Children, Chronic Rhinosinusitis
Conditions
Keywords
Chronic rhinosinusitis, Computed tomography scan, Methylprednisolone
Brief 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.
Interventions
DRUGmethylprednisolone
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.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
All patients presented with nasal and/or postnasal purulence, and one or more of the following symptoms: nasal obstruction, cough, halitosis, headache, or facial pain/pressure. The diagnosis of CRS was made on the basis of sinonasal symptoms and signs present for a period of more than 3 months in the presence of abnormalities on coronal sinus CT scans. \-
Exclusion criteria
Patients were excluded if they had used systemic corticosteroids in the last 2 months prior to the study, systemic antibiotics and inhaler or intranasal corticosteroids in the last 4 weeks prior to the study or if they had other respiratory disorders (cystic fibrosis, ciliary dyskinesia, nasal polyps, large adenoids, asthma), immune deficiency, systemic disease, gastro-esophageal reflux, aspirin sensitivity, and acquired or congenital sinonasal abnormalities, or a contraindication to corticosteroid use. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in total symptom score and coronal CT score after treatment | One month | Rhinosinusitis symptoms were assessed by the patients and their parents with the use of a visual analogue scale (VAS) rating symptoms from 0 (none) to 10 (most severe). A coronal sinus CT scanning was performed on all subjects before and at the end of the treatment. The scans were evaluated and scored according to the Lund-Mackay staging system. |
Secondary
| Measure | Time frame |
|---|---|
| mean changes in individual symptom scores after treatment | One month |
| relapse rate | Six months |
| tolerability of oral methylprednisolone tablet | One month |
Countries
Turkey (Türkiye)
Outcome results
None listed