OMEPRAZOLE IN THE LONG-TERM TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE - A DOUBLE-BLIND RANDOMIZED DOSE-FINDING STUDY

Background: Omeprazole is effective in the treatment of reflux oesopha gitis, and it is important to determine the lower dose limit with stil l appropriate clinical efficacy. Methods: Patients with endoscopic oes ophagitis grade 1-4 (N = 220) were randomized to double-blind treatmen t with 20 mg or 40 mg omeprazole daily for 4-8 weeks. Those healed aft er this initial treatment phase were re-randomized to double-blind tre atment with 20 mg omeprazole daily (n = 67), 10 mg omeprazole daily (n = 68), or placebo (n = 33) for 6 months. Remission was defined as the absence of any endoscopic sign of oesophagitis. Results: Healing rate s were increased with 40 mg omeprazole, the therapeutic gain compared with the 20-mg dose being 15% after 4 and 8 weeks. The proportion of p atients in remission after 6 months was 59% with 20 mg omeprazole, 35% with 10 mg omeprazole, and 0% with placebo. Conclusion: Maintenance t reatment with 10 mg omeprazole can prevent recurrence of oesophagitis in about one-third of patients with all grades of oesophagitis, and 20 mg omeprazole in about twice as many.