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July 1997

Antibiotic Treatment of Children With Secretory Otitis Media: Amoxicillin-Clavulanate Is Superior to Penicillin V in a Double-blind Randomized Study

Author Affiliations

From the Department of Ear-Nose-Throat—Head and Neck Surgery, Gentofte University Hospital (Drs Thomsen and Balle), Gentofte; the Ear-Nose-Throat Clinic, Elsinore (Dr Sederberg-Olsen); and the Department of Clinical Microbiology, Herlev University Hospital, Herlev (Dr Hartzen), Denmark.

Arch Otolaryngol Head Neck Surg. 1997;123(7):695-699. doi:10.1001/archotol.1997.01900070039006

Objective:  To compare the effect of 2 different antimicrobial agents in the treatment of secretory otitis media (SOM).

Design:  Prospective, double-blind, randomized study.

Patients:  From a pool of 1450 children (aged 1-10 years) with SOM, defined by tympanometry as having type B or C2 tympanograms, 429 with SOM of at least 3 months' duration were included in the trial. After exclusion of 69 patients, the remaining 360 were evenly distributed among 4 treatment groups: penicillin V (Primcillin) for 14 and 28 days, and amoxicillin and clavulanate potassium in combination (Spektramox) for 14 and 28 days. Criteria for improvement was a change in tympanometric findings to type C1 or type A.

Results:  The success rates were in favor of amoxicillin-clavulanate treatment for 28 days (P<.001) (rates for respective 14- and 28-day groups: penicillin V, 23% and 19%; amoxicillin-clavulanate, 31% and 44%). Antimicrobial therapy was more efficient (P<.001) in unilateral vs bilateral disease.

Conclusion:  Antibiotic treatment improves the middle ear status in patients with SOM, and amoxicillin-clavulanate provides superior improvement to penicillin V.Arch Otolaryngol Head Neck Surg. 1997;123:695-699