A CLINICAL-TRIAL OF HYPERTONIC SALINE NASAL SPRAY IN SUBJECTS WITH THE COMMON COLD OR RHINOSINUSITIS

Objective: To determine whether hypertonic saline nasal spray relieves nasal symptoms and shortens illness duration in patients with the com mon cold or acute rhinosinusitis. Design: Randomized trial with 2 cont rol groups. Setting: Two family practice clinics. Participants: One hu ndred forty-three adult patients with a cold or sinus infection. Patie nts with allergic rhinitis, symptoms for more than 3 weeks, or other r espiratory diagnoses were excluded, as were those who had used topical decongestants. Intervention: Hypertonic saline or normal saline spray 3 times a day or observation. Subjects completed a 7-day symptom chec klist that included a well-being question (''Do you feel back to norma l?''). Main Outcome Measures: Nasal symptom score (sum of scores for n asal congestion, rhinorrhea, and headache) on day 3 and day of well-be ing (day of symptom resolution). Results: Data were collected for 119 subjects. No difference was found in either primary outcome when hyper tonic saline was compared with either normal saline or observation. Me an 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 hyperto nic saline, normal saline, and observation groups, respectively. Day 3 mean nasal symptom score was 3.8 (95% CI, 3.0-4.5) for hypertonic sal ine, 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 s aline spray again. Thirty-two percent noted burning, compared with 13% of the normal saline group (P=.05). Conclusion: Hypertonic saline doe s not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis.