Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.

Autor:	Corazziari ES; Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy., Gasbarrini A; Medicina Interna e Gastroenterologia, CEMAD Centro Malattie Dell'Apparato Digerente, Università Cattolica Del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS. Rome, Italy., D'Alba L; Department of Gastroenterology and Digestive Endoscopy, Azienda Ospedaliera San Giovanni Addolorata, Rome, Italy., D'Ovidio V; Unit of Gastroenterology and Digestive Endoscopy, S. Eugenio Hospital, Rome, Italy., Riggio O; Dipartimento di Medicina Traslazionale e di Precisione, Sapienza University of Rome, Rome, Italy., Passaretti S; Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy., Annibale B; Dipartimento Scienze Medico-Chirurgiche e Medicina Traslazionale, Universita' Sapienza Roma, Ospedale Universitario Sant'Andrea, Rome, Italy., Cicala M; Department of Digestive Diseases, Campus Bio Medico University, Rome, Italy., Repici A; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy., Bassotti G; Gastroenterology & Hepatology Section, Department of Medicine & Surgery, University of Perugia, Perugia, Italy., Ciacci C; PO di Malattie Dell'Apparato Digerente, Università di Salerno, AOU San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy., Di Sabatino A; First Department of Medicine, University of Pavia, Pavia, Italy., Neri M; Department of Medicine and Ageing Sciences and Center for Advanced Studies and Technology (CAST), 'G. D'Annunzio' University of Chieti-Pescara, Chieti-Pescara, Italy., Bragazzi MC; Dip. Di Scienze e Biotecnologia Medico Chirurgiche, Sapienza University of Rome, Rome, Italy., Ribichini E; Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy., Radocchia G; Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy., Iovino P; PO di Malattie Dell'Apparato Digerente, Università di Salerno, AOU San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy., Marazzato M; Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy., Schippa S; Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy., Badiali D; Dipartimento di Medicina Traslazionale e di Precisione, Sapienza University of Rome, Rome, Italy.
Jazyk:	angličtina
Zdroj:	The American journal of gastroenterology [Am J Gastroenterol] 2023 Nov 01; Vol. 118 (11), pp. 2014-2024. Date of Electronic Publication: 2023 Jun 13.
DOI:	10.14309/ajg.0000000000002360
Abstrakt:	Introduction: In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are widely used, alone or as add-on treatment, to increase response to proton-pump inhibitors, which are not indicated in infancy and pregnancy and account for significant cost expenditure. Methods: In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. Gut microbiota change was assessed. Results: A 2-week treatment with Poliprotect proved noninferior to omeprazole for symptom relief (between-group difference in the change in visual analog scale symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% confidence interval: Poliprotect 3.9, 2.8-5.0; omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. Discussion: Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15). (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)
Databáze:	MEDLINE
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