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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

  • R Gürkov (a1), L B Filipe Mingas (a1), T Rader (a2), J Louza (a1), B Olzowy (a1) and E Krause (a1)...

Abstract

Objective:

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.

Methods:

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).

Results:

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).

Conclusion:

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.

Copyright

Corresponding author

Address for correspondence: Dr Robert Gürkov, Dept of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany Fax: +49 89 70956869 E-mail: Robert.Guerkov@med.uni-muenchen.de

References

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