Efficacy of a topical suspension of bacterial antigens for the management of chronic suppurative otitis media.

Abstract

The aim of this study was to compare the efficacy and safety of a topical suspension of bacterial antigens for the management of chronic suppurative otitis media (CSOM). Two-hundred ten patients with CSOM were enrolled in this study. The patients were divided into two numerically equal groups and randomized to receive a topical suspension of bacterial antigens, Lantigen B (group A), or placebo (group B), according to the following protocol: 5 drops thrice a day for 12 consecutive weeks in the external acoustic duct. The topical suspension of bacterial antigens and placebo were administered by identical, anonymous dispensers in order to maintain double-blind conditions. Before, at the end and 3 months, and after the end of the treatment, all patients who entered in the study underwent pure tone audiometry, microscopic examination of ears, microbiological examination of the ear swab, aural suctioning and subjective assessment of symptoms by visual analog scale. In group A, we saw a statistically significant improvement in the different items measured. A topical suspension of bacterial antigens was significantly more effective than placebo in the treatment of CSOM.

• Authors: Renzo Mora, Francesco Antonio Salzano, Enzo Mora, Luca Guastini
• Journal: European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery (Eur Arch Otorhinolaryngol) Vol. 269 Issue 6 Pg. 1593-7 (Jun 2012) ISSN: 1434-4726 [Electronic] Germany
• PMID: 22037722 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Adjuvants, Immunologic
• Antigens, Bacterial
• Broncho-Vaxom
• Cell Extracts
• Suspensions

Topics

• Adjuvants, Immunologic (administration & dosage, therapeutic use)
• Administration, Topical
• Adult
• Aged
• Aged, 80 and over
• Antigens, Bacterial (administration & dosage, therapeutic use)
• Bacteria (immunology)
• Cell Extracts (administration & dosage, therapeutic use)
• Chronic Disease
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Otitis Media, Suppurative (drug therapy, microbiology)
• Prospective Studies
• Suspensions
• Treatment Outcome