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).
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Data availability
No datasets were generated or analysed during the current study.
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Funding
This study was supported by the National Natural Science Foundation of China (82070551 and 81770538), the Taishan Scholars Program of Shandong Province, and the National Clinical Research Center for Digestive Diseases supporting technology project (2015BAI13B07).
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Yu-Ming Ding and Yue-Yue Li designed and planned the study. Miao Duan, Zhong-Xue Han, Xiao-Hui Song, Feng-Lan Zhang, Zhi Wang, Zhang Ning, Shu-yan Zeng, Qing-Zhou Kong, Wen-Lin Zhang, Min-Juan Lin, Bo-Shen Lin, Xue-ping Nan, and Hui Wang collected the data. Jing Liu and Meng Wan performed statistical analysis. Yu-Ming Ding prepared the original draft. Yue-Yue Li, Xiu-Li Zuo, and Yan-Qing Li supported editing of the original draft and critically revised the manuscript. All authors approved the final draft.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the Helsinki Declaration and its later amendments. The study was approved by the Medical Ethics Committee of Qilu Hospital of Shandong University (No. 2021028).
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Ding, YM., Duan, M., Han, ZX. et al. Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days. Dig Dis Sci (2024). https://doi.org/10.1007/s10620-024-08460-3
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DOI: https://doi.org/10.1007/s10620-024-08460-3