Single dose of betamethasone in combined medical treatment of secretory otitis media.
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.
Hemlin
C
C
Department of Otorhinolaryngology, Karolinska Hospital, Stockholm, Sweden.
Carenfelt
C
C
Papatziamos
G
G
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
D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D010919:Placebos; D020682:Cefixime; D001623:Betamethasone; D002439:Cefotaxime