Cisapride versus metoclopramide in the treatment of functional dyspepsia. A double-blind comparative trial.

Abstract

The efficacy and tolerability of cisapride (5 mg three times daily) and metoclopramide (10 mg three times daily) were evaluated in a randomized double-blind trial in patients with functional dyspepsia. Sixty patients, equally distributed in the two groups, entered the trial. After 4 weeks of treatment there was a significant improvement of symptom severity versus base line (p < 0.001) in both groups. The percentage of responders (with no or only mild symptoms) was 87% in the cisapride group and 77% in the metoclopramide group (no statistically significant intergroup difference). At the follow-up visit 2 weeks after completion of the trial this response rate was significantly higher in the cisapride group (73%) than in the metoclopramide group (47%) (p < 0.05). Four of the patients receiving cisapride and 2 of the patients receiving metoclopramide reported adverse events. On assessment of extrapyrimidal symptoms, relevant clinical values were found in one patient receiving metoclopramide. Increased prolactin concentrations were observed in seven patients of the metoclopramide group versus only 1 of the cisapride group (p < 0.05). The present data indicate that during the 2 weeks after completion of treatment in patients with functional dyspepsia, cisapride may result in a better, more sustained overall response when compared with metoclopramide.