A Cochrane review «»1 «Coleman C, Moore M. ...»1 [withdrawn from publication] included 15 studies with a total of 2695 subjects with acute otitis media.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).
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