OMEPRAZOLE V RANITIDINE FOR PREVENTION OF RELAPSE IN REFLUX ESOPHAGITIS - A CONTROLLED DOUBLE-BLIND TRIAL OF THEIR EFFICACY AND SAFETY

The aim of this study was to compare recurrence rates of reflux oesoph agitis (after endoscopic healing with omeprazole) over a 12 month peri od of randomised, double blind, maintenance treatment with either dail y omeprazole (20 mg every morning; n=53), weekend omeprazole (20 mg on three consecutive days a week, n=55) or daily ranitidine (150 mg twic e daily, n=51). Patients were assessed for relapse by endoscopy (with gastric biopsy) at six and 12 months, or in the event of symptomatic r ecurrence, and serum gastrin was monitored. At 12 months, the estimate d proportions of patients in remission (actuarial life table method) w ere 89% when receiving daily omeprazole compared with 32% when receivi ng weekend omeprazole (difference 57%, p<0.001, 95% confidence interva ls: 42% to 71%) and 25% when receiving daily ranitidine (difference 64 %, p<0.001, 95% confidence intervals: 50% to 78%). Median gastrin conc entrations increased slightly during the healing phase, but remained w ithin the normal range and did not change during maintenance treatment . No significant pathological findings were noted, and no adverse even ts were attributable to the study treatments. In conclusion, for patie nts who respond favourably to acute treatment with omeprazole 20 mg ev ery morning, the drug is a safe and highly effective maintenance treat ment for preventing relapse of reflux oesophagitis and its associated symptoms over 12 months. By contrast, weekend omeprazole and daily ran itidine were ineffective.