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

Hao Mei; Yan Guo; Jing-Tao Zhao; Jun Yang; Wen-Jing Sun; De-Kui Zhang; Ping He; Gang Shi; Na-Yun Su; Ran Han; Chun-Hui Lan

doi:10.1177/17562848221142925

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

Therap Adv Gastroenterol. 2022 Dec 26:15:17562848221142925. doi: 10.1177/17562848221142925. eCollection 2022.

Authors

Hao Mei¹, Yan Guo¹, Jing-Tao Zhao¹, Jun Yang², Wen-Jing Sun³, De-Kui Zhang⁴, Ping He⁵, Gang Shi⁶, Na-Yun Su¹, Ran Han⁷, Chun-Hui Lan¹

Affiliations

¹ Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing 400042, P. R, China.
² Department of Gastroenterology, People's Hospital of Chongqing Banan District, Chongqing, China.
³ Department of Gastroenterology, The 13th People's Hospital of Chongqing, Chongqing, China.
⁴ Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, China.
⁵ Department of Gastroenterology, Yongchuan Hospital of Chongqing Medical University, Chongqing, China.
⁶ Department of Gastroenterology, Chongqing Red Cross Hospital, Chongqing, China.
⁷ Department of Gastroenterology, Guizhou Provincial People's Hospital, Guiyang, China.

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).

Keywords: Helicobacter pylori; bismuth-containing quadruple therapy; drug-induced adverse event; eradication therapy; high-dose dual therapy.