Efficacy and tolerance of an oral enzyme combination in painful osteoarthritis of the hip. A double-blind, randomised study comparing oral enzymes with non-steroidal anti-inflammatory drugs.
Klein G, Kullich W, Schnitker J, Schwann H. Efficacy and tolerance
of an oral enzyme combination in painful osteoarthritis of the hip.
A double-blind, randomised study comparing oral enzymes with
non-steroidal anti-inflammatory drugs. Clin Exp Rheumatol. 2006
Jan-Feb;24(1):25-30.
OBJECTIVE: The objective of this study was to establish the
non-inferiority of anoral enzyme therapy (Phlogenzym-(PE)) as
compared to the non-steroidalanti-inflammatory drug (NSAID)
diclofenac (DC) in patients with osteoarthritis(OA) of the hip.
METHODS: Ninety patients presenting with painful episodes of OA of
the hip were treated for 6 weeks in one study centre in a phase
III,randomised, double blind, parallel group trial. Altogether, 45
patients weretreated in the PE group and 45 patients were treated in
the DC group. Primaryefficacy criteria were: WOMAC dimensions pain,
joint stiffness and function, and Lequesne index as multiple
endpoint according to O'Brien. The efficacy criteriawere analysed
applying the test of non-inferiority with regard to mean changesand
frequencies, t-test, U test, ANCOVA and descriptive methods.
RESULTS: Within the 6 weeks observation period, the adjusted changes
from baseline to endpoint ofthe target parameters worked out as
follows (adjusted differences, mean +/- SEM):WOMAC subscale pain (PE
-10.3 +/- 1.2, DC -9.5 +/- 1.2), WOMAC subscale joint stiffness (PE
-3.9 +/- 0.5, DC -3.6 +/- 0.5), WOMAC subscale physical function(PE
-31.7 +/- 3.5, DC -29.7 +/- 3.5), Lequesne's index (PE -2.89 +/-
0.47, DC-2.27 +/- 0.47). Non-inferiority of PE as compared to DC
with regard to the O'Brien's global sum of the standardised adjusted
changes from baseline to end point in pain, stiffness, physical
function, and Lequesne's index was established with p = 0.0025. PE
was simultaneously non-inferior as compared to DCwith regard to the
4 single endpoints: WOMAC subscale pain (p = 0.0033), WOMACsubscale
joint stiffness (p = 0.0061), WOMAC subscale physical function (p
=0.0039), Lequesne's index (p = 0.0008) (closed test procedure). The
equivalence tests remained insignificant due to comparatively lower
effects of DC. For 71.1% of the PE patients and for 61.4% of the DC
patients rates of good or very goodglobal investigator assessments
of efficacy were calculated (test ofnon-inferiority: p = 0.0011). In
the majority of patients, tolerability wasjudged in both drug groups
as very good or good. CONCLUSION: This trial showed significant
non-inferiority from 6 weeks treatment with PE in patients with OA
ofthe hip with regard to the WOMAC dimensions pain, stiffness and
physical function, to Lequesne's index, to the investigator and
patients assessments ofefficacy, and to the responder rates based on
pain, physical function, andpatient assessment of efficacy. With
regard to drug tolerability some tendencies in favour of PE were
detected. However, in this study there was no realdifference between
PE and DC 100 mg/day, implying an equal benefit-risk relation
between the substances. PE may well be recommended for the treatment
of patients with osteoarthritis of the hip with signs of
inflammation as indicated by a high pain level.
PMID:
16539815