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  • Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg)

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Helicobacter pylori
Original research
Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg)
  1. Ángeles Pérez-Aisa1,2,
  2. Olga P Nyssen3,4,
  3. Alma Keco-Huerga5,
  4. Luís Rodrigo6,
  5. Alfredo J Lucendo4,7,8,9,
  6. Blas J Gomez-Rodriguez10,
  7. Juan Ortuño11,
  8. Mónica Perona12,
  9. José María Huguet13,
  10. Oscar Núñez14,
  11. Luis Fernandez-Salazar15,16,
  12. Jesus Barrio17,
  13. Angel Lanas18,19,20,
  14. Eduardo Iyo21,
  15. Pilar Mata Romero22,
  16. Miguel Fernández-Bermejo23,
  17. Barbara Gomez24,
  18. Ana Garre3,4,
  19. Judith Gomez-Camarero25,
  20. Luis Javier Lamuela18,26,
  21. Ana Campillo27,
  22. Luisa de la Peña-Negro28,
  23. Manuel Dominguez Cajal29,
  24. Luis Bujanda4,30,
  25. Diego Burgos-Santamaría31,
  26. Fernando Bermejo32,33,
  27. Víctor González-Carrera34,
  28. Ramón Pajares35,36,
  29. Pedro Almela Notari37,
  30. Javier Tejedor-Tejada38,
  31. Montserrat Planella39,
  32. Itxaso Jiménez40,
  33. Yolanda Arguedas Lázaro41,
  34. Antonio Cuadrado-Lavín42,
  35. Isabel Pérez-Martínez43,
  36. Edurne Amorena44,
  37. Jesús M Gonzalez-Santiago4,45,
  38. Teresa Angueira7,
  39. Virginia Flores46,
  40. Samuel J Martínez-Domínguez18,19,20,
  41. Manuel Pabón-Carrasco5,
  42. Benito Velayos15,16,
  43. Alicia Algaba32,33,
  44. Consuelo Ramírez39,
  45. Enrique Alfaro Almajano18,19,20,
  46. Manuel Castro-Fernandez5,
  47. Noelia Alcaide15,16,
  48. Patricia Sanz Segura41,
  49. Anna Cano-Català47,
  50. Natalia García-Morales48,49,
  51. Leticia Moreira50,51,
  52. Francis Mégraud52,
  53. Colm O'Morain53,
  54. Xavier Calvet4,54,
  55. Javier P Gisbert3,4
  1. 1Department of Gastroenterology, Hospital Costal del Sol, Marbella, Spain
  2. 2Redes de Investigación Cooperativa orientada a Resultados en Salud (RICORS), Marbella, Spain
  3. 3Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Madrid, Spain
  4. 4Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain
  5. 5Department of Gastroenterology, Hospital de Valme, Sevilla, Spain
  6. 6Gastroenterology Service, Hospital Universitario Central de Asturias, Oviedo, Spain
  7. 7Department of Gastroenterology, Hospital General Tomelloso, Tomelloso, Spain
  8. 8Instituto de Investigación Sanitaria de Castilla-La Mancha (IDISCAM), Madrid, Spain
  9. 9Instituto de Investigación Sanitaria Princesa (IIS-Princesa), UniversidadAutónoma de Madrid (UAM), Madrid, Spain
  10. 10Department of Gastroenterology, Hospital Virgen de la Macarena, Seville, Spain
  11. 11Department of Gastroenterology, Hospital Universitari i Politècnic La Fe, Valencia, Spain
  12. 12Department of Gastroenterology, Hospital Quiron Marbella, Marbella, Spain
  13. 13Gastroenterology Unit, Consorci Hospital General Universitari de Valencia, Valencia, Spain
  14. 14Department of Digestive Diseases, Hospital Universitario Sanitas La Moraleja, Madrid, Spain
  15. 15Gastroenterologia, Hospital Clínico Universitario Valladolid, Gerencia Regional de Salud (SACYL), Valladolid, Spain
  16. 16Facultad de Medicina, Universidad de Valladolid, Valladolid, Spain
  17. 17Department of Gastroenterology, Hospital Rio Hortega, Valladolid, Spain
  18. 18Instituto de Investigación Sanitària de Aragón (IIS Aragorn), Zaragoza, Spain
  19. 19Facultad de Medicina. Universidad de Zaragoza, Zaragoza, Spain
  20. 20Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain
  21. 21Digestive Service, Hospital Comarcal de Inca, Inca, Mallorca, Spain
  22. 22Department of Gastroenterology, Hospital Universitario de Caceres, Cáceres, Spain
  23. 23Digestive Service, Clínica San Francisco, Cáceres, Spain
  24. 24Department of Gastroenterology, Hospital de Mataró, Mataro, Spain
  25. 25Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain
  26. 26Department of Gastroenterology, Hospital Universitario Miguel Servet, Zaragoza, Spain
  27. 27Department of Gastroenterology, Hospital Reina Sofía, Tudela, Spain
  28. 28Digestive Diseases Department, Hospital of Viladecans, Viladecans, Spain
  29. 29Department of Gastroenterology, Hospital General San Jorge, Huesca, Spain
  30. 30Department of Gastroenterology, Hospital Donostia, Instituto Biodonostia, Universidad del País Vasco (UPV/EHU), San Sebastian, Spain
  31. 31Department of Gastroenterology and Hepatology, Hospital Universitario Ramon y Cajal, Madrid, Spain
  32. 32Department of Gastroenterology, Hospital Universitario de Fuenlabrada, Madrid, Spain
  33. 33Instituto de Investigación Sanitaria La Paz, Madrid, Spain
  34. 34Department of Gastroenterology, Hospital General de Almansa, Almansa, Albacete, Spain
  35. 35Department of Gastroenterology, Hospital Universitario Infanta Sofía, San Sebastian de los Reyes, Madrid, Spain
  36. 36Medicine Department, Universidad Europea de Madrid SLU, Madrid, Spain
  37. 37Digestive Service, Hospital General Universitari de Castelló, Castellon de la Plana, Spain
  38. 38Department of Gastroenterology, Hospital Universitario de Cabueñes, Gijon, Spain
  39. 39Department of Gastroenterology, Hospital Universitari Arnau de Vilanova, Lleida, Spain
  40. 40Department of Gastroenterology, Hospital Universitario de Galdakao-Usansolo, Galdakao, Spain
  41. 41Department of Gastroenterology, Hospital Royo Villanova, Zaragoza, Spain
  42. 42Digestive Service, Hospital Universitario Marqués de Valdecilla, Santander, Spain
  43. 43Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain
  44. 44Department of Gastroenterology, Complejo Hospitalario de Navarra, Pamplona, Spain
  45. 45Department of Gastroenterology, Complejo Universitario de Salamanca. IBSAL, Salamanca, Spain
  46. 46Department of Gastroenterology, Hospital General Universitario Gregorio Marañón - Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
  47. 47Department of Gastroenterology, Research and Innovation Unit, Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Spain
  48. 48Digestive Service, Complexo Hospitalario Universitario de Vigo Sergas, Vigo, Spain
  49. 49South Galicia Health Research Institute, Vigo, Spain
  50. 50Department of Gastroenterology, Hospital Clínic-UB, Barcelona, Spain
  51. 51Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain
  52. 52Université de Bordeaux, Bordeaux, France
  53. 53Department of Gastroenterology, Faculty of Health Science, Trinity College Dublin, Dublin, Ireland
  54. 54Digestive Diseases Department, Parc Taulí, Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí, Departament de Medicina, Universitat Autònoma de Barcelona, Sabadell, Spain
  1. Correspondence to Dr Xavier Calvet, Servei d'Aparell Digestiu. Dep. de Medicina, Institut d’Investigació i Innovació Parc Taulí, Sabadell 082028, Spain; xcalvet{at}tauli.cat

