title: Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial.
abstract: BACKGROUND
  Chronic rhinosinusitis (CRS) with nasal polyposis is common. The long-term efficacy and safety of approaches to medical management are not well-known.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of a 2-week regimen of oral steroid therapy followed by 26 weeks of sequential topical steroid maintenance therapy.
  
  
  METHODS
  Parallel randomized trial with computer-generated block randomization and central allocation. Patients and investigators were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00788749)
  
  
  METHODS
  A specialty rhinology clinic in Tayside, Scotland.
  
  
  METHODS
  60 adults with CRS and moderate-sized or larger nasal polyps who were referred by their primary physicians for specialty care.
  
  
  METHODS
  Patients were randomly assigned in a 1:1 ratio to receive oral prednisolone, 25 mg/d, or placebo for 2 weeks, followed in both groups by fluticasone propionate nasal drops, 400 µg twice daily, for 8 weeks and then fluticasone propionate nasal spray, 200 µg twice daily, for 18 weeks.
  
  
  METHODS
  Polyp grading (primary outcome), hyposmia score, quality of life, symptoms, nasal patency, adrenal function, and bone turnover.
  
  
  RESULTS
  The mean decrease in polyp grade from baseline to 2 weeks was 2.1 units (SD, 1.1) in the prednisolone group and 0.1 unit (SD, 1.0) in the placebo group (mean difference between groups, -1.8 units [95% CI, -2.4 to -1.2 units]; P < 0.001). The difference between groups was -1.08 units (CI, -1.74 to -0.42 unit; P = 0.001) at 10 weeks and -0.8 unit (CI, -1.8 to 0.2 unit; P = 0.11) at 28 weeks. The mean decrease in hyposmia score from baseline to 2 weeks was 31.12 mm (SD, 30.1) in the prednisolone group and 1.41 mm (SD, 30.6) in the placebo group (mean difference between groups, -28.33 mm [CI, -42.71 to -13.96 mm]; P = 0.002). The difference between groups was -16.06 mm (CI, -30.99 to -1.13 mm; P = 0.03) at 10 weeks and -12.13 mm (CI, -30.55 to 6.29 mm; P = 0.19) at 28 weeks. Prednisolone therapy resulted in transient suppression of adrenal function and increase in bone turnover after 2 weeks, with a return to baseline at 10 and 28 weeks.
  
  
  CONCLUSIONS
  Patients were referred from primary care to a single-center rhinology clinic, which limits the generalizability of results. Serial measurements of surrogates of nasal inflammation (such as nitric oxide or cytokine levels) were not performed.
  
  
  CONCLUSIONS
  Initial oral steroid therapy followed by topical steroid therapy seems to be more effective over 6 months than topical steroid therapy alone in decreasing polyp size and improving olfaction in patients referred for specialty care of CRS with at least moderate nasal polyposis.
  
  
  BACKGROUND
  Chief Scientist Office, Scotland; National Health Service Tayside Small Grants Scheme; and an Anonymous Trust grant from University of Dundee.
authors.affiliation: Ninewells Hospital, University of Dundee, United Kingdom.
authors.forename: Sriram
authors.initials: S
authors.lastname: Vaidyanathan
authors.forename: Martyn
authors.initials: M
authors.lastname: Barnes
authors.forename: Peter
authors.initials: P
authors.lastname: Williamson
authors.forename: Pippa
authors.initials: P
authors.lastname: Hopkinson
authors.forename: Peter T
authors.initials: PT
authors.lastname: Donnan
authors.forename: Brian
authors.initials: B
authors.lastname: Lipworth
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002908:Chronic Disease; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009298:Nasal Polyps / Q000150:complications / Q000188:drug therapy*; D059085:Nasal Sprays; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012220:Rhinitis / Q000150:complications / Q000188:drug therapy*; D012852:Sinusitis / Q000150:complications / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D059085:Nasal Sprays; D011239:Prednisolone