Background/Aims: Patients with reflux esophagitis have rapid relapses
after treatment withdrawal. This study was designed to investigate the
relapse rate of symptomatic esophagitis during maintenance treatment
with omeprazole or ranitidine. Methods: Patients with endoscopically v
erified acute erosive or ulcerative esophagitis were initially treated
with 20-40 mg omeprazole daily for 8-12 weeks. After healing, the pat
ients were randomized to maintenance treatment with omeprazole (20 or
10 mg each morning) or ranitidine (150 mg twice daily). Control endosc
opy was performed at the end of the healing phase and after 12 months
of maintenance treatment or symptomatic relapse. Results: Of 426 initi
ally treated patients, 392 were healed and entered the maintenance stu
dy. The estimated proportions of patients in remission after 12 months
of maintenance treatment with 20 mg omeprazole once daily (n = 131),
10 mg omeprazole once daily (n = 133), and 150 mg ranitidine twice dai
ly (n = 128) were 72%, 62%, and 45%, respectively. Both the 10- and 20
-mg doses of omeprazole were significantly better than the dose of ran
itidine (P < 0.001. and P < 0.005, respectively). There was no signifi
cant difference between the 10- and 20-mg doses of omeprazole (P = 0.0
6). Conclusions: Maintenance treatment with omeprazole (20 or 10 mg on
ce daily) is superior to ranitidine (150 mg twice daily) in keeping pa
tients with erosive reflux esophagitis in remission over a 12-month pe
riod.