A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Medicated versus saline nose drops in the management of upper respiratory infection.
To determine whether hypertonic saline nasal spray relieves nasal symptoms and shortens illness duration in patients with the common cold or acute rhinosinusitis.
                Randomized trial with 2 control groups.
                Two family practice clinics.
                One hundred forty-three adult patients with a cold or sinus infection. Patients with allergic rhinitis, symptoms for more than 3 weeks, or other respiratory diagnoses were excluded, as were those who had used topical decongestants.
                Hypertonic saline or normal saline spray 3 times a day or observation. Subjects completed a 7-day symptom checklist that included a well-being question ("Do you feel back to normal?").
                Nasal symptom score (sum of scores for nasal congestion, rhinorrhea, and headache) on day 3 and day of well-being (day of symptom resolution).
                Data were collected for 119 subjects. No difference was found in either primary outcome when hypertonic saline was compared with either normal saline or observation. Mean day of well-being was 8.3 (95% confidence interval [CI], 6.9-9.7), 9.2 (95% CI, 6.9-11.43), and 8.0 (95% CI, 6.7-9.3) days in the hypertonic saline, normal saline, and observation groups, respectively. Day 3 mean nasal symptom score was 3.8 (95% CI, 3.0-4.5) for hypertonic saline, 3.7 (95% CI, 2.9-4.5) for normal saline, and 4.1 (95% CI, 3.5-4.7) for observation. Only 44% of the patients would use the hypertonic saline spray again. Thirty-two percent noted burning, compared with 13% of the normal saline group (P = .05).
                Hypertonic saline does not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis. To evaluate the potential of nasal isotonic saline application to prevent reappearance of cold and flu in children during the winter.
                Prospective, multicenter, parallel-group, open, and randomized comparison.
                Eight pediatric outpatient clinics.
                A total of 401 children (aged 6-10 years) with uncomplicated cold or flu.
                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.
                The primary efficacy end points were nasal symptoms resolution during acute illness (visits 1 and 2). 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).
                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 < .05 for both). 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). 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 < .05 for all). 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 < .05 for all). Similar results were found at the final visit.
                Children in the saline group showed faster resolution of some nasal symptoms during acute illness and less frequent reappearance of rhinitis subsequently. Seventy-four children from three weeks to two years of age with various upper respiratory symptoms were randomly assigned to three groups: two intervention groups (saline nose drops; medicated nose drops) and a control group (no nose drops). Forty-six children returned for check-up two days later. Subjects in all three groups improved between first and second contact. There was no significant difference between the three groups. It is concluded that medicated nose drops are not essential in the treatment of upper respiratory infection and rhinitis.
Included trials were too small and had too high a risk of bias to be confident about the possible benefits of nasal saline irrigation in acute URTIs. Future trials should involve much larger numbers of participants and be rigorously designed and controlled.