Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trialBMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7425.1201 (Published 20 November 2003) Cite this as: BMJ 2003;327:1201
- Frank A M van Balen, general practitioner ()1,
- W Martijn Smit, medical student1,
- Nicolaas P A Zuithoff, statistician1,
- Theo J M Verheij, professor of general practice1
- Correspondence to: F A M van Balen
- Accepted 10 October 2003
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.
Main outcome measures 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.
Contributors FAMvB was responsible for the study design, data collection, statistical analysis, and writing the paper; he will act as guarantor for the paper. WMS was responsible for data collection and assisted in the statistical analysis and writing the paper. NPAZ was responsible for the statistical analysis. TJMV was responsible for the study design, data collection, and writing the paper.
Funding Fund for Common Disorders from Dutch College of General Practitioners and Foundation for the Advancement of Appropiate Drug Usage in the Central Region of the Netherlands. The guarantor accepts full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish
Competing interests None declared
Ethical approval The ethical committee of the University Medical Centre Utrecht approved the study protocol, and all participants gave written informed consent before enrolment.