Topical quinolone vs. antiseptic for treating chronic suppurative otitis media: a randomized controlled trial.
OBJECTIVE
To compare a topical quinolone antibiotic (ciprofloxacin) with a cheaper topical antiseptic (boric acid) for treating chronic suppurative otitis media in children.


METHODS
Randomized controlled trial.


METHODS
A total of 427 children with chronic suppurative otitis media enrolled from 141 schools following screening of 39 841 schoolchildren in Kenya. Intervention Topical ciprofloxacin (n = 216) or boric acid in alcohol (n = 211); child-to-child treatment twice daily for 2 weeks.


METHODS
Resolution of discharge (at 2 weeks for primary outcome), healing of the tympanic membrane, and change in hearing threshold from baseline, all at 2 and 4 weeks.


RESULTS
At 2 weeks, discharge was resolved in 123 of 207 (59%) children given ciprofloxacin, and in 65 of 204 (32%) given boric acid (relative risk 1.86; 95% CI 1.48-2.35; P < 0.0001). This effect was also significant at 4 weeks, and ciprofloxacin was associated with better hearing at both visits. No difference with respect to tympanic membrane healing was detected. There were significantly fewer adverse events of ear pain, irritation, and bleeding on mopping with ciprofloxacin than boric acid.


CONCLUSIONS
Ciprofloxacin performed better than boric acid and alcohol for treating chronic suppurative otitis media in children in Kenya.
Macfadyen
Carolyn
C
International Health Research Group, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK. cmacfadyenuk@yahoo.co.uk
Gamble
Carrol
C
Garner
Paul
P
Macharia
Isaac
I
Mackenzie
Ian
I
Mugwe
Peter
P
Oburra
Herbert
H
Otwombe
Kennedy
K
Taylor
Stephen
S
Williamson
Paula
P
D000293:Adolescent; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D001888:Boric Acids / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D002939:Ciprofloxacin / Q000627:therapeutic use*; D003906:Developing Countries; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006311:Hearing Disorders / Q000209:etiology; D006801:Humans; D007630:Kenya; D008297:Male; D010035:Otitis Media, Suppurative / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D000891:Anti-Infective Agents, Local; D001888:Boric Acids; D002939:Ciprofloxacin; C032688:boric acid