Three Part Question
In [a systemically well child with otitis media] are [oral antibiotics better than placebo] at [decreasing time to recovery and reducing the incidence of secondary complications]?
A 2 year old child is brought into the emergency department with a general malaise and irritability for the last 24 hours. Examination of the right ear reveals a diffusely red bulging ear drum. A diagnosis of acute otitis media is made. You wonder whether there is any evidence that oral antibiotics would decrease the time to recovery and prevent secondary complications.
Medline 1966-11/00 using the OVID interface.
[(exp otitis media OR otitis media.mp OR acute otitis media.mp OR acute red ear.mp) AND (exp antibiotics OR antibiotic$.mp OR exp amoxycillin OR amoxycillin.mp OR exp amoxicillin-potassium clavulanate combination OR augmentin.mp OR co-amoxyclav.mp OR exp erythromycin OR exp erythromycin estolate OR erythromycin.mp OR exp penicillins OR penicillin.mp OR non-antibiotic treatment.mp OR placebo.mp)] AND maximally sensitive RCT filter LIMIT to human AND english.
865 papers were found of which 10 were relevant and had been meta-analysed by the Cochrane review group which was last updated on 28/04/2000. No further relevant papers have been published since. A meta-analysis done in 1994 was also selected.
|Author, date and country
||Study type (level of evidence)
|Rosenfeld RM et al,|
|33 trials including 5400 children with acute otitis media
Antibiotics vs no antibiotics||Meta-analysis||Complete clinical resolution of signs (primary control)||Compared with placebo or no drug, antimicrobial therapy increased primary control by 13.7% (8.2% to 19.2%) (NNT=7)||Outcome not patient orientated|
|Glasziou PP et al,|
|7 trials with patient related outcomes. Total inclusion of 2,202 children with acute otitis media.
Antibiotics vs no antibiotics||Systematic review||Hearing between 1 and 3 months||No significant difference||Only one episode of mastoiditis in all the trials|
|Pain between 2 and 7 days||28% (CI 15%-38%) relative reduction with antibiotics (NNT=17)|
|Pain at 24 hours||No difference|
Most cases of otitis media will spontaneously resolve.
A recent Cochrane review on this subject has been published in August 2004. This BET will be re-examined in light of this and updated shortly.
Clinical Bottom Line
There is benefit from the use of antibiotics in otitis media.
- Rosenfeld RM, Vertrees JE, Carr J et al. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials J Pediatr 1994;124(3):355-67.
- Glasziou PP, Del Mar CB, Hayem M. Antibiotics for acute otitis media in children (Cochrane Review) In: The Cochrane Library, Issue 3, 2000. Oxford: Update Software.