Comparative efficacy of two anti-bacterial/anti-inflammatory formulations (Auricularum otic powder and Dex-Otic drops) in the medical treatment of otitis externa.
BACKGROUND
Otitis externa (OE) is a common disorder which can cause severe pain and discomfort with discharge and hearing loss. The majority of topical preparations for OE treatment contain a combination of steroids and antibiotics and are administered as ear drops. Otic powder preparations are less common. We found no studies which compared the efficacy of the two dosage forms.


OBJECTIVE
The purpose of the study was to compare the healing process of the external ear canal when treated locally either with otic powder (Auricularum), a preparation containing antibiotic, steroidal and antimycotic components, or with otic drops (Dex-Otic), a commercial ear drop preparation containing antibiotic and steroidal components.


METHODS
The study was designed as an open, randomised, comparative clinical trial. Ambulatory patients suffering from OE were examined by an ear specialist and randomly divided into an otic powder (Auricularum) treatment group and an ear drop (Dex-Otic) treatment group. Each treatment group was treated in accordance with the daily doses recommended by the manufacturers. Patients were treated for a period of 14 days and examined on days 0, 3, 7, 10 and 14. Clinical signs and symptoms recorded were pain, erythema, swelling and discharge.


RESULTS
A total of 67 patients entered the study. The probability of healing within 7 days was 74% in the otic powder group as opposed to 40% in the ear drops group (log rank test, p = 0.0013). The probability of total pain relief after 3 days of treatment was 60% in the otic powder group compared to 53% in the ear drops group (log rank test, p = 0.0001).


CONCLUSIONS
We conclude that treatment with an otic powder (Auricularum) may promote earlier healing and pain relief than does treatment with otic drops (Dex-Otic).
Yaniv
Eitan
E
Hasharon Hospital, Petach Tikva, Israel.
Shevro
Jacob
J
Nageris
Benny
B
Lapidot
Moshe
M
Hadar
Tuvia
T
Cahani
Barbara
B
Zegerman
Chaim
C
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D003907:Dexamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D009761:Nystatin / Q000008:administration & dosage / Q000627:therapeutic use*; D010032:Otitis Externa / Q000188:drug therapy*; D010118:Oxytetracycline / Q000008:administration & dosage / Q000627:therapeutic use*; D011112:Polymyxin B / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; C059464:auricularum; D009761:Nystatin; D003907:Dexamethasone; D011112:Polymyxin B; D010118:Oxytetracycline