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April 1989

Antibiotic Treatment of Children With Secretory Otitis Media: A Randomized, Double-blind, Placebo-Controlled Study

Author Affiliations

From the Ear-Nose-Throat Department, Gentofte University Hospital, Hellerup (Drs Thomsen, Balle, Stangerup, and Bondesson); the Department of Clinical Microbiology, Herlev University Hospital (Dr Vejlsgaard), and the Ear-Nose-Throat Clinic (Dr Sederberg-Olsen), Helsingør, Denmark.

Arch Otolaryngol Head Neck Surg. 1989;115(4):447-451. doi:10.1001/archotol.1989.01860280045015

• A double-blind, randomized, place-bo-controlled clinical trial was conducted to evaluate one month of amoxicillinclavulanate potassium treatment of children with secretory otitis media. In total, 264 children, aged 1 to 10 years, were randomly assigned to either antibiotic or placebo treatment; 43 patients were excluded during treatment, equally distributed in both groups, leaving 221 patients completing the trial. The inclusion criterion was a type C2 and type B tympanometry result of at least three months' duration. Tympanometry was performed every month for 12 additional months. At the end of the treatment period, the disease was reversed in 61% in the antibiotic-treated group compared with 30% in the placebo-treated group P<.0001), and the improvement was

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