Background: Sucralfate has an inhibitory action against Helicobacter pylori and enhances the anti-H. pylori activity of antimicrobials.
Aim: To evaluate the efficacy and safety of sucralfate-based eradication therapy for H. pylori infection, compared with that based on lansoprazole, in a randomized multicentre study.
Subjects and methods: The subjects were 150 H. pylori-positive patients. They were randomly assigned to one of two regimens for 2 weeks: sucralfate 1 g t.d.s., amoxycillin 500 mg t.d.s., and clarithromycin 400 mg b.d. (SAC regimen: 75 patients); or lansoprazole 30 mg o.m. with the same antimicrobial medications (LAC regimen: 75 patients). Cure of infection was assessed by a 13C urea breath test 1 month after completion of treatment.
Results: Eight patients (four in the SAC group and four in LAC group) could not continue therapy because of severe diarrhoea, and three did not take the 13C urea breath test after therapy. Cure rates for intention-to-treat, all-patients-treated, and per protocol analysis in the SAC group were 80%, 83%, and 88%, respectively, and those in the LAC group were 87%, 87%, and 92%, respectively. There were no significant differences in cure rate or adverse effects between the two regimens.
Conclusion: Sucralfate in combination with amoxycillin and clarithromycin is as effective as lansoprazole-based eradication therapy for H. pylori.