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). Conclusion: Oral methylprednisolone is well tolerated and provides added benefit to treatment with antibiotics for children with CRS. (J Allergy Clin Immunol 2011;128:348-52.)