Skip to main navigation
Skip notifications
Access to POEMs and Essential Evidence Plus will no longer be included in CMA membership as of Dec. 1, 2023.
Search
Chronic sinusitis: saline irrigation helps somewhat; steroid doesn't add more benefit
Clinical Question
In patients with chronic rhinosinusitis, does the addition of budesonide 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 be shown to provide extra benefit. 2b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Self-funded or unfunded
Setting: Outpatient (specialty)
Synopsis
These researchers recruited 80 patients with chronic rhinosinusitis (2 or more symptoms, including mucopurulent drainage, nasal obstruction, facial pain, and decreased sense of smell at least 12 weeks) to be randomized, allocation concealment unknown, to receive treatment using a large-volume saline sinus irrigation with either placebo or budesonide 1 mg once daily for 30 days. The patients, average age 51 years, had a Sino-Nasal Outcome Test (SNOT-22) 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 significant dropouts, did not have the power to find a difference if one exists. I'm a little grumpy that the authors did not give specific data to judge the degree of benefit beyond a 9-point improvement for the responders.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA
Comments
Dommage que l’etude N’avait pas la force pour voir une vrai différence mais dans les constances l’ajout d’une corticostéroïde ne semble pas apporter le bénéfice espéré.
Agree with review about low power. Also worth noting that the high number of dropouts also carries a high risk for bias in the results. Study was not worth a SNOT.
Good poem
Excellent
With 30 days of continuous large-volume basis-sinus lavage, it’s surprising to me they had only a 33% dropout of testees. All that to demonstrate an effect! I once had such a problem, and I know from experience that if offered a steroid supplement or not I would surely go for it.
Chronic sinusitis control
My own experience of using budesonide irrigations daily for two years, plus several patients beg to differ.. it helps a GREAT deal, I disbelieve the validity of the findings of this trial