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. 2025 Jul 4.
doi: 10.1111/apt.70261. Online ahead of print.

Effectiveness and Safety of First-Line Non-Bismuth Quadruple Concomitant Therapy Versus Single-Capsule Bismuth Quadruple Therapy

Olga P Nyssen  1 , Nuria Montes  2 , Ángeles Pérez-Aísa  3 , Samuel J Martínez-Domínguez  4 , Javier Tejedor-Tejada  5 , Alfredo J Lucendo  6 , Jose M Huguet  7 , Ana Garre  1 , Luis Bujanda  8 , Manuel Pabón-Carrasco  9 , Manuel Castro-Fernández  9 , Monica Perona  10 , Inmaculada Ortiz-Polo  11 , Óscar Núñez  12 , Maria Soledad Marcos  13 , Blas José Gómez Rodríguez  14 , Antonio Moreno Loro  15 , Fernando Bermejo  16 , Jesús Barrio  17 , Eduardo Iyo  18 , Eva Barreiro Alonso  19 , Virginia Flores  20 , Alma Keco-Huerga  14 , Pilar Mata-Romero  21 , Judith Gomez-Camarero  22 , Miguel Fernández-Bermejo  23 , Manuel Domínguez Cajal  24 , Daniel Martin-Holgado  22 , Benito Velayos  25 , Montserrat Planella  26 , Noelia Alcaide  25 , Ana Beatriz Pozo Blanco  27 , Luis Fernández-Salazar  28 , Ramón Pajares Villarroya  29 , Mónica Sánchez Alonso  30 , Pilar Pazo Mejide  31 , Manuel Jiménez-Moreno  22 , Antonia Perelló  18 , Marta Pascual-Mato  32 , Eduardo Albéniz  33 , Goretti Hernández  34 , Maria Fraile Gonzalez  35 , Senador Moran Sanchez  36 , Jesús Daniel Fernández de Castro  37 , Anna Cano-Català  38 , Pablo Parra  1 , Leticia Moreira  39 , Francis Mégraud  40 , Colm O'Morain  41 , Javier P Gisbert  1 ; Hp‐EuReg investigators
Collaborators, Affiliations

Effectiveness and Safety of First-Line Non-Bismuth Quadruple Concomitant Therapy Versus Single-Capsule Bismuth Quadruple Therapy

Olga P Nyssen et al. Aliment Pharmacol Ther. .

Abstract

Background: The V Spanish Consensus Conference on Helicobacter pylori recommended either a 14-day non-bismuth quadruple concomitant therapy (CT: proton pump inhibitor [PPI], clarithromycin, amoxicillin, and metronidazole) or a 10-day bismuth-containing quadruple therapy (Sc-BQT: PPI, bismuth, tetracycline, and metronidazole in a single capsule). The relative advantages of each remain uncertain.

Aim: To compare the effectiveness and safety of first-line empirical CT versus Sc-BQT in Spain.

Methods: We analysed data from treatment-naïve patients enrolled in the European Registry on H. pylori Management (Hp-EuReg; 2013-2024). Multivariate logistic regression with propensity score weighting and bootstrap analysis (10,000 replicas) estimated modified intention-to-treat effectiveness and safety.

Results: We evaluated 13,787 treatments: 7234 (52%) with CT-10 and 14 days, and 6553 (48%) with Sc-BQT-every 6 and 8 h. Sc-BQT showed greater effectiveness than 14-day CT (94% vs. 91%; p < 0.001). However, 14-day CT with standard-dose PPI (93%) outperformed Sc-BQT every 6 h with low-dose PPI (90%) (p = 0.043). Sc-BQT every 8 h with high-dose PPI achieved the highest eradication (98%) (p = 0.015). Adherence was similar with Sc-BQT (94%) and 14-day CT (93%), being highly associated with eradication success (p < 0.001). Sc-BQT, particularly with low- or standard-dose PPI, had a better safety profile (p < 0.001).

Conclusion: Sc-BQT is more effective, better tolerated, and more broadly applicable than 14-day CT. Both regimens achieved ≥ 90% success, but Sc-BQT's stewardship-friendly profile further supports its use as first-line therapy for H. pylori eradication.

Keywords: H. pylori; amoxicillin; bismuth; clarithromycin; concomitant; eradication treatment; metronidazole; single capsule; tetracycline.

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References

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