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Decongestants and antihistamines for acute otitis media in children
C A Flynn1, G Griffin, F Tudiver
1Department of Family Medicine, State University of New York Upstate Medical University, Suite 200, 475 Irving Avenue, Syracuse, New York 13210, USA. flynnc@upstate.edu
Insights
Decongestant and antihistamine therapies offer no significant benefit for acute otitis media (AOM) in children and may increase side effects. Combined treatment showed minimal statistical improvement, but overall, these medications are not recommended for AOM.
Area of Science:
- Pediatric Otolaryngology
- Pharmacological Interventions
- Evidence-Based Medicine
Background:
- Acute otitis media (AOM) is a common childhood illness with most cases resolving spontaneously.
- The efficacy of decongestant and antihistamine therapy for AOM in children remains uncertain despite frequent recommendations.
Purpose of the Study:
- To evaluate the effectiveness of decongestant (DC) and antihistamine (AH) treatments in children with AOM.
- To assess the impact of these therapies on AOM resolution, medication side effects, and complication rates.
Main Methods:
- A comprehensive literature search was performed across multiple databases (Cochrane's Controlled Trials Registry, Medline, Embase).
- Included were randomized controlled trials (RCTs) assessing DC or AH for pediatric AOM, with no quality or language restrictions.
- Data were independently extracted and analyzed using pooled relative risks and numbers needed to treat.
Main Results:
- High spontaneous healing rates for AOM were observed, with persistent AOM below 23% in control groups.
- No significant additional benefit was found for individual DC, AH, or any medication (DC and/or AH) subgroups.
- Combined DC + AH treatment showed a statistically significant but clinically minor reduction in persistent AOM at 2 weeks (NNT 10.5).
- Increased risk of medication side effects was noted for intervention groups (NNH 16.6 for any medication, NNH 14.3 for DC).
- Lower-quality studies suggested benefit, while higher-quality studies found no benefit.
Conclusions:
- Current evidence does not support the use of decongestant, antihistamine, or combined DC/AH treatments for pediatric AOM due to lack of clinical benefit and increased risk of side effects.
- The marginal statistical benefit observed with combination therapy is likely of limited clinical significance and may be influenced by study design limitations.
Background:
Acute otitis media (AOM) is a common and important source of morbidity in children, although most cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit.
Objectives:
To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, medication side effects, and complications of AOM.
Search Strategy:
Comprehensive search of Cochrane's Controlled Trials Registry, Medline and Embase was conducted. Bibliographic review and requests for information from study authors and pharmaceutical companies supplemented this.
Selection Criteria:
Randomized controlled trials evaluating decongestant (DC) or antihistamine (AH) treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. There were no quality or language restrictions.
Data Collection And Analysis:
Investigators independently evaluated studies for inclusion, performed validity assessments, and completed data extraction. Dichotomous data were pooled to generate relative risks and numbers needed to treat, and homogeneity was assessed using approximate chi-square tests.
Main Results:
For the combined control groups, healing rates at 2 weeks were high, with rates of persistent AOM <23%. No additional benefit was demonstrated from intervention subgroupings DC, AH, or any medication (DC and/or AH). Only the combined treatment (DC + AH) group demonstrated statistically lower rates of persistent AOM at the 2-week period (RR 0.76, 95% CI, NNT 10.5, 95% CI). No benefit was found for other outcomes including early or late cure rates, symptom resolution, prevention of surgery or other complications. There was an increased risk of medication side effects for those receiving an intervention, which reached statistical significance for the "any medication" and decongestant groupings (NNH 16.6, 14.3 respectively, 95% CI ). Validity subanalyses demonstrated that lower quality studies found benefit, but analysis of those studies with higher validity scores found no benefit to treatment.
Reviewer'S Conclusions:
Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant, antihistamine, or combined DC/AH treatment in children with AOM. The small statistical benefit found in the combination medication group is of small clinical significance and study design may be biasing the results.
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