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A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media.
J Pediatr. 2003 Sep; 143(3):377-85.JPed

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.

Authors+Show Affiliations

Department of Pediatrics, University of Texas Medical Branch, Galveston, Texas 77555-0371, USA. Tchonmai@utmb.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

14517524

Citation

Chonmaitree, Tasnee, et al. "A Randomized, Placebo-controlled Trial of the Effect of Antihistamine or Corticosteroid Treatment in Acute Otitis Media." The Journal of Pediatrics, vol. 143, no. 3, 2003, pp. 377-85.
Chonmaitree T, Saeed K, Uchida T, et al. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003;143(3):377-85.
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. The Journal of Pediatrics, 143(3), 377-85.
Chonmaitree T, et al. A Randomized, Placebo-controlled Trial of the Effect of Antihistamine or Corticosteroid Treatment in Acute Otitis Media. J Pediatr. 2003;143(3):377-85. PubMed PMID: 14517524.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. AU - Chonmaitree,Tasnee, AU - Saeed,Kokab, AU - Uchida,Tatsuo, AU - Heikkinen,Terho, AU - Baldwin,Constance D, AU - Freeman,Daniel H,Jr AU - McCormick,David P, PY - 2003/10/1/pubmed PY - 2003/12/5/medline PY - 2003/10/1/entrez SP - 377 EP - 85 JF - The Journal of pediatrics JO - J. Pediatr. VL - 143 IS - 3 N2 - 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. SN - 0022-3476 UR - https://www.unboundmedicine.com/medline/citation/14517524/A_randomized_placebo_controlled_trial_of_the_effect_of_antihistamine_or_corticosteroid_treatment_in_acute_otitis_media_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(03)00293-2 DB - PRIME DP - Unbound Medicine ER -