title: Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian aboriginal children with recently treated chronic suppurative otitis media: a randomized controlled trial.
abstract: 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). Otoscopic, 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% CI: -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.
authors.affiliation: Menzies School of Health Research, Darwin, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Leach
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Wood
authors.forename: Edna
authors.initials: E
authors.lastname: Gadil
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Stubbs
authors.forename: Peter
authors.initials: P
authors.lastname: Morris
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001315:Australia; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005601:Framycetin / Q000008:administration & dosage / Q000627:therapeutic use; D006096:Gramicidin / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D010035:Otitis Media, Suppurative / Q000188:drug therapy* / Q000208:ethnology / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D006096:Gramicidin; D005601:Framycetin; D002939:Ciprofloxacin; D003907:Dexamethasone