Aim: To study the efficacy of esomeprazole-based triple therapy in Helicobacter pylori eradication and to evaluate, by a randomized trial, the effect of increasing the dose of esomeprazole or prolonging the treatment.
Methods: Four-hundred and fifty duodenal ulcer patients were randomized to receive: (1) esomeprazole (20 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1 g b.i.d.), for 7 days (E20-7d); (2) esomeprazole (40 mg b.i.d.) with the same antibiotics, also for 7 days (E40-7d); and (3) esomeprazole (40 mg b.i.d.) with the same antibiotics, for 10 days (E40-10d). Cure rates were evaluated by (13)C-urea breath test.
Results: One-hundred and fifty patients received each treatment. Groups were comparable in terms of demographic variables. Eight percent of the patients did not return for follow-up. Compliance (98%) and side effects (only mild to moderate) in the two groups were comparable. Per-protocol cure rates were 83.5% (E20-7d), 84.8% (E40-7d), and 88.2% (E40-10d). Intention-to-treat cure rates were, respectively, 74%, 78%, and 80% (nonstatistically significant differences).
Conclusions: Esomeprazole-based triple therapies offer comparable efficacy to omeprazole-based therapies used in previous studies. Increasing the dose of esomeprazole or prolonging the treatment does not improve the results. Therefore, if esomeprazole-based triple therapy is used in duodenal ulcer patients, a regimen with only 20 mg twice daily of esomeprazole and for only 7 days may be sufficient.