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

Abstract

To assess the effectiveness of a food supplement (Tinnitan Duo V R ) containing 5-hydroxytryptophan, Ginkgo biloba, 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. Sixtyone 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 (À15.7 and À7.5, respectively; p ¼ 0.001). The emotional subscale score significantly decreased after 3 months of treatment by À5.6 in the PP (p ¼ 0.001) and by À2.6 in the ITT populations (p ¼ 0.001). Perceived tinnitus loudness significantly decreased after 3 months of treatment (p ¼ 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.

Efficacy and safety of post-auricular injection of methylprednisolone sodium succinate and lidocaine in the treatment of acute tinnitus, and its effect on sleep quality

“…The results showed that values of total effectiveness of treatment in the research group after one course of treatment, and after three months of treatment, were significantly higher than those of the reference group. This is consistent with a previous finding which showed that after treatment, there were markedly improved THI scores in the research group and reference group, but with lower scores in the research group [13]. In this study, after treatment, the pure tone threshold and PSQ1 scores of the two groups of patients were significantly decreased, with lower outcomes in the research group than in the reference group.…”

Ginkgo biloba Administered Singly and Combined With Antioxidants in Tinnitus Patients

“…In concurrence, the study conducted by Kim, et al [ 11 ] depicted no significant change in SF-36 scores of patients treated with 160 mg of Ginkgo biloba . Likewise, Knäpper, et al [ 35 ] studied the effect of supplementation of Tinnitan Duo (food supplement, containing 5-hydroxy tryptophan, Ginkgo biloba , magnesium, zinc melatonin, vitamin B5 and B6) in patients with subjective tinnitus and emotional affectation for 3 months. The study resulted in improved emotional affectation and safety profile with no adverse effects.…”

“…THI score was calculated on the basis of three subscales categorized as functional, emotional and catastrophic. Further, as per the grading system, determined by the British Association of Otolaryngologists, Head and Neck Surgeons, THI total score was interpreted and graded into varied levels: very mild (0-16), mild (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36), moderate (38-56), severe (58-76), and catastrophic (78-100) [26]. The present study concluded Ginkgo biloba along with antioxidants was more effective in improving THI and VAS scores in patients as compared to Ginkgo Fig.…”