title: Single dose of betamethasone in combined medical treatment of secretory otitis media.
abstract: With the objective of evaluating the efficacy of cefixime and the combination of cefixime and betamethasone in the treatment of secretory otitis media (SOM), we enrolled 142 children 2 to 12 years old in a randomized, double-blind, placebo-controlled study. All children suffered from SOM, verified by otomicroscopy and tympanometry, of at least 3 months' duration. Active treatment was a 10-day course of cefixime with and without a single dose of 6 mg betamethasone. On hundred forty children were available for efficacy evaluation 14 to 23 days after the start of treatment. A statistically significant treatment effect was found in the group treated with cefixime plus betamethasone (n = 59), with a 44.1% cure rate as compared to 19.7% in the cefixime-treated group (n = 61; p < .005) and 5% in the placebo group (n = 20; p < .005). Relapse rates were high and no statistically differences between groups remained at last valid visit. Adverse events possibly or probably associated with active treatment were reported in 11 cases (9.2%). One patient reported a severe adverse event. No serious events occurred. The study did not show any significant long-term effect of cefixime treatment or any long-term treatment benefit with the addition of betamethasone to the antibiotic.
authors.affiliation: Department of Otorhinolaryngology, Karolinska Hospital, Stockholm, Sweden.
authors.forename: C
authors.initials: C
authors.lastname: Hemlin
authors.forename: C
authors.initials: C
authors.lastname: Carenfelt
authors.forename: G
authors.initials: G
authors.lastname: Papatziamos
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D001623:Betamethasone / Q000008:administration & dosage* / Q000627:therapeutic use*; D020682:Cefixime; D002439:Cefotaxime / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D008297:Male; D001936:Moraxella catarrhalis / Q000302:isolation & purification; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000382:microbiology; D010919:Placebos; D012008:Recurrence; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D010919:Placebos; D020682:Cefixime; D001623:Betamethasone; D002439:Cefotaxime