Dexamethasone phosphate in antibiotic ear drops for the treatment of acute bacterial otitis externa.
OBJECTIVE
To compare the efficacy and safety of polymyxin sulfate 7500 IU/neomycin sulfate 3500 IU/dexamethasone phosphate 0.1% (PN+Dx) otic solution with polymyxin sulfate 7500 IU/neomycin sulfate 3500 IU (PN-Dx) in patients with acute bacterial otitis externa (AOE), in order to determine the possible benefit of the addition of dexamethasone.


METHODS
Active controlled, double-blind, randomized, parallel group, multi-center clinical trial in ear, nose, and throat (ENT) specialist practices with a planned interim analysis for sample size adaptation. In total, 338 patients aged 18-76 who had a previous episode of otitis externa within the last year were randomized to receive 10 +/- 2 days of treatment with two drops, three times daily, of either PN+Dx or PN-Dx.


METHODS
Change in the clinical symptom score (consisting of the subscores redness, swelling, pain, and secretion) and of the visual analogue scale (VAS) rating for pain from Visit 1 (Day 1) to Visit 2 (Day 4 +/- 1), patient's assessment of efficacy at Visit 3 (Day 10 +/- 2), and the frequency and type of adverse events.


RESULTS
There was a significantly greater reduction of swelling from Visit 1 to Visit 2 with PN+Dx, and more patients rated the efficacy of PN+Dx as 'very good' or 'good' at Visit 3 (p = 0.03). There was also a significantly greater decrease in the clinical symptom score from Visit 1 to Visit 2 in the PN+Dx group in patients who had at least a moderately severe symptom score with more than seven points at Visit 1 (p = 0.01) and in patients suffering from their current episode of otitis externa for more than 2 days (p = 0.02). In total, 14 adverse events were reported during the study period with no related adverse drug reactions for PN+Dx.


CONCLUSIONS
The addition of dexamethasone phosphate to polymyxin B/neomycin significantly reduces swelling in patients with AOE and leads to significantly higher patient's ratings of treatment efficacy. It especially leads to an overall reduction of symptoms in cases of moderately or more severe otitis externa and cases lasting for more than 2 days.
Mösges
Ralph
R
Institute of Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Germany. Ralph@Moesges.de
Schröder
Timo
T
Baues
Christian M
CM
Sahin
Kurtuluş
K
D000208:Acute Disease; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004333:Drug Administration Routes; D004423:Ear; D006801:Humans; D010032:Otitis Externa / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D003907:Dexamethasone