1. Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days.
- Author
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Ding YM, Duan M, Han ZX, Song XH, Zhang FL, Wang Z, Ning Z, Zeng SY, Kong QZ, Zhang WL, Liu J, Wan M, Lin MJ, Lin BS, Nan XP, Wang H, Li YY, Zuo XL, and Li YQ
- Subjects
- Humans, Middle Aged, Male, Female, Adult, Pyrroles administration & dosage, Pyrroles adverse effects, Proton Pump Inhibitors administration & dosage, Proton Pump Inhibitors adverse effects, Breath Tests, Treatment Outcome, Aged, China, Helicobacter Infections drug therapy, Helicobacter Infections diagnosis, Helicobacter pylori drug effects, Drug Therapy, Combination, Tetracycline administration & dosage, Tetracycline therapeutic use, Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents adverse effects, Bismuth administration & dosage, Bismuth therapeutic use, Bismuth adverse effects, Clarithromycin administration & dosage, Amoxicillin administration & dosage, Sulfonamides administration & dosage, Drug Administration Schedule
- 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
13 C-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)., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)- Published
- 2024
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