Background: The aim of our study was to establish whether one-week triple therapy regimen (omeprazole, amoxicillin, azithromycin) with low dose (2 x 20 mg/day) or high dose omeprazole (2 x 40 mg/day) is more effective in curing H. pylori infection in patients with active duodenal ulcer disease.
Methods: One hundred and twenty patients with duodenal ulcer and H. pylori infection were treated with amoxicillin 2 x 1000 mg/day for the first 7 days plus azithromycin 500 mg/day for the first 6 days. Patients were randomly assigned to receive either omeprazole 2 x 20 mg/day for the first 7 days (group A; n = 60) or omeprazole 2 x 40 mg/day for the first 7 days (group B; n = 60). After 7 days all patients in both groups continued treatment with omeprazole (40 mg/day (days 8-14) and 20 mg/day (days 15-28)). H. pylori status was determined by urease test and histology before the treatment and 4 weeks after cessation of any medication.
Results: One hundred and thirteen patients completed the study. H. pylori infection was eradicated in 73.2% [41/56] of patients in group A (intention-to-treat [ITT] analysis: 68.3%; 95% CI: 58.6-80.4%) vs. 82.5% [47/57] of patients in group B (ITT analysis: 78.3%; 95% CI: 67.8-87.9%; NS). All ulcers had healed after 4 weeks of omeprazole treatment. Side effects, usually minor, were recorded in 12.5% (group A) and in 14% (group B) of patients (NS), but therapy was discontinued for only one patient in group B (NS).
Conclusion: There was no statistically significant difference between one-week triple therapy regimen (omeprazole, amoxicillin, azithromycin) with high dose omeprazole (2 x 40 mg/day) and regimen with low dose omeprazole (2 x 20 mg/day) in curing H. pylori infection in patients with active duodenal ulcer disease.