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

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.

Fig. 1

Subgroups with impaired cicatrization patterns: Change vs pre-inclusion in RhinoQOL Impact or NOSE score. *p < 0.05; **p < 0.01; ***p < 0.001 in mineral group: change vs pre-inclusion significantly > 20 points. †p < 0.05; ††p < 0.01; †††p < 0.001 in normal saline group: change vs pre-inclusion significantly > 20 points. Sample sizes: impaired RhinoQoL at pre-inclusion subgroup a: mineral: n = 52; normal saline: n = 55. > 60 year subgroup, b, c: mineral: n = 16; NaCl: n = 23. Smokers subgroup, d mineral: n = 23; NaCl: n = 27

Fig. 2

Lund–Kennedy endoscopic score: evolution and subjects (%) with complete cicatrization. ***Mineral group vs baseline, p ≤ 0.001; †††NaCl group vs baseline, p ≤ 0.001

Fig. 3

Lund–Kennedy endoscopic score: evolution of crusts

Fig. 4

Lund–Kennedy endoscopic score: evolution of secretions

Fig. 5

Mucociliary clearance measured by rhinoscintigraphy