Efficacy and Safety of Tegoprazan Combined with High-Dose Amoxicillin Dual Therapy versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Prospective Cohort Study
Abstract
Objective: : To compare the efficacy and safety of tegoprazan-based high-dose amoxicillin dual therapy versus standard bismuth-containing quadruple therapy for Helicobacter pylori (H. pylori) eradication, and to evaluate the non-inferiority of the dual regimen.
Methods:: This single-center, prospective, open-label cohort study enrolled 200 treatment-naïve patients with H. pylori infection confirmed by ¹³C/¹⁴C-urea breath test between August 2024 and March 2026. Patients voluntarily selected either the dual therapy group (tegoprazan 50 mg twice daily plus amoxicillin 1.0 g three times daily for 14 days; n=100) or the quadruple therapy group (lansoprazole 20 mg twice daily, amoxicillin 1.0 g twice daily, furazolidone 0.1 g twice daily, and colloidal bismuth pectin 0.15 g three times daily for 14 days; n=100). The primary endpoint was the eradication rate assessed at least 4 weeks post-treatment. Analyses were conducted using the full analysis set (FAS), modified full analysis set (mFAS), and per-protocol set (PPS). Non-inferiority was predefined with a margin of -10%. Multivariable logistic regression was employed to adjust for potential confounders (age, gender).
Results:: In the FAS, the eradication rate was 95.0% (95% CI: 88.7%–98.4%) in the dual therapy group versus 91.0% (95% CI: 83.6%–95.8%) in the quadruple therapy group. The risk difference was 4.0% (95% CI: -3.4% to 4.0%), with the lower limit of the CI above the prespecified non-inferiority margin (-10%), meeting…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
Read the paper
Related studies
- Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2018
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study
- Occupation and risk of severe COVID-19: prospective cohort study of 120,075 UK Biobank participants
- Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study
- Comparison of the characteristics, morbidity, and mortality of COVID-19 and seasonal influenza: a nationwide, population-based retrospective cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.