During the same period children in the saline group also reported significantly fewer illness days (31% vs 75%), school absences (17% vs 35%), and complications (8% vs 32%) ( P < .05įor 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 antiinfectives (6% vs 21%) ( P < .05įor all). During the prevention phase (at visit 3, 8 weeks after study entry) patients in the saline group showed significantly lower scores in sore throat, cough, nasal obstruction, and secretion ( P < .05 for all). Results At visit 2, patients in the saline group achieved primary end points (measured on a 4-point numeric scale on which 1 indicated no symptoms and 4, severe symptoms) in the parameters nasal secretion and obstruction (mean scores vs nonsaline group, 1.79 vs 2.10 and 1.25 vs 1.58, respectively) ( P < .05įor both). We also looked for reappearance of cold or flu, consumption of medication, complications, days off school, and reported days of illness during the following weeks when preventive potential was evaluated (visits 3 and 4). Main Outcome Measures The primary efficacy end points were nasal symptoms resolution during acute illness (visits 1 and 2).
Interventions We randomly assigned patients to 2 treatment groups, one with just standard medication, the other with nasal wash with a modified seawater solution (Physiomer) plus standard medication, and observed them for 12 weeks. Patients A total of 401 children (aged 6-10 years) with uncomplicated cold or flu. Setting Eight pediatric outpatient clinics. Objective To evaluate the potential of nasal isotonic saline application to prevent reappearance of cold and flu in children during the winter.ĭesign Prospective, multicenter, parallel-group, open, and randomized comparison. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.
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