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

• 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

Abstract

[Background]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. [Methods]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. [Results]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). [Conclusions]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.

Journal

• BMC medicine

  BMC medicine 12 2014-11-19

  BioMed Central Ltd.

Keywords

• Dexamethasone
• Drug delivery system
• IGF-1
• Local application
• Sudden sensorineural hearing loss

Details

• CRID: 1050564285753133184
• NII Article ID: 120005517912
• ISSN: 17417015
• HANDLE: 2433/192275
• Text Lang: en
• Article Type: journal article
• Data Source:
  • IRDB
  • CiNii Articles