Background: Helicobacter pylori is strongly associated with peptic ulcer: H. pylori eradication markedly decreases the recurrence rate of duodenal and gastric ulcer, but the optimum length of antibiotic therapy in the eradication of H. pylori is still unclear.
Aim: To verify the effectiveness and side-effect profile of an eradicating regimen consisting of omeprazole 20 mg daily for 4 weeks and, during the first week, combination antimicrobial treatment with tinidazole 500 mg b.d. plus clarithromycin 250 mg b.d. in patients with active duodenal and gastric ulcer.
Methods: One hundred and ninety-six duodenal ulcer patients and 27 gastric ulcer patients with H. pylori infection were admitted into an open prospective study. Compliance was assessed by an accurate interview.
Results: Overall, H. pylori was successfully eradicated in 201 of 223 patients (intention-to-treat 90.1%; 95% CI = 85-94%): 176 of 196 duodenal ulcer patients became H. pylori-negative (89.8%; CI = 85-94%) as well as 25 of 27 gastric ulcer patients (92.6%; CI = 76-99%). Compliance was excellent in 221 of 223 (99.1%) patients evaluated as having taken all the medication as prescribed. Sixteen patients (7.2%) developed mild side effects during treatment.
Conclusion: This combination treatment had excellent results with almost absolute compliance and a very low rate of minor side effects.