Randomized controlled trial of prednisone in treating acute subjective tinnitus patients with normal pure-tone thresholds

Abstract

The effectiveness of steroid therapy for acute subjective tinnitus (AST) without sudden hearing loss remains controversial. This randomized controlled trial evaluated the effectiveness of short-term oral prednisone (STOP) in patients with AST. The STOP group received a 14-day tapering prednisone for the initial 14 days, and both groups took Ginkgo biloba extract throughout the 3-month follow-up period. The primary outcome was the 12-week change in Tinnitus Handicap Inventory (THI) scores, assessed via intention-to-treat analysis. At the 12-week follow-up, the STOP medication significant reduced THI scores (-27 · 34 [95% CI, -31 · 14 to -23 · 55]) versus control (-15 · 37 [95% CI, -18 · 5 to -12 · 23]), with a mean difference of -11 · 97 points (95% CI, -16 · 85 to -7·09; p < 0 · 0001). Sensitivity analyses and post hoc analyses corroborated these findings. In summary, the STOP treatment plus Ginkgo biloba could effectively lessen the self-reported tinnitus severity in patients with AST.

Keywords: Clinical neuroscience; Therapeutics.

Graphical abstract

Figure 1

Study profile

Figure 2

Effect of STOP compared with placebo Data in the center of (A and B) present individual participant changes in the THI for the control and STOP group. The box-and-whisker plots show the median (horizontal line within each box), mean (circle), interquartile range (box top and bottom), and maximum and minimum changes in THI (whiskers). The box plots at the far right present between-group changes between baseline and 12 weeks.

Figure 3

Subgroup and post-hoc analysis (A) Prespecified subgroup analyses in terms of a more than 50% THI score reduction from baseline. The forest plot shows the adjusted OR with 95%CI. Left-pointing and right-pointing arrows represent favoring the control or the STOP group, respectively. (B) The rate of change in THI scores among the three conditions of baseline tinnitus duration was analyzed using a one-way analysis of variance (ANOVA) followed by Tukey’s post-hoc analysis (per-protocol population). (C) The rate of change in THI scores among the four types of baseline audiometry curve diagrams was analyzed as 1) flat-type, 2) descending-type, 3) ascending-type, and 4) reverse U-shaped type. Statistical differences between the two groups at given time-points are denoted on the plots by asterisks: ∗p < 0.05, ∗∗p < 0.01, ∗∗∗p < 0.001.