title: Efficacy and tolerability of systemic methylprednisolone in children and adolescents with chronic rhinosinusitis: a double-blind, placebo-controlled randomized trial.
abstract: BACKGROUND
  The place of systemic corticosteroids in the treatment of children with chronic rhinosinusitis (CRS) remains unclear.
  
  
  OBJECTIVE
  We sought to assess the effectiveness and tolerability of oral methylprednisolone as an anti-inflammatory adjunct in the treatment of CRS in children.
  
  
  METHODS
  Forty-eight children (age, 6-17 years) with clinically and radiologically proved CRS were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C) and methylprednisolone or AMX/C and placebo twice daily for 30 days. Oral methylprednisolone was administered for the first 15 days with a tapering schedule. Primary parameters were mean change in symptom and sinus computed tomographic (CT) scan scores after treatment. Secondary study parameters were mean changes in individual symptom scores after treatment, relapse rate, and tolerability.
  
  
  RESULTS
  Forty-five patients completed the study: 22 received AMX/C and methylprednisolone, and 23 received AMX/C and placebo. Both groups demonstrated significant improvements in symptom and sinus CT scores when comparing baseline values with end-of-treatment values (P < .001). Methylprednisolone as an adjunct was significantly more effective than placebo in reducing CT scores (P = .004), total rhinosinusitis symptoms (P = .001), and individual symptoms of nasal obstruction (P = .001), postnasal discharge (P = .007), and cough (P = .009). At the end of treatment, 48% of the children in the placebo group still had abnormal findings on CT scans versus 14% in the methylprednisolone group (P = .013). Therapy-related adverse events were not different between groups. Although insignificant, the incidence of clinical relapses was also less in the methylprednisolone group (25%) compared with that in the placebo group (43%, P = .137).
  
  
  CONCLUSIONS
  Oral methylprednisolone is well tolerated and provides added benefit to treatment with antibiotics for children with CRS.
authors.affiliation: Department of Pediatrics, Division of Pediatric Allergy and Clinical Immunology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey. fadil@doctor.com
authors.forename: Fadıl
authors.initials: F
authors.lastname: Ozturk
authors.forename: Arzu
authors.initials: A
authors.lastname: Bakirtas
authors.forename: Fikret
authors.initials: F
authors.lastname: Ileri
authors.forename: Ipek
authors.initials: I
authors.lastname: Turktas
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D011859:Radiography; D012220:Rhinitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D012852:Sinusitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D015898:Tomography Scanners, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone