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Eur Arch Otorhinolaryngol. 2019 Feb;276(2):447-457. doi: 10.1007/s00405-018-5232-9. Epub 2018 Dec 8.

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

Author information

1
ENT Department, CHU Bordeaux, 33000, Bordeaux, France. ludovic.de-gabory@chu-bordeaux.fr.
2
CHU Bordeaux, CIC 14-01 IT, 33000, Bordeaux, France. ludovic.de-gabory@chu-bordeaux.fr.
3
Univ. Bordeaux, 33000, Bordeaux, France. ludovic.de-gabory@chu-bordeaux.fr.
4
ENT Department, University Hospital of Bordeaux, Hôpital Pellegrin, Centre F-X Michelet, Place A. Raba-Léon, 33076, Bordeaux Cedex, France. ludovic.de-gabory@chu-bordeaux.fr.
5
ENT Department, Intercommunal Hospital of Créteil, Paris, France.
6
ENT Department, Saint-Augustin Private Hospital, Bordeaux, France.
7
ENT Department, University Hospital of Toulouse, Toulouse, France.
8
ENT Department, University Hospital of Nancy, Nancy, France.
9
ENT Department, University Hospital of Strasbourg, Strasbourg, France.
10
ENT Department, University Hospital of Tours, Tours, France.
11
Nuclear Medicine Department, Saint-Augustin Private Hospital, Bordeaux, France.
12
ENT Department, University Hospital of Lille, Lille, France.
13
ENT Department, University Hospital of Nantes, Nantes, France.
14
CHU Bordeaux, CIC 14-01 IT, 33000, Bordeaux, France.
15
Univ. Bordeaux, 33000, Bordeaux, France.
16
Nuclear Medicine Department, CHU Bordeaux, 33000, Bordeaux, France.

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.

KEYWORDS:

Chronic rhinosinusitis; Lund–Kennedy endoscopic score; Mucociliary clearance; Nasal irrigation; Nasal polyposis

PMID:
30536161
PMCID:
PMC6394433
DOI:
10.1007/s00405-018-5232-9
[Indexed for MEDLINE]
Free PMC Article

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