SINGLE-DOSE OF BETAMETHASONE IN COMBINED MEDICAL-TREATMENT OF SECRETORY OTITIS-MEDIA

With the objective of evaluating the efficacy of cefixime and the comb ination of cefixime and betamethasone in the treatment of secretory ot itis media (SOM), we enrolled 142 children 2 to 12 years old in a rand omized, double-blind, placebo-controlled study. All children suffered from SOM, verified by otomicroscopy and tympanometry, of at least 3 mo nths' duration. Active treatment was a 10-day course of cefixime with and without a single dose of 6 mg betamethasone. One hundred forty chi ldren were available for efficacy evaluation 14 to 23 days after the s tart of treatment. A statistically significant treatment effect was fo und in the group treated with cefixime plus betamethasone (n = 59), wi th a 44.1% cure rate as compared to 19.7% in the cefixime-treated grou p (n = 61; p<.005) and 5% in the placebo group (n = 20; p<.005). Relap se rates were high and no statistically significant differences betwee n groups remained at last valid visit. Adverse events possibly or prob ably associated with active treatment were reported in 11 cases (9.2%) . One patient reported a severe adverse event. No serious events occur red. The study did not show any significant long-term effect of cefixi me treatment or any long-term treatment benefit with the addition of b etamethasone to the antibiotic.