Efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori infection: a multicenter, randomized controlled clinical trial

Abstract

Background: A high-dose proton pump inhibitor (PPI)-amoxicillin dual therapy has been investigated for treatment of patients with Helicobacter pylori ( H. pylori) infection. Currently, the efficacy of this dual therapy remains inconclusive, with controversial findings from various single-center clinical trials. Objectives: To assess the efficacy and safety of high-dose dual therapy (HDDT) compared with the bismuth-containing quadruple therapy (BQT) in treatment-naive patients with H. pylori infection. Design: A multicenter, open-label, randomized controlled clinical trial. Methods: Three hundred and forty treatment-naïve patients with H. pylori infection were prospectively recruited from seven participating hospitals. The enrolled patients were randomized into one of two treatment groups: the HDDT group (esomeprazole, 20 mg four times daily; amoxicillin, 750 mg four times daily) and the BQT group (esomeprazole, 20 mg, twice daily; bismuth potassium citrate, 600 mg, twice daily; amoxicillin, 1 g, twice daily; metronidazole, 400 mg, four times daily). The primary outcome was eradication rate, and secondary outcomes were safety and patient compliance. Results: The eradication rates in the HDDT group versus the BQT group were 86.47% versus 87.06% on intention-to-treat (ITT) analysis, 91.88% versus 92.50% on modified ITT (MITT) analysis, and 91.77% versus 93.04% on per-protocol (PP) analysis, with no significant differences between the two groups. The patient compliance rates in the HDDT group versus the BQT group were 97.02% versus 95.86%, and no significant difference was found between the two groups. Notably, the HDDT group exhibited significantly lower incidence in the drug-induced adverse events (AEs) compared to the BQT group (16.67% versus 47.94%). Conclusion: HDDT is equally efficacious in eradicating H. pylori infection and resulted in good patient compliance and safety compared with BQT. These findings provide evidence in support of HDDT as a first-line treatment for H. pylori infection. Registration: This clinical trial was registered at The Chinese Clinical Trial Registry (trial registration number: ChiCTR2000039096).

Clinical Study on the Eradication of Helicobacter pylori by Vonoprazan Combined with Amoxicillin for 10‐Day Dual Therapy

“…Esomeprazole and vonoprazan, administered at varying doses and treatment durations, exhibit distinct safety and efficacy profiles. The H. pylori eradication rates are 86.47% in ITT analysis, 91.77% in PP analysis, and 16.67% in adverse reaction rates after treatment with 20 mg of esomeprazole qid and 750 mg of amoxicillin qid for 14 days 38 . For patients treated with 40 mg of esomeprazole and 1000 mg of amoxicillin tid for 14 days are 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) respectively in ITT, MITT, and PP analyses, respectively, with an adverse reaction rate is 11.1% 39 .…”

“…The H. pylori eradication rates are 86.47% in ITT analysis, 91.77% in PP analysis, and 16.67% in adverse reaction rates after treatment with 20 mg of esomeprazole qid and 750 mg of amoxicillin qid for 14 days. 38 For patients treated with 40 mg of esomeprazole and 1000 mg of amoxicillin tid for 14 days are 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) respectively in ITT, MITT, and PP analyses, respectively, with an adverse reaction rate is 11.1%. 39 Administering amoxicillin (1000 mg once/day) and esomeprazole (40 mg once/day) results in a 66.7% eradication rate for patients who failed to eradicate H. pylori twice after a 14-day treatment.…”

High‐dose dual therapy versus bismuth‐containing quadruple therapy for the eradication of Helicobacter pylori: A systematic review and meta‐analysis

“…Of the 42 reports selected for detailed evaluation, 22 studies were excluded because of non-RCT (n = 1), using interventions that did not meet the criteria (n = 16), with insufficient data for analysis (n = 1), using antibiotics that were considerably different from other included studies (n = 2), and duplicates (n = 2). Finally, 20 studies [19][20][21][22][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] including 7891 patients were eligible for our systematic review and meta-analysis. The article selection process is illustrated in…”

“…All studies were published between 2003 and 2023 and conducted in four countries, of which 18 were conducted in China, [19][20][21][22][26][27][28][29][30][31][32][34][35][36][37][38][39][40] one in Germany and Austria, 25 and one in Colombia. 33 Of the 20 trials included, 18 were full-text articles, [19][20][21][22]25,27,[29][30][31][32][33][34][35][36][37][38][39][40] and two were conference abstracts. 26,28 After excluding the studies that did not mention the age of the subjects, 26,28,37 older, except for those in the studies of Hsu et al 19 (≥20 years) and…”

“…Yang et al 38 (≥60 years). Thirteen studies were bi-center or multicenter RCTs [19][20][21][25][26][27][28][31][32][33][34]36,37 and seven were single-center RCTs. 22,29,30,35,[38][39][40] The tests to diagnose H. pylori and confirm H. pylori eradication included rapid urease test (RUT), 13 C-or 14 C-urea breath test (UBT), stool antigen test (SAT), histological examination, and biopsy culture.…”