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WITHDRAWN: Decongestants and antihistamines for acute otitis media in children
Cassie Coleman1, Michael Moore
1Department of Paediatrics, Wycombe Hospital, The Walled Garden, High Street, Maidenhead, Berkshire, UK, SL6 5NB.
Insights
Decongestant and antihistamine therapies offer no proven benefit for acute otitis media (AOM) in children and increase side effect risks. Combination therapy showed minimal statistical benefit, but its clinical significance is questionable for treating AOM.
Area of Science:
- Pediatrics
- Otolaryngology
- Pharmacology
Background:
- Acute otitis media (AOM) is a prevalent childhood illness causing significant morbidity.
- Spontaneous resolution is common in AOM cases.
- The efficacy of decongestant and antihistamine therapies for AOM remains uncertain.
Purpose of the Study:
- To evaluate the effectiveness of decongestant and antihistamine treatments in children diagnosed with AOM.
- To assess impacts on AOM resolution, symptom improvement, medication side effects, and complication rates.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials (RCTs).
- Searched multiple databases including CENTRAL, MEDLINE, and EMBASE.
- Included 15 RCTs involving 2695 participants, focusing on patient-oriented outcomes.
Main Results:
- Combined decongestant-antihistamine therapy showed a statistically significant reduction in persistent AOM at two weeks (RR 0.76).
- No significant benefits were observed for early cure rates, symptom resolution, or prevention of complications.
- Interventions led to a 5-8 fold increased risk of side effects, particularly with decongestants.
Conclusions:
- Current evidence does not support the routine use of decongestants for AOM in children due to lack of benefit and increased side effects.
- The observed statistical benefit of combination therapy is minimal and potentially biased by study design.
- Routine antihistamine use for pediatric AOM is not recommended.
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.
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:
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).
Selection Criteria:
Randomized controlled trials (RCTs) evaluating decongestant or antihistamine treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant.
Data Collection And Analysis:
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.
Main 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.
Authors' 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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