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

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

ABSTRACT

Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with Helicobacter pylori (H. pylori) infection. This study 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. Patients were 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). A 13C-urea breath test was performed at least 6 weeks post-treatment to evaluate H. pylori eradication.

RESULTS

A total of 406 patients were randomly assigned to the two treatment groups. The intention-to-treat eradication rates were 91.63% for TET-T and 90.15% for TET-F, with per-protocol eradication rates of 95.34% for TET-T and 95.72% for TET-F. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%), 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.

PMID: 39097924 | DOI: 10.1111/hel.13121

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