Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Treatment: A Multicenter Real-World Observational Study.

BACKGROUND/AIMS: Minocycline is a semisynthetic tetracycline with potent antimicrobial activity against Helicobacter pylori (H. pylori) and favorable pharmacokinetic properties. Although minocycline-based bismuth quadruple therapy (BQT) has shown encouraging eradication rates in controlled studies, evidence from real-world practice remains limited. This study assessed the effectiveness, safety, and cost-effectiveness of minocycline-containing BQT in a real-world setting.

MATERIALS AND

METHODS

In this multicenter, real-world observational study conducted at 25 hospitals in Fujian Province, China, between January and March 2025, adults with confirmed H. pylori infection were treated with 1 of 3 14-day BQT regimens: PBAC (amoxicillin- clarithromycin), PBMC (minocycline-clarithromycin), or PBML (minocycline levofloxacin), each combined with esomeprazole and bismuth. The primary endpoint was H. pylori eradication confirmed by a 13C-urea breath test after treatment. Secondary endpoints included adverse events, treatment adherence, and cost-effectiveness.

RESULTS

Of the 347 enrolled patients (PBAC, n = 115; PBMC, n = 117; and PBML, n = 115), 330 completed treatment and follow-up and were included in the per-protocol (PP) analysis. In the intention-to-treat analysis, eradication rates were 77.4% (89/115), 85.5% (100/117), and 84.3% (97/115) in the PBAC, PBMC, and PBML groups, respectively (P = .217); corresponding PP eradication rates were 80.9% (89/110), 90.9% (100/110), and 88.2% (97/110) (P = .079). Minocycline-containing regimens achieved numerically higher eradication rates than the amoxicillin-containing regimen. Adverse events occurred in 32.7%, 20.9%, and 23.6% of patients in the PBAC, PBMC, and PBML groups, respectively, while treatment adherence exceeded 94% in all groups. Pharmacoeconomic analysis identified PBML as the most cost-effective regimen (5.38 Chinese Yuan [CNY] per 1% eradication), followed by PBAC (5.41 CNY per 1% eradication) and PBMC (6.06 CNY per 1% eradication).

CONCLUSION

Minocycline-containing BQT demonstrated good tolerability, favorable cost effectiveness, and numerically higher eradication rates in routine clinical practice. It may represent a practical alternative to conventional amoxicillin- or tetracycline-based regimens. Further randomized trials are needed to validate these findings.