CLINICAL EFFICACY, SAFETY AND TOLERANCE OF MEBEVERINE SLOW-RELEASE (200MG) VS MEBEVERINE TABLETS IN PATIENTS WITH IRRITABLE-BOWEL-SYNDROME

In an open prospective parallel group multicentre study, 54 patients w ith irritable bowel syndrome were randomised to receive oral mebeverin e slow release 200mg twice daily (n = 26) or mebeverine tablets 135mg 3 times daily (n = 28) for 3 weeks. Eight gastrointestinal symptoms an d 3 nongastrointestinal symptoms were evaluated. The analysis of the d ata did not demonstrate a difference in efficacy between the treatment groups. Both mebeverine preparations, the tablet and the new slow rel ease formulation in microgranules, were found to be safe and well tole rated. Of the 54 patients who entered the study, 6 discontinued medica tion prematurely, and 48 were included in the final analysis. Systolic and diastolic blood pressure and pulse rate did not show a significan t change over time nor a difference between groups. No serious adverse drug event was reported. The investigator's global impression of comp liance after 1 and 3 weeks of treatment did not show a significant dif ference between treatment groups. The idea of reducing the number of d aily doses from 3 to 2 by using a slow-release formulation was confirm ed in this study.