Abstract
OBJECTIVE: To evaluate the efficacy of 2 drug combinations on tinnitus severity and associated stress, depression, sleep, and anxiety. STUDY DESIGN: A randomized, double-blind, placebo-controlled clinical trial conducted between 2019 and 2023 for an 8-week duration. SETTING: Single institution tertiary care center. METHODS: The study recruited adult patients with moderate to severe tinnitus for 6 months or more. In total, 81 patients were assessed for eligibility, 78 were enrolled and randomized, and 67 were included in the per-protocol analysis. Patients were randomized into 3 groups (1:1:1). Group NT received nortriptyline-topiramate, group VP received verapamil-paroxetine, and group P received placebo. RESULTS: A total of 19 patients in group NT, 22 in group VP, and 26 patients in group P were included in the per-protocol analysis. In group NT, the Tinnitus Functional Index (TFI) score decreased from 58.4 ± 13.9 (baseline) to 46.3 ± 17.5 (end-of-trial) (P < .001). Similarly, in group VP, the TFI score decreased from 54.6 ± 17.5 to 42.2 ± 16.1 (P = .004). However, group P did not demonstrate any significant decrease in the TFI score from 51.2 ± 18.6 to 45.2 ± 20.1 (P = .086). The between-arm analysis did not yield any statistical significance decrease in the TFI score (analysis of variance, P = .265). CONCLUSION: Both combinations of drugs were promising in improving tinnitus severity. However, larger-scale trials with longer follow-up periods are warranted to validate our findings between groups.