A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media

Tasnee Chonmaitree, Kokab Saeed, Tatsuo Uchida, Terho Heikkinen, Constance D. Baldwin, Daniel H. Freeman, David P. McCormick

Research output: Contribution to journalArticle

34 Citations (Scopus)

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 mg/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 ear 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 ear effusion. The efficacy of 7- to 10-day treatment of AOM with corticosteroid, in addition to antibiotic, deserves further investigation.

Original languageEnglish (US)
Pages (from-to)377-385
Number of pages9
JournalJournal of Pediatrics
Volume143
Issue number3
DOIs
StatePublished - Sep 1 2003

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Histamine Antagonists
Otitis Media
Adrenal Cortex Hormones
Randomized Controlled Trials
Otitis Media with Effusion
Placebos
Chlorpheniramine
Anti-Bacterial Agents
Therapeutics
Recurrence
Ceftriaxone
Prednisolone
Treatment Failure
Pharmaceutical Preparations
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Chonmaitree, T., Saeed, K., Uchida, T., Heikkinen, T., Baldwin, C. D., Freeman, D. H., & McCormick, D. P. (2003). A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. Journal of Pediatrics, 143(3), 377-385. https://doi.org/10.1067/S0022-3476(03)00293-2

A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. / Chonmaitree, Tasnee; Saeed, Kokab; Uchida, Tatsuo; Heikkinen, Terho; Baldwin, Constance D.; Freeman, Daniel H.; McCormick, David P.

In: Journal of Pediatrics, Vol. 143, No. 3, 01.09.2003, p. 377-385.

Research output: Contribution to journalArticle

Chonmaitree, T, Saeed, K, Uchida, T, Heikkinen, T, Baldwin, CD, Freeman, DH & McCormick, DP 2003, 'A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media', Journal of Pediatrics, vol. 143, no. 3, pp. 377-385. https://doi.org/10.1067/S0022-3476(03)00293-2
Chonmaitree, Tasnee ; Saeed, Kokab ; Uchida, Tatsuo ; Heikkinen, Terho ; Baldwin, Constance D. ; Freeman, Daniel H. ; McCormick, David P. / A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. In: Journal of Pediatrics. 2003 ; Vol. 143, No. 3. pp. 377-385.
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