An open, prospective, randomized, 6-month, clinical trial was performed on 198 patients with healed duodenal ulcers (DUs) to compare three omeprazole schedules for the prevention of ulcer relapse - 20 mg daily (group 1), 20 mg every other day (group 2), and 40 mg on Saturday and Sunday (group 3). Patients were followed up at 3-month intervals; endoscopy and laboratory screening (including basal serum gastrin measurement) were performed at baseline, after 6 months, and in the event of any symptomatic relapse. One-way analysis of variance, the chi-square test, and Student's t test on paired data were used for statistical analysis of the study data. Per protocol analysis (PPa) and a more restrictive analysis (Ra) considering all dropouts as treatment failures were also used. Patients were randomly assigned to one of three treatment groups: 67 to group 1, 69 to group 2, and 62 to group 3. Thirty-two patients dropped out of the study, 14 in group 1, 3 in group 2, and 15 in group 3. Confirmed ulcer relapse rates were 3.8% in group 1, 19.7% in group 2, and 23.4% in group 3 (PPa, P <0.01). Ra rates were 23.9%, 23.2%, and 41.9%, respectively (P <0.03). No severe side effects were recorded. Over a 6-month period, omeprazole 20 mg daily appeared to be the most effective maintenance treatment for healed DU. All three omeprazole schedules were well tolerated.
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