Dual therapy with high or low doses of omeprazole does not achieve an acceptable rate of Helicobacter pylori eradication in duodenal ulcer patients. A multicentre randomized long-term detailed study.

Background: It has been reported that dual therapy with high doses of omeprazole and amoxycillin proves efficient for Helicobacter pylori eradication.

Aim: To compare the efficacy, safety and tolerability of eradicating regimens with omeprazole/amoxycillin.

Methods: In this randomized multicentre study, 267 duodenal ulcer patients were treated for 2 weeks with omeprazole 40 bid (Group A) or 20 mg bid (Group B), respectively, and with amoxycillin 0.5 g. qid followed by 4 weeks of 20 mg omeprazole om. Helicobacter pylori status was assessed by both histology and urease test in the antrum and the corpus. The patients were then followed-up for 9 months.

Results: Helicobacter pylori infection was cured in 62.9% of group A (95% CI: 53.8-71.4) and in 44.8% of group B (95% CI: 35.6-54.3; p = 0.007). Healing was achieved in 91.9% of patients in group A (95% CI:85.7-96.1), and in 87.9% of patients in group B (95% CI:80.6-93.2). The estimated probability of being in ulcer remission for cured patients was 0.95 (95% CI: 0.90-0.99) and for the not cured was 0.41 (95% CI: 0.24-0.59; p = 0.0001). However, between the two treatment groups no significant differences in symptom relief or ulcer recurrence were observed. Both regimens were well tolerated with minor side-effects occurring likewise within the two groups. At two months in cured patients antral histology revealed a total (group A + B) prevalence of 13.7% of active chronic gastritis.

Conclusions: This long-term, large-size study clearly indicates that dual therapy does not represent a truly effective eradication therapy and this regime cannot be recommended.