Minocycline is noninferior to tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori (H pylori) empirical rescue treatment, according to study results published in the Journal of Gastroenterology.
Researchers performed a multi-center, randomized-controlled, noninferiority trial (ClinicalTrials.gov Identifier: NCT04531059). A total of 368 patients who had positive C-urea breath tests (UBTs) and who had failed at least 2 attempts at therapy with amoxicillin, clarithromycin, nitroimidazoles, or fluoroquinolones were enrolled in the study. All patients had baseline esophagogastroduodenoscopy and gastric biopsies for urease testing, histology, and H pylori culture. Patients naive to H pylori treatment were excluded along with patients who were aged younger than 18 or older than 80 years, had severe systemic disease, malignancy, pregnancy or lactation, history of gastrectomy, or recent use of certain medications.
Patients were randomly assigned 1:1 to receive minocycline or tetracycline bismuth quadruple therapy. The minocycline group received:
- esomeprazole 20 mg twice daily
- bismuth potassium citrate 600 mg twice daily
- metronidazole 400 mg twice daily
- minocycline 100 mg twice daily
The other group received tetracycline 500 mg 4 times a day, instead of minocycline.
The primary outcome evaluated was the eradication rate of H pylori infection in each treatment group, determined by C-UBT at least 6 weeks after completion of therapy. Secondary outcomes included the frequency of overall adverse events, adherence rate, antibiotic resistance rates, and the effect of antibiotic resistance on the eradication rate.
The eradication rates for minocycline and tetracycline were 88.0% and 88.6%, respectively. Adverse events occurred in 55.4% and 53.3% of the minocycline and tetracycline groups, respectively. Dizziness, nausea, fatigue, and vomiting were the most commonly reported adverse events.
Study limitations include the open-label design and complications with patient adherence.
“[M]inocycline-based quadruple therapy with high dosage of metronidazole was shown to be an effective alternative to classical bismuth quadruple therapy for H pylori rescue treatment, irrespective of metronidazole resistance,” the study authors wrote. “However, relatively high incidence of adverse events in both regimens should be emphasized.”
Disclosure: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the author’s disclosures.
This article originally appeared on Gastroenterology Advisor
Huang Y, Chen J, Ding Z, et al. Minocycline vs. tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori rescue treatment: a multicentre, randomized controlled trial. Journal of Gastroenterology. Published online April 12, 2023. doi:10.1007/s00535-023-01991-y