title: Ethics of Placebo Control in Trials for Idiopathic Sudden Sensorineural Hearing Loss.
abstract: 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.
authors.affiliation: ENT Department, Hospital Vital Alvarez-Buylla, Mieres, Spain Maldonado2000@gmail.com.
authors.forename: Miguel
authors.initials: M
authors.lastname: Maldonado Fernández
authors.affiliation: Clinical Research Compliance, Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Kornetsky
authors.affiliation: Department of Psychiatry, Hospital de Cabueñes / Hospital Fundación de Jove, Gijón, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Rubio Rodriguez
mesh_terms: D032984:Ethics, Research; D019317:Evidence-Based Medicine; D005938:Glucocorticoids / Q000627:therapeutic use*; D006319:Hearing Loss, Sensorineural / Q000188:drug therapy*; D003639:Hearing Loss, Sudden / Q000188:drug therapy*; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*
chemical_list: D005938:Glucocorticoids; D010919:Placebos
keywords: clinical trial; placebo; steroids; sudden hearing loss