Positive pressure therapy for Ménière’s disease

Webster, Katie E; George, Ben; Galbraith, Kevin; Harrington-Benton, Natasha A; Judd, Owen; Kaski, Diego; Maarsingh, Otto R; MacKeith, Samuel; Ray, Jaydip; Vugt, Vincent A Van; Burton, Martin J

doi:10.1002/14651858.cd015248.pub2

Cited by 3 publications

(2 citation statements)

References 50 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…c) There is insufficient evidence for the effectiveness of many other measures that have been recommended, such as life-style changes, e.g., low salt diet ( 19 ), diuretics ( 4 ), pulsed low-pressure delivery ( 20 ), surgical interventions ( 21 ), intratympanic steroids ( 22 ), and intratympanic gentamicin ( 23 ). All in all, there is very limited evidence for the efficacy of any prophylactic therapy in MD that does not impair vestibular function.…”

Section: Discussionmentioning

confidence: 99%

Examination of betahistine bioavailability in combination with the monoamine oxidase B inhibitor, selegiline, in humans—a non-randomized, single-sequence, two-period titration, open label single-center phase 1 study (PK-BeST)

Strupp,

Churchill,

Naumann

et al. 2023

Front. Neurol.

View full text Add to dashboard Cite

BackgroundBetahistine was registered in Europe in the 1970s and approved in more than 80 countries as a first-line treatment for Menière's disease. It has been administered to more than 150 million patients. However, according to a Cochrane systematic review of betahistine and recent meta-analyses, there is insufficient evidence to say whether betahistine has any effect in the currently approved dosages of up to 48 mg/d. A combination with the monoamine oxidase B (MAO-B) inhibitor, selegiline, may increase the bioavailability of betahistine to levels similar to the well-established combination of L-DOPA with carbidopa or benserazide in the treatment of Parkinson's disease. We investigated the effect of selegiline on betahistine pharmacokinetics and the safety of the combination in humans.MethodsIn an investigator-initiated prospective, non-randomized, single-sequence, two-period titration, open label single-center phase 1 study, 15 healthy volunteers received three single oral dosages of betahistine (24, 48, and 96 mg in this sequence with at least 2 days' washout period) without and with selegiline (5 mg/d with a loading period of 7 days). Betahistine serum concentrations were measured over a period of 240 min at eight time points (area under the curve, AUC0-240 min). This trial is registered with EudraCT (2019-002610-39) and ClinicalTrials.gov.FindingsIn all three single betahistine dosages, selegiline increased the betahistine bioavailability about 80- to 100-fold. For instance, the mean (±SD) of the area under curve for betahistine 48 mg alone was 0.64 (+/-0.47) h*ng/mL and for betahistine plus selegiline 53.28 (+/-37.49) h*ng/mL. The half-life time of around 30 min was largely unaffected, except for the 24 mg betahistine dosage. In total, 14 mild adverse events were documented.InterpretationThis phase 1 trial shows that the MAO-B inhibitor selegiline increases betahistine bioavailability by a factor of about 80 to 100. No safety concerns were detected. Whether the increased bioavailability has an impact on the preventive treatment of Menière's disease, acute vestibular syndrome, or post-BPPV residual dizziness has to be evaluated in placebo-controlled trials.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT05938517?intr=betahistine%20and%20selegiline&rank=1, identifier: NCT05938517.

show abstract

Section: Discussionmentioning

confidence: 99%

Examination of betahistine bioavailability in combination with the monoamine oxidase B inhibitor, selegiline, in humans—a non-randomized, single-sequence, two-period titration, open label single-center phase 1 study (PK-BeST)

Strupp,

Churchill,

Naumann

et al. 2023

Front. Neurol.

