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- Title
Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days.
- Authors
Ding, Yu-Ming; Duan, Miao; Han, Zhong-Xue; Song, Xiao-Hui; Zhang, Feng-Lan; Wang, Zhi; Ning, Zhang; Zeng, Shu-yan; Kong, Qing-Zhou; Zhang, Wen-Lin; Liu, Jing; Wan, Meng; Lin, Min-Juan; Lin, Bo-Shen; Nan, Xue-ping; Wang, Hui; Li, Yue-Yue; Zuo, Xiu-Li; Li, Yan-Qing
- Abstract
Background: Bismuth-containing quadruple therapy is the first-line treatment for eradicating Helicobacter pylori (H. pylori). The optimal duration for H. pylori eradication using bismuth-containing quadruple therapy remains controversial. Therefore, we aimed to compare the clinical effects of the 10- and 14-day bismuth-containing quadruple treatment regimen to eradicate H. pylori. Methods: Treatment-naïve patients with H. pylori infection (n = 1300) were enrolled in this multicenter randomized controlled study across five hospitals in China. They were randomized into 10- or 14-day treatment groups to receive bismuth-containing quadruple therapy as follows: vonoprazan 20 mg twice daily; bismuth 220 mg twice daily; amoxicillin 1000 mg twice daily; and either clarithromycin 500 mg twice daily or tetracycline 500 mg four times daily. At least 6 weeks after treatment, we performed a 13C-urea breath test to evaluate H. pylori eradication. Results: The per-protocol eradication rates were 93.22% (564/605) and 93.74% (569/607) (p < 0.001) and the intention-to-treat eradication rates were 88.62% (576/650) and 89.38% (581/650) (p = 0.007) for the 10- and 14-day regimens, respectively. Incidence of adverse effects was lower in patients who received 10- vs. 14 days of treatment (22.59% vs. 28.50%, p = 0.016). We observed no significant differences in the compliance to treatment or the discontinuation of therapy because of severe adverse effects between the groups. Conclusion: Compared with the 14-day bismuth-containing quadruple regimens, the 10-day regimen demonstrated a non-inferior efficacy and lower incidence of adverse effects. Therefore, the 10-day regimen is safe and tolerated and could be recommended for H. pylori eradication (NCT05049902).
- Subjects
CHINA; HELICOBACTER pylori infections; HELICOBACTER pylori; CLINICAL trials; TERMINATION of treatment; PATIENT compliance; BREATH tests
- Publication
Digestive Diseases & Sciences, 2024, Vol 69, Issue 7, p2540
- ISSN
0163-2116
- Publication type
Article
- DOI
10.1007/s10620-024-08460-3