Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2003 Nov 22;327(7425):1201-5.
doi: 10.1136/bmj.327.7425.1201.

Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trial

Frank A M van Balen  1 , W Martijn Smit, Nicolaas P A Zuithoff, Theo J M Verheij
Affiliations
Clinical Trial

Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trial

Frank A M van Balen et al. BMJ. .

Abstract

Objective: To compare the clinical efficacy of ear drops containing acetic acid, corticosteroid and acetic acid, and steroid and antibiotic in acute otitis externa in primary care.

Design: Randomised controlled trial.

Setting: 79 general practices, Netherlands.

Participants: 213 adults with acute otitis externa.

Primary outcome: duration of symptoms (days) according to patient diaries. Secondary outcome: cure rate according to general practitioner completed questionnaires and recurrence of symptoms between days 21 and 42.

Results: Symptoms lasted for a median of 8.0 days (95% confidence interval 7.0 to 9.0) in the acetic acid group, 7.0 days (5.8 to 8.3) in the steroid and acetic acid group, and 6.0 days (5.1 to 6.9) in the steroid and antibiotic group. The overall cure rates at seven, 14, and 21 days were 38%, 68%, and 75%, respectively. Compared with the acetic acid group, significantly more patients were cured in the steroid and acetic acid group and steroid and antibiotic group at day 14 (odds ratio 2.4, 1.1 to 5.3, and 3.5, 1.6 to 7.7, respectively) and day 21 (5.3, 2.0 to 13.7, and 3.9, 1.7 to 9.1, respectively). Recurrence of symptoms between days 21 and 42 occurred in 29% (50/172) of patients and was seen significantly less in the steroid and acetic acid group (0.3, 0.1 to 0.7) and steroid and antibiotic group (0.4, 0.2 to 1.0) than in the acetic acid group.

Conclusions: Ear drops containing corticosteroids are more effective than acetic acid ear drops in the treatment of acute otitis externa in primary care. Steroid and acetic acid or steroid and antibiotic ear drops are equally effective.

PubMed Disclaimer

Figures

Fig 1
Fig 1
Flow of patients with acute otitis externa through trial of three treatments, with assessment at 7, 14, and 21 days
Fig 2
Fig 2
Kaplan Meier plot for resolution of symptoms of otitis externa in 213 patients treated with ear drops containing acetic acid, steroid and acetic acid, or steroid and antibiotic
See this image and copyright information in PMC

Comment in

References

    1. Rooijackers-Lemmens E, Van Wijngaarden JJ, Opstelten W, Broen A, Romeijnders ACM. NHG-standaard otitis externa. Huisarts Wet 1995;28(6): 265-71.
    1. Rowlands S, Devalia H, Smith C, Hubbard R, Dean A. Otitis externa in UK general practice: a survey using the UK General Practice Research Database. Br J Gen Pract 2001;51: 533-8. - PMC - PubMed
    1. Calderon R, Mood EW. An epidemiological assessment of water quality and `swimmer's ear.' Arch Environ Health 1982;37(5): 300-5. - PubMed
    1. Springer GL, Shapiro ED. Fresh water swimming as a risk factor for otitis externa: a case controlled study. Arch Environ Health 1985;40: 202-6. - PubMed
    1. Van Asperen IA, De Rover CM, Schijven JF, Oetomo SB, Schellekens JF, Van Leeuwen NJ, et al. Risk of otitis externa after swimming in recreational fresh water lakes containing Pseudomonas aeruginosa. BMJ 1995;311: 1407-10. - PMC - PubMed