title: Antibiotic treatment of children with secretory otitis media. A randomized, double-blind, placebo-controlled study.
abstract: A double-blind, randomized, placebo-controlled clinical trial was conducted to evaluate one month of amoxicillin-clavulanate 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 less than .0001), and the improvement was persistently significant in favor of antibiotic for eight months. The effect was present in all age groups and independent of laterality of disease. The middle-ear status at the end of treatment was the determining factor for the outcome of tympanometry the year following treatment. From the end of treatment, there was no difference between tympanometry in a patient having been treated with the antibiotic and a patient having been treated with placebo. Antibiotic treatment shifts the individual patient from poor to better tympanometric conditions, so antibiotics can be recommended in the treatment of secretory otitis media before inserting ventilating tubes.
authors.affiliation: Ear-Nose-Throat Department, Gentofte University Hospital, Hellerup, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Thomsen
authors.forename: J
authors.initials: J
authors.lastname: Sederberg-Olsen
authors.forename: V
authors.initials: V
authors.lastname: Balle
authors.forename: R
authors.initials: R
authors.lastname: Vejlsgaard
authors.forename: S E
authors.initials: SE
authors.lastname: Stangerup
authors.forename: G
authors.initials: G
authors.lastname: Bondesson
mesh_terms: 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*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D011897:Random Allocation; D013997:Time Factors
chemical_list: D002969:Clavulanic Acids; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin