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

Objective To assess intermittent treatment over 12 months in patients wit s ymptomatic gastro-oesophageal reflux disease. Design Randomised, multicentre, double blind, controlled study. Patients wi th 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 week s. Patients remaining symptomatic had omeprazole 10 mg or ranitidine dose d oubled 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 wer e 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 i ntermittent treatment, and outcomes ranked from best to worst. Results 704 patients were randomised, 677 were eligible for analyses; 318 r eached the end of the study with intermittent treatment without recourse to maintenance antisecretory drugs. The median number of days off active trea tment during follow up was 142 for the entire study (281 for the 526 patien ts who reached a treatment related end point). Thus, about half the patient s 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 i n the best outcome ranks (no relapse or one (or more) relapse but in remiss ion until 12 months); 630 (93%) had three or fewer relapses in the intermit tent 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 hea rtburn in half of patients with uncomplicated gastro-oesophageal reflux dis ease. It is simple and applicable in general practice, where most patients are se en.