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Heartburn treatment in primary care: randomised, double blind study for 8 weeks
J G Hatlebakk1, A Hyggen, P H Madsen
1Department of Medicine, Haukeland Sykehus, University of Bergen, N-5021 Bergen, Norway.
BMJ (Clinical Research Ed.)
|August 27, 1999
Summary
Omeprazole effectively controlled heartburn in 71% of patients, significantly outperforming cisapride and placebo. Cisapride showed no significant benefit over placebo for heartburn relief.
Area of Science:
- Gastroenterology
- Pharmacology
Background:
- Heartburn is a common symptom managed in primary care.
- Proton pump inhibitors like omeprazole and prokinetic agents like cisapride are used for treatment.
Purpose of the Study:
- To compare the efficacy and tolerability of omeprazole versus cisapride against placebo for heartburn control.
- To evaluate treatment outcomes in primary care patients with heartburn and mild reflux esophagitis.
Main Methods:
- A randomized, double-blind, placebo-controlled study was conducted in 65 Norwegian primary care practices.
- 483 patients with frequent heartburn were treated with omeprazole 20 mg daily, cisapride 20 mg twice daily, or placebo for 8 weeks.
Main Results:
- Omeprazole achieved adequate heartburn control in 71% of patients after 4 weeks, significantly higher than cisapride (22%) and placebo (18%).
- Cisapride's efficacy was not significantly different from placebo; however, omeprazole showed significant improvement (P<0.0001).
- Adverse events were reported more frequently with cisapride than with omeprazole or placebo.
Conclusions:
- Omeprazole 20 mg once daily is a highly effective treatment for heartburn relief in primary care.
- Cisapride 20 mg twice daily demonstrated no significant advantage over placebo for controlling heartburn symptoms.