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
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.
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