Evidence is Limited for the Efficacy and Safety of Corticosteroid Irrigation in Chronic Rhinosinusitis (CRS)

High-volume nasal irrigation has been shown to have benefits in CRS patients. Addition of high-dose corticosteroid to saline irrigations is increasingly common, though guidelines note inadequate evidence to confirm efficacy. We summarize existing evidence and usage trends. Reviewed literature on corticosteroid irrigation in CRS. Budesonide claims data [2007-2016; Covance Inc] were evaluated for patients with a CRS-related diagnosis. Seventeen efficacy (15 budesonide; 1 mometasone; 1 fluticasone) and/or safety studies (3 weeks-22 months) were identified. Most were uncontrolled (n=12) versus randomized (n=5); small and underpowered (≤10 subjects: n=3; 11-49: n=9; 50-100: n=4; ≥100: n=1) and conducted in CRS sub-populations (eg, post-sinus surgery: n=9). The 3 which were generalizable (ie, n≥50) and controlled, failed to show a statistically significant difference versus control (saline irrigation). One small study (n=35) demonstrated benefit on imaging but mixed results on symptoms. Evidence of, or a trend toward, HPA axis suppression was apparent in 2/6 studies. Annual claims data showed increasing use of Budesonide Respules® with increased costs (mean prescription number=6 among patients with ≥1 prescription; mean cost=$210/prescription). Adherence was reported to be adversely affected by third party coverage and irrigation solution preparation time, and 2.5% ± 1.6% of irrigation doses are retained in the nose. Evidence for efficacy of adding corticosteroid to nasal irrigations is low-quality, with reported possible benefits limited to a sub-population with previous surgery. Adequate, well-controlled studies are needed to address dosing issues, efficacy, safety, adherence, and patient selection in order to understand the role of adding corticosteroid to nasal irrigations in CRS.