(HealthDay News) – For children with acute otitis media with tympanostomy tubes (AOMT), ciprofloxacin plus fluocinolone is more effective than ciprofloxacin or fluocinolone alone, according to a study published online Dec. 22 in JAMA Otolaryngology-Head & Neck Surgery.
Zorik Spektor, MD, from the Center for Pediatric ENT-Head and Neck Surgery in Boynton Beach, FL, and colleagues examined the efficacy and safety of topical ciprofloxacin plus fluocinolone acetonide otic solution relative to cipfloxacin otic solution alone and fluocinolone acetonide otic solution alone for AOMT treatment. Data were included for two twin multicenter randomized trials. The study population included 662 children with AOMT in at least one ear who were randomized to ciprofloxacin plus fluocinolone (223 children), ciprofloxacin alone (221 children), or fluocinolone alone (218 children) for seven days.
The researchers found that the median time to cessation of otorrhea was 4.23 days in patients receiving ciprofloxacin plus fluocinolone, 6.95 days in those receiving ciprofloxacin alone, and not estimable in those receiving fluocinolone alone (P<0.001). At the test-of-cure visit, the clinical cure rate was 80.6, 67.4, and 47.6%, respectively, in the ciprofloxacin plus fluocinolone, ciprofloxacin, and fluocinolone groups, respectively. The corresponding sustained microbiological cure rates were 79.7, 67.7, and 37.6%.
“The combination of ciprofloxacin plus fluocinolone is more effective than treatment with ciprofloxacin or fluocinolone alone for AOMT, and it is safe and well tolerated in children,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Laboratorios SALVAT SA, which sponsored the clinical trials as part of the U.S. Food and Drug Administration approval of ciprofloxacin plus fluocinolone combination for treatment of AOMT.