Background: The necessity of increasing intragastric pH during eradication treatment in Helicobacter pylori infected patients is well established. However, the optimal dose of the proton pump inhibitors used in eradication regimen is still a subject of debate.
Aims: To compare the efficacy and tolerability of a double vs. a single daily dose of pantoprazole in a 7-day triple therapy in eradicating H. pylori.
Methods: In this regional, multicentre, comparative, randomized and double-blind study, H. pylori-positive patients with non-ulcer dyspepsia were treated for 7 days with clarithromycin 500 mg b.d. and amoxycillin 1000 mg b.d. and either a double (2 x 40 mg, Group 2PCA) or a single (40 mg, Group 1PCA) daily dose of pantoprazole. H. pylori infection was assessed at entry and at the end (day 38) of the study by histology and culture, or in some cases by 13C-urea breath test.
Results: From 203 patients recruited, 192 patients (96 in Group 2PCA and 96 in Group 1PCA) formed the intention-to-treat population. Twenty-six of them judged as major protocol violators were excluded from the per protocol analysis. H. pylori eradication rate was 75% in Group 2PCA and 56% in Group 1PCA in intention-to-treat analysis, and 80% in Group 2PCA and 59% in Group 1PCA in per protocol analysis (P < 0.05). The primary resistance to clarithromycin was 10.5%. The eradication rates for the clarithromycin susceptible strains were 86% for Group 2PCA and 71% for Group 1PCA in per protocol analysis (P < 0.05). Both regimens led to similar improvement of clinical symptoms and were equally well tolerated.
Conclusion: A double (2 x 40 mg) daily dose of pantoprazole in a 7-day triple therapy is more effective than a single (40 mg) dose of this drug in eradication of H. pylori.