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. 2014 May 6;8(2):e67–e72.

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© Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale

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The results of 3 hypothetical trials comparing treatment y with treatment x, illustrating the concept of noninferiority. In all 3 cases, the lower bound of the 95% confidence interval (CI) is less than 0; as such, all of these trials fail to demonstrate superiority of treatment y over treatment x. However, the lower bound of each 95% CI lies above the noninferiority margin, ƒ (blue shaded area); as such, all of these trials demonstrate noninferiority of treatment y with respect to treatment x. As a general principle, for any additional studies, the lower bound of the 95% CI falling in the blue shaded area would indicate noninferiority of treatment y with respect to treatment x.