Systemic Methylprednisolone in Chronic Rhinosinusitis
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
The place of systemic corticosteroids in the treatment of children with chronic
rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability
of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in
children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS
were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C)
and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered for the
first 15 days with a tapering schedule. Primary parameters were mean change in symptom and
sinus computed tomography (CT) scan scores after treatment. Secondary study parameters were
mean changes in individual symptom scores after treatment, relapse rate and tolerability.
Forty-five patients completed the study, 22 received AMX/C and MP, and 23 AMX/C and P. Both
groups demonstrated significant improvements in symptom and sinus CT scores, comparing
baseline to end of the treatment (p<0.001). Methylprednisolone as an adjunct was
significantly more effective than placebo in reducing CT scores (p=0.004), total
rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001),
postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the
children in the P group still had abnormal findings in CT versus 14% in the MP group (p =
0.013). Therapy-related adverse events were not different between groups. Although
insignificant, the incidence of clinical relapses was also less in the MP group (25%)
compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit
to treatment with antibiotics for children with CRS.