Comparison between optimized bismuth quadruple therapy and standard clarithromycin-based triple therapy for first-line Helicobacter pylori eradication: a double-blind randomized controlled trial

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dc.article.number101312
dc.catalogadoraba
dc.contributor.authorMedel Jara, Patricio Andrés
dc.contributor.authorLatorre Selvat, Gonzalo Ignacio
dc.contributor.authorFuentes López, Eduardo
dc.contributor.authorPizarro Rojas, Margarita Alicia
dc.contributor.authorViviani García, Paola
dc.contributor.authorChahuán Abde, Javier Nicolás
dc.contributor.authorMaquilón Tamayo, Sara Andrea
dc.contributor.authorCorsi Sotelo, Óscar Felipe
dc.contributor.authorReyes Placencia, Diego Armando
dc.contributor.authorEspino Espino, Alberto Antonio
dc.contributor.authorVargas Dominguez, José Ignacio
dc.contributor.authorWichmann Pérez, Ignacio Alberto
dc.contributor.authorHarris D., Paul R.
dc.contributor.authorSerrano Berrios, Carolina Lourdes
dc.contributor.authorBuruato García, Isabella María
dc.contributor.authorSandoval, Christopher
dc.contributor.authorVarela, Nelson M.
dc.contributor.authorCerpa, Leslie
dc.contributor.authorQuiñones, Luis
dc.contributor.authorMegraud Francis
dc.contributor.authorHuang, Robert J.
dc.contributor.authorShah, Shailja C.
dc.contributor.authorRiquelme Pérez, Arnoldo
dc.date.accessioned2025-11-28T15:55:40Z
dc.date.available2025-11-28T15:55:40Z
dc.date.issued2026
dc.description.abstractBackgroundHelicobacter pylori eradication reduces the risk of peptic ulcer disease and gastric cancer. In Chile, the effectiveness of standard triple therapy has dropped below 80%. We compared optimized bismuth quadruple therapy: esomeprazole 40 mg three times a day, amoxicillin 1 gr three times a day, metronidazole 500 mg three times a day, and bismuth subsalicylate 369 mg three times a day for 14 days, and standard triple therapy omeprazole 20 mg twice a day, amoxicillin 1 gr twice a day, and clarithromycin 500 mg twice a day for 14 days in a Chilean population.MethodsRandomized double-blind clinical trial. 127 treatment-naïve individuals with confirmed active H. pylori were recruited. The primary outcome was successful H. pylori eradication, at least 4 weeks post-treatment. We assessed H. pylori resistance to clarithromycin and participants’ CYP2C19 genotype/phenotype. We compared eradication success between the groups using intention-to-treat and per-protocol analyses. The trial adhered to CONSORT guidelines. NTC-Number: NCT05664685 (trial completed).Findings127 participants were recruited and randomized (64 standard triple therapy, 63 optimized bismuth quadruple therapy). Men were 44% (56/127), and the mean age was 48 (standard deviation: 14.2) in the sample. Baseline characteristics between the two groups were similar. In intention-to-treat analysis, optimized bismuth quadruple therapy had a significantly higher eradication rate versus standard triple therapy: 95% (60/63) [95% CI 86%–99%] vs. 81% (52/64) [70%–89%], p = 0.033. Adverse events were comparable: optimized bismuth quadruple therapy 67% (42/63) [54%–77%] vs. standard triple therapy 66% (42/64) [53%–76%], p = 1.00. There was no difference in baseline clarithromycin resistance or CYP2C19 polymorphisms.InterpretationOptimized bismuth quadruple therapy eradication is higher than standard triple therapy in treatment-naïve individuals with active H. pylori, without difference in adverse events or adherence. Optimized bismuth quadruple therapy is a reliable and safe empiric eradication therapy, especially in areas with high clarithromycin resistance.
dc.description.funderFONDECYT; Folio: 1230504 AR
dc.description.funderANID/FONDAP; Folio: 152220002 AR
dc.description.funderHorizon 2020 program of European Union; Folio: 825832 AR
dc.description.funderANID/FONDAP; Folio: 15130011
dc.format.extent12 páginas
dc.fuente.origenORCID
dc.identifier.doi10.1016/j.lana.2025.101312
dc.identifier.issn2667-193X
dc.identifier.urihttps://doi.org/10.1016/j.lana.2025.101312
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/107174
dc.information.autorucDepartamento de Ciencias de la Salud; Fuentes Lopez, Eduardo; 0000-0002-0141-0226; 1013849
dc.information.autorucEscuela de Medicina; Riquelme Pérez, Arnoldo; 0000-0002-8259-8960; 3538
dc.information.autorucEscuela de Medicina; Medel Jara, Patricio Andrés; S/I; 187147
dc.information.autorucEscuela de Medicina; Latorre Selvat, Gonzalo Ignacio; S/I; 179226
dc.information.autorucEscuela de Medicina; Pizarro Rojas, Margarita Alicia; 0000-0003-3063-3143; 102250
dc.information.autorucEscuela de Medicina; Viviani García, Paola; 0000-0003-2886-5228; 729
dc.information.autorucEscuela de Medicina; Chahuán Abde, Javier Nicolás; 0000-0003-1261-6200; 187210
dc.information.autorucEscuela de Medicina; Maquilón Tamayo, Sara Andrea; S/I; 1052492
dc.information.autorucEscuela de Medicina; Reyes Placencia, Diego Armando; 0000-0001-6371-3516; 194184
dc.information.autorucEscuela de Medicina; Vargas Dominguez, José Ignacio; 0000-0002-1547-2292; 120713
dc.information.autorucEscuela de Medicina; Espino Espino, Alberto Antonio; 0000-0001-5707-6290; 146018
dc.information.autorucEscuela de Medicina; Wichmann Pérez, Ignacio Alberto; 0000-0002-1115-2937; 149908
dc.information.autorucEscuela de Medicina; Harris D., Paul R.; 0000-0001-6226-0957; 80706
dc.information.autorucActividades Universitarias-Dri; Buruato García, Isabella María; S/I; 1318399
dc.information.autorucFacultad de Ciencias Biológicas; Serrano Berrios, Carolina Lourdes; S/I; 95245
dc.language.isoen
dc.nota.accesocontenido completo
dc.revistaThe Lancet Regional Health - Americas
dc.rightsacceso abierto
dc.rights.licenseAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectHelicobacter pylori
dc.subjectAntibiotics
dc.subjectBismuth quadruple therapy
dc.subjectStandard triple therapy
dc.subjectPPI
dc.subject.ddc610
dc.subject.ods03 Good health and well-being
dc.subject.odspa03 Salud y bienestar
dc.titleComparison between optimized bismuth quadruple therapy and standard clarithromycin-based triple therapy for first-line Helicobacter pylori eradication: a double-blind randomized controlled trial
dc.typeartículo
dc.volumen53
sipa.codpersvinculados1013849
sipa.codpersvinculados3538
sipa.codpersvinculados187147
sipa.codpersvinculados179226
sipa.codpersvinculados102250
sipa.codpersvinculados729
sipa.codpersvinculados187210
sipa.codpersvinculados1052492
sipa.codpersvinculados194184
sipa.codpersvinculados120713
sipa.codpersvinculados146018
sipa.codpersvinculados149908
sipa.codpersvinculados80706
sipa.codpersvinculados1318399
sipa.codpersvinculados95245
sipa.trazabilidadORCID;2025-11-24
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