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Title: A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.
Authors: Nakagawa, Takayuki  kyouindb  KAKEN_id
Kumakawa, Kozo
Usami, Shin-ichi
Hato, Naohito
Tabuchi, Keiji
Takahashi, Mariko
Fujiwara, Keizo
Sasaki, Akira
Komune, Shizuo
Sakamoto, Tatsunori  kyouindb  KAKEN_id  orcid (unconfirmed)
Hiraumi, Harukazu
Yamamoto, Norio  kyouindb  KAKEN_id  orcid (unconfirmed)
Tanaka, Shiro  kyouindb  KAKEN_id  orcid (unconfirmed)
Tada, Harue  kyouindb  KAKEN_id
Yamamoto, Michio  kyouindb  KAKEN_id
Yonezawa, Atsushi  kyouindb  KAKEN_id  orcid (unconfirmed)
Ito-Ihara, Toshiko
Ikeda, Takafumi  kyouindb  KAKEN_id
Shimizu, Akira  kyouindb  KAKEN_id
Tabata, Yasuhiko  kyouindb  KAKEN_id
Ito, Juichi
Author's alias: 中川, 隆之
Keywords: Dexamethasone
Drug delivery system
Local application
Sudden sensorineural hearing loss
Issue Date: 19-Nov-2014
Publisher: BioMed Central Ltd.
Journal title: BMC medicine
Volume: 12
Thesis number: 219
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.
Description: 突発性難聴に対する新規治療法の有効性を報告. 京都大学プレスリリース. 2014-12-10.
Rights: © 2014 Nakagawa et al.; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
DOI(Published Version): 10.1186/s12916-014-0219-x
PubMed ID: 25406953
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