Clinical Question

In patients with chronic rhinosinusitis, does the addition of budesonide (Rhinocort) to a saline irrigation solution result in further improvement in symptoms?

Bottom Line

This study showed that patients with chronic rhinosinusitis who continue to use a saline nasal wash (NeilMed) will often experience an improvement in symptoms that can be clinically meaningful, but the addition of the corticosteroid budesonide has yet to show an extra benefit. (Level of Evidence = 2b)

Synopsis

These researchers recruited 80 patients with chronic rhinosinusitis (two or more symptoms, including mucopurulent drainage, nasal obstruction, facial pain, and decreased sense of smell for at least 12 weeks) to be randomized, allocation concealment unknown, to receive treatment using a large-volume saline sinus irrigation with placebo or budesonide, 1 mg once daily, for 30 days. The patients, average age 51 years, had a Sino-Nasal Outcome Test score of 44.1 out of a possible 110. A significant number of patients dropped out (23%), leaving 61 to be evaluated. The average decrease in scores was 20.7 points in the treated group and 13.6 points in the control group, which was not statistically significant. More participants in the treated group (79%) received a clinically important benefit of at least a 9-point improvement than in the saline-only group (59%; not statistically different). This small study, with a significant drop-out rate, did not have the power to find a difference if one exists. The authors did not give specific data to judge the degree of benefit beyond a 9-point improvement for the responders.

Study design: Randomized controlled trial (double-blinded)

Funding source: Self-funded or unfunded

Allocation: Uncertain

Setting: Outpatient (specialty)

Reference: Tait S, Kallogjeri D, Suko J, Kukuljan S, Schneider J, Piccirillo JF. Effect of budesonide added to large-volume, low-pressure saline sinus irrigation for chronic rhinosinusitis: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2018;144(7):605–612.

Editor's Note: Dr. Shaughnessy is an Assistant Medical Editor for AFP.