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.