Journal Article

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

Schippa, Serena, Badiali, Danilo, Corazziari, Enrico Stefano, Di Sabatino, Antonio, Ribichini, Emanuela, Riggio, Oliviero, Neri, Matteo, Radocchia, Giulia, D'Alba, Lucia, Gasbarrini, Antonio, Annibale, Bruno, Bragazzi, Maria Consiglia, Cicala, Michele, Bassotti, Gabrio, Marazzato, Massimiliano, Iovino, Paola, Ciacci, Carolina, Passaretti, Sandro, D'Ovidio, Valeria, Repici, Alessandro

2023

Overview

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. 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. 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. 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).

• Publisher: Wolters Kluwer,Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
• Subject: Abdominal Pain - drug therapy / Antacids / Anti-Ulcer Agents - therapeutic use / Double-Blind Method / Drug dosages / Dyspepsia - drug therapy / Endoscopy / Esophagitis - chemically induced / Functional GI Disorders / Gastroesophageal reflux / Heartburn - drug therapy / Heartburn - etiology / Humans / Lesions / Microbiota / Omeprazole - therapeutic use / Pain / Patients / Peptic Ulcer - complications / Pregnancy / Proton Pump Inhibitors - therapeutic use / Quality of life / Questionnaires / Treatment Outcome