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




AuthorsChonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH, McCormick DP

PublisherMOSBY-ELSEVIER

Publication year2003

JournalJournal of Pediatrics

Journal name in sourceJOURNAL OF PEDIATRICS

Journal acronymJ PEDIATR-US

Volume143

Issue3

First page 377

Last page385

Number of pages9

ISSN0022-3476

DOIhttps://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.



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