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- Title
Colloidal bismuth pectin‐containing quadruple therapy as the first‐line treatment of Helicobacter pylori infection: A multicenter, randomized, double‐blind, non‐inferiority clinical trial.
- Authors
Xie, Yong; Hu, Yi; Zhu, Yin; Wang, Hong; Wang, Qi‐Zhi; Li, Yan‐Qing; Wang, Jiang‐Bin; Zhang, Zhen‐Yu; Zhang, De‐Kui; Liu, Xiao‐Wei; Lu, Nong‐Hua
- Abstract
Background: Bismuth‐containing quadruple therapy is an effective regimen for Helicobacter pylori (H. pylori) treatment. No head‐to‐head comparison trials have been conducted to evaluate the efficacy of colloidal bismuth pectin (CBP) in quadruple therapy for eradicating H. pylori. We aimed to compare the efficacy and safety of CBP quadruple therapy and bismuth potassium citrate (BPC) quadruple therapy for 14 days in the first‐line treatment of H. pylori. Methods: In this multicenter, randomized, double‐blind, non‐inferiority clinical trial, H. pylori‐infected subjects without eradication history were randomized to receive amoxicillin 1 g twice daily, tetracycline 500 mg three time daily, esomeprazole 20 mg twice daily in combination with CBP 200 mg three time daily or BPC 240 mg twice daily for 14 days. 13C‐urea breath tests were used to access the eradication rate at least 4 weeks after treatment. Results: Between April 2021 and July 2022, 406 patients were assessed for eligibility and 339 subjects were randomized. The cure rates (primary outcome) of CBP and BPC quadruple therapy were 90.5% and 92.3% (p = 0.56) by intention‐to‐treat analysis, respectively, and 96.1% and 96.2% (p = 1.00) by per‐protocol analysis, respectively. CBP quadruple therapy was non‐inferior to BPC quadruple therapy in the intention‐to‐treat and per‐protocol analysis (p < 0.025). The frequency of adverse events and compliance were not different among the two groups (p > 0.05). Conclusions: Both CBP and BPC quadruple therapy for 14 days provide high efficacy, good compliance, and safety in the first‐line treatment of H. pylori in China.
- Subjects
CHINA; HELICOBACTER pylori infections; BISMUTH; CLINICAL trials; HELICOBACTER pylori; BREATH tests
- Publication
Helicobacter, 2023, Vol 28, Issue 3, p1
- ISSN
1083-4389
- Publication type
Article
- DOI
10.1111/hel.12978