Systemic Methylprednisolone in Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis; Children
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): methylprednisolone
Intervention type(s): Drug
Intervention description(s): Patients enrolled in the study were given either oral amoxicillin/clavulanate (AMX/C) or metylprednisolone (MP) (group MP) or AMX/C and placebo (group P) twice daily using a random allocation chart based on a table of random numbers. Oral AMX/C was administered 45/6.4 mg/kg/d (maximum 2000/285 mg/d) for 30 days for both groups. Oral MP was administered for the first 15 days: 1 mg/kg/d (maximum 40 mg/d) for 10 days, 0.75 mg/kg/d for 2 days, 0.5 mg/kg/d for 2 days, and 0.25 mg/kg/d for 1 day. Placebo tablets contained lactose and were of same size and color as MP tablets.
Other intervention name(s): Prednol tablet; Augmentin suspension/tablet
Intervention MeSH terms: Amoxicillin-Potassium Clavulanate Combination; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic rhinosinusitis; Computed tomography scan; Methylprednisolone