Journal Article Multicenter Study Observational Study Ppublish
PubMed: 41935593 DOI: 10.1016/j.cgh.2026.03.029
Higher Doses of Bismuth and Antibiotics Do Not Improve Helicobacter pylori Treatment Effectiveness: Results From the European Registry on Helicobacter pylori Management.
Clin Gastroenterol Hepatol 24(11):2978-2989
Authors: Samuel J Martínez-Domínguez, Ángel Lanas, Enrique Ceamanos, Irina Voynovan, Laimas Jonaitis, Ludmila Vologzanina, Alfredo J Lucendo, Galyna Fadieienko, Aiman S Sarsenbaeva, Boris D Starostin, Oleg Zaytsev, Umud Mahmudov, Sayar R Abdulkhakov, Sabir Sagdati, Tatiana Ilchishina, Igor Bakulin, Manuel Pabón-Carrasco, Oleksiy Gridnyev, Ana Garre, Sergey Alekseenko, Ángeles Pérez-Aísa, Alla Kononova, Jesús Barrio, Óscar Núñez, Ludmila V Morkovkina, Galina Tarasova, Emin Mammadov, Dmitrii Andreev, Cem Simsek, Luis Bujanda, Quliyev Fərid Vidadi Oğlu, Natalia Bakanova, Piotr Eder, György Miklós Buzás, Dmitry S Bordin, Juozas Kupcinskas, Gülüstan Babayeva, Vladimir Milivojevic, Wojciech Marlicz, Mónica Sánchez Alonso, Virginia Flores, Manuel Jiménez-Moreno, Irene Arteagoitia, Anna Cano-Català, Pablo Parra, Leticia Moreira, Francis Mégraud, Colm O'Morain, Javier P Gisbert, Olga P Nyssen
Affiliations
- Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Facultad de Medicina Universidad de Zaragoza, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Zaragoza, Spain.
- Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Facultad de Medicina Universidad de Zaragoza, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Zaragoza, Spain.
- A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russia.
- Department of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
- Gastrocentr, Perm, Russia.
- Department of Gastroenterology, Hospital General de Tomelloso, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Investigación Sanitaria de Castilla-La Mancha (IDISCAM), Tomelloso, Spain.
- Department the Division for the Study of the Digestive Diseases and its Comorbidity With Noncommunicable Diseases, Government Institution L.T. Malaya Therapy National Institute of NAMS of Ukraine, Kharkiv, Ukraine.
- Department of Gastroenterology, Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russia.
- Saint Petersburg State Budgetary Institution Healthcare City Policlinic 38, Saint Petersburg, Russia.
- First Clinical Medical Centre, Kovrov, Russia.
- Modern Hospital, Baku, Azerbaijan.
- Kazan State Medical University, Kazan Federal University, Kazan, Russia.
- Department of Gastroenterology and Endoscopy, Gastromedica GM, Novi Pazar, Serbia.
- Department of Gastroenterology, SM Clinic, Saint Petersburg, Russia.
- II Mechnikov North-Western State Medical University, Saint Petersburg, Russia.
- Department of Gastroenterology, Hospital Universitario Virgen de Valme, Sevilla, Spain.
- Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
- Department of Hospital Therapy, Far Eastern State Medical University, Khabarovsk, Russia.
- Department of Gastroenterology, Hospital Universitario Costa del Sol, Redes de Investigación Cooperativa Orientada a Resultados en Salud (RICORS), Marbella, Spain.
- Tver State Madical University, Tver, Russia.
- Department of Gastroenterology, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain.
- Department of Gastroenterology, Hospital Universitario Sanitas La Moraleja, Facultad de Medicina, Universidad CEU San Pablo, Madrid, Spain.
- Republican Gastroenterology Center, Republican Clinical Hospital of the Ministry of Health and Social Development of Chuvashia, Cheboksary, Russia.
- Department of Gastroenterology, Rostov State Medical University, Rostov-on-Don, Russia.
- Department of Internal Medicine and Gastroenterology, Azerbaijan State Advanced Training Institute for Doctors Named by A. Aliyev, Baku, Azerbaijan.
- Moscow State University of Medicine and Dentistry, Moscow, Russia.
- Department of Gastroenterology, Hacettepe University, Mehmet Akif Inan, Health Sciences University, Medical Center, HC International Clinic, Ankara, Turkey.
