Twelve-day quintuple regime containing four antibiotics as a rescue therapy for Helicobacter pylori eradication in the central region of Portugal.

Background: Helicobacter pylori eradication rates with standard triple therapy in many countries are clinically unacceptable. Fluoroquinolone resistance is increasing and jeopardizing second-line regimens. There is a growing need for an effective strategy in patients who failed previous therapies.

Methods: This is a single-center, non-randomized clinical study conducted in the central region of Portugal. Sixty-four patients were included with a positive 13C-urea breath test (UBT) or histology for H. pylori, and at least one failed eradication attempt. The patient cohort included 71.7% of females with a median of age of 52 (range 23-87). They were treated with a twelve-day regimen consisting of a proton-pump inhibitor (PPI) bid, amoxicillin at 1,000 mg 12/12 h and levofloxacin at 500 mg bid during the first seven days, followed by PPI bid, clarithromycin at 500 mg 12/12h and either tinidazole or metronidazole at 500 mg bid/tid for five days. Eradication was assessed by UBT. The local Ethics Committee approved this study.

Results: Eradication therapy was prescribed due to dyspepsia (66.7%), peptic ulcer (10%) and thrombocytopenia (8.3%). The median number of failed therapies was one (range 1-4). The eradication rate was 64.6% according to an intention-to-treat analysis (95% CI: 53-77%), and 70% by the per-protocol analysis (95% CI: 58-82%). Age, smoking, indication for eradication, previous therapies and the use of a second-generation or full-dose PPI did not affect success rates.

Conclusions: Even though treatment with four antibiotics was used, this "reinforced" therapy achieved suboptimal results. This fact highlights the lack of effective H. pylori antimicrobials and suggests that second-line treatment in our region should be prescribed according to susceptibility testing.