Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial

Objective: To compare normal saline (NS) vs. NS + budesonide irrigations in post-functional endoscopic sinus surgery (FESS) patients with chronic rhinosinusitis with polyposis (CRSwNP). Currently, no evidence exists for NS + budesonide irrigation over NS irrigation alone. Study design: Prospective, single-blind, randomized controlled trial. Methods: Subjects were prospectively enrolled to NS or NS + budesonide arms. Patients were evaluated at pre-operative and three post-operative visits (POV): POV1 (1-2 weeks post-op), POV2 (3-8 weeks post-op), and POV3 (3-6 months post-op). Patients were evaluated by three quality of life (QOL) questionnaires (SNOT-22, RSOM-31, and RSDI) and two olfaction scores (UPSIT and the PEA test). Results: Fifty patients were randomized, with 25 patients in the NS arm and 25 patients in the NS + budesonide arm. Two patients had unexpected pathology and were excluded from the study. By POV2 and POV3, patients experienced a significant improvement in all three QOL surveys, although the degree of improvement between arms was not significant up through POV3. Neither arm experienced significant olfactory improvement up through POV3. Conclusions: While both NS and NS + budesonide treatments improve QOL for post-FESS patients, neither intervention significantly increases QOL as compared to the other. Olfaction was not significantly improved in either treatment group.