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

Takayuki Nakagawa, Kozo Kumakawa, Shin ichi Usami, Naohito Hato, Keiji Tabuchi, Mariko Takahashi, Keizo Fujiwara, Akira Sasaki, Shizuo Komune, Tatsunori Sakamoto, Harukazu Hiraumi, Norio Yamamoto, Shiro Tanaka, Harue Tada, Michio Yamamoto, Atsushi Yonezawa, Toshiko Ito-Ihara, Takafumi Ikeda, Akira Shimizu, Yasuhiko Tabata & 1 others Juichi Ito

Research output: Contribution to journalArticle

33 Citations (Scopus)

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.

Original languageEnglish
Article number219
JournalBMC Medicine
Volume12
Issue number1
DOIs
Publication statusPublished - Nov 19 2014
Externally publishedYes

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Sudden Hearing Loss
Somatomedins
Adrenal Cortex Hormones
Randomized Controlled Trials
Hearing
Therapeutics
Confidence Intervals
Tympanic Membrane Perforation
Safety
Hydrogels
Middle Ear
Gelatin
Dexamethasone

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

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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.

In: BMC Medicine, Vol. 12, No. 1, 219, 19.11.2014.

Research output: Contribution to journalArticle

Nakagawa, T, Kumakawa, K, Usami, SI, Hato, N, Tabuchi, K, Takahashi, M, Fujiwara, K, Sasaki, A, Komune, S, Sakamoto, T, Hiraumi, H, Yamamoto, N, Tanaka, S, Tada, H, Yamamoto, M, Yonezawa, A, Ito-Ihara, T, Ikeda, T, Shimizu, A, Tabata, Y & Ito, J 2014, 'A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment', BMC Medicine, vol. 12, no. 1, 219. https://doi.org/10.1186/s12916-014-0219-x
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. / A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment. In: BMC Medicine. 2014 ; Vol. 12, No. 1.
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AU - Usami, Shin ichi

AU - Hato, Naohito

AU - Tabuchi, Keiji

AU - Takahashi, Mariko

AU - Fujiwara, Keizo

AU - Sasaki, Akira

AU - Komune, Shizuo

AU - Sakamoto, Tatsunori

AU - Hiraumi, Harukazu

AU - Yamamoto, Norio

AU - Tanaka, Shiro

AU - Tada, Harue

AU - Yamamoto, Michio

AU - Yonezawa, Atsushi

AU - Ito-Ihara, Toshiko

AU - Ikeda, Takafumi

AU - Shimizu, Akira

AU - Tabata, Yasuhiko

AU - Ito, Juichi

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N2 - 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.

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KW - Dexamethasone

KW - Drug delivery system

KW - IGF-1

KW - Local application

KW - Sudden sensorineural hearing loss

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