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 verified acute erosive or ulcerative esophagitis were initially treated with 20-40 mg omeprazole daily for 8-12 weeks. After healing, the patients were randomized to maintenance treatment with omeprazole (20 or 10 mg each morning) or ranitidine (150 mg twice daily). Control endoscopy was performed at the end of the healing phase and after 12 months of maintenance treatment or symptomatic relapse.
Results: Of 426 initially treated patients, 392 were healed and entered the maintenance study. The months of maintenance treatment with 20 mg omeprazole once daily (n = 131), 10 mg omeprazole once daily (n = 133), and 150 mg ranitidine twice daily (n = 128) were 72%, 62%, and 45%, respectively. Both the 10- and 20-mg doses of omeprazole were significantly better than the dose of ranitidine (P < 0.001 and P < 0.005, respectively). There was no significant difference between the 10- and 20-mg doses of omeprazole (P = 0.06).
Conclusions: Maintenance treatment with omeprazole (20 or 10 mg once daily) is superior to ranitidine (150 mg twice daily) in keeping patients with erosive reflux esophagitis in remission over a 12-month period.