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Systemic steroid for chronic otitis media with effusion in children
Ellen M Mandel1, Margaretha L Casselbrant, Howard E Rockette
1ENT Research Center, Department of Pediatric Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA. mandele@pitt.edu
Pediatrics
|November 29, 2002
Summary
A short course of steroid and amoxicillin showed initial benefit for middle ear effusion (MEE) in children. However, this benefit was not sustained, suggesting limited long-term efficacy for this treatment approach.
Area of Science:
- Pediatric Otolaryngology
- Pharmacological Interventions
- Clinical Trial Research
Background:
- Chronic middle ear effusion (MEE) is a common condition in children.
- The optimal treatment strategy for MEE remains under investigation.
Purpose of the Study:
- To evaluate the efficacy of a short course of prednisolone with amoxicillin versus amoxicillin alone for chronic MEE.
- To compare the effectiveness of 2 weeks versus 4 weeks of amoxicillin treatment, with or without steroid.
Main Methods:
- A double-blind, randomized trial involving children aged 1-9 years with MEE.
- Four treatment arms were utilized, varying steroid and amoxicillin duration.
- Efficacy was assessed via otoscopy, tympanometry, and audiometry at multiple time points.
Main Results:
- Initially, 33.3% of children receiving steroid + amoxicillin were effusion-free at 2 weeks, compared to 16.7% with amoxicillin alone.
- At 4 weeks, the effusion-free rates were 32.8% (steroid group) and 20.0% (placebo group), with no significant difference.
- Recurrence rates were similar between groups by 4 months, and allergy testing did not predict treatment response.
Conclusions:
- While steroid + amoxicillin showed a short-term advantage, the difference was not significant by 4 weeks.
- Prolonging amoxicillin treatment beyond 14 days did not improve outcomes.
- Universal recommendation of this steroid regimen for chronic MEE is not supported; amoxicillin use should not exceed 14 days.