[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.