10-Day versus 14-day bismuth quadruple therapy for first-line eradication of Helicobacter pylori infection: a randomised, open-label, non-inferiority trial

Er-Hsiang Yang; Wei-Ying Chen; Hsueh-Chien Chiang; Chung-Hao Li; I-Hsuan Wu; Po-Jun Chen; Chung-Tai Wu; Yu-Ching Tsai; Wei-Chun Cheng; Chien-Jui Huang; Bor-Shyang Sheu; Hsiu-Chi Cheng

doi:10.1016/j.eclinm.2024.102529

10-Day versus 14-day bismuth quadruple therapy for first-line eradication of Helicobacter pylori infection: a randomised, open-label, non-inferiority trial

EClinicalMedicine. 2024 Mar 11:70:102529. doi: 10.1016/j.eclinm.2024.102529. eCollection 2024 Apr.

Authors

Er-Hsiang Yang¹, Wei-Ying Chen^{1

2}, Hsueh-Chien Chiang^{1

3}, Chung-Hao Li^{4

5}, I-Hsuan Wu^{6

7}, Po-Jun Chen¹, Chung-Tai Wu^{1

3}, Yu-Ching Tsai^{1

8}, Wei-Chun Cheng^{1

2

8}, Chien-Jui Huang^{1

3}, Bor-Shyang Sheu^{1

3}, Hsiu-Chi Cheng^{1

3

9}

Affiliations

¹ Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
² Department of Public Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
³ Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
⁴ Department of Family Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan.
⁵ School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.
⁶ Department of Family Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
⁷ Department of Health Management Centre, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
⁸ Department of Gastroenterology and Hepatology, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.
⁹ Institute of Molecular Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

Abstract

Background: Bismuth quadruple therapy is currently consensus recommendation for first-line Helicobacter pylori (H. pylori) treatment; however, the optimal duration is unknown. We compared the efficacy of 10-day bismuth quadruple therapy with that of 14-day bismuth quadruple therapy for first-line eradication.

Methods: For our multicentre, parallel randomised, open-label, and non-inferiority study, we recruited H. pylori treatment-naïve patients from one medical centre and one teaching hospital in Taiwan. Patients were randomly assigned (1:1) to receive 10-day (PBMT-10) or 14-day (PBMT-14) bismuth quadruple therapy. The primary outcome was the eradication rate as determined by intention-to-treat (ITT) and per-protocol (PP) analyses. The eradication rates between the two groups were compared using a one-sided α value of 0.025 and a non-inferiority margin of 7%. The secondary outcomes were the rate of adverse effects. The trial is registered with ClincialTrials.gov (NCT04527055).

Findings: From August 3, 2020 to April 28, 2023, 313 H. pylori treatment-naïve patients (PBMT-10 = 157; PBMT-14 = 156) were enrolled. 35 patients were excluded from PP analyses. The eradication rates (95% CI) for PBMT-10 and PBMT-14 were respectively 92.4% (88.2%-96.5%) and 92.9% (88.9%-97.0%) by ITT analyses, and 97.9% (95.5%-100.0%) and 99.3% (97.8%-100.0%) by PP analyses. The eradication rates for PBMT-10 were non-inferior to those for PBMT-14 (absolute difference [lower boundary of the one-sided 97.5% CI] -0.6% [-6.7%], P_NI = 0.020 in ITT analyses, -1.4% [-5.8%], P_NI = 0.007 in PP analyses). The rates of overall adverse effects (54.1% versus 57.1%, P = 0.604) were similar between the two groups; nevertheless, the rates of dizziness (18.5% versus 34.0%, P = 0.003) and vomiting (4.5% versus 12.8%, P = 0.008) were lower in PBMT-10 than in PBMT-14.

Interpretation: The 10-day bismuth quadruple therapy was non-inferior to the 14-day therapy as a first-line treatment for eradicating H. pylori infection and had no different rates of overall adverse effects, but less serious adverse events in terms of dizziness and vomiting.

Funding: The National Science and Technology Council and Ministry of Health and Welfare, Taiwan.

Keywords: Bismuth quadruple therapy; First-line eradication; Helicobacter pylori; Non-inferiority trial.

Associated data

ClinicalTrials.gov/NCT04527055