Objective: To evaluate two different therapies, omeprazole/amoxicillin versus omepra-zole alone, in the treatment of duodenal ulcer patients with respect to eradication of Helicobacter pylori and time in remission during a 6-month follow-up after cessation of therapy.
Design: Double-blind, randomized, parallel groups.
Setting: Outpatient referrals in nine Swedish centres.
Patients: This study included 248 patients with active duodenal ulcer.
Main outcome measures: Endoscopic and symptomatic evaluation of time in remission. Culture, histology and serology for determination of H. pylori status.
Results: Eradication of H. pylori was 54 compared with 4% and the proportion of patients in remission at 6 months was 70 compared with 36% in the omeprazole/amoxicillin treated group versus the group treated with omeprazole alone. Of the patients who became H. pylori-negative, 84% were in remission throughout the study.
Conclusion: H. pylori is an almost obligate prerequisite for duodenal ulcer disease. Amoxicillin added to omeprazole nearly doubled the proportion of patients in remission at 6 months follow-up. The eradication rate of H. pylori in patients with excellent compliance was 74%.
1993. Vol. 5, no 5, 325-332 p.