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

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.

TRIAL REGISTRATION:

UMIN Clinical Trials Registry Number UMIN000004366, October 30th, 2010.

• Authors: 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, Juichi Ito
• Journal: BMC medicine (BMC Med) Vol. 12 Pg. 219 (Nov 19 2014) ISSN: 1741-7015 [Electronic] England
• PMID: 25406953 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Glucocorticoids
• Insulin-Like Growth Factor I
• Dexamethasone

Topics

• Administration, Cutaneous
• Dexamethasone (administration & dosage)
• Female
• Glucocorticoids (administration & dosage)
• Hearing Loss, Sudden (drug therapy, physiopathology)
• Hearing Tests
• Humans
• Injections, Intra-Articular
• Insulin-Like Growth Factor I (administration & dosage)
• Japan
• Male
• Middle Aged
• Treatment Outcome
• Tympanic Membrane