[Treatment with omeprazole, clarithromycin and amoxicillin over 6 days in patients with Helicobacter pylori-infected duodenal ulcer].

OBJECTIVE: To investigate the eradication rate of Helicobacter pylori with omeprazole, amoxicillin and clarithromycin during 6 days in patients with duodenal ulcer. To compare the reliability of the analysis of the eradication with urea-13C breath test performed one month and 3 months after therapy. To evaluate the one-year reinfection rate. PATIENTS AND METHODS: Prospective study including 99 patients with duodenal ulcer (65 with acute disease and 34 in maintenance treatment) infected by Helicobacter pylori (urease rapid test and urea-13C breath test positive). Patients were treated with omeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g, b.i.d., during 6 days. The infection status was investigated 1 and 3 months after treatment by urea-13C breath test. The one-year reinfection rate was investigated using the same test. RESULTS: Per protocol eradication rates were 76% (95%-CI: 66-84) one month and 73% (95%-CI: 63-81) 3 months after treatment. In the intention to treat analysis, eradication rates were 74% (95%-CI: 64-82) and 70% (95%-CI: 60-79), respectively. Side effects were mild and uncommon. The rate of false negative urea-13C breath test results one month after therapy with respect to 3 months was 4.2% (95%-CI: 0.8-11.7). One-year reinfection rate determined in 56 patient was absent. CONCLUSIONS: The eradication of Helicobacter pylori with triple therapy for 6 days in patients with duodenal ulcer is not satisfactory. To investigate Helicobacter pylori infection with urea-13C breath test one month after treatment overestimates the results of the eradication. One-year reinfection rate is clinically irrelevant.