January 22, 2008 — Saline nasal wash is associated with faster resolution of some nasal symptoms during acute rhinitis in children and with less frequent reappearance of rhinitis, according to the results of a study reported in the January issue of the Archives of Otolaryngology–Head & Neck Surgery.

"The primary objectives of this trial were to (1) prove the efficacy and safety of nasal saline wash as adjunctive treatment during uncomplicated acute rhinitis for the resolution of nasal symptoms and (2) evaluate its potential to prevent the recurrence of cold and flu and complications," write Ivo Šlapak, MD, from Pediatric Otorhinolaryngology Clinic, Teaching Hospital Brno, Prague, in the Czech Republic, and colleagues. "Secondary objectives included the evaluation of 2 different cleansing strengths (a medium jet and a fine spray) and 2 isotonic formulations with different ionic compositions (a nasal wash formula and a dual formula used for eye and nose wash)."

This prospective, multicenter, parallel-group, open, and randomized comparison took place at 8 pediatric outpatient clinics. The investigators randomized 401 children (aged 6 - 10 years) with uncomplicated cold or flu to 2 treatment groups: 1 with just standard medication and the other with nasal wash with a modified seawater solution (Physiomer; Goemar Laboratoire de la Mer, Saint Malo, France) plus standard medication. The duration of the study was 12 weeks.

The main outcome measures for efficacy were resolution of nasal symptoms during the acute illness (visits 1 and 2). Individual symptoms, such as nasal secretion and obstruction, were measured on a 4-point numeric scale on which 1 indicated no symptoms and 4, severe symptoms. Secondary outcomes were reappearance of cold or flu, medication use, complications, days missed from school, and reported days of illness during the following weeks (visits 3 and 4).

At visit 2, patients in the saline group had fewer symptoms of nasal secretion and obstruction vs children in the medication-only group (mean scores, 1.79 vs 2.10 and 1.25 vs 1.58, respectively;
P < .05 for both).

At visit 3 (8 weeks after study entry), patients in the saline group had significantly lower scores vs those in the medication-only group for sore throat, cough, nasal obstruction, and secretion (P < .05 for all). By visit 3, significantly fewer children in the saline group were using antipyretics (9% vs 33%), nasal decongestants (5% vs 47%), mucolytics (10% vs 37%), and systemic antibiotics (6% vs 21%; P < .05 for all).

Compared with children in the medication-only group, those in the saline group also reported significantly fewer illness days (31% vs 75%), school absences (17% vs 35%), and complications (8% vs 32%) at visit 3 (P < .05 for all). Findings were similar at visit 4.

Limitations of the study include lack of blinding, disparity between statistical and clinical significance in the symptom score, and use of a self-designed outcome scale without any additional analysis to establish a minimal clinically significant difference.

"Children in the saline group showed faster resolution of some nasal symptoms during acute illness and less frequent reappearance of rhinitis subsequently," the study authors write. "Results showing reduction in URTIs [upper respiratory tract infections] were robust and consistent in a number of parameters, including rhinologic symptoms, medication consumption, reported illness, school absence, and complication rate. Children showed a higher acceptance for the milder cleansing strength (fine spray)."

Goemar Laboratoire de la Mer (the maker of Physiomer) funded this study. Some of the study authors have disclosed various financial relationships with GlaxoSmithKline, Servier, Roche, Zentiva, Pfizer, Schering AG, Sanofi-Aventis, Gedeon-Richter, Eli Lilly, Astellas, Merck & Co Inc, Schering-Plough, Piere Fabre, and Artu.

Arch Otolaryngol Head Neck Surg. 2008;134:67-74.

Clinical Context

Study Highlights

• The main objectives of this study were to evaluate the efficacy and safety of nasal saline wash for resolution of nasal symptoms when used as adjunctive treatment during uncomplicated acute rhinitis and to assess whether saline irrigation was associated with prevention of recurrence of cold and flu and complications.
• Secondary objectives were comparison of irrigation with a medium jet vs a fine spray and comparison of 2 formulations differing in ionic compositions (a nasal wash formula and a dual formula used for eye and nose wash).
• From January to April 2006, this prospective, parallel-group, open, and randomized comparison trial was performed at 8 pediatric outpatient clinics, with follow-up through 12 weeks.
• The investigators randomized 401 children, aged 6 to 10 years with uncomplicated cold or flu to receive standard medication only or standard medication plus nasal wash with Physiomer, a modified seawater solution.
• The main outcome measures for efficacy were resolution of nasal symptoms during the acute illness (visits 1 and 2; no later than 3 weeks after onset of symptoms).
• Individual symptoms, such as nasal secretion and obstruction, were measured on a 4-point numeric scale from 1 (no symptoms) to 4 (severe symptoms).
• Secondary outcomes were reappearance of cold or flu, medication use, complications, days missed from school, and reported days of illness during the following weeks (visits 3 and 4).
• At visit 2, patients in the saline group had fewer symptoms of nasal secretion and obstruction vs children in the medication-only group (mean scores, 1.79 vs 2.10 and 1.25 vs 1.58, respectively; P < .05 for both).
• Compared with the medication-only group, the saline group also reported using less medication at visit 2. This difference was significant for nasal decongestants (P < .001) and mucolytics (P = .002).
• At visit 2, the saline nasal wash group also had a greater improvement in health status, as determined by physicians, vs the control group (P = .02).
• At visit 3 (8 weeks after study entry), the saline group had lower mean scores vs the medication-only group for sore throat, cough, nasal obstruction, and secretion (P < .05 for all).
• By visit 3, fewer children in the saline group vs those in the medication-only group were using antipyretics (9% vs 33%), nasal decongestants (5% vs 47%), mucolytics (10% vs 37%), and systemic antibiotics (6% vs 21%; P < .05 for all).
• Compared with children in the medication-only group, those in the saline group also reported significantly fewer illness days (31% vs 75%), school absences (17% vs 35%), and complications (8% vs 32%) at visit 3 (P < .05 for all).
• Findings were similar at visit 4. Parents in the saline group reported greater satisfaction with the treatment.
• Based on these findings, the investigators concluded that nasal saline irrigation was associated with faster resolution of some nasal symptoms during the following weeks.
• There were no significant differences in findings with different cleansing strengths (medium jet and fine spray) or ionic composition of the saline.
• Children showed a higher acceptance for irrigation with the fine spray. Participants did not complain much about tolerability of nasal irrigation, and good compliance seemed to be confirmed by the weight of returned empty bottles. Only 1 patient was excluded for poor compliance.
• Nosebleeds occurred in 3 patients.
• Limitations of the study include lack of blinding, disparity between statistical and clinical significance in the symptom score, and use of a self-designed outcome scale without any additional analysis to establish a minimal clinically significant difference.

Pearls for Practice

• Children with acute rhinitis treated with saline nasal wash plus medications had fewer symptoms of nasal secretion and obstruction during the acute phase of the illness (up to 3 weeks) vs children treated with medication alone.
• During the following weeks (up to 12 weeks), the saline-plus-medication group had significantly fewer illness days (31% vs 75%), school absences (17% vs 35%), and complications (8% vs 32%) and used fewer medications vs the group treated with medication alone.

CME Test