Table 4.
Primary and secondary outcomes
| Intratympanic Dex | Topical IGF-1 | P value | |
|---|---|---|---|
| Primary outcome | |||
| Proportion of patients showing hearing recovery at 8 weeks | 53.6% (30/56) | 66.7% (38/57) | 0.109 |
| [95% CI: 39.7–67.0] | [95% CI: 52.9–8.6] | ||
| Complete recovery | 0.0% (0/56) | 3.5% (2/57) | |
| Marked recovery | 16.1% (9/56) | 24.6% (14/57) | |
| Slight recovery | 37.5% (21/56) | 38.6% (22/57) | |
| No recovery | 46.4% (26/56) | 33.3% (19/57) | |
| Secondary outcomes | |||
| Proportion of patients showing hearing recovery at 12 weeks | 55.4% (31/56) | 70.7% (41/58) | 0.066 |
| [95% CI: 41.5–68.7] | [95% CI: 57.3–81.9] | ||
| Complete recovery | 0.0% (0/56) | 5.2% (3/58) | |
| Marked recovery | 21.4% (12/56) | 31.0% (18/58) | |
| Slight recovery | 33.9% (19/56) | 34.5% (20/58) | |
| No recovery | 44.6% (25/56) | 29.3% (17/58) | |
| Proportion of patients showing hearing recovery at 16 weeks | 54.7% (29/53) | 67.9% (36/53) | 0.116 |
| [95% CI: 40.4–68.4] | [95% CI: 53.7–80.1] | ||
| Complete recovery | 0.0% (0/53) | 5.7% (3/53) | |
| Marked recovery | 22.6% (12/53) | 24.5% (13/53) | |
| Slight recovery | 32.1% (17/53) | 37.7% (20/53) | |
| No recovery | 45.3% (24/53) | 32.1% (17/53) | |
| Adverse events | |||
| Serious | 0.0% (0/58) | 0.0% (0/59) | >0.999 |
| Non-serious | 43.1% (25/58) | 35.0% (21/59) | 0.452 |
| Tympanic membrane perforation | 15.5% (9/58) | 0.0% (0/59) | 0.001* |
| Otitis media | 1.7% (1/58) | 6.8% (4/59) | 0.364 |
| Otitis externa | 0.0% (0/58) | 1.7% (1/59) | >0.999 |
| Tinnitus | 8.6% (5/58) | 0.0% (0/59) | 0.027* |
| Nausea/Vomit | 3.4% (2/58) | 3.4% (2/59) | >0.999 |
| Others | 24.1% (14/58) | 30.5% (18/59) | 0.535 |
Asterisks indicate statistical significance with Fisher’s exact test.