Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian aboriginal children with recently treated chronic suppurative otitis media - A randomized controlled trial

Background: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. Methods: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscoplic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. Results: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% Cl: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare. Conclusions: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.