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


METHODS
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.


METHODS
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.
Couzos
Sophie
S
National Aboriginal Community Controlled Health Organisation, PO Box 168, Deakin, ACT 2600, Australia. scouzos@tpgi.com.au
Lea
Traven
T
Mueller
Reinhold
R
Murray
Richard
R
Culbong
Margaret
M
D000287:Administration, Topical; D000293:Adolescent; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D002939:Ciprofloxacin / Q000008:administration & dosage; D003153:Community Health Services; D003907:Dexamethasone / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005601:Framycetin / Q000008:administration & dosage; D006096:Gramicidin / Q000008:administration & dosage; D006801:Humans; D007223:Infant; D008297:Male; D010035:Otitis Media, Suppurative / Q000188:drug therapy* / Q000473:pathology; D011206:Povidone-Iodine / Q000008:administration & dosage; D011793:Queensland; D016896:Treatment Outcome; D014904:Western Australia; D000095283:Australian Aboriginal and Torres Strait Islander Peoples
D000890:Anti-Infective Agents; D006096:Gramicidin; D005601:Framycetin; D002939:Ciprofloxacin; D003907:Dexamethasone; D011206:Povidone-Iodine