Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community-based, multicentre, double-blind randomised controlled trial

Sophie Couzos, Traven Lea, Margaret Culbong, Reinhold Mueller and Richard Murray
Med J Aust 2003; 179 (4): 185-190.


Objectives: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone-iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children.

Design and participants: Aboriginal community-controlled, community-based, multicentre, double-blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM.

Main outcome measures: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10–21 days after starting treatment.

Results: 111 children aged 1–14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group (P = 0.009, absolute difference of 24.6% [95% CI, 15.8%–33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%).

Conclusions: Twice-daily ear cleaning and topical ciprofloxacin is effective at community-level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first-line treatment.

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  • Sophie Couzos1
  • Traven Lea2
  • Margaret Culbong3
  • Reinhold Mueller4
  • Richard Murray5

  • 1 National Aboriginal Community Controlled Health Organisation, Deakin, ACT.
  • 2 School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD.
  • 3 Kimberley Aboriginal Medical Services Council, Broome, WA.



NACCHO acknowledges its former Chair, the late Dr Puggy Hunter as the instigator of the trial and thanks its Board of Directors for direction and oversight, and the following Aboriginal Community Controlled Health Services: Geraldton Regional Aboriginal Medical Service, Wirraka Maya Health Service, Kimberley Aboriginal Medical Services Council (Bidyadanga Community Clinic, Yura Yungi Aboriginal Medical Service, Derby Aboriginal Medical Service), Aboriginal and Islander Community Health Service, Brisbane, Goondir Aboriginal and Torres Strait Islander Community Health Service, Townsville Aboriginal and Islander Community Health Service, Cherbourg Health Action Group. Thanks also to the technical consortium for advice on the protocol and training: James Cook University (Professor Ian Ring), Telethon Institute for Child Health Research (Dr Deborah Lehmann, Dr Sandra Eades, Dr Anne Read), Otolaryngologists (Mr Harvey Coates, Mr Francis Lannigan), WA Centre for Pathology and Medical Research (Dr Clay Golledge, Mr Rod Bowman), Australian Hearing (Mr Ian Henderson) and Irene Nannup and the Derbarl Yerrigan Aboriginal Medical Service, Perth WA. The study was supported by: National Health and Medical Research Council, the Commonwealth Department for Education, Training and Youth Affairs, and RioTinto Aboriginal Foundation. Alcon Laboratories Australia Pty Ltd provided the pharmaceuticals.

Competing interests:

None identified.

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