- Department of Gastroenterology, Biodonostia Health Research Institute, San Sebastián, Spain; Department of Medicine, Universidad del País Vasco (UPV/EHU), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), San Sebastián, Spain.
- National Oncology Centre, Baku, Azerbaijan.
- Medical Center Mediceya, Izhevsk, Russia.
- Department of Gastroenterology, Dietetics and Internal Medicine, Poznań University of Medical Sciences, Poznan, Poland; Department of Gastroenterology, H. Święcicki University Hospital, Poznan, Poland.
- Department of Gastroenterology, Ferencváros Health Center, Budapest, Hungary.
- Department of Pancreatic, Biliary and Upper Digestive Tract Disorders, A. S. Loginov Moscow clinical Scientific Center, Moscow, Russia; Department of Outpatient Therapy and Family Medicine, Tver State Medical University, Tver, Russia; Department of Propaedeutic of Internal Diseases and Gastroenterology, Russian University of Medicine, Moscow, Russia.
- Department of Gastroenterology and Hepatology, University Clinical Centre of Serbia, Belgrade University, Belgrade, Serbia.
- Department of Gastroenterology, Pomeranian Medical University in Szczecin, The Centre for Digestive Diseases, Endoklinika, Szczecin, Poland.
- Department of Gastroenterology, Hospital Universitario Santa Bárbara, Puertollano, Spain.
- Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
- Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain.
- Department of Gastroenterology, Hospital de Cruces, Barakaldo, Spain.
- Gastrointestinal Oncology, Endoscopy, and Surgery (GOES) Research Group, Althaia Xarxa Assistencial Universitària de Manresa, Institut de Recerca i Innovació en Ciències de la Vida i de la Salut de la Catalunya Central (IRIS-CC), Manresa, Spain.
- Department of Gastroenterology, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
- INSERM U1312, BRIC, Université de Bordeaux, Bordeaux, France.
- School of Medicine, Trinity College Dublin, Dublin, Ireland.
Abstract
BACKGROUND & AIMS
Evidence on optimal bismuth and antibiotic dosing is limited. We aimed to analyze the effectiveness of bismuth-containing quadruple regimens according to drug dosage.
METHODS
This was an analysis of an international, prospective, non-interventional registry on the management of Helicobacter pylori infection by European gastroenterologists (European Registry on Helicobacter pylori Management [Hp-EuReg]). Patients receiving empirical bismuth-containing quadruple therapies in any treatment line and registered from 2013 to 2024 were included. Effectiveness was assessed using a modified intention-to-treat (mITT) analysis.
RESULTS
A total of 10,767 first-line records were analyzed. The clarithromycin-amoxicillin-bismuth (CAB) scheme was >90% effective with standard doses of amoxicillin and clarithromycin (2000 mg/d and 1000 mg/d), regardless of bismuth dose. The bismuth-metronidazole-tetracycline (BMTc) regimen achieved >90% effectiveness with tetracycline ≥1500 mg/d, metronidazole 1500 mg/d, and bismuth ≥480 mg/d. The amoxicillin-metronidazole-bismuth (AMB) regimen reported ≈90% mITT with amoxicillin 2000 mg/d, metronidazole ≥1000 mg/d, and bismuth 480 mg/d. The clarithromycin-metronidazole-bismuth (CMB) showed ≥90% mITT with metronidazole ≥800 mg/d, without improvement from increasing bismuth dose. In the amoxicillin-levofloxacin-bismuth (ALB) regimen, mITT was >90%, with no benefit from increasing levofloxacin >500 mg/d. A total of 2952 second- to sixth-line treatments were analyzed, all showing mITT <90% (ALB, 83%; BMTc, 79%; CAB, 88%; MDB, 63%; AMB, 88%), with no significant differences with different bismuth doses.
CONCLUSIONS
Increasing antibiotic or bismuth doses above the standard did not improve effectiveness of H pylori treatment. Adherence, treatment length, and proton pump inhibitor co-therapy may be more impactful than escalation of antibiotics/bismuth doses.
CLINICALTRIALS
gov, Number: NCT02328131.
MeSH
Levofloxacin, Metronidazole, Clarithromycin, Amoxicillin, Tetracycline, Therapeutics