Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy
| Autor: | Serena Preyer, Corinna Engel, Rainer Zimmermann, Jürgen Mertens, Stefan K. Plontke, Hans-Peter Zenner, Assen Koitschev, Andy Weidner, Christoph Meisner, Hubert Löwenheim |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Hearing loss Hearing Loss Sensorineural Placebo-controlled study Salvage therapy Placebo Dexamethasone Catheterization law.invention Placebos Audiometry Double-Blind Method Randomized controlled trial law Multicenter trial medicine Humans Treatment Failure Glucocorticoids Aged business.industry Drug Administration Routes Hearing Loss Sudden Middle Aged Interim analysis medicine.disease Surgery Treatment Outcome Round Window Ear Otorhinolaryngology Anesthesia Female Sensorineural hearing loss medicine.symptom business |
| Zdroj: | The Laryngoscope. 119:359-369 |
| ISSN: | 1531-4995 0023-852X |
| Popis: | Objectives: To study the safety and efficacy of continuous intratympanic dexamethasone-phosphate (Dex-P) for severe to profound sudden idiopathic sensorineural hearing (ISSHL) or sudden idiopathic anacusis after failure of systemic therapy. Study Design: Randomized, double-blind, placebo controlled multicenter trial. Methods: Patients with ISSHL and insufficient recovery (mean 4PTA = 97 dB HL) after systemic high dose glucocorticoid therapy received either Dex-P (4mg/ml) or placebo (NaCl 0.9%) continuously applied for 14 days into the round window niche via a temporarily implanted catheter. For ethical reasons, intratympanic treatment was continued with Dex-P in all patients for another 14 days after the placebo-controlled study period. According to a two-step adaptive study design an interim analysis was performed after inclusion of 23 patients. Results: Intention-to-treat analysis for the primary outcome criterion (4PTA: 0.5-3kHz) during the placebo controlled study period (14 days) showed an average hearing improvement in the treatment group of 13.9 dB (SD: 21.3) and in the placebo group of 5.4 dB (SD: 10.4). This difference in hearing improvement between the two groups (mean: 8.4 dB, SD: 17.0, 95% CI: −7.1–24.1) was statistically not significant (p = .26). Of the secondary outcome parameters, the largest benefit of local salvage therapy was found for maximum speech discrimination with an improvement of 24.4% (SD: 32.0) in the treatment and 4.5% (SD: 7.6) in the placebo group (p = 0.07). After a 3 month follow-up period (i.e. after all patients received intratympanic Dex-P) hearing improvement in the two groups was very similar. No serious adverse events were observed. Sample size calculation after the interim analysis resulted in stopping of the trial. Conclusions: The tendency toward better hearing improvement in the treatment group, the rather conservative inclusion criteria, the limited placebo-controlled observation period and the absence of serious adverse events supports further investigation local inner ear drug delivery as a first or second line treatment option for ISSHL. Laryngoscope, 119:359–369, 2009 |
| Databáze: | OpenAIRE |
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