Topical treatment of acute otitis externa: clinical comparison of an antibiotics ointment alone or in combination with hydrocortisone acetate.

The study was designed to investigate the potential contribution of hydrocortisone acetate to the efficacy and safety of an antibiotics ointment in the treatment of acute otitis externa (AOE). In a double-blind study 151 patients with a unilateral acute bacterial otitis externa were randomized either to receive an ointment with polymyxin-B sulfate (7,500 I.E./g) + bacitracin (300 I.E./g) alone (AB) or the same antibiotic ointment with 10 mg hydrocortisone acetate/g ointment (AB + HC). Primary efficacy endpoint was the change of an aggregate clinical symptom score (CSS) (subscores: redness, swelling, pain and secretion) found at Visit 2 versus baseline (Visit 1). Secondary outcome parameters were the change of the CSS from Visit 1 to the study termination, and the changes in the subscores and of a visual analog scale for pain. In the group treated with AB + HC, significantly more patients with severe redness [14 (56%) vs. 7 (28%), P = 0.045] or severe secretion [23 (70%) vs. 10 (40%), P = 0.024] at inclusion were symptom-free at the last visit. Fewer pain-relieving tablets (1.1 +/- 2.2 vs. 2.3 +/- 4.6 paracetamol tablets) were used in the AB + HC-group. In the steroid group there was a slightly larger though not significant reduction in CSS at Visit 2 and Visit 3 versus baseline. Similar results were documented for redness, pain and secretion. No serious adverse events occurred. Both ointments are effective and safe in the topical treatment of AOE. Hydrocortisone acetate combined with the antibiotics improved individual symptoms better as did the steroid-free ointment.