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

Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Budesonide / administration & dosage*
  • Chronic Disease
  • Female
  • Glucocorticoids / administration & dosage*
  • Humans
  • Male
  • Middle Aged
  • Nasal Polyps / complications
  • Nasal Polyps / pathology
  • Nasal Polyps / surgery*
  • Postoperative Care*
  • Prospective Studies
  • Quality of Life
  • Recovery of Function
  • Rhinitis / complications
  • Rhinitis / pathology
  • Rhinitis / surgery*
  • Single-Blind Method
  • Sinusitis / complications
  • Sinusitis / pathology
  • Sinusitis / surgery*
  • Smell
  • Therapeutic Irrigation
  • Treatment Outcome

Substances

  • Glucocorticoids
  • Budesonide