DOUBLE-BLIND-STUDY OF THE EFFECT OF CISAPRIDE ON CONSTIPATION AND ABDOMINAL DISCOMFORT AS COMPONENTS OF THE IRRITABLE-BOWEL-SYNDROME

Aim: To study the effect of prokinetic treatment with cisapride in pat ients with constipation-predominant irritable bowel syndrome, Patients and methods: Ninety-six patients were randomly assigned to treatment with either cisapride 5 mg three times daily or placebo three times da ily for a period of 12 weeks. The dosage could be doubled after 4 week s. Presence of the target symptoms abdominal pain, constipation and ab dominal bloating was an obligatory criterion for inclusion in the stud y, Results: After 12 weeks of treatment, 31%, 56% and 27% of the cisap ride treated patients were found to be without the three target sympto ms (P < 0.05). The corresponding percentages for the placebo-treated p atients were 31%, 58% and 19%, respectively, (P < 0.05), The visual an alogue scale (VAS) symptom scores assessed by the patients for global rating of bowel disease, general well-being and frequency of stool pas sage improved significantly within each treatment group (P < 0.05), Ev aluation of efficacy parameters using intention-to-treat analysis show ed no statistically significant differences between the groups, Using efficacy analysis, the difficulty of stool passage showed a significan tly higher improvement with cisapride (P less than or equal to 0.05), Conclusions: These results indicate that cisapride is not superior to placebo in the treatment of constipation and abdominal discomfort as c omponents of irritable bowel syndrome, It may, hovever, be of use in i mproving the difficulty of stool passage.