TOPLINE:

The rate of Helicobacter pylori eradication was higher with optimized bismuth quadruple therapy than with standard triple therapy among treatment-naive individuals with active H pylori infection, with no between-group difference in rates of adverse events or treatment adherence.

METHODOLOGY:

• Researchers conducted a randomized clinical trial comparing rates of H pylori eradication between optimized bismuth quadruple therapy and standard triple therapy in 127 treatment-naive Chilean individuals with confirmed active H pylori infection (mean age, 47.6 years; 44% male).
• Participants were randomly assigned to receive one of the following:
  • Optimized bismuth quadruple therapy for 14 days (n = 63): esomeprazole 40 mg, amoxicillin 1 g, metronidazole 500 mg, and bismuth subsalicylate 369 mg three times daily
  • Standard triple therapy for 14 days (n = 64): omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily.
• The primary outcome was successful H pylori eradication, defined as a negative urea breath test performed at least 4 weeks post-treatment.
• At baseline, clarithromycin resistance testing was conducted on H pylori-positive gastric mucosa biopsies, and CYP2C19 genotyping was performed on blood samples to determine proton pump inhibitor metabolizer status.
• Treatment adherence and the occurrence of adverse events were assessed via a questionnaire at the 14-day follow-up.

TAKEAWAY:

• In the intention-to-treat analysis, in which participants were assessed according to their randomized assignment, those on optimized bismuth quadruple therapy achieved a higher eradication rate than those on standard triple therapy (95% vs 81%; risk ratio for eradication success, 1.17; P = .033).
• In the per-protocol analysis, which included only participants who followed the treatment as prescribed, optimized bismuth quadruple therapy showed a similar benefit over standard triple therapy (P = .025).
• Clarithromycin resistance and the distribution of CYP2C19 genotypes at baseline were similar between treatment groups.
• Mild-to-moderate adverse events were common and occurred at similar rates in both groups; no serious adverse events were reported, and rates of treatment adherence were also similar.

IN PRACTICE:

“For clinicians caring for subjects with H pylori infection, especially in zones with known high resistance to clarithromycin (> 15%), this fully optimized o-BQT [bismuth quadruple therapy] therapy is a reliable and safe option as a first-line empiric eradication therapy,” the authors of the study wrote.

SOURCE:

The study was led by Patricio Andrés Medel-Jara, Facultad de Medicina, Programa de Doctorado en Epidemiología, Pontificia Universidad Católica de Chile, Santiago, Chile. It was published online on November 22, 2025, in The Lancet Regional Health – Americas.

LIMITATIONS:

The study relied on a questionnaire to assess treatment adherence, the occurrence of adverse reactions, and comorbidities, which may have introduced recall bias. Randomization resulted in imbalanced groups, with differences in some baseline characteristics.

DISCLOSURES:

The study was supported by grants from multiple organizations, including FONDECYT, ANID-FONDAP, and the Horizon 2020 program of the European Union. One author disclosed receiving consulting fees from Phathom Pharmaceuticals and RedHill Biopharma, and another reported receiving urea breath test supplies from Meridian, as well as bismuth subsalicylate and placebos for the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.