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A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease
BACKGROUND/AIMS: We aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride. METHODS: A total of 116 ERD patients...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Korean Society of Neurogastroenterology and Motility
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5383116/ https://www.ncbi.nlm.nih.gov/pubmed/28192647 http://dx.doi.org/10.5056/jnm16100 |
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author | Lee, Ju Yup Kim, Sung Kook Cho, Kwang Bum Park, Kyung Sik Kwon, Joong Goo Jung, Jin Tae Kim, Eun Young Jang, Byung Ik Lee, Si Hyung |
author_facet | Lee, Ju Yup Kim, Sung Kook Cho, Kwang Bum Park, Kyung Sik Kwon, Joong Goo Jung, Jin Tae Kim, Eun Young Jang, Byung Ik Lee, Si Hyung |
author_sort | Lee, Ju Yup |
collection | PubMed |
description | BACKGROUND/AIMS: We aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride. METHODS: A total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at weeks 4 and 8. The primary endpoint was the endoscopic healing rate of ERD after 8 weeks of treatment. RESULTS: Endoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, the total GERD symptom score changes relative to the baseline significantly improved in the E+M group than that of the E only group (−13.4 ± 14.7 vs −8.0 ± 12.3, P = 0.041), and upper abdominal pain and belching score changes showed significantly improved in the E+M group than that of the E only group (P = 0.018 and P = 0.013, respectively). CONCLUSIONS: The combination of a proton pump inhibitor with mosapride shows a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms, such as upper abdominal pain and belching in ERD patients. |
format | Online Article Text |
id | pubmed-5383116 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Korean Society of Neurogastroenterology and Motility |
record_format | MEDLINE/PubMed |
spelling | pubmed-53831162017-04-07 A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease Lee, Ju Yup Kim, Sung Kook Cho, Kwang Bum Park, Kyung Sik Kwon, Joong Goo Jung, Jin Tae Kim, Eun Young Jang, Byung Ik Lee, Si Hyung J Neurogastroenterol Motil Original Article BACKGROUND/AIMS: We aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride. METHODS: A total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at weeks 4 and 8. The primary endpoint was the endoscopic healing rate of ERD after 8 weeks of treatment. RESULTS: Endoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, the total GERD symptom score changes relative to the baseline significantly improved in the E+M group than that of the E only group (−13.4 ± 14.7 vs −8.0 ± 12.3, P = 0.041), and upper abdominal pain and belching score changes showed significantly improved in the E+M group than that of the E only group (P = 0.018 and P = 0.013, respectively). CONCLUSIONS: The combination of a proton pump inhibitor with mosapride shows a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms, such as upper abdominal pain and belching in ERD patients. Korean Society of Neurogastroenterology and Motility 2017-04 2017-04-01 /pmc/articles/PMC5383116/ /pubmed/28192647 http://dx.doi.org/10.5056/jnm16100 Text en © 2017 The Korean Society of Neurogastroenterology and Motility This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Lee, Ju Yup Kim, Sung Kook Cho, Kwang Bum Park, Kyung Sik Kwon, Joong Goo Jung, Jin Tae Kim, Eun Young Jang, Byung Ik Lee, Si Hyung A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease |
title | A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease |
title_full | A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease |
title_fullStr | A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease |
title_full_unstemmed | A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease |
title_short | A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease |
title_sort | double-blind, randomized, multicenter clinical trial investigating the efficacy and safety of esomeprazole single therapy versus mosapride and esomeprazole combined therapy in patients with esophageal reflux disease |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5383116/ https://www.ncbi.nlm.nih.gov/pubmed/28192647 http://dx.doi.org/10.5056/jnm16100 |
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