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Ciprofloxacin plus fluocinolone acetonide versus ciprofloxacin alone in the treatment of diffuse otitis externa

Published online by Cambridge University Press:  07 July 2014

J Lorente ,
F Sabater ,
M P Rivas ,
J Fuste ,
J Risco  and
M Gómez
J Lorente*
Affiliation:
Servicio de Otorrinolaringología (ORL), Hospital Vall d'Hebron, Barcelona, Spain
F Sabater
Affiliation:
Servicio ORL, Hospital Clínic i Provincial, Barcelona, Spain
M P Rivas
Affiliation:
Servicio ORL, Hospital de Viladecans, Spain
J Fuste
Affiliation:
CAP Poble Nou, Barcelona, Spain
J Risco
Affiliation:
Servicio ORL, Hospital Universitari Juan XXIII, Tarragona, Spain
M Gómez
Affiliation:
Servicio ORL, Hospital de Poniente, El Ejido, Almería, Spain
*
Address for correspondence: Dr Juan Lorente Guerrero, Servicio ORL, Hospital Vall d'Hebron, Passeig de la Vall d'Hebron, 119–129, 08035 Barcelona, Spain E-mail: [email protected]
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Abstract

Objective:

We aimed to evaluate the clinical efficacy of ciprofloxacin plus fluocinolone acetonide (antibiotic plus corticosteroid) ear drops compared to ciprofloxacin (antibiotic) ear drops in diffuse otitis externa.

Methods:

This was a multicentre, randomised, parallel-group, double-blind study involving 590 patients of both sexes aged 7 years or older.

Results:

The rate of clinical cure was higher (p = 0.01) with ciprofloxacin plus fluocinolone acetonide than with ciprofloxacin alone. The mean total symptom score was lower with ciprofloxacin plus fluocinolone acetonide (p = 0.005). No differences were found in the percentage of patients reporting resolution of otalgia between patients receiving ciprofloxacin plus fluocinolone acetonide and patients receiving only ciprofloxacin. Resolution of oedema and otorrhoea (p = 0.003 and p = 0.002, respectively) was higher with ciprofloxacin plus fluocinolone acetonide, as was eradication or presumed eradication (p = 0.003). There were eight mild adverse events, three with the ciprofloxacin plus fluocinolone acetonide combination (not related to the treatment) and five when ciprofloxacin was administered alone (directly related to the treatment).

Conclusions:

Ciprofloxacin plus fluocinolone acetonide is a more effective treatment for diffuse otitis externa than ciprofloxacin alone. The ciprofloxacin plus fluocinolone acetonide combination also has an excellent safety profile.

Keywords

Ear, ExternalFluocinolone AcetonideCiprofloxacinAdministration, Topical
Type
Main Articles
Information
The Journal of Laryngology & Otology , Volume 128 , Issue 7 , July 2014 , pp. 591 - 598
Copyright
Copyright © JLO (1984) Limited 2014 

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