Topical insulin-like growth factor 1 treatment using gelatin hydrogels for glucocorticoid-resistant sudden sensorineural hearing loss: a prospective clinical trial.
BACKGROUND
Sudden sensorineural hearing loss (SSHL) is a common condition in which patients lose the hearing in one ear within 3 days. Systemic glucocorticoid treatments have been used as standard therapy for SSHL; however, about 20% of patients do not respond. We tested the safety and efficacy of topical insulin-like growth factor 1 (IGF1) application using gelatin hydrogels as a treatment for SSHL.


METHODS
Patients with SSHL that showed no recovery to systemic glucocorticoid administration were recruited. We applied gelatin hydrogels, impregnated with recombinant human IGF1, into the middle ear. The primary outcome measure was the proportion of patients showing hearing improvement 12 weeks after the test treatment. The secondary outcome measures were the proportion of patients showing improvement at 24 weeks and the incidence of adverse events. The null hypothesis was that 33% of patients would show hearing improvement, as was reported for a historical control after hyperbaric oxygen therapy.


RESULTS
In total, 25 patients received the test treatment at a median of 23 days (range 15-32) after the onset of SSHL, between 2007 and 2009. At 12 weeks after the test treatment, 48% (95% CI 28% to 69%; P = 0.086) of patients showed hearing improvement, and the proportion increased to 56% (95% CI 35% to 76%; P = 0.015) at 24 weeks. No serious adverse events were observed.


CONCLUSIONS
Topical IGF1 application using gelatin hydrogels is well tolerated and may be efficacious for hearing recovery in patients with SSHL that is resistant to systemic glucocorticoids.
Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. tnakagawa@ent.kuhp.kyoto-u.ac.jp
Takayuki
T
Nakagawa
Tatsunori
T
Sakamoto
Harukazu
H
Hiraumi
Yayoi S
YS
Kikkawa
Norio
N
Yamamoto
Kiyomi
K
Hamaguchi
Kazuya
K
Ono
Masaya
M
Yamamoto
Yasuhiko
Y
Tabata
Satoshi
S
Teramukai
Shiro
S
Tanaka
Harue
H
Tada
Rie
R
Onodera
Atsushi
A
Yonezawa
Ken-ichi
K
Inui
Juichi
J
Ito
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006319:Hearing Loss, Sensorineural / Q000188:drug therapy*; D006801:Humans; D020100:Hydrogels / Q000008:administration & dosage* / Q000009:adverse effects; D007334:Insulin-Like Growth Factor I / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D005938:Glucocorticoids; D020100:Hydrogels; D007334:Insulin-Like Growth Factor I