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. STUDY DESIGN: Randomized controlled trial. Experimental subjects used nasal irrigation daily for 6 months. POPULATION: Seventy-six 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 < or =.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 < or =.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.
RCT Entities:
OBJECTIVES: To test whether daily hypertonicsaline nasal irrigation improves sinus symptoms and quality of life and decreases medication use in adult subjects with a history of sinusitis. STUDY DESIGN: Randomized controlled trial. Experimental subjects used nasal irrigation daily for 6 months. POPULATION: Seventy-six 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 < or =.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 < or =.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 hypertonicsaline 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.
Authors: B A Stuck; C Bachert; P Federspil; W Hosemann; L Klimek; R Mösges; O Pfaar; C Rudack; H Sitter; M Wagenmann; R Weber; K Hörmann Journal: HNO Date: 2012-02 Impact factor: 1.284
Authors: B A Stuck; C Bachert; P Federspil; W Hosemann; L Klimek; R Mösges; O Pfaar; C Rudack; H Sitter; M Wagenmann; K Hörmann Journal: HNO Date: 2007-10 Impact factor: 1.284
Authors: Supriya D Hayer; David P Rabago; Iliya P Amaza; Tony Kille; Christopher L Coe; Aleksandra Zgierska; Larissa Zakletskaia; Marlon P Mundt; Dean Krahn; Chidi N Obasi; Rachel C Molander Journal: Contemp Clin Trials Date: 2015-01-24 Impact factor: 2.226