Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: A randomized controlled trial

OBJECTIVES: To test whether daily hypertonic saline nasal irrigation improves sinus symptoms and quality of life and decreases medication use in adult subjects with a history of sinusitis. OBJECTIVES Randomized controlled trial. Experimental subjects used nasal irrigation daily for 6 months. POPULATION Seventy-3six subjects from primary, care (n = 70) and otolaryngology (n = 6) clinics with histories of frequent sinusitis were randomized to experimental (n = 52) and control (n = 24) groups. OUTCOMES MEASURED: Primary outcome measures included the Medical Outcomes Survey Short Form (SF-12), the Rhinosinusitis Disability Index (RSDI), and a Single-Item Sinus-Symptom Severity Assessment (SIA); all 3 were completed at baseline, 1.5, 3, and 6 months. Secondary outcomes included daily assessment of compliance and biweekly assessment of symptoms and medication use. At 6 months, subjects reported on side effects, satisfaction with nasal irrigation, and the percentage of change in their sinus-related quality of life. RESULTS: No significant baseline differences existed between the 2 groups. Sixty-nine subjects (90.8%) completed the study. Compliance averaged 87%. Experimental group RSDI scores improved from 58.4 ± 2.0 to 72.8 ± 2.2 (P≲.05) compared with those of the control group (from 59.6 ± 3.0 to 60.4 ± 1.1); experimental group SIA scores improved from 3.9 ± 0.1 to 2.4 ± 0.1 (P≲.05) compared with those of the control group (from 4.08 ± 0.15 to 4.07 ± 0.27). The number needed to treat to achieve 10% improvement on RSDI at 6 months was 2.0. Experimental subjects reported fewer 2-week periods with sinus-related symptoms (P < .05), used less antibiotics (P < .05), and used less nasal spray (P = .06). On the exit questionnaire 93% of experimental subjects reported overall improvement of sinus-related quality of life, and none reported worsening (P < .001), on average, experimental subjects reported 57 ± 4.5% improvement, Side effects were minor and infrequent. Satisfaction was high. We found no statistically significant improvement on the SF-12. CONCLUSIONS: Daily hypertonic saline nasal irrigation improves sinus-related quality of life, decreases symptoms, and decreases medication use in patients with frequent sinusitis. Primary care physicians can feel comfortable recommending this therapy.