Combination treatment for swimmer's ear safe, efficacious
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Combining the corticosteroid fluocinolone acetonide with ciprofloxacin was safe and efficacious in treating swimmer’s ear, although it was not superior to treatment with either agent alone, according to a study published in JAMA Network Open.
Current clinical guidelines for uncomplicated acute otitis externa (AOE) — a condition also known as “swimmer’s ear” — recommend topical antibiotics, which typically include fluoroquinolones like ciprofloxacin and ofloxacin or aminoglycosides such as neomycin and gentamicin, with cure rates that range from 65% to 90%, Laurence Chu, MD, CPI, FACS, chief medical officer and certified principal investigator at Benchmark Research, and colleagues wrote. Topical antibiotics are usually “the preferred first-line treatment” because they demonstrate a low risk for adverse events, minimize the development of antibiotic resistance and because “they can reach high local concentrations in the affected area,” the researchers added.
Previous research has shown that the combination of ciprofloxacin plus fluocinolone acetonide was superior to ciprofloxacin alone for diffuse otitis externa, and superior to ciprofloxacin or fluocinolone acetonide alone for children with acute otitis media with tympanostomy, according to Chu and colleagues. In AOE, the researchers wrote that adding fluocinolone acetonide to the recommended ototopical treatment “is believed to enhance the resolution of the inflammatory response and improve associated symptoms.”
For the current study, Chu and colleagues evaluated the superiority of combination treatment vs. monotherapy for AOE. The randomized, double-blind clinical trial included 467 patients, who were assigned to either ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%; ciprofloxacin alone; or fluocinolone alone twice daily for 7 days.
The patients were assessed during four visits. The first was a baseline; the second was a telephone visit, in which patients reported AOE symptoms; the third was at the end of treatment; and the final was the test of cure, which took place on days 15 to 17. During the third and fourth visits, the researchers assessed vital signs and clinical response to treatment. If ear discharge was present, the researchers collected a sample for microbiological evaluation. The primary outcome was therapeutic cure at the end of the treatment period.
At visit three — the end of treatment visit — Chu and colleagues reported that the therapeutic cure rate in the modified intent-to-treat population was 61.2% in the ciprofloxacin plus fluocinolone group, which was statistically comparable to that of the ciprofloxacin alone group (53.8%; difference in response rate = 7.3%; 95% CI, –6.6 to 21.2) and fluocinolone alone group (44.4%; difference in response rate = 16.7%; 95% CI, –0.6 to 34).
At visit four, ciprofloxacin plus fluocinolone was significantly superior to ciprofloxacin (87.4% vs. 75.8%; difference in response rate = 11.6%; 95% CI, 0.7-22.4), according to the researchers.
When evaluating other outcomes, Chu and colleagues found that the combination regimen was associated with a statistically faster resolution of otalgia (median, 5 days) when compared with fluocinolone alone (median, 7.7 days) and ciprofloxacin alone (median, 5.9 days). It also demonstrated superiority in sustained microbiological response when compared with fluocinolone alone (91.3% vs. 75.6%; difference in response rate = 15.7%; 95% CI, 2-29.4) and ciprofloxacin alone (81.3%; difference in response rate = 9.9%; 95% CI, 0.3-19.6).
In addition, the combination was superior when it came to the microbiological outcome vs. fluocinolone at visit three (96.1% vs. 82.2%; difference in response rate = 13.9%; 95% CI, 2.1%-25.7%) and ciprofloxacin at visit four (94.2% vs. 84.6%; difference in response rate = 9.6%; 95% CI, 0.9-18.2).
Although the researchers concluded that the ciprofloxacin and fluocinolone combination did not demonstrate superiority vs. either agent alone for the primary outcome of therapeutic cure, they noted that “the findings suggest the benefits of combining the antibiotic ciprofloxacin and the corticosteroid fluocinolone acetonide to better manage patients with AOE, with regard to both the bacterial infection and the typical disease signs and symptoms.”
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