36329
document
Dexamethasone phosphate in antibiotic ear drops for the treatment of acute bacterial otitis externa . OBJECTIVES 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 . RESEARCH DESIGN AND 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 . MAIN OUTCOME MEASURES 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 .
36330
Intervention_Pharmacological
Dexamethasone phosphate
36331
Intervention_Pharmacological
antibiotic ear drops
36332
Intervention_Pharmacological
polymyxin sulfate 7500 IU/neomycin sulfate 3500 IU/dexamethasone phosphate 0.1 % ( PN+Dx ) otic solution
36333
Intervention_Pharmacological
polymyxin sulfate 7500 IU/neomycin sulfate 3500 IU ( PN-Dx )
36334
Intervention_Pharmacological
PN+Dx
36335
Intervention_Control
PN-Dx
36336
Intervention_Pharmacological
dexamethasone phosphate
36337
Intervention_Pharmacological
polymyxin B/neomycin
36338
Outcome_Physical
Change in the clinical symptom score ( consisting of the subscores redness , swelling , pain , and secretion )
36339
Outcome_Physical
visual analogue scale ( VAS )
36340
Outcome_Pain
rating for pain
36341
Outcome_Other
patient 's assessment of efficacy
36342
Outcome_Adverse-effects
frequency and type of adverse events
36343
Outcome_Physical
swelling
36344
Outcome_Other
efficacy
36345
Outcome_Physical
clinical symptom score
36346
Outcome_Physical
severe symptom score
36347
Outcome_Adverse-effects
adverse drug reactions
36348
Participant_Condition
acute bacterial otitis externa
36349
Participant_Condition
patients with acute bacterial otitis externa ( AOE )
36350
Participant_Condition
multi-center clinical trial in ear , nose , and throat ( ENT ) specialist practices
36351
Participant_Sample-size
338
36352
Participant_Age
aged 18-76
36353
Participant_Condition
episode of otitis externa
36354
Participant_Condition
patients with AOE