Oral enzyme combination versus diclofenac in the treatment of osteoarthritis of the knee--a double-blind prospective randomized study.
Akhtar NM, Naseer R, Farooqi AZ, Aziz
W, Nazir M. Oral enzyme combination versus diclofenac in the
treatment of osteoarthritis of the knee--a double-blind prospective
randomized study. Clin Rheumatol. 2004 Oct;23(5):410-5. Epub 2004
Jul 24.
Pakistan King Edward Medical College Lahore, Mayo Hospital.
The aim of this study was to compare the efficacy and safety of an
oralenzyme-rutosid combination (ERC) containing rutosid and the
enzymes bromelain andtrypsin, with that of diclofenac in patients
with osteoarthritis (OA) of theknee. A total of 103 patients
presenting with painful episodes of OA of the knee were treated for
6 weeks in two study centers in a randomized, double-blind,parallel
group trial. Altogether, 52 patients were treated in the ERC group
and51 patients were treated in the diclofenac group. Primary
efficacy criteria were Lequesne's Algofunctional Index (LFI) and a
'complaint index', including pain at rest, pain on motion and
restricted function. The efficacy criteria were analyzedby applying
the Wilcoxon-Mann-Whitney test that provides the Mann-Whitneyestimator
(MW) as a measure of relevance. Non-inferiority was considered to
beproven if the lower bound of the 97.5% one-sided confidence
interval (CI-LB) was higher than MW = 0.36 (benchmark of not yet
relevant inferiority). Bothtreatments resulted in clear
improvements. Within the 6-week observation period, the mean value
of the LFI decreased from 13.0 to 9.4 in the ERC group and from12.5
to 9.4 in the diclofenac group. Non-inferiority of ERC was
demonstrated byboth primary criteria, LFI (MW = 0.5305; CI-LB =
0.4171) and complaint index (MW = 0.5434; CI-LB = 0.4296).
Considerable improvements were also seen in secondary efficacy
criteria, with a slight tendency towards superiority of ERC. The
global judgment of efficacy by physician resulted in at least good
ratings for 51.4% of the ERC patients, and for 37.2% of the
diclofenac patients. In the majority ofpatients tolerability was
judged in both drug groups as very good or good. Thecurrent study
indicates that ERC can be considered as an effective and
safealternative to NSAIDs such as diclofenac in the treatment of
painful episodes of OA of the knee. Placebo-controlled studies are
now needed to confirm theseresults.