue scale (VAS), global assessment of efficacy and tolerability
(by both patients and one physician), and various laboratory
parameters. Patients were evaluated at baseline, at weekly intervals
throughout the 3-week treatment period, and at 7 weeks (i.e. 4 weeks
after discontinuing therapy).
Results: The Lequesne
index improved continuously in both groups: from 13.56 at baseline
to 3.10 after 3 weeks (end of therapy) to 2.05 at 7 weeks
(follow-up) in the enzyme group, and from 14.04 to 3.50 to 2.24,
respectively, in the diclofenac group. Statistical evaluation showed
the treatment groups to be equivalent; the lower bound of the 95%
confidence interval of the Mann-Whitney estimator was above 0.44
(the limit for equivalence) at all time points. Global assessment of
efficacy and tolerability of the drugs was 'very good' or 'good' for
the majority patients.
Conclusions: Short-term
evaluation indicates that oral enzymes may be considered an
effective and safe alternative to NSAIDs such as diclofenac in the
treatment of painful gonarthritis.
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