Antibiotic treatment of children with secretory otitis media. Amoxicillin-clavulanate is superior to penicillin V in a double-blind randomized study.

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.