Antimicrobial therapy for children with adenotonsillar hypertrophy and obstructive sleep apnea: a prospective randomized trial comparing azithromycin vs placebo.
OBJECTIVE: Multiple clinical trials demonstrate the value of administering antibiotics for recurrent tonsillitis. However, there is no consensus as to the role of antibiotics in the management of adenotonsillar hypertrophy and obstructive sleep apnea (OSA). It has been suggested that antibiotics may reduce adenotonsillar size, improve obstructive symptoms, and obviate the need for surgery. The goal of this pilot study was to evaluate the efficacy of a broad-spectrum antibiotic in the management of adenotonsillar hypertrophy and OSA. METHODS: Twenty-two children ages 2 through 12, with evidence of OSA, were enrolled in this double-blinded, prospective clinical trial. Children were randomly assigned into 1 of 2 groups. Group I received azithromycin for a 30-day period (12 mg/kg on days 1-5; the regimen was repeated on days 11-15 and days 21-25). Group II received a placebo administered in the same regimen for a 30-day period. Overnight polysomnography was performed before and within 2 weeks after drug administration. RESULTS: Polysomnographic indices of OSA severity appear to indicate an improvement in the antibiotic as compared to the placebo group, but a comparison of mean +/- standard error for each parameter failed to demonstrate statistical significance using the paired t test. Only 1 of 11 (9%) children had normalization of their polysomnographic parameters. CONCLUSIONS: These results suggest that a course of a broad-spectrum antibiotic may be effective in temporarily improving OSA due to adenotonsillar hypertrophy, but does not appear to obviate the need for surgery.