J. Dent et al., OMEPRAZOLE V RANITIDINE FOR PREVENTION OF RELAPSE IN REFLUX ESOPHAGITIS - A CONTROLLED DOUBLE-BLIND TRIAL OF THEIR EFFICACY AND SAFETY, Gut, 35(5), 1994, pp. 590-598
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.