D B Welling1, H N Nagaraja. 1. Departments of Otolaryngology and Statistics, Ohio State University, OH, USA.
Abstract
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.
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.