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

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Abstract

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.

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Acknowledgment

The authors gratefully acknowledge Dr. Thomas McDonald’s continuous scientific support of this project. We thank Dr. Irmtrud Pelzer for her valuable contributions in designing and conducting this study, and Mrs. Gena Kittel for proofreading the manuscript. The following ENT specialists participated in this study: Dr. med. Rüdiger Gering (Willich), Dr. med. Dieter Leithäuser (Warburg), Dr. med. Alfred Nachtsheim (Aachen), Dr. med. Norbert Pasch (Aachen), Dr. med. Anke Prasch-Beginen (Viersen), Ralf Sählbrandt (Duisburg), Dr. med. Wilhelm Schütz (Jülich), Dr. med. Martin Sondermann (Aachen), Dr. med. Joachim Spaeth (Düren), Dr. med. Tatjana von Stackelberg (Düsseldorf), Dr. med. Gerd Aretz (Mönchengladbach).

Financial disclosure

The corresponding author (RM) and the statistician (JL) have served as scientific advisors for the pharmaceutical company of the marketed product described in this publication. (The corresponding author has been a scientific advisor to the pharmaceutical company marketing the investigated product.)

Funding/support

This study was funded by an unrestricted research grant from Alcon® Pharma Germany GmbH.

Role of sponsor

The sponsor has taken no influence on the performance of this clinical trial. All data were collected and analyzed by an independent CRO. This manuscript has been written by the authors.

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Authors and Affiliations

  1. Institute of Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany

    Ralph Mösges & Christian M. Domröse

  2. Medicomp GmbH, 82152, Planegg-Martinsried, Germany

    Jürgen Löffler

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  1. Ralph Mösges
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  2. Christian M. Domröse
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  3. Jürgen Löffler
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Correspondence to Ralph Mösges.

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Mösges, R., Domröse, C.M. & Löffler, J. Topical treatment of acute otitis externa: clinical comparison of an antibiotics ointment alone or in combination with hydrocortisone acetate. Eur Arch Otorhinolaryngol 264, 1087–1094 (2007). https://doi.org/10.1007/s00405-007-0314-0

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  • DOI: https://doi.org/10.1007/s00405-007-0314-0

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