ABSTRACT
To assess the effectiveness of a food supplement (Tinnitan Duo®) 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. 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; p = 0.001). The emotional subscale score significantly decreased after 3 months of treatment by -5.6 in the PP (p = 0.001) and by -2.6 in the ITT populations (p = 0.001). Perceived tinnitus loudness significantly decreased after 3 months of treatment (p = 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.
Subject(s)
Tinnitus , Humans , Tinnitus/drug therapy , Tinnitus/complications , Tinnitus/psychology , Prospective Studies , Magnesium , Dietary Supplements , ZincABSTRACT
Presentamos un estudio piloto para evaluar la eficacia de la suspensión estática facial con las suturas Silhouette. Operamos con esta técnica a una paciente con parálisis facial total y completa secundaria a una tuberculosis ótica. Actualmente presenta mejoría de su asimetría facial así como de la masticación y habla. Y con ello una recuperación de su autoestima y de su interacción social. La suspensión estática facial con estas suturas es una alternativa a las técnicas dinámicas en los pacientes que no quieren o no pueden someterse a estas cirugías (AU)
We present a pilot study to evaluate the benefit of static facial suspension with Silhouette sutures. We operated on a female patient with complete facial palsy secondary to otic tuberculosis. The patient has currently achieved satisfactory facial symmetry, mastication and speech production. As a result, self-esteem and social interaction have also been recovered. Static facial suspension with Silhouette sutures is an alternative to dynamic techniques in patients who do not wish to or cannot undergo those more complex surgeries (AU)
Subject(s)
Humans , Female , Aged , Facial Paralysis/surgery , Bone Wires , Recovery of Function , Speech Disorders/rehabilitation , Deglutition Disorders/rehabilitationABSTRACT
We present a pilot study to evaluate the benefit of static facial suspension with Silhouette sutures. We operated on a female patient with complete facial palsy secondary to otic tuberculosis. The patient has currently achieved satisfactory facial symmetry, mastication and speech production. As a result, self-esteem and social interaction have also been recovered. Static facial suspension with Silhouette sutures is an alternative to dynamic techniques in patients who do not wish to or cannot undergo those more complex surgeries.
