Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions : A Randomized, Controlled Trial
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology..
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).
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2023 |
---|---|
Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:118 |
---|---|
Enthalten in: |
The American journal of gastroenterology - 118(2023), 11 vom: 01. Nov., Seite 2014-2024 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Corazziari, Enrico Stefano [VerfasserIn] |
---|
Links: |
---|
Themen: |
Anti-Ulcer Agents |
---|
Anmerkungen: |
Date Completed 03.11.2023 Date Revised 17.11.2023 published: Print-Electronic ClinicalTrials.gov: NCT03238534 Citation Status MEDLINE |
---|
doi: |
10.14309/ajg.0000000000002360 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM358092361 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM358092361 | ||
003 | DE-627 | ||
005 | 20231226074016.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.14309/ajg.0000000000002360 |2 doi | |
028 | 5 | 2 | |a pubmed24n1193.xml |
035 | |a (DE-627)NLM358092361 | ||
035 | |a (NLM)37307528 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Corazziari, Enrico Stefano |e verfasserin |4 aut | |
245 | 1 | 0 | |a Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions |b A Randomized, Controlled Trial |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 03.11.2023 | ||
500 | |a Date Revised 17.11.2023 | ||
500 | |a published: Print-Electronic | ||
500 | |a ClinicalTrials.gov: NCT03238534 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology. | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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) | ||
650 | 4 | |a Randomized Controlled Trial | |
650 | 4 | |a Multicenter Study | |
650 | 4 | |a Journal Article | |
650 | 4 | |a Research Support, Non-U.S. Gov't | |
650 | 7 | |a Omeprazole |2 NLM | |
650 | 7 | |a KG60484QX9 |2 NLM | |
650 | 7 | |a Anti-Ulcer Agents |2 NLM | |
650 | 7 | |a Proton Pump Inhibitors |2 NLM | |
700 | 1 | |a Gasbarrini, Antonio |e verfasserin |4 aut | |
700 | 1 | |a D'Alba, Lucia |e verfasserin |4 aut | |
700 | 1 | |a D'Ovidio, Valeria |e verfasserin |4 aut | |
700 | 1 | |a Riggio, Oliviero |e verfasserin |4 aut | |
700 | 1 | |a Passaretti, Sandro |e verfasserin |4 aut | |
700 | 1 | |a Annibale, Bruno |e verfasserin |4 aut | |
700 | 1 | |a Cicala, Michele |e verfasserin |4 aut | |
700 | 1 | |a Repici, Alessandro |e verfasserin |4 aut | |
700 | 1 | |a Bassotti, Gabrio |e verfasserin |4 aut | |
700 | 1 | |a Ciacci, Carolina |e verfasserin |4 aut | |
700 | 1 | |a Di Sabatino, Antonio |e verfasserin |4 aut | |
700 | 1 | |a Neri, Matteo |e verfasserin |4 aut | |
700 | 1 | |a Bragazzi, Maria Consiglia |e verfasserin |4 aut | |
700 | 1 | |a Ribichini, Emanuela |e verfasserin |4 aut | |
700 | 1 | |a Radocchia, Giulia |e verfasserin |4 aut | |
700 | 1 | |a Iovino, Paola |e verfasserin |4 aut | |
700 | 1 | |a Marazzato, Massimiliano |e verfasserin |4 aut | |
700 | 1 | |a Schippa, Serena |e verfasserin |4 aut | |
700 | 1 | |a Badiali, Danilo |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t The American journal of gastroenterology |d 1953 |g 118(2023), 11 vom: 01. Nov., Seite 2014-2024 |w (DE-627)NLM000025445 |x 1572-0241 |7 nnns |
773 | 1 | 8 | |g volume:118 |g year:2023 |g number:11 |g day:01 |g month:11 |g pages:2014-2024 |
856 | 4 | 0 | |u http://dx.doi.org/10.14309/ajg.0000000000002360 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 118 |j 2023 |e 11 |b 01 |c 11 |h 2014-2024 |