Endolymphatic Duct Blockage for Refractory Ménière's Disease: Assessment of Endolymphatic Sac Biopsy on Short-Term Surgical Outcomes.
OBJECTIVES The main goal of this paper was to statistically reevaluate the efficacy of the endolymphatic shunt procedure for Meniere's disease. METHODS Thomsen et al (Arch Otolaryngol 1981;107:271-7) reported on the placebo effect in surgery for Meniere's disease in a controlled double-blind study. Thirty patients with typical Meniere's disease in whom medical treatment failed participated in the study. A placebo-controlled blinded surgical study has not since been replicated. We performed a retrospective statistical analysis using data extracted from the published report and reanalyzed it using both the original and new statistical measures and techniques. RESULTS The original conclusions drawn by Thomsen et al differed considerably from ours in 5 key areas, including postoperative vertigo, nausea and vomiting, tinnitus, and combined score. CONCLUSIONS This analysis strongly supports the effectiveness of the endolymphatic shunt in the management of Meniere's disease and refutes the placebo effect previously proposed.