Pretreatment Antimicrobial Susceptibility-Guided Vs. Clarithromycin-Based Triple Therapy for Helicobacter pylori Eradication in a Region With High Rates of Multiple Drug Resistance

OBJECTIVES: Helicobacter pylori eradication rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. We sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy for H. pylori eradication in a region with high rates of multiple drug resistance. METHODS: Consecutive H. pylori-infected patients with gastric epithelial neoplasms were randomized to receive antimicrobial susceptibility-guided therapy or clarithromycin-based triple therapy for 7 days. In patients in whom the infection was not eradicated, antibiotics were given according to an initial antimicrobial susceptibility test as a second-line therapy in both groups. Eradication rates, antibiotics resistance rates, and drug compliance owing to adverse effects were compared between the groups. RESULTS: In total, 114 patients were enrolled, and 112 completed the protocols. Drug compliance and side effects were similar between the groups. The intention-to-treat eradication rates were 94.7% (95% confidence interval (CI) = 88.8-100%, 54/57) in the antimicrobial susceptibility-guided group and 71.9% (95% CI = 60.2-83.5%, 41/57) in the clarithromycin-based triple therapy group after the initial treatment (P = 0.002), whereas the per-protocol (PP) eradication rates were 96.4% (95% CI = 91.5-100%, 54/56) in the antimicrobial susceptibility-guided group and 73.2% (95% CI = 61.5-84.8%, 41/56) in the clarithromycin-based triple therapy group (P = 0.001). In H. pylori with clarithromycin resistance, the eradication failure rate with first-line treatment was lower in the susceptibility-guided therapy group (0%, 0/12) compared with the clarithromycin-based triple therapy group (80.0%, 95% CI = 59.7-100%, 12/15) by PP analysis (P < 0.001). CONCLUSIONS: Pretreatment antimicrobial susceptibility-guided therapy is more effective than clarithromycin-based triple therapy for H. pylori eradication in a region with high rates of multiple drug resistance.