Abstract
Background
Treatment for Ménière's disease remains a subject of debate. A surgical technique in which the endolymphatic duct is blocked was proposed as a new treatment modality for patients with intractable Ménière's disease, but a double-blind trial was lacking. Therefore, the aim of this double-blind trial was to assess whether EDB is more effective than ESD in patients with intractable Ménière's disease.Methods
This is a double-blind, randomised, multicentre trial comparing endolymphatic duct blockage (EDB) to endolymphatic sac decompression (ESD). Patients had unilateral, active Ménière's disease despite treatment with at least two corticosteroid injections. All patients were recruited from two university and five non-university hospitals in the Netherlands. During surgery, patients were randomly assigned to either the EDB or ESD group. Following surgery, patients were followed for 1 year, with both physical visits and an app in which attacks could be reported. Both patients and investigators were blinded throughout the follow-up period. The primary outcome was freedom from vertigo attacks at 12 months, defined as no attacks during the preceding 6 months. Secondary outcome measures included attack incidence, quality of life, dizziness, tinnitus, and inner ear function. Analyses were performed according to the intention-to-treat principle. This trial was registered in the ISRCTN registry (registered 24-02-2021, https://www.isrctn.com/ISRCTN12074571).Findings
Between 23 June 2021 and 12 September 2023, 75 patients with definite Ménière's disease were enrolled; 39 underwent EDB, while 36 underwent ESD. No loss to follow-up was recorded. At 12 months, 23/39 (59%) patients in the EDB group and 24/36 (67%) in the ESD group were free from vertigo attacks (OR 0.72, 95% CI 0.28-1.84; p = 0.65). Secondary outcomes, including quality of life, dizziness, tinnitus, and hearing function did not differ between groups. Higher baseline patients expectations were associated with treatment success. Three serious adverse events occurred (one in the EDB group, two in the ESD group) and no deaths were reported.Interpretation
This trial does not demonstrate a benefit of EDB over ESD for patients with refractory Ménière's disease. Given the comparable outcomes between groups, EDB should not be preferred over ESD. The association between baseline expectations and outcome suggests that non-specific treatment effects may contribute to perceived benefit. Future studies should consider inclusion of a non-surgical or sham-surgery control to more definitely determine the effect of this type of surgery, although such trials would be challenging.Funding
Dutch National Healthcare Institute and ZonMw ('Veelbelovende Zorg' grant).