Two-year follow-up of patients with duodenal ulcer after treatment with omeprazole and amoxycillin/placebo

Abstract

We randomized in a double-blind controlled study 165 patients (102 males), mean age 55 (range 22-80) years, 45% smokers, with active duodenal ulcer to receive either omeprazole 40rag bid and amoxycillin 750 mg bid (O/A) or omeprazole 40rag bid and placebo (O/P) for two weeks. Endoscopic healing was assessed after 2 weeks. Patients not healed received another two weeks of omeprazole 20rag om. Endoscopy and Helicobacter pylori (HP) status assessed by culture, histology and serology were done before treatment and 6, 12, and 24 months after treatment and at ulcer relapse. In the case of a first relapse patients received a second course with the active treatment. Patients with a second relapse reached a study end-point. Results, Ulcer healing after 2 weeks was 78% in the O/A group (n=ll0) and 78% in the O/P group (n=55). 31132 patients not healed at 2 weeks healed after open treatment with omeprazole. Five patients (3%) were HP negative or had uncertain HP status at entry and were excluded from the analysis of HP eradication. The intention-to-treat analysis showed that 41% and 2% (p < 0.001) became HP negative in the O/A and O/P groups, respectively. Ulcer relapse occurred in 34% of the patients in the O/A group and 87% in the O/P group (p < 0.001). The figure shows time to relapse in relation to treatment and HP status after treatment.