A1 Refereed original research article in a scientific journal
A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media
Authors: Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH, McCormick DP
Publisher: MOSBY-ELSEVIER
Publication year: 2003
Journal: Journal of Pediatrics
Journal name in source: JOURNAL OF PEDIATRICS
Journal acronym: J PEDIATR-US
Volume: 143
Issue: 3
First page : 377
Last page: 385
Number of pages: 9
ISSN: 0022-3476
DOI: https://doi.org/10.1067/S0022-3476(03)00293-2(external)
Abstract
Objectives To determine whether the adjunctive drugs antihistamine and corticosteroid improve immediate and long-term outcomes of acute otitis media (AOM).Study design Children with AOM (3 mos-6 y) were enrolled in a randomized, double-blind, placebo-controlled trial. All 179 children received one dose of intramuscular ceftriaxone and were assigned to receive either chlorpheniramine maleate (0.35 nig/kg/d) and/or prednisolone (2 mg/kg/day) or placebo for 5 days. Main outcome measures were rate of treatment failure during the first 2 weeks, duration of middle car effusion, and rate of recurrences of AOM to 6 months.Results Clinical outcomes and recurrence rates did not differ significantly with treatment. Children who received antihistamine alone had significantly longer duration of middle ear effusion (median, 73 days) than subjects in other treatment groups (median, 23 to 36 days, P = .04). Temporary normalization of tympanometric findings on day 5 occurred more frequently in the corticosteroid-treated group (P = .04).Conclusions Five-day treatment with antihistamine or corticosteroid, in addition to antibiotic, did not improve AOM outcomes. Antihistamine use during an acute episode of OM should be avoided, since the drug may prolong the duration of middle car effusion. The efficacy, of 7- to 10-day treatment of AOM with corticosteroid, in addition to antibiotic, deserves further investigation.
Objectives To determine whether the adjunctive drugs antihistamine and corticosteroid improve immediate and long-term outcomes of acute otitis media (AOM).Study design Children with AOM (3 mos-6 y) were enrolled in a randomized, double-blind, placebo-controlled trial. All 179 children received one dose of intramuscular ceftriaxone and were assigned to receive either chlorpheniramine maleate (0.35 nig/kg/d) and/or prednisolone (2 mg/kg/day) or placebo for 5 days. Main outcome measures were rate of treatment failure during the first 2 weeks, duration of middle car effusion, and rate of recurrences of AOM to 6 months.Results Clinical outcomes and recurrence rates did not differ significantly with treatment. Children who received antihistamine alone had significantly longer duration of middle ear effusion (median, 73 days) than subjects in other treatment groups (median, 23 to 36 days, P = .04). Temporary normalization of tympanometric findings on day 5 occurred more frequently in the corticosteroid-treated group (P = .04).Conclusions Five-day treatment with antihistamine or corticosteroid, in addition to antibiotic, did not improve AOM outcomes. Antihistamine use during an acute episode of OM should be avoided, since the drug may prolong the duration of middle car effusion. The efficacy, of 7- to 10-day treatment of AOM with corticosteroid, in addition to antibiotic, deserves further investigation.