Objective: To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients.
Design: Randomised, double blind, placebo controlled study.
Setting: 65 primary care practices in Norway.
Participants: 483 untreated patients with complaints of heartburn >/=3 days a week, with at most grade 1 reflux oesophagitis.
Interventions: Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks.
Main outcome measures: Adequate control of heartburn, defined as </=1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment.
Results: In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, P<0.0001; cisapride v placebo, non-significant). Results were comparable in patients with or without reflux oesophagitis. In patients treated with omeprazole only, symptom control was achieved significantly more often in patients positive for Helicobacter pylori. Antacid use was 2-3 times greater in patients taking cisapride or placebo than in those taking omeprazole. Relief of non-reflux symptoms did not significantly differ between the three groups. Significantly more patients taking cisapride reported adverse events than those taking omeprazole or placebo.
Conclusions: Omeprazole 20 mg once daily was highly effective in relieving heartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo.