Evidence summaries

Editors
Last reviewed as up-to-date 5.9.2017 • Latest change 21.10.2011

Level of evidence: A
Use of decongestants and antihistamines for acute otitis media or otitis
media with effusion in children does not improve clinically important
outcomes but gives an increased risk of side effects.

A Cochrane review «»1 «Coleman C, Moore M. ...»1 [withdrawn from publication] included
15 studies with a total of 2695 subjects with acute otitis media. Only the combined
decongestant-antihistamine group demonstrated statistically lower rates of persistent AOM
at the two week period (fixed relative risk [RR] 0.76; 95% confidence interval [CI] 0.60 to
0.96; number needed to treat [NNT] 10). No benefit was found for early cure rates, symptom
resolution, prevention of surgery or other complications. Pooled analysis for all
medications, decongestants alone or in combination found no benefit. Those treated with
antihistamines alone, however, were more likely to still have AOM at the four week time
frame (RR 1.91; 95% CI 1.01 to 3.64; NNH = 5.9). There was a five to eight -fold increased risk
of side effects for those receiving an intervention, which reached statistical significance for
all decongestant groupings. Validity subanalyses demonstrated that lower quality studies
found benefit, while analysis of those studies with higher validity scores found no benefit of
treatment.

Authors' comment: If one were to accept the possibility that combined

decongestant/antihistamines are statistically beneficial, the clinical significance of these
results is minimal. Over 70% of those without DC/AH treatment resolved by the two week
period. No benefit was demonstrated for more patient-oriented symptom resolution, or
complications such as hearing loss or the need for surgery. The decision to use these
interventions in the clinical setting must also be balanced with the consistently
demonstrated increased risk of side effects.

A Cochrane review «»2 «Griffin G, Flynn CA. Antihistamines and/or deconge...»2 included 16
studies with a total of 1 880 subjects who had otitis media with effusion. Patients with acute
otitis media, patients with anatomical deformity, or patients with other chronic
immunocompromised states were excluded. No statistical or clinical benefit was found for
any of the interventions or outcomes studied. However, treated study subjects experienced
11% more side effects than untreated subjects (number needed to treat to harm = 9).

The following decision support rules contain links to this evidence summary:

Avoiding decongestants and antihistamines in otitis media in children

«http://www.ebmeds.org/ebmeds/ebmeds_home.asp?
mode=scripts&submode=view&id=scr00424&country=UK»1

This document is linked to the following articles:

Välikorvatulehdus (lasten äkillinen) «Välikorvatulehdus (lasten äkillinen)»1

References
1. Coleman C, Moore M. WITHDRAWN: Decongestants and antihistamines for acute otitis
media in children. Cochrane Database Syst Rev 2011;(3):CD001727. «PMID:
21412874»PubMed
2. Griffin G, Flynn CA. Antihistamines and/or decongestants for otitis media with effusion
(OME) in children. Cochrane Database Syst Rev 2011;(9):CD003423. «PMID:
21901683»PubMed.

Article ID: evd00636

© 2019 Duodecim Medical Publications Ltd