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Study question What is the long term efficacy of betahistine dihydrochloride on the incidence of vertigo attacks in patients with Meniere’s disease, compared with placebo?Methods The BEMED trial is a multicentre, double blind, randomised, placebo controlled, three arm, parallel group, phase III, dose defining superiority trial conducted in 14 German tertiary referral centres (for neurology or ear, nose, and throat). Adults aged 21-80 years (mean age 56 years) with definite unilateral or bilateral Meniere’s disease were recruited from March 2008 to November 2012. Participants received placebo (n=74), low dose betahistine (2×24 mg daily, (n=73)), or high dose betahistine (3×48 mg daily, (n=74)) over nine months. The primary outcome was the number of attacks per 30 days, based on patients’ diaries during a three month assessment period at months seven to nine. An internet based randomisation schedule performed a concealed 1:1:1 allocation, stratified by study site. Secondary outcomes included the duration and severity of attacks, change in quality of life scores, and several observer-reported parameters to assess changes in audiological and vestibular function.Study answer and limitations Incidence of attacks related to Meniere’s disease did not differ between the three treatment groups (P=0.759). Compared with placebo, attack rate ratios were 1.036 (95% confidence interval 0.942 to 1.140) and 1.012 (0.919 to 1.114) for low dose and high dose betahistine, respectively. The overall monthly attack rate fell significantly by the factor 0.758 (0.705 to 0.816; P<0.001). The population based, mean monthly incidence averaged over the assessment period was 2.722 (1.304 to 6.309), 3.204 (1.345 to 7.929), and 3.258 (1.685 to 7.266) for the placebo, low dose betahistine, and high dose betahistine groups, respectively. Results were consistent for all secondary outcomes. Treatment was well tolerated with no unexpected safety findings. Without a control group of patients who did not receive any intervention to follow the natural course of the disease, the placebo effect could not be accurately assessed and differentiated from spontaneous remission and fluctuation of symptoms. What this study adds Current evidence is limited as to whether betahistine prevents vertigo attacks caused by Meniere’s disease, compared with placebo. The trial provides information on symptom relief on placebo intervention which is relevant for the design of future studies on potential disease modifying treatments in patients with Meniere’s disease.Funding, competing interests, data sharing Support from the German Federal Ministry of Education and Research (BMBF support code 01KG0708). Potential competing interests have been reported in full at the end of the paper on thebmj.com. Data are available from the corresponding author (Michael.Strupp@med.uni-muenchen.de) or biostatistician (mansmann@ibe.med.uni-muenchen.de).Study registration EudraCT no 2005-000752-32; ISRCTN no ISRCTN44359668.

Meniere Disease keeps challenges in its diagnosis and treatment since was defined by Prosper Meniere at the beginning of 19th Century. Several classifications and definition were made until now and speculations still exist on its etiology. As the etiology remains speculative the treatment models remain in discussion also. The European Academy of Otology and Neurotology Vertigo Guidelines Study Group intended to work on the diagnosis and treatment of Meniere's disease and created the European Positional Statement Document also by resuming the consensus studies on it. The new techniques on diagnosis are emphasized as well as the treatment models for each stage of the disease are clarified by disregarding the dilemmas on its treatment. The conservative, noninvasive and invasive therapeutic models are highlighted.

IntroductionMenière’s disease (MD) is a multifactorial disease characterised by recurring vertigo, tinnitus and fluctuating sensorineural hearing loss as typical clinical symptoms. For patients with MD with poor response to non-invasive treatments, it is recommended to use intratympanic gentamicin treatment. The destruction of vestibular organs by gentamicin may cause residual vestibular symptoms, notably unsteadiness. However, most previous clinical studies paid little attention to this issue. Currently, vestibular rehabilitation treatment (VRT) has been proven to be an effective method for controlling vestibular symptoms and has been applied to patients with various vestibular diseases. The aim of this study is to investigate the efficacy of VRT versus usual care in MD patients who experience persistent unsteadiness for 1 month after intratympanic gentamicin treatment, in order to understand whether VRT has a positive impact on balance maintenance and vertigo control in patients with MD.Methods and analysisRandomised, assessor-blinded, controlled clinical trials will be used to compare the efficacy of balance function before and after VRT. Patients with MD who experience chronic unsteadiness for 1 month after intratympanic gentamicin treatment will be recruited and receive VRT, mainly including gaze stability training, gait rehabilitation, vestibular habituation training, etc. The outcomes assessments will be conducted at baseline and at eighth week and sixth month post-randomisation. The primary outcome will be the improvements in vestibular function quantified through the Functional Gait Assessment. The secondary outcomes will include sensory organisation test, vestibular laboratory tests (video head impulse test, caloric test and vestibular evoked myogenic potentials), Menière’s disease outcomes questionnaire, visual vertigo analogue scale and vestibular activities and participation measure.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2024020). The study results will be disseminated via peer-reviewed journals and conferences.Trial registration number NCT06143462.

