Osteoarthritis
|
Considering patients
with osteoarthritis,
also known as degenerative joint disease:
A 2006 six week phase III,
randomized, double blind, parallel group study
compared systemic enzyme support with diclofenac the generic
name for a nonsteroidal anti-inflammatory drug that is
widely used to treat arthritis. Keep in mind that diclofenac
can increase the risk of life-threatening heart or
circulation problems, including heart attack or stroke – and
the longer it is used, the greater the risk.
Contrast that to those studies that conclude that Wobenzym®
reduced the risk if myocardial infarction. Now, consider
this: the 2006 study found systemic enzymes were as
effective as diclofenac – and noted that the systemic
enzymes were better tolerated. A 2004 randomized, double-blind, parallel group trial by a different group of researchers came to the same conclusion. Within the six week observation period, they noted that that systemic enzyme support “can be considered as an effective and safe alternative to NSAIDs such as diclofenac in the treatment of painful episodes of OA of the knee.” And before that, a 2001 randomized, controlled, single-blind study of seven weeks duration found that systemic enzyme support “is as efficacious and well tolerated as diclofenac” in the management of active osteoarthritis. A number of studies conclude that Wobenzym® is an effective and safe alternative to NSAIDS in the treatment of painful episodes of osteoarthritis of the knee and hip47-49. So, we see that systemic enzyme support is as effective as – and in my opinion safer than - nonsteroidal anti-inflammatory drugs for the management of osteoarthritis. We see similar results for rheumatoid arthritis and other forms of arthritis. From FREQUENTLY ASKED QUESTIONS, with answers by Joseph J Collins, RN, ND Read the special section: JOINT PAIN & WOBENZYM® |
What the literature says about Systemic Enzyme Support and:
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.
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.
External Link:
PMID: 15278753
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 jointstiffness (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 theO'Brien's global sum of the standardised adjusted
changes from baseline toendpoint in pain, stiffness, physical
function, and Lequesne's index wasestablished 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
equivalencetests 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 showedsignificant non-inferiority from 6
weeks treatment with PE in patients with OA ofthe hip with regard to
the WOMAC dimensions pain, stiffness and physicalfunction, 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.
External Link:
PMID: 16539815
Efficacy and tolerability of oral enzyme therapy as compared to
diclofenac in active osteoarthrosis of knee joint: an open
randomized controlled clinical trial.
Tilwe GH, Beria S, Turakhia NH, Daftary GV, Schiess W. Efficacy and
tolerability of oral enzyme therapy as compared to diclofenac in
active osteoarthrosis of knee joint: an open randomized controlled
clinical trial. J Assoc Physicians India. 2001 Jun;49:617-21.
OBJECTIVE: To compare the efficacy and tolerability of an oral
enzyme preparation(Phlogenzym) with that of an NSAID (diclofenac) in
the treatment of activeosteoarthrosis. METHODS: Prospective,
randomized, controlled, single-blind study of seven weeks duration
at a tertiary care centre wherein 50 patients aged 40-75 years, with
activated osteoarthrosis of knee joint were randomized to
receivephlogenzym tablets (2-3 tablets, bid) or diclofenac sodium 50
mg bid for threeweeks. RESULTS: At the end of therapy (three weeks)
and at follow-up visit atseven weeks there was reduction in pain and
joint tenderness and swelling in bothgroups, and slight improvement
in the range of movement in the study group. Thereduction in joint
tenderness was greater (p < 0.05) in the study group
receivingphlogenzym. CONCLUSION: Phlogenzym is as efficacious and
well tolerated asdiclofenac sodium in the management of active
osteoarthrosis over three weeks of treatment.
External Link:
PMID: 11584936]