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Decongestants and antihistamines for acute otitis media in children
C A Flynn1, G H Griffin, J K Schultz
1Family Medicine, SUNY Upstate Medical University, Suite 200, 475 Irving Avenue, Syracuse, NY 13210, USA. flynnc@upstate.edu
Insights
Decongestant and antihistamine therapies offer no significant benefit for acute otitis media (AOM) in children and increase side effect risks. Combined treatments show minimal, potentially biased, statistical advantages, not supporting routine use.
Area of Science:
- Pediatrics
- Otolaryngology
- Pharmacology
Background:
- Acute otitis media (AOM) is a prevalent childhood illness causing significant morbidity.
- Current recommendations often include decongestant and antihistamine therapies, but their efficacy remains uncertain.
Purpose of the Study:
- To evaluate the effectiveness of decongestant and antihistamine treatments in children diagnosed with AOM.
- Key outcomes assessed include AOM resolution, symptom improvement, medication side effects, and complication rates.
Main Methods:
- A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted.
- Searches included major databases (CENTRAL, MEDLINE, EMBASE) and reference lists, with no quality or language restrictions.
- Data extraction and validity assessments were performed independently by investigators.
Main Results:
- Fifteen trials with 2695 participants were analyzed.
- Combined decongestant-antihistamine therapy showed a statistically significant, but clinically minimal, reduction in persistent AOM at two weeks (NNT=10).
- No benefits were observed for early cure, symptom resolution, or complication prevention; however, side effect risks increased five to eightfold.
Conclusions:
- Decongestant treatment for pediatric AOM is not supported due to lack of efficacy and increased adverse events.
- While a small statistical benefit was noted for combination therapy, potential study design biases limit its clinical significance.
- Routine use of antihistamines for AOM in children is not recommended.
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, symptom resolution, medication side effects, and complications of AOM.
Search Strategy:
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2003); MEDLINE (January 1966 to December 2003), EMBASE (January 1990 to July 2003) and reference lists of articles for this updated review. We also contacted study authors and pharmaceutical companies.
Selection Criteria:
Randomized controlled trials evaluating decongestant or antihistamine 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; homogeneity was assessed using approximate chi-square tests.
Main Results:
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.
Reviewers' 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.
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