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This article is intended for primary care clinicians, otolaryngologists, infectious disease specialists, allergists, and other specialists who care for patients with chronic rhinosinusitis.
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CME/CE Released: 11/26/2007
Valid for credit through: 12/12/2009
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November 26, 2007 — Large-volume, low positive-pressure nasal irrigation with saline was more effective than saline sprays for the treatment of chronic nasal and sinus symptoms in a community-based population, according to the results of a prospective, randomized controlled trial published in the November issue of the Archives of Otolaryngology–Head Neck Surgery.
"Many otolaryngologists recommend use of irrigations for a wide array of sinonasal conditions," write Melissa A. Pynnonen, MD, from the University of Michigan Health System in Ann Arbor, and colleagues. "Nasal saline sprays are often used as an alternative to saline irrigations because saline spray is often perceived to be equivalent to and better tolerated than irrigation. . . . The present study was designed to compare the efficacy of saline spray with saline irrigation with respect to disease-specific quality of life change in a general population of patients with chronic nasal and sinus complaints."
In a community setting, 127 adults with chronic nasal and sinus symptoms were randomized to receive saline irrigation performed
with large volume and delivered with low positive pressure
(n = 64) or saline spray (n = 63) for 8 weeks. The primary endpoints were change in severity of symptoms, which was reflected
in a mean 20-Item Sino-Nasal Outcome Test (SNOT-20) score; change in frequency of symptoms measured with a global question;
and change in medication use.
Of the 127 patients enrolled in this study, 121 were evaluable. At all 3 time points, the irrigation group had lower SNOT-20
scores vs the spray group: 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). In symptom frequency, 40% of patients in the irrigation group reported symptoms "often or always" at 8 weeks, as
did 61% in the spray group (absolute risk reduction, 0.2; 95% confidence interval, 0.02 - 0.38;
P = .01). Both groups had similar differences in sinus medication use.
Overall compliance was high in both groups, but participants in the spray group were more compliant than those in the irrigation group (P = .04). Adverse effects were common in both groups, but most were minor, and none led to discontinuation of treatment.
"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," the study authors write. "The greater efficacy of irrigation over saline spray may be due to greater volume, increased delivery pressure, and mechanical debridement achieved with irrigations."
Limitations of the study include slightly insufficient power to detect change in medication use or to evaluate the potential heterogeneous subgroups of patients with nasal symptoms, lack of blinding, and the possibility for patient over-reporting of compliance.
"Our findings also suggest that the benefit of saline irrigations as adjunctive therapy for chronic nasal and sinus-related symptoms could be expanded beyond the otolaryngologist's armamentarium and incorporated into the general practice of other clinical health care providers who frequently evaluate patients with such symptoms," the study authors conclude. "Primary care physicians and physician extenders may prove to be essential in explaining the benefits and usefulness of saline irrigations to patients in the community."
NeilMed Pharmaceuticals, the maker of Sinus Rinse, the saline irrigation used in the study, supported this study. Three of the study authors have received funding. The remaining study authors have disclosed no relevant financial relationships.
Arch Otolaryngol Head Neck Surg. 2007;133:1115-1120.
Chronic rhinosinusitis (CRS) affects 36 million Americans each year, and allergic and nonallergic forms of rhinitis affect millions more. Therapy is usually directed at the underlying cause and includes antibiotics, antihistamines, and anti-inflammatory drugs. Nonallergic rhinitis frequently coexists with allergic rhinitis, and nasal irrigation has been recommended to cleanse the nasal passages, with 2 recent trials demonstrating the efficacy of nasal irrigations in nonsurgical patients. Use of nasal saline may exert local effects of decreased viscosity of secretions; removal of debris; and decreased edema, allergens, and inflammatory mediators by a mechanical lavage action, but it is unclear whether nasal spray or nasal irrigation is more efficacious.
This is an 8-week randomized, open trial comparing the effects of nasal irrigation and nasal spray with use of normal saline solutions on the symptoms of CRS for 2 to 8 weeks of treatment.
