CISAPRIDE VERSUS METOCLOPRAMIDE IN THE TREATMENT OF FUNCTIONAL DYSPEPSIA - A DOUBLE-BLIND COMPARATIVE TRIAL

The efficacy and tolerability of cisapride (5 mg three times daily) an d metoclopramide (10 mg three times daily) were evaluated in a randomi zed double-blind trial in patients with functional dyspepsia. Sixty pa tients, equally distributed in the two groups, entered the trial. Afte r 4 weeks of treatment there was a significant improvement of symptom severity versus base line (p < 0.001) in both groups. The percentage o f responders (with no or only mild symptoms) was 87% in the cisapride group and 77% in the metoclopramide group (no statistically significan t intergroup difference). At the follow-up visit 2 weeks after complet ion of the trial this response rate was significantly higher in the ci sapride group (73%) than in the metoclopramide group (47%) (p < 0.05). Four of the patients receiving cisapride and 2 of the patients receiv ing metoclopramide reported adverse events. On assessment of extrapyri midal symptoms, relevant clinical values were found in one patient rec eiving metoclopramide. Increased prolactin concentrations were observe d in seven patients of the metoclopramide group versus only 1 of the c isapride group (p < 0.05). The present data indicate that during the 2 weeks after completion of treatment in patients with functional dyspe psia, cisapride may result in a better, more sustained overall respons e when compared with metoclopramide.