Objectives Endolymphatic hydrops (EH) can be studied in patients by MRI. With the semi-quantitative grading system, previous imaging studies showed discrepancies in the occurrence and grading of EH in patients with Meniere’s disease (MD). Here, we compared the inversion of the saccule to utricle area ratio (SURI) with the semi-quantitative method of grading conventionally used to diagnose MD. Methods Imaging was carried out on a 3-T MRI scanner. We performed 3D-FLAIR sequences 4 h after a single intravenous dose of contrast agent. Two radiologists independently studied the morphology of the inner ear structures in the healthy subjects and MD patients. Each subject was then graded on the basis of the EH semi-quantitative analysis and on saccular morphology using axial and sagittal reference slices in the vestibule plane. Results Thirty healthy subjects and 30 MD patients had MRI scans. Using the semi-quantitative method, we found no significant difference in the number of subjects with EH between the two groups. SURI was found in 15 out of 30 MD patients and in none of the 30 healthy subjects. In three MD patients the saccule was not visible. Conclusion SURI is currently the most specific criterion for imaging diagnosis of MD. Key points • Half of MD patients presented with inversion of the saccule to utricle ratio. • Saccular analysis is crucial when assessing patients with Meniere’s disease. • In some patients, the saccule is not visible, suggestive of intra-labyrinthine fistulae.

Meniere’s disease (MD) is a chronic, relapsing inner ear disorder characterized by episodes of vertigo, fluctuating sensorineural hearing loss, tinnitus, and aural fullness. Although its etiology has long remained elusive, accumulating evidence implicates immune dysregulation as a central contributor to disease pathogenesis, particularly in patients who do not respond to standard therapies. This review synthesizes current insights into the immunopathological mechanisms underlying MD, focusing on the roles of both innate and adaptive immune cells—including macrophages, dendritic cells, T cells, and B cells—in promoting inflammation, endolymphatic hydrops, and sensory dysfunction. We examine the contribution of these immune cells to tissue damage, along with the roles of cytokine signaling and immune complex deposition. Emerging immunotherapies, including corticosteroids, biologics, and inflammasome inhibitors, are evaluated for their therapeutic potential. The review also highlights promising directions in precision medicine, such as immune profiling, biomarker discovery, and stratified clinical trials aimed at personalizing treatment. By integrating recent immunological advances with clinical management strategies, we underscore the potential of immune guided approaches to transform the diagnosis, treatment, and long-term care of patients with MD.

The symptoms of Meniere’s disease (MD) are generally considered to be related to endolymphatic hydrops (EH). There are many recent reports supporting the possibility that vasopressin (VP) is closely linked to the formation of EH in Meniere’s disease. Based on this, we developed a clinically relevant animal model of Meniere’s disease in which a VP type 2 receptor agonist was administered after electrocauterization of the endolymphatic sac. We report live imaging of the internal structure, and functional changes of the inner ear after electrocauterization of the endolymphatic sac and administration of a VP type 2 receptor agonist. In this model, the development of EH was visualized in vivo using optical coherence tomography, there was no rupture of Reissner’s membrane, and low-tone hearing loss and vertiginous attacks were observed. This study suggested that acute attacks are caused by the abrupt development of EH. This is the first report of live imaging of the development of EH induced by the administration of a VP type 2 receptor agonist.

Meniere’s disease (MD) represents one of the vertigo disorders characterized by triad symptoms (recurrent vertigo, fluctuating hearing loss, tinnitus or ear fullness). The diagnosis of MD relies on the accurate and detailed taking of medical history, and the differentiation between MD and vestibular migraine (VM) is of critical importance from the perspective of the treatment efficacy. VM is a highly prevalent vertigo condition and its typical symptoms (headache, vestibular symptoms, cochlear symptoms) mimic those of MD. Furthermore, the misdiagnosis in MD and VM could lead to VM patients mistakenly receiving the traumatic treatment protocol designed for MD, and sustaining unnecessary damage to the inner ear. Fortunately, thanks to the advances in examination technologies, the barriers to their differentiation are being gradually removed. These advances enhance the diagnostic accuracy of vertigo diseases, especially VM and MD. This review focused on the differentiation of VM and MD, with an attempt to synthesize existing data on the relevant battery of differentiation diagnosis (covering core symptoms, auxiliary tests [audiometry, vestibular tests, endolymphatic hydrops tests]) and longitudinal follow-up. Since the two illnesses are overlapped in all aspects, no single test is sufficiently specific on its own, however, patterns containing all or at least some features boost specificity.

Background Vertigo and dizziness are often not fully explained by an organic illness, but instead are related to psychiatric disorders. This study aimed to evaluate psychiatric comorbidity and assess psychosocial impairment in a large sample of patients with a wide range of unselected organic and non-organic (ie, medically unexplained) vertigo/dizziness syndromes. Methods This cross-sectional study involved a sample of 547 patients recruited from a specialised interdisciplinary treatment centre for vertigo/dizziness. Diagnostic evaluation included standardised neurological examinations, structured clinical interview for major mental disorders (SCID-I) and self-report questionnaires regarding dizziness, depression, anxiety, somatisation and quality of life. Results Neurological diagnostic workup revealed organic and non-organic vertigo/dizziness in 80.8% and 19.2% of patients, respectively. In 48.8% of patients, SCID-I led to the diagnosis of a current psychiatric disorder, most frequently anxiety/phobic, somatoform and affective disorders. In the organic vertigo/dizziness group, 42.5% of patients, particularly those with vestibular paroxysmia or vestibular migraine, had a current psychiatric comorbidity. Patients with psychiatric comorbidity reported more vertigo-related handicaps, more depressive, anxiety and somatisation symptoms, and lower psychological quality of life compared with patients without psychiatric comorbidity. Conclusions Almost half of patients with vertigo/dizziness suffer from a psychiatric comorbidity. These patients show more severe psychosocial impairment compared with patients without psychiatric disorders. The worst combination, in terms of vertigo-related handicaps, is having non-organic vertigo/dizziness and psychiatric comorbidity. This phenomenon should be considered when diagnosing and treating vertigo/dizziness in the early stages of the disease.

Autoimmunity appears to be associated with the pathophysiology of Meniere's disease (MD), an inner ear disorder characterized by episodes of vertigo associated with hearing loss and tinnitus. However, the prevalence of autoimmune diseases (AD) in patients with MD has not been studied in individuals with uni or bilateral sensorineural hearing loss (SNHL). We estimated the prevalence of AD in 690 outpatients with MD with uni or bilateral SNHL from otoneurology clinics at six tertiary referral hospitals by using clinica criteria and an immune panel (lymphocyte populations, antinuclear antibodies, C3, C4 and proinflammatory cytokines TNFα, INFγ). The observed prevalence of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and ankylosing spondylitis (AS) was higher than expected for the general population (1.39 for RA, 0.87 for SLE and 0.70 for AS, respectively). Systemic AD were more frequently observed in patients with MD and diagnostic criteria for migraine than cases with MD and tension-type headache (p = 0.007). There were clinical differences between patients with uni or bilateral SNHL, but no differences were found in the immune profile. Multiple linear regression showed that changes in lymphocytes subpopulations were associated with hearing loss and persistence of vertigo, suggesting a role for the immune response in MD. Despite some limitations, MD displays an elevated prevalence of systemic AD such as RA, SLE and AS. This finding, which suggests an autoimmune background in a subset of patients with MD, has important implications for the treatment of MD.

Patients with Meniere’s disease (MD) often suffer from vertiginous symptoms during bad weather. Endolymphatic hydrops (EH) have been thought to be the pathological basis of MD. However, the relationship between EH and weather has not been clarified. Endolymphatic space (ELS) volume can be evaluated using three-dimensional analysis of 3-Tesla magnetic resonance imaging (3T-MRI) after intravenous injection of gadolinium enhancement. In this study, we examined the correlations between the 24-h atmospheric pressure change from the day before, that is, MRI scanning, and the ELS rates of the unilateral MD (uMD) and patients with chronic rhinosinusitis as a control group. Atmospheric pressure data for the day before and on the day of each patient’s MRI were obtained from the Japan Meteorological Agency data (JMA). There was no significant correlation between the atmospheric pressure change and the ELS rate on the affected and healthy sides or bilaterally in the control group. However, in those with developed MD (average hearing levels in the affected ear of 40–70 dB), a significant negative correlation was found between atmospheric pressure change and vestibular ELS rate on the affected side. Negative atmospheric pressure changes may influence vestibular ELS volume in patients with moderate hearing impairment.