Tailored Helicobacter pylori therapy is more effective than conventional therapy: a randomized-controlled trial

Abstract

Background and aims Tailored (culture and sensitivity) therapy has gained attention over recent years as an effective option for eradication of Helicobacter pylori infection. The authors aimed to assess the efficacy of antibiotics sensitivity-guided therapy versus clarithromycin or levofloxacin triple therapies as the first-line therapy for H. pylori. Patients and methods Dyspeptic patients who underwent esophagogastroduodenoscopy were prospectively enrolled. Patients with positive H. pylori results by the rapid urease test were randomized to receive either antibiotics sensitivity-guided therapy or empirical clarithromycin or levofloxacin-based triple therapy for 14 days. Antimicrobial sensitivity tests for seven antibiotics (clarithromycin, amoxicillin, metronidazole, levofloxacin, tetracycline, nitrofurantoin, and rifampicin) were performed using the disk-diffusion method. Group A received antibiotics sensitivity-guided therapies that included esomeprazole plus two antibiotics for which the isolates were sensitive and group B received conventional therapies that included esomeprazole, amoxicillin plus clarithromycin or levofloxacin for 2 weeks. Eradication of H. pylori was checked using stool antigen 4 weeks after therapy. Results A total of 25 patients completed the study in each group. Both studied groups were matched for baseline characteristics. The most commonly used regimen in the antimicrobial sensitivity-based therapy was clarithromycin-based triple therapy (46.5%), followed by levofloxacin-based triple therapy and levofloxacin and nitrofurantoin plus esomeprazole. The association analysis demonstrated that, in the intention-to-treat populations, the H. pylori eradication rate was significantly higher in the antibiotic sensitivity-guided therapy group [85.7% (24/28) vs. 53.3% (16/30) in the conventional therapy group (P=0.035). In the per-protocol populations, the eradication rate was 96% for the sensitivity-guided therapy group and 64% for the conventional therapy group (P=0.005). The rates of adverse events were similar in both sensitivity-guided and conventional therapies, with no significant differences (P=0.527). Conclusions Culture-based eradication therapy demonstrated superior eradication rates than empirical therapy as a first-line therapy for H. pylori in a region with high rates of antimicrobial resistance.