Background & Aims: The updated Italian guidelines advise a standard 14-day triple therapy for first-line H. pylori eradication. This prospective study evaluated the cure rate following a 14-day triple therapy with either a standard or double-dose proton pump inhibitor (PPI).

Methods. A total of 145 consecutive patients with H. pylori infection were randomized to receive a 14-day, first-line triple therapy with clarithromycin 500 mg, amoxicillin 1 g and esomeprazole at either 20 mg (standard therapy) or 40 mg (double-dose therapy), each given twice daily.

Results. At intention-to-treat analysis, H. pylori infection was cured in 73.9% (95% CI: 63.9−84) and 81.9% (95% CI: 73−90.8) following standard and double-dose therapy, respectively, and in 78.2% (95% CI: 68.5−87.9) and 85.5% (95% CI: 77.2−93.8) at per-protocol analysis. No statistically significant difference occurred. Overall, 16.4% and 19.4% patients in the standard and double-dose therapy regimen complained of side effects.

Conclusion. The success rate of both standard and double-dose 14-day triple therapies for first-line H. pylori treatment was unsatisfactory. A prolonged 14-day levofloxacin-based triple therapy for second-line H. pylori eradication seems to be promising.

Abbrevations: ITT: Intention To Treat; NUD: non ulcer dyspepsia; PP: PerAdd Contributor Protocol; PPI: proton pump inhibitors; PUD: peptic ulcer disease; UBT: urea breath test.


Helicobacter pylori, triple therapy, levofloxacin, rescue therapy