Abstract

Background The recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with three times a day schedules. In clinical practice, many gastroenterologists use four capsule scBQT three times a day. However, the effectiveness and safety of this latter approach remain uncertain.

Aim To assess the effectiveness and safety of scBQT administered three times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg).

Methods All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analysed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given three times a day were calculated and compared with the four times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection.

Results Of the 3712 cases, 2516 (68%) were four times a day and 1196 (32%) three times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The three times a day schedule showed significantly better overall cure rates than four times a day (1047/1112, 94%; 95% CI 92.7 to 95.6 vs 2207/2423, 91%; 95% CI 89.9 to 92.2, respectively, p=0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, three times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection.

Conclusions ScBQT prescribed three times a day was more effective than the traditional four times a day schedule. No differences were observed in treatment adherence or safety.

  • helicobacter pylori

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/gutjnl-2022-329259

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • XC and JPG are joint senior authors.

    • Twitter @Ana_Campillo, @CalvetXMD

    • ÁP-A and OPN contributed equally.

    • Contributors ÁP-A: planned and coordinated the study; extracted, analysed, summarised and interpreted the data; wrote the first draft and approved the submitted manuscript. XC: principal Investigator and guarantor of the study, planned and coordinated the study; extracted, analysed, summarised and interpreted the data; wrote the first draft and approved the submitted manuscript. OPN: planned and coordinated the study; extracted, analysed, summarised and interpreted the data; wrote the first draft; scientific director and member of the project’s scientific committee; planned and coordinated the study; designed and programmed the electronic case report form; analysed the data; critically reviewed the manuscript drafts and approved the submitted manuscript. LR, AJL, BJGR, JO, MP, JMH, ON, LF-S, JB, ÁL, EI, PMR, MF-B, BG, JG-C, LJL, AC, LdlP-N, MDC, LB, DB-S, FB, VG-C, RP, PAN, JT-T, MP, IJ, YAL, AC-L, IP-M, EA, JMG-S, TA, VF, SJM-D, MP-C, BV, AA, CR, EAA, MC-F, NA and PSS: acted as recruiters, critically reviewed the manuscript drafts and approved the submitted manuscript. AC-C: technical project manager, critically reviewed the manuscript drafts and approved the submitted manuscript. NG-M: critically reviewed the manuscript drafts and approved the submitted manuscript. OPN, LM, FM and CO: members of the project’s scientific committee, critically reviewed the manuscript drafts and approved the submitted manuscript. JPG: principal investigator of the project and member of the project’s scientific committee, obtained funding, designed the protocol and planned the study, acted as recruiter, analysed and interpreted the data, critically reviewed the manuscript drafts and approved the final submitted manuscript.

    • Funding This project was promoted and funded by the European Helicobacter and Microbiota Study Group, the Spanish Association of Gastroenterology and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas.

    • Competing interests XC has received research grants and fees for lectures from Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly Spindler, Allergan, Diasorin, Gebro Pharma and Richen. OPN received research funding from Allergan and Mayoly Spindler. Dr Bordin served as a lecturer for Astellas, AstraZeneca, KRKA, and Abbott. FM is a consultant for PHATHOM and DaVoltera and has received grants from Allergan, bioMerieux and Mobidiag. The remaining authors declare no conflict of interest.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.