Original Research

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

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KEY POINTS FOR CLINICIANS
  • Nasal irrigation improved sinus symptoms and decreased sinus medication use.
  • Patient satisfaction and compliance were high for nasal irrigation.
  • Patient training in nasal irrigation technique should be provided.
ABSTRACT
  • 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 ≤ .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.

Sinusitis is a common clinical problem with significant morbidity and often refractory symptoms that accounted for approximately 26.7 million office and emergency visits and resulted in $5.8 billion spent in direct costs in 1996.1 Sinusitis was the fifth most common diagnosis for which antibiotics were prescribed from 1985 to 1992.2 In 1992, 13 million prescriptions were written for sinusitis, up from 5.8 million in 1985.2 The number of US chronic sinusitis cases in 1994 was estimated at 35 million, for a prevalence of 134 per 1000 patients.3 The effect of sinusitis on patients’ quality of life (QOL) is significant and can rate as high as back pain, congestive heart disease, and chronic obstructive pulmonary disease on some measures.4

Hypertonic nasal irrigation is a therapy that flushes the nasal cavity with saline solution, facilitating a wash of the structures within. Originally part of the Yogic tradition, this technique is anecdotally regarded as safe and effective; it has been suggested as adjunctive therapy for sinusitis and sinus symptoms.5-7 Potential efficacy is supported by the observation that hypertonic saline improves mucociliary clearance,8 thins mucus,9,10 and may decrease inflammation.8 Optimal irrigant salinity and pH are unclear.10,11 Several small trials examining nasal irrigation have suggested that nasal irrigation is safe, improves nasal symptoms, and is physically tolerable, but inclusion criteria, intervention protocols, and methodological quality vary.12-18 Improvement of QOL scores12-14 and several surrogate measures14-16 have been reported. No study has rigorously evaluated nasal irrigation over a longer period for its effect on QOL, antibiotic and nasal medication use, symptom severity, compliance, and side effects.

We conducted a randomized controlled trial to test the hypotheses that daily hypertonic saline nasal irrigation improves symptoms, decreases antibiotic and nasal medication use, and improves QOL in adult subjects with a history of sinusitis.

Methods

The study protocol was approved by the University of Wisconsin Health Sciences Human Subjects Committee. Subjects were enrolled from May to August 2000 and, after a study period of 6 months, were exited from November 2000 to February 2001. No prior studies existed at inception to guide sample size estimation. Power calculations performed before study initiation indicated that a sample size of 60 subjects would provide 80% power to detect a 10% difference in the Rhinosinusitis Disability Index (RSDI) between study groups. Due to the high patient burden of this study, we assumed a 25% dropout rate.

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