Mulsal® N in the Treatment of Epicondylitis lateralis humeri (MU-693 602)

Mulsal^® N in the Treatment of Epicondylitis lateralis humeri (English Summary)

Wirksamkeit und Verträglichkeit
Studien-Nr.: MU-693 602
Randomisierte doppelblinde Parallelgruppenstudie gegen Placebo
Integrierter biometrisch-medizinischer Abschlußbericht gemäß FDA- und CPMP-Richtlinien

Leiter der Studie: Dr. med. Klaus Uffelmann

Lehrbeauftragter für Allgemeinmedizin der Universität Marburg, Krälingstraße 13, D-35285 Gemünden, Germany

Auswertung durch: MUCOS Pharma GmbH & Co, Abt. Klinische Forschung, Kirchplatz 8, D-82538 Geretsried, Germany
Bericht erstellt durch: PharmaScript, Kathi-Kobus-Steig 1, D-82515 Wolfratshausen, Germany

Summary

In this placebo controlled double-blind multisite clinical trial it could be demonstrated that the therapy of epicondylitis lateralis humeri with the enzyme preparation Mulsal^® N is very successful. The enzyme therapy was compared with placebo.
74 patients with epicondylitis lateralis humeri were taken into this multisite clinical trial and randomised into two groups. 38 patients received Mulsal^® N (enzyme group) and 36 patients placebo (placebo group). The study was carried out in eleven centers. The data of all patients was evaluable.
The principal investigator was Klaus Uffelmann, M.D., general practitioner, Krälingstrasse 13, D-35285 Gemünden.
The patients received 4 tablets t.i.d. (i.e. 12 tablets per day) of the study medication for 4 weeks. After the end of the therapy two more follow-up examinations were performed.
At baseline the patients were comparable with regard to age, height and duration of the epicondylitis lateralis humeri (p > 0.05, Wilcoxon-Mann-Whitney-U-test). There was a difference between the groups with regard to weight (p = 0,0124), which was considered not relevant.
As main endpoint for statistical evaluation the sumscore of the various kinds of pain and of dysfunction was defined.
As secondary criteria the restricted movement, the amount of analgetics taken and the global judgements by the physician and by the patients were evaluated, descriptively.
The main endpoint showed a statistically significant difference (p < 0.05) from the 2nd till the 6th week in favour of the enzyme group.
The symptom "restricted movement" was at the end of the therapy in the enzyme group more than 20% better than in the placebo group. The amount of analgetics taken (Diclofenac) was after 4 weeks 3.4 times higher in the placebo group than in the enzyme group, the difference was statistically significant from the 2nd week (p<0.05).
The efficacy of the drug was judged in the enzyme group by the physician at the end of the therapy as 2.0 ("good") and as 2.1 ("good") by the patients. In the placebo group the physician judged the efficacy of the drug as 3.7 ("moderate" to "unsatisfactory") and the patients as 3.5 ("moderate" to "unsatisfactory"). The difference between the groups was highly significant (p < 0.0001 ).
The tolerance of the drugs was judged by the physician in the enzyme group as 1.8 ("very good" to "good") and in the placebo group as 1.9 ("good") and by the patients as 1.6 ("very good" to "good") in the enzyme group and as 1.7 ("very good" to "good") in the placebo group. There were no differences between the groups (p > 0.05).
Adverse events were documented in three patients in the enzyme group and in four patients in the placebo group. In most of the cases the gastrointestinal tract was involved. They started on average after 13.0 days in the enzyme group and after 12.5 days in the placebo group. The duration was on average 5.7 days in the enzyme group and 6.7 days in the placebo group. They were judged as "mild" to "moderate" in both groups. In all cases of the enzyme group the patient's outcome was without sequelae and in the placebo group in two cases the patient's outcome was without sequelae and in the other two cases data was missing. With regard to the frequencies of adverse events there was no difference between the groups (p = 0.7071 ). The evaluations performed on each center showed no center specific relevant differences. Therefore the final evaluation was done on the pooled data of all centers.