Antimicrobial therapy for otitis media with effusion ('secretory' otitis media)
E. I. Cantekin, T. W. McGuire and T. L. Griffith
Department of Otolaryngology, University of Pittsburgh, PA.
OBJECTIVE--To determine the effectiveness of antimicrobial treatment for
otitis media with effusion ("secretory" otitis media) in children. DATA
SOURCE--We report the reexamination of a previously published study by
Mandel et al that evaluated the efficacy of a 2-week course of
antimicrobials (amoxicillin trihydrate) with and without a 4-week course of
an oral decongestant-antihistamine combination in a double-blind,
placebo-controlled, randomized trial involving 518 infants and children
with otitis media with effusion. DATA SYNTHESIS--At 4 weeks, amoxicillin
efficacy as determined by a tympanometric criterion (P = .121) or by a
measure of improvement in hearing (P = .311) was insignificant. Only by
otoscopic judgment, which is shown to contain a systematic bias as used in
this clinical trial, could an argument be made for a marginal efficacy of
amoxicillin at the 4-week end point. Logistic regression analyses of the
combined effects of treatment and prognostic factors showed no significant
differences between placebo- and antibiotic-treated groups for unilateral
effusions and for bilateral effusions. When subjects with unilateral and
bilateral effusions were combined, the estimated efficacy of antibiotic
treatment was 12.3% by otoscopy (P = .014) and 4.8% by tympanometry (P =
.171). We also demonstrate the sensitivity of outcome to diagnostic
measures used and provide statistical evidence questioning the validity of
otoscopic observations in this study. Six weeks after the termination of
amoxicillin therapy, the recurrence of effusion was two to six times higher
in the amoxicillin-treated children than in those treated with placebo (P =
.001), and resolution of effusion was not significantly different among
antibiotic and placebo groups (13.6% and 11.3%, respectively; P = .477).
CONCLUSIONS--Amoxicillin with and without decongestant-antihistamine
combination is not effective for the treatment of persistent asymptomatic
middle-ear effusions in infants and children.
