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Efficacy and safety of an oral enzyme
combination compared to NSAIDs in activated degenerative
rheumatic joint disease
Bock P.1, Hanisch
J.1, Schiess W.2,
Stauder G.2, Wittenborg
A.3
1 IFAG, Institute for Medical Research and
Statistics, Basle, Switzerland.
2 Dept. Clinical Research, Mucos Pharma GmbH,
Geretsried, Germany.
3 Center of Rheumatology Ruhrgebiet, Herne,
Germany.
7th Interscience World Conference on Inflammation, Antirheumatics,
Analgesics, Immunomodulators, Geneva, Switzerland. 19-21
May 97,
published in Inter. Journal of Tissue Reactions Vol.
XIX, No. 1/2, pp. 26-27, 1997 - Abst. 16, ISSN 0250-0868
149K/245 (19-04-2) |
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Abstract
Methods
Therapeutical data of 3028 not preselected patients with
activated degenerative rheumatic diseases from 379 medical
offices were evaluated using a reference-controlled, parallel
group, multicentric, retrolective analysis of therapeutic
data (RetrospectTM) to examine the efficacy and safety of
oral enzymes (OE) as compared to nonsteroidal anti-inflammatory
drugs (NSAIDs). Identical inclusion criteria were laid down
in a written study protocol. Data of 2137 patients treated
with OE and of 891 patients treated with NSAIDs were available
for analysis. As primary test criterion of efficacy the multivariate "Global-Symptom-Score" was
used, based on the changes in the scores of the cardinal
symptoms, and analysed using the non-parametric methods by
Wei and Lachin. Duration of disease and judgement of efficacy
were secondary efficacy criteria. For safety assessment unwanted
drug reactions and subjective judgements were compared. The
sensitivity of statistical test results to changes in the
definition of the populations was assessed by means of predefined
subgroup analyses.
Results
Both therapy groups were well balanced (basic patient data,
initial severity of symptoms). Unwanted drug reactions were
reported in 4.3% and 31.8% in the OE and the NSAIDs group,
resp. Predominant adverse effects observed under the OE therapy
were mild gastrointestinal symptoms, lasting for less than
a week, while under NSAIDs moderate gastrointestinal symptoms,
lasting for 1-2 weeks, were the most frequent adverse effects.
The safety was rated to be "very high" for OE and
NSAIDs in 84% and 29%, resp. In all diagnostic strata the
medical rating of safety of OE was significantly (p<0.0001
) and distinctly higher than for NSAIDs. For all diagnostic
strata, both the Global-Symptom-Score and the medical judgement
of the efficacy were significantly superior (p<0.001 )
for the OE group compared to the NSAIDs group. The duration
of therapy under OE was longer than under NSAIDs.
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