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).


METHODS
Prospective, double-blind, randomized study.


METHODS
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.


CONCLUSIONS
Antibiotic treatment improves the middle ear status in patients with SOM, and amoxicillin-clavulanate provides superior improvement to penicillin V.
Thomsen
J
J
Department of Ear-Nose-Throat-Head and Neck Surgery, Gentofte University Hospital, Denmark.
Sederberg-Olsen
J
J
Balle
V
V
Hartzen
S
S
D000158:Acoustic Impedance Tests; D000658:Amoxicillin / Q000627:therapeutic use; D019980:Amoxicillin-Potassium Clavulanate Combination; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D018579:Patient Selection; D010404:Penicillin V / Q000627:therapeutic use*; D012074:Remission Induction; D013997:Time Factors
D002969:Clavulanic Acids; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D010404:Penicillin V