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

Abstract

Background: Helicobacter pylori eradication rates with standard triple therapy in many countries are clinically unacceptable. Fluoroquinolone resistance is increasing and jeopardizing secondline 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 13 C-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 12/12h and levofloxacin at 500 mg bid during the first seven days, followed by PPI bid, clarithromycin at 500 mg 12/12 h 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.

Helicobacter pylori antibiotic resistance in Portugal: Systematic review and meta‐analysis

“…25 Despite having high resistance rates, it is possible to achieve therapeutic response using higher doses of this antibiotic or longer duration of treatment, and therefore, monoresistance to this antibiotic may not be a major issue. 5 Moreover, among children, resistance to MTZ was not as high as it is within adults, and therefore, this antibiotic should be used as first-line therapy.…”

“…Additionally, when low resistance to quinolones is observed, a second-line levofloxacin (LVX)-based triple therapy is also an alternative. 3,5,12 Sequential therapy has also shown efficacy; however, its complexity may decrease patient compliance. 3 It is assumed that Portugal has high resistance rates to Hp, but actually there are few published studies documenting it and their results are controversial.…”

“…It was classified in 1994 as a group I human carcinogen for gastric adenocarcinoma, and its infection is one of the major public health issues worldwide …”

“…However, if there is high dual resistance, BQT is the suggested treatment. Additionally, when low resistance to quinolones is observed, a second‐line levofloxacin (LVX)‐based triple therapy is also an alternative . Sequential therapy has also shown efficacy; however, its complexity may decrease patient compliance …”

“…4 It was classified in 1994 as a group I human carcinogen for gastric adenocarcinoma, and its infection is one of the major public health issues worldwide. 5 Portugal is one of the countries with the highest prevalence of Hp infection. In children, older age is associated with higher DOI: 10.1111/hel.12493…”