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

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

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intranasal
  • Chlorides / administration & dosage*
  • Endoscopy
  • Ethmoid Sinus / surgery
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nasal Polyps / prevention & control
  • Nasal Polyps / surgery
  • Patient Satisfaction
  • Postoperative Care*
  • Prospective Studies
  • Quality of Life
  • Rhinitis / prevention & control
  • Saline Solution / administration & dosage*
  • Sinusitis / prevention & control
  • Sodium Bicarbonate / administration & dosage*
  • Therapeutic Irrigation / methods*

Substances

  • Chlorides
  • Saline Solution
  • Sodium Bicarbonate