Both 14-day hybrid and bismuth quadruple therapies cure most patients with Helicobacter pylori infection in populations with moderate antibiotic resistance: a randomized controlled trial [PublishAheadOfPrint]

BACKGROUND & AIM: Hybrid therapy is a novel two-step treatment achieving a high eradication rate for H. pylori infection. Currently, whether this new therapy achieves a higher eradication rate than bismuth quadruple therapy remains an unanswered question. The aim of this prospective, randomized, comparive study was to investigate the efficacies of 14-day hybrid therapy and bismuth quadruple therapy in the treatment of H. pylori infection.

METHODS: From July 2013 to June 2015, eligible H. pylori-infected subjects were randomly assigned to receive either 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with pantoprazole plus amoxicillin, followed by a 7-day quadraple therapy with pantoprazole plus amoxicillin, clarithromycin and metronidazole). H. pylori status was examined 6 weeks after the end of treatment.

RESULT: Three hundred and thirty H. pylori-infected participants were randomized to receive 14-day bismuth quadruple therapy (n = 164) or 14-day hybrid therapy (n = 166). The eradication rates by intention-to-treat analysis were similar: 93.9% vs 92.8% (95% confidence interval [CI]: -4.3% - 5.4%; P = 0.68). Per-protocol analysis yielded similar results (96.7% vs 94.9%; P = 0.44). However, bismuth quadruple therapy had a higher frequency of adverse events than hybrid therapy (55.5% vs 15.7%; 95% CI: 30.4% - 49.2%; P < 0.001). The two treatments exhibited comparable drug adherence (93.9% vs 97%, respectively). The resistance rates of antibiotics were: clarithromycin 16.7%; amoxicillin 1.3%; metronidazole 25%, and tetracycline 0% of patients, respectively. In the bismuth quadruple therapy group, the eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (70.0% vs 96.4%; P = 0.04). In the hybrid therapy group, no significant impact of clarithromycin or metronidazole resistance on eradication rates was identified.

CONCULSIONS: Both 14-day hybrid and bismuth quadruple therapies cure most patients with H. pylori infection in populations with moderate antibiotic resistance. However, the former has fewer adverse effects than the latter. ClinicalTrials.gov number: NCT02541864.

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