Effects of Middle Ear Pressure Changes on Clinical Symptoms in Patients with Ménière's Disease - a Clinical Multicentre Placebo-controlled Study

Abstract

O 8 dkvist LM, Arlinger S, Billermark E, Densert B, Lindholm S, Wallqvist J. Effects of middle ear pressure changes on clinical symptoms in patients with Ménière's disease-a clinical multicentre placebo-controlled study. Acta Otolaryngol 2000; Suppl 543: 99 -101.Different medical and surgical methods have been tried in attempting to reduce endolymphatic pressure in Ménière's disease. Pressure treatment has a role on the treatment staircase, after pharmacological treatment and before destructive methods. Pressure chamber treatment has shown that some patients respond well to the treatment with diminishing inner ear symptoms and also some hearing improvement. Earlier studies have shown that electrocochlear measurements improve after local pressure treatment in the ear. The present study was a prospective randomized placebo controlled, multicentre clinical trial. 56 patients with active Ménière's disease, age 20 -65 years, with a hearing loss of 20 -65 dB PTA participated. A total of 31 patients completed 2 weeks use with an active apparatus (Meniett) and 25 patients completed the 2 weeks with the placebo gadget. Both machines were produced by Pascal Medical, Halmstad, Sweden. Two weeks before the start of treatment a grommet was placed in the tympanic membrane. A significant improvement concerning frequency and intensity of vertigo, dizziness, aural pressure and tinnitus was reported by the active group on the visual analogue scales (VAS) questionnaire. In the placebo group no change was the most common finding, followed by worsening of the symptoms and a few improvements. The function in professional and family life improved during active treatment and did not during placebo treatment. Pure-tone audiometry did not improve after placebo treatment, but improved at the frequencies 500 Hz and 1,000 Hz after active treatment. The study showed an improvement in the inner ear symptoms after Meniett treatment. The mechanism may be explained by the influence on the round window membrane pressure receptors or an endolymphatic flow out through the pressure release points, such as the endolymphatic duct and sac, thus activating the longitudinal flow. Other mechanisms are also possible.

The Effects of Transtympanic Micropressure Treatment in People With Unilateral Ménière's Disease

“…This study confirms and extends (from 2 weeks to 4 months) the findings of Odkvist et al 10 regarding the beneficial effect of the Meniett device on vertigo control and functionality. However, we did not observe a comparable beneficial effect on hearing.…”

“…Because we have documented a significant reduction in definitive vertigo and days lost from work in the 4-month study, we are continuing to monitor participants' unblinded outcomes for a full 2 years. Of note, the 2-year results reported by Densert and Sass 11 of the subjects in the Odkvist et al 10 Guidelines for reporting the unblinded, uncontrolled clinical results of surgical therapy for Ménière's disease have been established. 12 These guidelines are based on a comparison of recalled overall vertigo severity before and 2 years after an operation.…”

Responses of the endolymphatic sac to perilymphatic injections and withdrawals: evidence for the presence of a one-way valve

“…These studies led to the development of a portable device with similar characteristics, the Meniett (Medtronic Xomed, Jacksonville, FL), which is currently being used to treat patients with MeniereÕs disease. Initial clinical trials with the device have been encouraging (Odkvist et al, 2000;Gates and Green, 2002), although some of the improvements may be related to the tympanostomy tube which alone appears to have beneficial effects (Montandon et al, 1989;Barbara et al, 2001). The underlying mechanisms by which the Meniett influences patientÕs symptoms have not been established.…”

Die transtympanale Applikation von Gentamicin bei Morbus Meni�re?weniger ist mehr!?

“…Die funktionserhaltenden Verfahren beinhalten die Saccus-Chirurgie mit allen ihren Variationen, die Tenotomie, die Einlage von Paukendrainage und neuerdings die damit verbundene Wechseldrucktherapie mit einem speziell dafür entwickeltem Gerät (Meniett ® ; [20,36]). Die beiden Gruppen unterscheiden sich wesentlich im Risiko der Nebenwirkung einer Hörschädi-gung.…”

“…Das Risiko einer ototoxischen Gehörschädi-gung ist minimal jedoch nicht gänzlich auszuschließen.Als Alternativen stehen die Einlage eines Paukenröhrchens und möglicherweise die anschließende gepulste Druckbehandlung, wie von Ödk-vist et al publiziert[20], zur Verfügung. Über den Wert der Tenotomie des M. tensor tympani und des M. stapedius kann heute nur spekuliert werden[10].…”