US EPA

3041055 

Technical Report 

Effective treatment of acute, diffuse otitis externa. 2. Controlled comparison of hydrocortisone-acetic acid, nonaqueous and hydrocortisone-neomycin-colistin otic solutions 

Kime, CE; Ordonez, GE; Updegraff, WR; Glassman, JM; Soyka, JP 

1978 

IPA/78/312209 

Ther 

Suppl 

English 

IPA COPYRIGHT: ASHP Eighty-three patients (92 infected ears), age 6 to 73 yr with 92 episodes of acute, diffuse otitis externa associated with bacterial pathogens and/or fungi complicated by inflammation were studied in a multi-investigator trial in which treatment was randomized and double blind using either a nonantibiotic otic solution (VoSol-HC; hydrocortisone-acetic acid, non-aqueous, propylene glycol, benzethonium chloride; I) or an antibiotic otic suspension, Coly-Mycin S (hydrocortisone-neomycin-colistin; II), for 11 days. Almost all had either pain and/or pruritus, or edema and erythema; and 86% had all 5 signs and symptoms of otitis externa (edema, discharge, pain, pruritus and erythema) of moderate to severe intensity. At the end of the therapeutic period, the overall mean clinical cure rates (symptom free) were 91% for I and 86% for II. Investigators' global evaluations rated both medications at 95% effective (ears cured or markedly improved). Microbial evaluations of ear material with identification of isolates were performed pretreatment, at 4 days, and posttreatment. Pseudomonas was the most frequent pathogen isolated, either alone or in combination with other pathogens or fungi. Both medications were effective in reducing pretreatment microbial populations by 94%. Both otic preparations effected an 88% microbial cure rate (no growth or absence of pathogens on culture) posttreatment but I had a higher microbial cure rate (71%) than II (49%) after 4 days. Since both preparations achieve equivalent clinical and microbial cure rates, choice of a nonantibiotic or an antibiotic topical otic preparation can be made on considerations other than efficacy.