Blog entry written on: Interventions for Menière’s disease: an umbrella systematic review (bmjebm-2020-111410).
Authors: Babette F. van Esch, Hester J. van der Zaag-Loonen, Tjasse D. Bruintjes, Ton Kuijpers, Peter Paul G. van Benthem
Are we able to rule out any treatment options when treating patients who are suffering from incapacitating attacks of vertigo accompanied with nausea, vomiting, fluctuating hearing loss, tinnitus and/or aural fullness, altogether known as Menière’s disease (MD)? The findings of a recent umbrella systematic review suggest that oral intake of betahistine or pressure pulse therapy (the Meniett device) do not reduce MD symptoms when compared to placebo.
Even though the disease was described as early as 1861 by Prosper Menière, there are still many unanswered questions regarding the pathophysiology of this disease and an evidence-based treatment is yet to be discovered. Current treatment options include: betahistine, diuretics, oral steroids and transtympanic application of gentamicin or corticosteroids, positive pressure therapy (the Meniett device) or ablative surgery such as vestibular nerve section, surgical labyrinthectomy and endolymphatic sac surgery. Since so many treatments exist without convincing results, it may be hard for patients and their physicians to select the best available treatment.
MD affects about 15.0000 adults in the Netherlands in whom symptoms may last up to 20 years. The progression of disease causes deterioration of sensorineural hearing loss due to the vertigo attacks. In general, otological symptoms, including tinnitus and aural fullness, start unilateral but may become bilateral. Moreover, balance problems occur due to damage of the labyrinthine part of the inner ear. Due to the incapacitating character of the disease patients and physicians tend to start with therapy although the beneficial effect of it may not have been established.
The current team members assessed all available data on systematic reviews (SRs) and placebo-controlled randomised trials (RCTs) aiming to summarise the efficacy of interventions for MD and to report on its clinical implication to identify areas for future valuable research. We identified five SRs and 25 RCTs in total enrolling 1248 MD patients. In general, the evidence was of a low level of certainty, i.e. the true effect may be substantially different from the estimated effect. Nonetheless, studies with the lowest risk of bias identified that betahistine (up to 144 mg per day) and positive pressure therapy probably do not reduce MD symptoms compared to placebo.
Additionally, intratympanic injection with gentamicin or steroids, or treatment with endolymphatic surgery may reduce symptoms in MD when compared to placebo. These conclusions were based on a low certainty of evidence and studies suffered from clinical heterogeneity: different treatment schedules, follow-up duration and definitions of outcomes.
It is imperative be aware that the added value of therapy remains disputable due to lack of knowledge on the natural course of the disease. This is considered to be the biggest flaw in current research regarding MD. Knowledge on the natural course of disease will further help us to estimate the added value of therapy and indeed, may be helpful for power calculations when designing future trials.
An online prospective registration system of patients’ characteristics may provide relevant information on epidemiological aspects and therapy regimes in which betahistine and positive pressure therapy should not be used and do not warrant further research. Resources should be directed elsewhere.
Dr. Babette F. van Esch, MD, PhD
Resident Otorhinolaryngology – Head and Neck Surgery
Department of Otorhinolaryngology – Head and Neck Surgery
Leiden, The Netherlands
Leiden University Medical Centre
Conflict of interest disclosures: None
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