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.
AU - McCormick, David P.
N1 - Funding Information:
Supported by NIH grant R01 DC 2620. The study was conducted on the General Clinical Research Center at the University of Texas Medical Branch at Galveston, funded by grant M01 RR 00073 from the National Center for Research Resources, NIH, USPHS.
PY - 2003/9/1
Y1 - 2003/9/1
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.
AB - 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.
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U2 - 10.1067/S0022-3476(03)00293-2
DO - 10.1067/S0022-3476(03)00293-2
M3 - Article
C2 - 14517524
AN - SCOPUS:0141839063
SN - 0022-3476
VL - 143
SP - 377
EP - 385
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 3
ER -