Benefits of a Natural Dietary Supplement for Tinnitus: An Observational Prospective Exploratory Study

Background/Objectives: The objective of the study was to assess the benefits on quality of life (QoL) of a natural-based dietary supplement in patients with tinnitus. Methods: An observational, prospective and exploratory study was conducted in 30 patients (mean age 50.7 years) diagnosed with tinnitus. The dietary supplement (Otocalm^®) contained L-theanine, Gingko biloba, melatonin, GABA, zinc, selenium and vitamins B3, B6 and B12, and was administered for 90 consecutive days. Clinical assessment included tone verbal audiometry, the Tinnitus Handicap Inventory (THI), the Goldberg anxiety and depression scale (GADS), and a 0-10 mm visual analogue scale (VAS) to score the intensity of tinnitus. Results: The mean THI score decreased from 40.8 at baseline to 30.9 at the end of the study (p = 0.012), and the percentage of patients with THI grade 1 (no handicap) increased from 3.3% to 20%. The mean anxiety score decreased from 4.7 to 3.0 (p = 0.006), and the percentage of patients scoring ≥ 4 in the GADS decreased from 63.3% to 33.3%. Changes in VAS scores and verbal tone audiometry were not observed. A decrease in the mean frequency of tinnitus from 2417.4 Hz to 1603.3 Hz (p = 0.519) was found. The product was safe and well-tolerated. Conclusions: The administration of a natural-based dietary supplement composed of L-theanine, Ginkgo biloba, melatonin, GABA, zinc, selenium, and group B vitamins during 90 days in patients with tinnitus was associated with a significant increase in QoL by reducing tinnitus-associated handicap and anxiety.