Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days
- 03.05.2024
- Original Article
- Verfasst von
- Yu-Ming Ding
- Miao Duan
- Zhong-Xue Han
- Xiao-Hui Song
- Feng-Lan Zhang
- Zhi Wang
- Zhang Ning
- Shu-yan Zeng
- Qing-Zhou Kong
- Wen-Lin Zhang
- Jing Liu
- Meng Wan
- Min-Juan Lin
- Bo-Shen Lin
- Xue-ping Nan
- Hui Wang
- Yue-Yue Li
- Xiu-Li Zuo
- Yan-Qing Li
- Erschienen in
- Digestive Diseases and Sciences | Ausgabe 7/2024
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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- Titel
- Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days
- Verfasst von
-
Yu-Ming Ding
Miao Duan
Zhong-Xue Han
Xiao-Hui Song
Feng-Lan Zhang
Zhi Wang
Zhang Ning
Shu-yan Zeng
Qing-Zhou Kong
Wen-Lin Zhang
Jing Liu
Meng Wan
Min-Juan Lin
Bo-Shen Lin
Xue-ping Nan
Hui Wang
Yue-Yue Li
Xiu-Li Zuo
Yan-Qing Li
- Publikationsdatum
- 03.05.2024
- Verlag
- Springer US
- Erschienen in
-
Digestive Diseases and Sciences / Ausgabe 7/2024
Print ISSN: 0163-2116
Elektronische ISSN: 1573-2568 - DOI
- https://doi.org/10.1007/s10620-024-08460-3
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