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 common cold or acute rhinosinusitis.

DESIGN

Randomized trial with 2 control groups.

SETTING

Two family practice clinics.

PARTICIPANTS

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.

INTERVENTION: 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?").

MAIN OUTCOME MEASURES: Nasal symptom score (sum of scores for nasal congestion, rhinorrhea, and headache) on day 3 and day of well-being (day of symptom resolution).

RESULTS

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).

CONCLUSION

Hypertonic saline does not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis.