Heartburn treatment in primary care: randomised, double blind study for 8 weeksBMJ 1999; 319 doi: https://doi.org/10.1136/bmj.319.7209.550 (Published 28 August 1999) Cite this as: BMJ 1999;319:550
- Jan G Hatlebakk, assistant professor ()a,
- Arild Hyggen, clinical research coordinatorb,
- Per H Madsen, specialist in primary care medicinec,
- Per O Walle, specialist in primary care medicined,
- Tom Schulz, senior consultant in gastroenterologye,
- Petter Mowinckel, head statisticianb,
- Tomm Bernklev, clinical research managerb,
- Arnold Berstad, professor, on behalf of the Norwegian Heartburn Study Groupa
- a Department of Medicine, Haukeland Sykehus, University of Bergen, N-5021 Bergen, Norway
- b Astra Norge, N-1471 Skårer, Norway
- c Lyshovden Legekontor, N-5148 Fyllingsdalen, Norway
- d General Practice, N-4900 Tvedestrand, Norway
- e Aust-Agder Central Hospital, N-4800 Arendal, Norway
- Correspondence to: J G Hatlebakk
- Accepted 24 May 1999
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.
In primary care patients, heartburn is commonly treated empirically
Most randomised clinical trials of treatment for heartburn have been conducted in specialist care, and documentation for empirical treatment is limited
Omeprazole was significantly more effective than cisapride or placebo in controlling heartburn and other symptoms of gastro-oesophageal reflux after 2, 4 and 8 weeks, whereas cisapride did not differ significantly from placebo
Omeprazole should be considered as a first choice for empirical treatment of heartburn in primary care
Funding Astra Norge, Norway
Competing interests AH, PM, and TB were employed by Astra Norge. JGH and AB have accepted fees from Astra Norge and Janssen Cilag for speaking TS has accepted fees from Astra Norge for organising education
website extra The sample size calculation, flow of participants through the trial, members of the Norwegian Heartburn Study Group, and participating gastroenterologists appear on the BMJ's website www.bmj.com
- Accepted 24 May 1999