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Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial
Background. This study, a randomized controlled trial, aims to demonstrate a clinically significant improvement in subacute and chronic otitis media with effusion through the administration of hyaluronic acid associated with hypertonic solution compared with the administration of hypertonic solution...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5582658/ https://www.ncbi.nlm.nih.gov/pubmed/28894768 http://dx.doi.org/10.1177/2333794X17725983 |
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author | Cioffi, Luigi Gallo, Patrizia D’Avino, Antonio Carlomagno, Francesco Aloi, Giuseppe D’Onofrio, Antonietta Del Gaizo, Donatella Giuliano, Maria De Franchis, Raffaella Sandomenico, Maria L. Pecoraro, Anna |
author_facet | Cioffi, Luigi Gallo, Patrizia D’Avino, Antonio Carlomagno, Francesco Aloi, Giuseppe D’Onofrio, Antonietta Del Gaizo, Donatella Giuliano, Maria De Franchis, Raffaella Sandomenico, Maria L. Pecoraro, Anna |
author_sort | Cioffi, Luigi |
collection | PubMed |
description | Background. This study, a randomized controlled trial, aims to demonstrate a clinically significant improvement in subacute and chronic otitis media with effusion through the administration of hyaluronic acid associated with hypertonic solution compared with the administration of hypertonic solution alone. The setting was an outpatient clinic of 20 primary care pediatrician offices affiliated with the 3 Local Health Units (Azienda Sanitaria Locale) of Naples. Materials and Methods. The study was conducted for 6 months, from October 2014 to the end of March 2015. The study saw the participation of 20 pediatricians who were experts in pneumatic otoscopy, each of whom enrolled 15 children. Each investigator was randomized to carry out the treatment with 3% hypertonic solution or high-molecular-weight hyaluronic acid + 3% hypertonic solution. Results. A total of 275 children were enrolled, of whom 11(equal to 4% ) were lost to follow-up. A total of 264 children completed the trial according to the protocol, 120 in the hyaluronic acid + hypertonic solution group and 144 in the hypertonic solution group. Hyaluronic acid associated with hypertonic solution and hypertonic solution alone administered by nasal lavage have proven to be safe and effective in the treatment of prolonged otitis media with effusion (initial score of −0.5, final score of 0.9, P < 001, for the hypertonic + hyaluronic acid group; initial score of −0.3, final score of 0.2, P < .001, for the hypertonic solution group). Though starting from a less favorable initial clinical score (−0.5 vs −0.3, P < .016), hyaluronic acid associated with hypertonic solution resulted in a significant increase in clinical healing (0.9 vs 0.2, P < .001). One interesting outcome was the significant reduction in the consumption of drugs (cortisone and antibiotics) during the follow-up. |
format | Online Article Text |
id | pubmed-5582658 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-55826582017-09-11 Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial Cioffi, Luigi Gallo, Patrizia D’Avino, Antonio Carlomagno, Francesco Aloi, Giuseppe D’Onofrio, Antonietta Del Gaizo, Donatella Giuliano, Maria De Franchis, Raffaella Sandomenico, Maria L. Pecoraro, Anna Glob Pediatr Health Original Article Background. This study, a randomized controlled trial, aims to demonstrate a clinically significant improvement in subacute and chronic otitis media with effusion through the administration of hyaluronic acid associated with hypertonic solution compared with the administration of hypertonic solution alone. The setting was an outpatient clinic of 20 primary care pediatrician offices affiliated with the 3 Local Health Units (Azienda Sanitaria Locale) of Naples. Materials and Methods. The study was conducted for 6 months, from October 2014 to the end of March 2015. The study saw the participation of 20 pediatricians who were experts in pneumatic otoscopy, each of whom enrolled 15 children. Each investigator was randomized to carry out the treatment with 3% hypertonic solution or high-molecular-weight hyaluronic acid + 3% hypertonic solution. Results. A total of 275 children were enrolled, of whom 11(equal to 4% ) were lost to follow-up. A total of 264 children completed the trial according to the protocol, 120 in the hyaluronic acid + hypertonic solution group and 144 in the hypertonic solution group. Hyaluronic acid associated with hypertonic solution and hypertonic solution alone administered by nasal lavage have proven to be safe and effective in the treatment of prolonged otitis media with effusion (initial score of −0.5, final score of 0.9, P < 001, for the hypertonic + hyaluronic acid group; initial score of −0.3, final score of 0.2, P < .001, for the hypertonic solution group). Though starting from a less favorable initial clinical score (−0.5 vs −0.3, P < .016), hyaluronic acid associated with hypertonic solution resulted in a significant increase in clinical healing (0.9 vs 0.2, P < .001). One interesting outcome was the significant reduction in the consumption of drugs (cortisone and antibiotics) during the follow-up. SAGE Publications 2017-09-01 /pmc/articles/PMC5582658/ /pubmed/28894768 http://dx.doi.org/10.1177/2333794X17725983 Text en © The Author(s) 2017 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page(https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Article Cioffi, Luigi Gallo, Patrizia D’Avino, Antonio Carlomagno, Francesco Aloi, Giuseppe D’Onofrio, Antonietta Del Gaizo, Donatella Giuliano, Maria De Franchis, Raffaella Sandomenico, Maria L. Pecoraro, Anna Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial |
title | Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial |
title_full | Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial |
title_fullStr | Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial |
title_full_unstemmed | Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial |
title_short | Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial |
title_sort | clinical improvement of subacute and chronic otitis media with effusion treated with hyaluronic acid plus hypertonic solution via nasal lavage: a randomized controlled trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5582658/ https://www.ncbi.nlm.nih.gov/pubmed/28894768 http://dx.doi.org/10.1177/2333794X17725983 |
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