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Effect of transtympanic low-pressure therapy in patients with unilateral Menière's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial.

TitleEffect of transtympanic low-pressure therapy in patients with unilateral Menière's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial.
Publication TypeJournal Article
Year of Publication2012
AuthorsGürkov R, Mingas LBFilipe, Rader T, Louza J, Olzowy B, Krause E
JournalJ Laryngol Otol
Volume126
Issue4
Pagination356-62
Date Published2012 Apr
ISSN1748-5460
KeywordsAdult, Aged, Aged, 80 and over, Audiometry, Pure-Tone, Betahistine, Caloric Tests, Double-Blind Method, Ear Canal, Equipment Design, Female, Histamine Agonists, Humans, Male, Medical Records, Meniere Disease, Middle Aged, Otolaryngology, Placebos, Pressure, Semicircular Canals, Severity of Illness Index, Treatment Failure, Treatment Outcome, Vertigo, Young Adult
Abstract

<p><b>OBJECTIVE: </b>To determine the effect of the Meniett low-pressure generator on the subjective symptoms and audiovestibular disease markers of patients with unilateral Menière's disease unresponsive to betahistine treatment.</p><p><b>METHODS: </b>Randomised, placebo-controlled, double-blinded, clinical trial at a tertiary referral centre. After ventilation tube placement, patients were randomised to the active treatment or placebo group. Monitoring comprised audiometry and air caloric testing and a vertigo diary (enabling calculation of vertigo and activity scores, and the number of vertigo days, vertigo-free days and sick days).</p><p><b>RESULTS: </b>Sixty-eight patients completed the study. For the active treatment versus placebo group, the following pre- and post-treatment values, and significances for treatment effect comparisons, were respectively seen: cumulative vertigo scores, 22.47 and 15.97 vs 20.42 and 19.23 (p = 0.048); vertigo days, 6.5 and 4.08 vs 5.94 and 5.52 (p = 0.102); sick days, 3.08 and 0.78 vs 2.87 and 3.45 (p = 0.041); vertigo-free days, 14.47 and 17.61 vs 15.48 and 17.58 (p = 0.362); activity score, 23.61 and 13.42 vs 24.68 and 20.23 (p = 0.078); low-tone hearing threshold, 49.15 and 53.18 dB nHL vs 41.66 and 46.10 dB nHL (p > 0.05); and slow phase velocity in response to caloric stimulation, 18.86 and 18.72 °/second vs 14.97 and 15.95 °/second, (p > 0.05).</p><p><b>CONCLUSION: </b>Use of the Meniett low-pressure generator improved patients' vertigo but not their hearing or vestibular function. This safe, minimally invasive treatment is recommended as second-line treatment for unilateral Menière's disease.</p>

DOI10.1017/S0022215112000102
Alternate JournalJ Laryngol Otol
Citation KeyCK33
PubMed ID22365373