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Randomized Controlled Trial
. 2015 Feb;35(1):39-44.

Efficacy and safety of ofloxacin and its combination with dexamethasone in chronic suppurative otitis media. A randomised, double blind, parallel group, comparative study

A Panchasara  1 , A Singh  2 , D Mandavia  1 , S Jha  2 , C Tripathi  1
Affiliations
Randomized Controlled Trial

Efficacy and safety of ofloxacin and its combination with dexamethasone in chronic suppurative otitis media. A randomised, double blind, parallel group, comparative study

A Panchasara et al. Acta Otorhinolaryngol Ital. 2015 Feb.

Abstract
in English, Italian

The role of corticosteroid in patients of chronic suppurative otitis media (CSOM) is unknown. In the present study, the efficacy and safety of ofloxacin alone (OA) and the ofloxacin + dexamethasone combination (ODC) is compared by studying clinical cure rates and adverse drug reactions in patients with CSOM. After prior permission from the Institutional Review Board and written informed consent from patients, pre-treatment clinical assessment and bacteriology of the middle ear discharge were done. The middle ear was categorised into active, mucoid or inactive according to the type of discharge. Grades of otorrhoea and size of tympanic membrane perforation were noted. CSOM with organisms sensitive to ofloxacin were treated either with OA or ODC eardrops for a period of 15 days. Post-treatment clinical cure (when grade of otorrhoea become 0) was recorded on the 5(th), 10(th) and 15(th) days and bacteriological assessment was recorded at the last visit. All parameters were analysed using Fisher's exact test. A total 110 patients were randomised. The most common microorganism associated with CSOM was Pseudomonas aeruginosa (45.45 %). Clinical improvement was seen in 84.61% and 86.79% of cases, but bacteriological improvement in only 82.69% and 77.35% of cases treated with OA and ODC, respectively. Shift of middle ear discharge from active to inactive was noted in 71.15% and 64.15% patients by the 10th day in the OA and ODC groups, respectively. As there was no difference in clinical or bacteriological improvement, it may be unnecessary to combine steroids with topical antibiotic preparations for management of CSOM.

Il ruolo dei farmaci corticosteroidei nei pazienti affetti da Otite Media Cronica Purulenta (OMCP) è sconosciuto. Nel presente studio sono state confrontate efficacia e sicurezza della terapia con Ofloxacina da sola (OS) con l'associazione di Ofloxacina + Desametasone (ODA), valutando il tasso di guarigione clinica e le reazioni avverse al farmaco in pazienti con OMCP. Previo consenso da parte del Institutional Review Board e adesione dei pazienti allo studio tramite consenso informato scritto, sono state effettuate valutazioni cliniche pre-trattamento ed esame colturale delle secrezioni provenienti dall'orecchio medio. In base alla tipologia di otorrea l'orecchio è stato classificato come attivo, mucoide o inattivo. Sono stati inoltre valutati il grado di otorrea e la dimensione della perforazione timpanica. I pazienti con OMCP in cui i microrganismi identificati risultavano sensibili all'Ofloxacina sono stati trattati in maniera randomizzata o con la sola Ofloxacina o con associazione Ofloxacina + Desametasone in gocce auricolari per 15 giorni. Il tasso di guarigione clinica alla fine del trattamento (ovvero quando il grado di otorrea risultava 0) è stato registrato al 5°, 10° e 15° giorno e in occasione dell'ultima visita è stata eseguito un esame colturale delle secrezioni. Tutti i parametri sono stati analizzati mediante il Test di Fisher. Sono stati reclutati in maniera randomizzata 110 pazienti. Il microrganismo associato più frequentemente al OMCP è risultato Pseudomonas aeruginosa (45,45%). È stato registrato un beneficio clinico in 84,61% dei casi trattati con OS e in 86,79% dei casi trattati con ODA ma la risoluzione dell'infezione all'esame batteriologico si è verificata solo nel 82,69% e nel 77,35% dei pazienti con OS e ODA rispettivamente. Il passaggio della forma attiva a quella inattiva è stato evidenziato al 10° giorno nel 71,15% e 64,15% dei pazienti trattati rispettivamente con OS e ODA. Dal momento che non è stata dimostrata nessuna differenza nel beneficio clinico e microbiologico, la combinazione di antibiotici topici e steroidi risulta sconsigliata nella terapia del OMCP.

Keywords: Antimicrobial agents; Chronic suppurative otitis media; Ofloxacin; Ofloxacin + dexamethasone.

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Figures

Fig. 1.
Fig. 1.
CONSORT statement.
Fig. 2.
Fig. 2.
Comparison of subjective assessment of active discharge. Subjective assessment of active discharge at day 0 compared with day 5, day 10 and day 15 in both groups.
See this image and copyright information in PMC

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