Objective: This study analyzes the effect of short- and long-term omeprazole (OM) on duodenal ulcer healing, recurrence, and H. pylori status.
Methods: Patients affected by active duodenal ulcer were randomly allocated to treatment with OM 20 mg or 40 mg once daily for 4 wk. Subsequently, patients with healed duodenal ulcer were randomly assigned to one of the following three groups: OM 20 mg once daily for 12 months, OM 20 mg alternate days for 12 months, and no treatment. Endoscopy was performed at entry, at 4 wk, and after 4, 8, and 12 months. Two biopsy specimens from antrum, body, and fundus were taken for histology and search for H. pylori. One hundred and eighty patients with active duodenal ulcer were admitted. Ninety-one were treated with OM 20 mg once daily and 89 with OM 40 mg for 4 wk.
Results: The results at 4 wk show 92.8% patients healed with OM 20 mg and 95.1% at 40 mg (NS). In the second part of the study, 96 of the patients who healed at 4 wk (45 with OM 20 mg, and 51 with OM 40 mg) entered the long-term study. Thirty-six patients received OM 20 mg daily for 12 months, 35 OM 20 mg on alternate days for 12 months, and 25 patients no treatment. The results show a healing rate of 100%, 100%, and 95% with OM 20 mg daily, of 97%, 95%, and 93% with OM 20 mg on alternate days, and of 81%, 50%, and 40% (p < 0.01) with no treatment at 4, 8, and 12 months, respectively. H. pylori that was found in 97% of patients at entry, at 4 wk was found in 92.8% of patients treated with OM 20 mg and in 97.5% of patients treated with OM 40 mg (NS). In one-third of the patients, H. pylori disappeared from the antrum but was found in the fundus. A 30% reduction in the presence of H. pylori was seen in the group treated with 20 mg daily for 12 months.
Conclusions: We conclude that both continuous and alternate-day long-term OM treatment at 20 mg are similarly efficacious in the prevention of duodenal ulcer recurrence. Healing active duodenal ulcers with 20 or 40 mg does not influence subsequent treatment. Long-term OM at 20 mg daily for 12 months suppresses H. pylori temporarily in one-third of the patients. In these patients however, H. pylori reactivates after the end of treatment.