OBJECTIVE: To determine if isotonic sodium chloride (hereinafter "saline") nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving quality of life and decreasing medication use. DESIGN: A prospective, randomized controlled trial. SETTING: Community. PARTICIPANTS: A total of 127 adults with chronic nasal and sinus symptoms. INTERVENTIONS: Patients were randomly assigned to irrigation performed with large volume and delivered with low positive pressure (n = 64) or spray (n = 63) for 8 weeks. MAIN OUTCOME MEASURES: Change in symptom severity measured by mean 20-Item Sino-Nasal Outcome Test (SNOT-20) score; change in symptom frequency measured with a global question; and change in medication use. RESULTS: A total of 121 patients were evaluable. The irrigation group achieved lower SNOT-20 scores than the spray group at all 3 time points: 4.4 points lower at 2 weeks (P = .02); 8.2 points lower at 4 weeks (P < .001); and 6.4 points lower at 8 weeks (P = .002). When symptom frequency was analyzed, 40% of subjects in the irrigation group reported symptoms "often or always" at 8 weeks compared with 61% in the spray group (absolute risk reduction, 0.2; 95% confidence interval, 0.02-0.38 (P = .01). No significant differences in sinus medication use were seen between groups. CONCLUSION: Nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays for treatment of chronic nasal and sinus symptoms in a community-based population.
RCT Entities:
OBJECTIVE: To determine if isotonic sodium chloride (hereinafter "saline") nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving quality of life and decreasing medication use. DESIGN: A prospective, randomized controlled trial. SETTING: Community. PARTICIPANTS: A total of 127 adults with chronic nasal and sinus symptoms. INTERVENTIONS:Patients were randomly assigned to irrigation performed with large volume and delivered with low positive pressure (n = 64) or spray (n = 63) for 8 weeks. MAIN OUTCOME MEASURES: Change in symptom severity measured by mean 20-Item Sino-Nasal Outcome Test (SNOT-20) score; change in symptom frequency measured with a global question; and change in medication use. RESULTS: A total of 121 patients were evaluable. The irrigation group achieved lower SNOT-20 scores than the spray group at all 3 time points: 4.4 points lower at 2 weeks (P = .02); 8.2 points lower at 4 weeks (P < .001); and 6.4 points lower at 8 weeks (P = .002). When symptom frequency was analyzed, 40% of subjects in the irrigation group reported symptoms "often or always" at 8 weeks compared with 61% in the spray group (absolute risk reduction, 0.2; 95% confidence interval, 0.02-0.38 (P = .01). No significant differences in sinus medication use were seen between groups. CONCLUSION: Nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays for treatment of chronic nasal and sinus symptoms in a community-based population.