A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment

• Published in: BMC medicine 2014-11, Vol.12 (1), p.219-219, Article 219
• Main Authors: Nakagawa, Takayuki, Kumakawa, Kozo, Usami, Shin-ichi, Hato, Naohito, Tabuchi, Keiji, Takahashi, Mariko, Fujiwara, Keizo, Sasaki, Akira, Komune, Shizuo, Sakamoto, Tatsunori, Hiraumi, Harukazu, Yamamoto, Norio, Tanaka, Shiro, Tada, Harue, Yamamoto, Michio, Yonezawa, Atsushi, Ito-Ihara, Toshiko, Ikeda, Takafumi, Shimizu, Akira, Tabata, Yasuhiko, Ito, Juichi
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Dexamethasone - administration & dosage; Drug delivery systems; Drugs; Female; Glucocorticoids - administration & dosage; Health aspects; Hearing Loss, Sudden - drug therapy; Hearing Loss, Sudden - physiopathology; Hearing Tests; Hospitals; Humans; Injections, Intra-Articular; Insulin-Like Growth Factor I - administration & dosage; Insulin-like growth factors; Japan; Male; Middle Aged; Otolaryngology; Science; Studies; Treatment Outcome; Tympanic Membrane; Vehicles
• ISSN: 1741-7015; 1741-7015
• DOI: 10.1186/s12916-014-0219-x

To date, no therapeutic option has been established for sudden deafness refractory to systemic corticosteroids. This study aimed to examine the efficacy and safety of topical insulin-like growth factor-1 (IGF-1) therapy in comparison to intratympanic corticosteroid therapy. We randomly assigned patients with sudden deafness refractory to systemic corticosteroids to receive either gelatin hydrogels impregnated with IGF-1 in the middle ear (62 patients) or four intratympanic injections with dexamethasone (Dex; 58 patients). The primary outcome was the proportion of patients showing hearing improvement (10 decibels or greater in pure-tone average hearing thresholds) 8 weeks after treatment. The secondary outcomes included the change in pure-tone average hearing thresholds over time and the incidence of adverse events. In the IGF-1 group, 66.7% (95% confidence interval [CI], 52.9-78.6%) of the patients showed hearing improvement compared to 53.6% (95% CI, 39.7-67.0%) of the patients in the Dex group (P = 0.109). The difference in changes in pure-tone average hearing thresholds over time between the two treatments was statistically significant (P = 0.003). No serious adverse events were observed in either treatment group. Tympanic membrane perforation did not persist in any patient in the IGF-1 group, but did persist in 15.5% (95% CI, 7.3-27.4%) of the patients in the Dex group (P = 0.001). The positive effect of topical IGF-1 application on hearing levels and its favorable safety profile suggest utility for topical IGF-1 therapy in patients with sudden deafness. UMIN Clinical Trials Registry Number UMIN000004366, October 30th, 2010.