Efficacy and Safety of 10-Day Minocycline Twice Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Prospective Single-Arm Study

Abstract

Background

Tetracycline has limited clinical application in Helicobacter pylori treatment because of difficulty in obtaining and increased adverse reactions. As a semisynthetic tetracycline, minocycline has demonstrated good potential for eradicating H. pylori infection. This study aimed to evaluate the efficacy and safety of 10-day minocycline-based quadruple therapy for H. pylori first-line treatment.

Methods

In this prospective trial, treatment-naïve adults with H. pylori infection received eradication therapy with rabeprazole 10 mg, minocycline 100 mg, amoxicillin 1000 mg, and bismuth potassium citrate 220 mg each given twice a day for 10 days. The primary outcome was the eradication rate. The secondary outcome was adverse effects. Eradication was confirmed by a negative urea breath test at least 6 weeks after the end of therapy.

Results

A total of 133 patients were included in the study. All of the patients completed the course of medication. We found that 10-day minocycline-amoxicillin quadruple therapy achieved an eradication rate of 83.5% (111/133, 95% CI 80.3%–86.7%) in intention-to-treat analysis and 90.2% (111/123, 95% CI 87.6%–92.8%) in per-protocol analysis. The treatment-emergent adverse events (TEAEs) were 15% (20/133), with the most common adverse event being dizziness (14/133, 10.5%). No severe adverse event was observed.

Conclusions

Ten-day minocycline-amoxicillin twice daily in bismuth-containing quadruple therapy appears to be effective and safe for naïve H. pylori patients.