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Document: 16
Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis
of 5400 children from thirty-three randomized trials.
Rosenfeld R M, Vertrees J E, Carr J, Cipolle R J, Giebink G S, Canafax D
M.
Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis
of 5400 children from thirty-three randomized trials.
Journal of Pediatrics,
1994,
124(3),
pp. 355-367
Record status
This record is a structured abstract written by CRD reviewers. The review has
met a set of quality criteria.
Author's objective
To review the clinical effectiveness of antimicrobial drugs for acute otitis
media (glue ear) in children. Type of intervention
Treatment
Specific interventions included in the review
Antimicrobial drugs administered for initial empiric treatment of simple acute
otitis media.
Participants included in the review
Children aged 4 weeks to 18 years old with acute otitis media and with no
underlying disorders (e.g. Down's syndrome, cleft palate, concurrent
illnesses) which might influence susceptibility to infection.
Outcomes assessed in the review
Primary endpoints were the absence (or otherwise) of all presenting signs and
symptoms of acute otitis media at the evaluation point closest to 7 to 14 days
after therapy was started, and improvement in the appearance of the tympanic
membrane. The secondary endpoint was the presence or absence of middle ear
effusion in both ears at the evaluation point closest to 30 days after therapy
was started.
Study designs of evaluations included in the review
Randomised controlled trials
What sources were searched to identify primary studies?
Medline 1966 to June 1992 (exploded MeSH heading otitis media/drug therapy and
limited search by (a) use of MeSH headings prospective studies, placebos,
random allocation, double-blind method or (explode) clinical trials or (b)
check tag comparative study or (c) publication type clinical trial; Current
Contents 1992 (volume 35, issues 13-26); articles from textbook
bibliographies; review articles; references from retrieved articles; and
symposium publications.
Criteria on which the validity (or quality) of studies was assessed
Randomised controlled study design in which at least one group was given one
of a set of 14 antimicrobial drugs to treat simple acute otitis media.
Studies of specific bacterial pathogens, studies which included myringotomy as
part of treatment, and studies which did not describe the type of otitis media
were excluded.
How were the judgements of validity (or quality) made?
Included studies were evaluated independently by two reviewers using a
checklist of methodological quality, and an overall quality score from 0-1 was
calculated for each study based on its performance on 11 quality items.
How were decisions on the relevence of primary studies made?
Two reviewers independently assessed blinded manuscripts using a checklist of
eligibility criteria.
How was the data extracted from primary studies?
Two reviewers independently extracted data, using patients (not ears) as the
unit of analysis.
Number of studies included
33 randomised controlled trials (47% were not double blind).
How were the studies combined?
(a) Assuming a fixed effects model, the exact maximum likelihood estimate of
the common odds ratio (with 95% confidence interval) was calculated. (b)
Using a random effects model, the pooled rate difference was calculated. If
the pooled rate difference was statistically significant, the number needed to
treat was calculated.
How were differences between studies investigated?
Sensitivity analysis was used to assess the impact of diagnostic specificity
and of the methodogical quality scores of the primary studies on results.
Pooled effect sizes were compared by type of antimicrobial drug.
Results of the review
The spontaneous rate of primary control without treatment was 81% (95%CI: 69%,
94%). Compared with placebos or no drug, the rate difference for primary
control for penicillin was 15.7% (95%CI: 4.7%, 26.7%), for aminopenicillin was
12.9% (95%CI: 6.8%, 19.0%), and for any antibiotic was 13.7% (95%CI: 8.2%,
19.2%). Six of every seven children with acute otitis media either do not need
antibiotics for primary control or will not respond to antibiotic therapy
(number needed to treat = 7). Results from the fixed and the random effect
analysis were consistent. No significant differences were found between
various antimicrobial agents. The senstivity analysis showed that these
results were robust to quality and diagnostic screening.
Was any cost information reported?
No
Author's conclusions
Antimicrobial drugs have a modest but significant impact on the primary
control of acute otitis media. Treatment with extended spectrum antibiotics
does not increase resolution of acute symptoms or middle ear effusion; initial
therapy should be guided by considerations of safety, tolerability, and
affordability, and not by the theoretical advantage of an extended
antibacterial spectrum.
CRD commentary
This review was rigorous in its methodology and the results appear robust. It
is not clear that all the children included in the primary studies had
bacteria in their middle ears, so the efficacy of antibiotics could be greater
than reported in this review if they were given in a more targeted way.
However, the review used diagnostic criteria which are likely to be reflected
in practice.
What are the implications of the review?
Antibiotics are of some benefit in the management of acute otitis media in
children if a bacterial cause is suspected. Cheaper standard spectrum
antibiotics are as effective as those with broad spectrum.
Subject index terms
Subject indexing assigned by NLM: Antibiotics/tu [therapeutic-use];
Otitis-Media/dt [drug-therapy]; Acute-Disease; Child,-Preschool; Infant-;
Multivariate-Analysis; Randomized-Controlled-Trials;
Sensitivity-and-Specificity; Female; Human; Male; Support,-U.S.-Gov't,-P.H.S.
Correspondence address
Richard M Rosenfeld, Department of Otolaryngology, Long Island College
Hospital, 340 Henry Street, Brooklyn, New York NY 11201, USA.
Copyright
University of York, 1998
Database no.: DARE-940081
