Endolymphatic duct blockage for Ménière's disease: a double-blind, randomised controlled trial

Area of Science:

• Otolaryngology
• Neurosurgery
• Clinical Trials

Background:

• Ménière's disease treatment is debated, particularly for intractable cases.
• Endolymphatic duct blockage (EDB) proposed as a novel surgical option.
• Lack of double-blind trials for EDB efficacy necessitated this study.

Purpose of the Study:

• To compare the efficacy of endolymphatic duct blockage (EDB) versus endolymphatic sac decompression (ESD).
• To assess EDB as a treatment for intractable unilateral Ménière's disease.
• To evaluate secondary outcomes including quality of life and auditory function.

Main Methods:

• Double-blind, randomized, multicenter trial.
• Compared EDB with ESD in patients with Ménière's disease refractory to corticosteroids.
• Primary outcome: freedom from vertigo attacks at 12 months; secondary outcomes: attack frequency, quality of life, hearing.

Main Results:

• 59% of EDB patients and 67% of ESD patients were vertigo-free at 12 months (p=0.65).
• No significant differences in vertigo freedom, attack incidence, or quality of life between EDB and ESD groups.
• Higher baseline patient expectations correlated with treatment success; no significant difference in adverse events.

Conclusions:

• Endolymphatic duct blockage (EDB) does not offer a significant advantage over endolymphatic sac decompression (ESD) for refractory Ménière's disease.
• Given comparable outcomes, EDB is not recommended over ESD.
• Non-specific treatment effects, possibly linked to patient expectations, may influence perceived outcomes.