Decongestants and antihistamines for acute otitis media in children.
BACKGROUND
Acute otitis media (AOM) is a common and important source of morbidity in children, although the majority of cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit.


OBJECTIVE
To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, symptom resolution, medication side effects, and complications of AOM.


METHODS
In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2); MEDLINE (January 2004 to May 2007); and EMBASE (July 2003 to May 2007).


METHODS
Randomized controlled trials (RCTs) evaluating decongestant or antihistamine treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant.


METHODS
The review authors independently evaluated studies for inclusion, performed validity assessments and completed data extraction. Dichotomous data were pooled to generate relative risks; homogeneity was assessed using approximate chi-square tests.


RESULTS
No new studies were included following this updated search. Fifteen trials involving 2695 people were included. 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. 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 sub analyses demonstrated that lower quality studies found benefit, while analysis of those studies with higher validity scores found no benefit of treatment.


CONCLUSIONS
Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant treatment in children with AOM. There was a small statistical benefit from combination medication use but the clinical significance is minimal and study design may be biasing the results. Thus, the routine use of antihistamines for treating AOM in children cannot be recommended.
Coleman
Cassie
C
Department of Paediatrics, Wycombe Hospital, The Walled Garden, High Street, Maidenhead, Berkshire, UK, SL6 5NB. cass81@doctors.org.uk
Moore
Michael
M
D000208:Acute Disease; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D014663:Nasal Decongestants / Q000627:therapeutic use*; D010033:Otitis Media / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic
D006634:Histamine H1 Antagonists; D014663:Nasal Decongestants