Endolymphatic Sac Surgery: Understanding the Historical Influence of Circumstance and Statistics.

In 1981, Danish physician Jens Thomsen conducted the first and only documented sham-controlled surgical trial in the history of otolaryngology. This trial is historically significant as it was the first in the field to use a methodologically sound study design to address a frustratingly complex disorder such as Ménière's disease. Despite this, historical interpretations of this work have varied, and questions about the results have been raised. We review the fascinating historical context of this landmark trial and detail how it was influenced by the rise of the randomized controlled trial. We examine how subsequent statistical analyses and interpretations of this historical work have affected surgical treatment paradigms in Ménière's disease, and we look forward to suggest the legacy of this work as a sham-controlled surgical trial in otolaryngology.