Effectiveness of Tinnitan Duo® in Subjective Tinnitus with Emotional Affectation: A Prospective, Interventional Study.

To assess the effectiveness of a food supplement (Tinnitan Duo®) containing 5-hydroxytryptophan, , magnesium, melatonin, vitamin B5 and B6, and zinc at improving tinnitus response and intensity. Prospective, single-center interventional study including patients with subjective tinnitus and emotional affectation. The primary endpoint was the change in the Tinnitus Handicap Inventory (THI) total score and the emotional subscale after 3 months of treatment. Secondary endpoints were the change from baseline to month 3 in (1) the Tinnitus Distress Rating (TDR) scale, and (2) in hearing status, and the safety profile of patients throughout the study. Sixty-one patients were included, and 29 completed the study. The THI total score was significantly reduced after 3 months of treatment in the per-protocol (PP, all the patients with no major protocol deviations) and intention-to-treat (ITT) populations (-15.7 and -7.5, respectively;  = 0.001). The emotional subscale score significantly decreased after 3 months of treatment by -5.6 in the PP ( = 0.001) and by -2.6 in the ITT populations ( = 0.001). Perceived tinnitus loudness significantly decreased after 3 months of treatment ( = 0.001). The audiogram showed no significant changes in hearing status after 3 months of treatment. Of the five adverse events (AEs) reported, all were mild or moderate, and three were related to the study treatment (two headaches and one dizziness). This new food supplement was associated with an improved tinnitus-related emotional affectation and with a good safety profile.