Background: Triple therapy currently forms the cornerstone of the treatment
of patients with Helicobacter pylori-positive duodenal ulcer.
Aim: To establish whether prolonged antisecretory therapy is necessary in p
atients with active duodenal ulcer.
Methods: A total of 77 patients with H. pylori-positive duodenal ulcer were
included in a prospective, controlled, double-blind study. All patients re
ceived a 7-day treatment with omeprazole 20 mg b.d., clarithromycin 500 mg
b.d. and amoxicillin 1000 mg b.d. Patients in the omeprazole group underwen
t an additional 14-day therapy with omeprazole 20 mg; patients in placebo g
roup received placebo. Endoscopy was performed upon inclusion in the study
and after 3 and 8 weeks.
Results: Seventy-four patients were eligible for a per protocol analysis af
ter 3 weeks, and 65 after 8 weeks. After 3 weeks, the healing rate was 89%
in the omeprazole group and 81% in the placebo group (P = 0.51). After 8 we
eks, the ulcer healed in 97% of the patients in the total group (95% CI: 92
.7-100%). H. pylori was eradicated in 88% of patients in the omeprazole gro
up and in 91% in the placebo group (P = 1.0). No statistically significant
differences between the groups were found in ulcer-related symptoms or in u
Conclusion: In patients with H. pylori-positive duodenal ulcer, a 7-day tri
ple therapy alone is sufficient to control the disease.