Colloidal bismuth pectin‐containing quadruple therapy as the first‐line treatment of Helicobacter pylori infection: A multicenter, randomized, double‐blind, non‐inferiority clinical trial

Author:

Xie Yong12,Hu Yi1ORCID,Zhu Yin1ORCID,Wang Hong3,Wang Qi‐Zhi4,Li Yan‐Qing5,Wang Jiang‐Bin6,Zhang Zhen‐Yu7,Zhang De‐Kui8ORCID,Liu Xiao‐Wei9,Lu Nong‐Hua12ORCID

Affiliation:

1. Department of Gastroenterology, Digestive Disease Hospital The First Affiliated Hospital Of Nanchang University Nanchang Jiangxi Province China

2. JiangXi Clinical Research Center for Gastroenterology Nanchang Jiangxi Province China

3. Department of Gastroenterology Affiliated Hospital Of Zunyi Medical University Zunyi Guizhou Province China

4. Department of Gastroenterology The First Affiliated Hospital Of Bengbu Medical College Bengbu Anhui Province China

5. Department of Gastroenterology Qilu Hospital Of Shandong University Jinan ShanDong province China

6. Department of Gastroenterology China‐Japan Union Hospital, Jilin University Changchun Jilin Province China

7. Department of Gastroenterology and Hepatology Nanjing First Hospital, Nanjing Medical University Nanjing Jiangsu China

8. Department of Gastroenterology Lanzhou University Second Hospital Lanzhou Gansu Province China

9. Department of Gastroenterology Xiangya Hospital Central South University Changsha Hunan Province China

Abstract

AbstractBackgroundBismuth‐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.MethodsIn 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.ResultsBetween 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).ConclusionsBoth 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.

Publisher

Wiley

Subject

Infectious Diseases,Gastroenterology,General Medicine

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