Hostname: page-component-586b7cd67f-t7fkt Total loading time: 0 Render date: 2024-11-28T02:18:55.673Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  27 February 2012

R Gürkov ,
L B Filipe Mingas ,
T Rader ,
J Louza ,
B Olzowy  and
E Krause
R Gürkov*
Affiliation:
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University of Munich, Germany
L B Filipe Mingas
Affiliation:
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University of Munich, Germany
T Rader
Affiliation:
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Johann Wolfgang Goethe University of Frankfurt, Germany
J Louza
Affiliation:
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University of Munich, Germany
B Olzowy
Affiliation:
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University of Munich, Germany
E Krause
Affiliation:
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University of Munich, Germany
*
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: [email protected]
Get access Rights & Permissions [Opens in a new window]

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.

Keywords

Menière's DiseasePressure TherapyBetahistineVertigo
Type
Main Articles
Information
The Journal of Laryngology & Otology , Volume 126 , Issue 4 , April 2012 , pp. 356 - 362
Copyright
Copyright © JLO (1984) Limited 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1Thorp, MA, Shehab, ZP, Bance, ML, Rutka, JA. Does evidence-based medicine exist in the treatment of Meniere's disease? A critical review of the last decade of publications. Clin Otolaryngol 2000;25:456–60CrossRefGoogle ScholarPubMed
2Tjernstrom, O. Effects of middle-ear pressure on the inner ear. Acta Otolaryngol 1977;83:11–15CrossRefGoogle ScholarPubMed
3Densert, B, Densert, O, Erlandsson, B, Sheppard, H. Transmission of complex pressure waves through the perilymphatic fluid in cats. Acta Otolaryngol 1986;102:403–9CrossRefGoogle ScholarPubMed
4Gates, GA, Green, JD, Tucci, DL, Telian, SA. The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease. Arch Otolaryngol Head Neck Surg 2004;130:718–25CrossRefGoogle ScholarPubMed
5Kim, HH, Wiet, RJ, Battista, RA. Trends in the diagnosis and the management of Meniere's disease: results of a survey. Otolaryngol Head Neck Surg 2005;132:722–6CrossRefGoogle ScholarPubMed
6Plontke, SK. Recent aspects in Meniere's disease [in German]. HNO 2007;55:12–14CrossRefGoogle ScholarPubMed
7Westhofen, M. Meniere's disease: evidence and controversies [in German]. HNO 2009;57:446–54CrossRefGoogle ScholarPubMed
8Zapala, DA, Sholt, KF, Lundy, LB. A comparison of water and air caloric responses and their ability to distinguish between patients with normal and impaired ears. Ear Hear 2008;29:585–600CrossRefGoogle ScholarPubMed
9Densert, B, Densert, O, Arlinger, S, Sass, K, Odkvist, L. Immediate effects of middle ear pressure changes on the electrocochleographic recordings in patients with Meniere's disease: a clinical placebo-controlled study. Am J Otol 1997;18:726–33Google ScholarPubMed
10Odkvist, LM, Arlinger, S, Billermark, E, Densert, B, Lindholm, S, Wallqvist, J. Effects of middle ear pressure changes on clinical symptoms in patients with Meniere's disease – a clinical multicentre placebo-controlled study. Acta Otolaryngol Suppl 2000;543:99–101CrossRefGoogle ScholarPubMed
11Thomsen, J, Sass, K, Odkvist, T, Arlinger, S. Local overpressure treatment reduces vestibular symptoms in patients with Meniere's disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol 2005;26:68–73CrossRefGoogle ScholarPubMed