YES,
THERE ARE.
"Based on the result of the phase I/II clinical trial described in 5.1., a randomized clinical study was performed (UMIN000004366). Treatment with intra-tympanic steroids, which has been widely used to treat systemic glucocorticoid-resistant SSHL (Choung et al., 2006; Haynes et al., 2007; Ho et al., 2004; Kakehata et al., 2011; Lee et al., 2010; Plontke et al., 2005; Roebuck and Chang, 2006), was chosen as the control treatment (Nakagawa et al., 2014). Patients who had been diagnosed as having SSHL and who had no recovery after systemic glucocorticoid treatment for more than 7 days were recruited within 25 days of SSHL onset. Patients (n ¼ 120) were recruited from nine tertiary referral hospitals in Japan and were randomly selected to receive either gelatin hydrogel impregnated with IGF1 on the round window membrane (62 patients) or intratympanic injections with Dex (58 patients). The primary outcome measure was the proportion of patients with improved hearing (10 dB in pure-tone average hearing thresholds) 8 weeks after treatment. The secondary outcome measures included changes in pure-tone average hearing thresholds over time and the incidence of adverse events. In the IGF1 group, 66.7% (95% CI, 52.9e78.6%) of the patients showed hearing improvement compared to 53.6% (95% CI, 39.7e67.0%) of the patients in the Dex group. There was no significant difference between the proportion of patients with improved hearing in each group (p =0.109), primarily because an unexpectedly high proportion of patients showed hearing improvements after Dex therapy compared with previous reports (Choung et al., 2006; Haynes et al., 2007; Ho et al., 2004; Kakehata et al., 2011; Nakagawa, 2014; Nakagawa et al., 2014; Plontke et al., 2005; Roebuck and Chang, 2006). A trend, however, was observed: a higher proportion of patients with 30 dB HL improvements in pure-tone average hearing thresholds was measured for the IGF1 group than in that the intra-tympanic steroids group. The difference in changes in pure-tone average hearing thresholds over time between the two treatment groups was found to be statistically significant (p = 0.003). In this trial, no adverse events were observed. The findings of this trial suggest that IGF1 is an effective treatment for SSHL and that IGF1 is a similar or superior therapy compared with intra-tympanic Dex therapy"
Source:
Insulin-like growth factor 1: A novel treatment for the protection or regeneration of cochlear hair cells Kohei Yamahara, Norio Yamamoto* , Takayuki Nakagawa, Juichi Ito Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-
8507, Japan
Ed, you do realize that just because you're not aware of something doesn't mean it doesn't exist, right?