1. Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial.
- Author
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Ding YM, Zhang QM, Li RL, Han ZX, Zhao Q, Xu LD, Wang KY, Nan XP, Duan M, Zeng SY, Kong QZ, Wang H, Wu XQ, Zhang N, Li YQ, Zuo XL, and Li YY
- Subjects
- Humans, Male, Middle Aged, Female, Adult, Treatment Outcome, China, Amoxicillin therapeutic use, Amoxicillin administration & dosage, Drug Administration Schedule, Esomeprazole therapeutic use, Esomeprazole administration & dosage, Aged, Young Adult, Breath Tests, Proton Pump Inhibitors therapeutic use, Proton Pump Inhibitors administration & dosage, Proton Pump Inhibitors adverse effects, Helicobacter Infections drug therapy, Tetracycline therapeutic use, Tetracycline administration & dosage, Tetracycline adverse effects, Bismuth therapeutic use, Bismuth adverse effects, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents adverse effects, Drug Therapy, Combination, Helicobacter pylori drug effects
- Abstract
Background: Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with Helicobacter pylori (H. pylori) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of H. pylori infection., Methods: This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with H. pylori infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a
13 C-urea breath test was performed to evaluate H. pylori eradication., Results: In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%-95.44%) versus 90.15% (183/203; 95% CI 86.05%-94.25%) (p = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%-98.31%) versus 95.72% (179/187; 95% CI 92.82%-98.62%) (p = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, p = 0.024), with no significant differences in compliance to treatment between the groups., Conclusion: As a first-line therapy for H. pylori infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions., Trial Registration: ClinicalTrials.gov identifier: NCT05431075., (© 2024 John Wiley & Sons Ltd.)- Published
- 2024
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