Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial.

Abstract

This randomized open-label trial compared the efficacy and tolerability of vortioxetine (15mg/daily) with different antidepressants in the treatment of patients with burning mouth syndrome (BMS). One and hundred fifty BMS patients were randomized into five groups and treated with either vortioxetine, paroxetine (20mg/daily), sertraline (50mg/daily), escitalopram (10mg/daily) or duloxetine (60mg/daily). The Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E) were performed at baseline and after 2, 4, 6, and 12months of treatment. Any adverse events (AEs) were tabulated for each group. Descriptive statistics, including the Kruskal-Wallis non-parametric test and the Friedman non-parametric test for median comparisons between different times, were used. All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI-I, and CGI-E scores in the long-term (p<.001). However, the response rate of the vortioxetine group showed a significant reduction after six months. The medians, after 6months, were as follows: VAS 0.0; T-PRI 2.0; HAM-A 7.0; HAM-D 7.0; CGI-I 1.0; and CGI-E 1.0 with a lower incidence of AEs (p<.019). Vortioxetine was efficacious with a shorter latency of action and fewer AEs compared with other ADs.