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Co-amoxiclav in recurrent acute otitis media: placebo controlled study
C L Appelman1, J Q Claessen, F W Touw-Otten
1Department of General Practice, University of Utrecht, The Netherlands.
BMJ (Clinical Research Ed.)
|December 7, 1991
Summary
Co-amoxiclav did not show significant benefit over placebo for treating recurrent acute otitis media in children over two years old. Children under two years old had a higher risk of irregular disease course, regardless of treatment.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Pharmacology
Background:
- Recurrent acute otitis media (RAOM) is common in children.
- Identifying effective treatments for RAOM is crucial for managing pediatric ear infections.
Purpose of the Study:
- To evaluate the efficacy of co-amoxiclav compared to placebo in children aged 6 months to 12 years with RAOM.
- To identify prognostic factors for the clinical course of RAOM in this pediatric population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in general practice in the Netherlands.
- 121 children with RAOM received either oral co-amoxiclav or placebo for seven days.
- The primary outcome measure was an irregular clinical course, defined as the presence of otalgia or fever (≥38°C) after three days.
Main Results:
- No significant difference in irregular clinical course was observed between the co-amoxiclav and placebo groups (16% vs. 19%).
- Age was a significant prognostic factor, with children under 2 years old having a higher risk of irregular disease course (28% co-amoxiclav vs. 58% placebo).
- In children aged 2 years and older, irregular courses were observed in 13% of the co-amoxiclav group and 7% of the placebo group.
Conclusions:
- Co-amoxiclav offers no significant advantage over placebo for treating RAOM in children over two years old.
- Children with RAOM face a higher risk of an irregular clinical course compared to those with a first episode of acute otitis media.