Ethics of Placebo Control in Trials for Idiopathic Sudden Sensorineural Hearing Loss

• Published in: Otolaryngology-head and neck surgery Vol. 155; no. 1; pp. 8 - 12
• Main Authors: Maldonado Fernández, Miguel, Kornetsky, Susan, Rubio Rodriguez, Laura
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-07-2016
• Subjects: clinical trial; Ethics, Research; Evidence-Based Medicine; Glucocorticoids - therapeutic use; Hearing Loss, Sensorineural - drug therapy; Hearing Loss, Sudden - drug therapy; Humans; placebo; Placebos; Randomized Controlled Trials as Topic - ethics; steroids; sudden hearing loss; clinical trial; sudden hearing loss; steroids; placebo
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1177/0194599816644440

Idiopathic sudden sensorineural hearing loss (ISSHL) involves sudden loss of hearing from cochlear or retrocochlear origin of unknown cause. Systemic corticosteroids may be considered in the management of ISSNHL. However, an updated Cochrane systematic review concludes that “the value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomized controlled trials is contradictory in outcome.” Therefore, a new clinical trial that addresses this question is mandatory. A first step in its design is to determine if placebo control would be ethically acceptable. We conclude that there is equipoise (uncertainty) about the use of corticosteroids for ISSHL. A new trial is justified—but with the inclusion of interim analyses to detect early imbalances on efficacy or safety and with the ability to stop the trial if needed.