General Practice

Symptomatic gastro-oesophageal reflux disease: double blind controlled study of intermittent treatment with omeprazole or ranitidine

K D Bardhan, consultant physician and gastroenterologist, ^a S Müller-Lissner, professor of gastroenterology, ^b M A Bigard, professor of gastroenterology, ^c G Bianchi Porro, professor of gastroenterology, ^d J Ponce, consultant gastroenterologist, ^e J Hosie, general practitioner, ^f Mairi Scott, general practitioner, ^g D G Weir, professor of gastroenterology, ^h K R W Gillon, head of projects, ⁱ R A Peacock, statistician, ⁱ Claire Fulton, clinical research manager, ^j for the European Study Group.

^a Rotherham General Hospitals NHS Trust, Rotherham S60 2UD, ^b Park-Klinik Weissensee, 13086 Berlin, Germany, ^c Hospital Brabois, 54500 Nancy, France, ^d Ospedale L Sacco, Milan 20157, Italy, ^e Servicio de Digestivo, CS La Fe Valencia, 46009 Valencia, Spain, ^f Great Western Medical Centre, Glasgow, G13 2SW, ^g Medical Centre, Glasgow G14 0XT, ^h St James's Hospital, Dublin 8, Republic of Ireland, ⁱ Astra Clinical Research Unit, Edinburgh EH7 4HG, ^j Astra Hässle AB, S-431 83 Mölndal, Sweden

Correspondence to: Dr Bardhan kdbardhan{at}d-morton.demon.co.uk

Objective: To assess intermittent treatment over 12 months in patients with symptomatic gastro-oesophageal reflux disease.
Design: Randomised, multicentre, double blind, controlled study. Patients with heartburn and normal endoscopy results or mild erosive changes received omeprazole 10 mg or 20 mg daily or ranitidine 150 mg twice daily for 2 weeks. Patients remaining symptomatic had omeprazole 10 mg or ranitidine dose doubled for another 2 weeks while omeprazole 20 mg was continued for 2 weeks. Patients who were symptomatic or mildly symptomatic were followed up for 12 months. Recurrences of moderate or severe heartburn during follow up were treated with the dose which was successful for initial symptom control.
Setting: Hospitals and primary care practices between 1994 and 1996.
Subjects: 677 patients with gastro-oesophageal reflux disease.
Main outcome measures: Total time off active treatment, time to failure of intermittent treatment, and outcomes ranked from best to worst.
Results: 704 patients were randomised, 677 were eligible for analyses; 318 reached the end of the study with intermittent treatment without recourse to maintenance antisecretory drugs. The median number of days off active treatment during follow up was 142 for the entire study (281 for the 526 patients who reached a treatment related end point). Thus, about half the patients did not require treatment for at least 6 months, and this was similar in all three treatment groups. According to outcome, 378 (72%) patients were in the best outcome ranks (no relapse or one (or more) relapse but in remission until 12 months); 630 (93%) had three or fewer relapses in the intermittent treatment phase. Omeprazole 20 mg provided faster relief of heartburn. The results were similar in patients with erosive and non-erosive disease.
Conclusions: Intermittent treatment is effective in managing symptoms of heartburn in half of patients with uncomplicated gastro-oesophageal reflux disease. It is simple and applicable in general practice, where most patients are seen.