View full text Add to dashboard Cite

show abstract

“…The air pressure pulses appear to act on endolymph fluid to prevent dizziness [61]. However, this treatment has been recently claimed to be very uncertain [62].…”

Section: Treatment Of Ménière's Diseasementioning

confidence: 99%

Mushrooms as Functional Foods for Ménière’s Disease

Bell,

Fernandes

2023

Applied Sciences

View full text Add to dashboard Cite

Food, not nutrients, is the fundamental unit in nutrition, and edible mushrooms are fungi that supply unique biological bioactive compounds, different from plant or animal origin, which significantly impact human health status. However, to date all these concepts are interpreted in different ways, with rapidly increasing knowledge on nutrition, medicine, molecular biology, and plant biotechnology changing the concepts of food, health, and agriculture. The bioactive elements conveyed by foodstuffs as nutrients or non-nutrients interfere with human metabolism and have influence on health, aging, and well-being. The influence of edible mushrooms on medicinal interventions has been known and studied for many years and their latest role in neurodegenerative disorders has been recently investigated, while their significance on many other diseases has been well demonstrated. Despite considerable research, the etiology and pathogenesis of Ménière’s disease remains controversial and undefined, although usually associated with allergic, genetic, or trauma sources, and with viral infections and/or immune system-mediated mechanisms. With treatment still unknown, our attention is towards the eventual impact of complementary dietary interventions, synthesizing the recent knowledge of some edible mushrooms and preparations on Ménière’s disease, which is a lifelong condition that can develop at any age, but most commonly emerges between 40 and 60 years of age. It is demonstrated that the oral administration of a biomass preparation, with 3 g/day of the mushroom Coriolus versicolor for 2 to 6 months, on some 40 human Ménière’s disease patients reduced systemic oxidative stress and cellular stress response, decreased the number of crises and their duration, and the frequency of symptoms, improving the clinical grading of tinnitus severity.

show abstract

Positive pressure therapy for Ménière’s disease

Webster

George

Galbraith

et al. 2023

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

Background Ménière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. It is often treated with medication, but different interventions are sometimes used. Positive pressure therapy is a treatment that creates small pressure pulses, generated by a pump that is attached to tubing placed in the ear canal. It is typically used for a few minutes, several times per day. The underlying cause of Ménière's disease is unknown, as is the way in which this treatment may work. The efficacy of this intervention at preventing vertigo attacks, and their associated symptoms, is currently unclear. Objectives To evaluate the benefits and harms of positive pressure therapy versus placebo or no treatment in people with Ménière's disease. Search methods The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022. Selection criteria We included randomised controlled trials (RCTs) and quasi‐RCTs in adults with a diagnosis of Ménière's disease comparing positive pressure therapy with either placebo or no treatment. We excluded studies with follow‐up of less than three months. Data collection and analysis We used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome ‐ improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease‐specific health‐related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome. Main results We included three studies with a total of 238 participants, all of which compared positive pressure using the Meniett device to sham treatment. The duration of follow‐up was a maximum of four months. Improvement in vertigo A single study assessed whether participants had an improvement in the frequency of their vertigo whilst using positive pressure therapy, therefore we are unable to draw meaningful conclusions from the results. Change in vertigo Only one study reported on the change in vertigo symptoms using a global score (at 3 to < 6 months), so we are again unable to draw meaningful conclusions from the numerical results. All three studies reported on the change in the frequency of vertigo. The summary effect showed that people receiving positive pressure therapy had, on average, 0.84 fewer days per month affected by vertigo (95% confiden...

show abstract

Positive pressure therapy for Ménière’s disease

Cited by 3 publications

References 50 publications

Examination of betahistine bioavailability in combination with the monoamine oxidase B inhibitor, selegiline, in humans—a non-randomized, single-sequence, two-period titration, open label single-center phase 1 study (PK-BeST)

Examination of betahistine bioavailability in combination with the monoamine oxidase B inhibitor, selegiline, in humans—a non-randomized, single-sequence, two-period titration, open label single-center phase 1 study (PK-BeST)

Mushrooms as Functional Foods for Ménière’s Disease

Positive pressure therapy for Ménière’s disease

Contact Info

Product

Resources

About