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European Archives of Oto-Rhino-Laryngology

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Open Access 01-02-2019 | Rhinology

Prospective, randomized, controlled, open-label study to compare efficacy of a mineral-rich solution vs normal saline after complete ethmoidectomy

Authors: Ludovic de Gabory, Virginie Escabasse, Philippe Boudard, Guillaume de Bonnecaze, Cécile Rumeau, Roger Jankowski, Christian Debry, Sylvain Morinière, Bertrand Merino, Geoffrey Mortuaire, Olivier Malard, Laurence Bordenave

Published in: European Archives of Oto-Rhino-Laryngology | Issue 2/2019

Abstract

Purposes

The purpose of this study was to compare the efficacy of a mineral-rich solution vs normal saline solution (0.9% NaCl) following endoscopic complete bilateral ethmoidectomy.

Methods

This was a prospective, multicenter, randomized, controlled, open-label trial in subjects suffering from steroid-resistant sinonasal polyposis. Adults performed 4 nasal irrigations of mineral or saline solutions daily for 28 days. Evaluations included subject-reported RHINO quality of life (QoL) and NOSE scores, tolerability, and satisfaction, the Lund–Kennedy endoscopic score and assessments of crusting, secretions and mucociliary clearance (rhinoscintigraphy).

Results

A total of 189 subjects were randomized. Clinically relevant improvements (> 20 points) in RhinoQOL and NOSE scores were measured in both groups without any significant inter-group difference. Among the subjects with impaired RhinoQOL at pre-inclusion, the change in Impact-RhinoQOL score was significantly superior in mineral-rich vs saline solution at day 21 (p = 0.028) and day 28 (p = 0.027). The Lund–Kennedy score continuously improved in both groups earlier with the mineral-rich solution. Crusts were significantly fewer in number and less severe/obstructive in patients receiving mineral-rich vs saline solution at day 7 (p = 0.026) and day 14 (p = 0.016). Furthermore, secretions disappeared significantly more quickly and were less thick/purulent with mineral-rich solution at day 14 (p = 0.002) and day 21 (p = 0.043). Less epistaxis was reported in the mineral vs saline solution (p = 0.008 at day 21).

Conclusions

Our findings indicate that the composition of a nasal irrigation solution influences endoscopic scores and QoL after sinus surgery for patients over 60, those with an initially poor QoL and higher symptom score, and smokers.

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Title: Prospective, randomized, controlled, open-label study to compare efficacy of a mineral-rich solution vs normal saline after complete ethmoidectomy
Authors: Ludovic de Gabory
Virginie Escabasse
Philippe Boudard
Guillaume de Bonnecaze
Cécile Rumeau
Roger Jankowski
Christian Debry
Sylvain Morinière
Bertrand Merino
Geoffrey Mortuaire
Olivier Malard
Laurence Bordenave
Publication date: 01-02-2019
Publisher: Springer Berlin Heidelberg
Published in: European Archives of Oto-Rhino-Laryngology / Issue 2/2019
Print ISSN: 0937-4477
Electronic ISSN: 1434-4726
DOI: https://doi.org/10.1007/s00405-018-5232-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Prospective, randomized, controlled, open-label study to compare efficacy of a mineral-rich solution vs normal saline after complete ethmoidectomy

Abstract

Purposes

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purposes

Methods

Results

Conclusions

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