A Multi-Compound Nutraceutical Formulation for Tinnitus Management: A Retrospective Observational Study
Abstract
Tinnitus is a multifactorial condition with limited effective treatment options. Natural compounds have been proposed to modulate molecular pathways potentially involved in its pathophysiology, although clinical evidence remains preliminary. This retrospective observational study, conducted without a control group, evaluated 92 patients receiving a multi-compound nutraceutical (4 capsules/day) containing Auricularia auricula-judae, Curcuma longa, Hericium erinaceus, Ganoderma lucidum, Berberis aristata, and Rosa canina. Tinnitus severity was assessed using the Tinnitus Handicap Inventory (THI) at baseline (T0), 1.5 months (T1), and 3 months (T2). Concurrently, hearing thresholds were evaluated at T0 and T2. Patients were stratified into secondary (Group A; N = 48) and primary (Group B; N = 44) tinnitus. THI scores decreased significantly in both groups over time (p < 0.001), with more than 90% of patients showing improvement. A shift toward lower severity grades was observed, with a reduction in moderate-to-catastrophic tinnitus. A decline in tinnitus grade occurred in 29% of patients, with no cases of worsening. At T2, approximately 30% of patients achieved a clinically relevant improvement (>7-point THI reduction). Hearing thresholds remained stable in both groups. A modest correlation between THI and dB variation was observed in Group A at T2 (r = 0.346; p < 0.05), although this exploratory finding should be interpreted with caution. These preliminary, hypothesis-generating findings suggest that the nutraceutical may represent a supportive option for tinnitus management, particularly in mild-to-moderate cases, with potential benefits for quality of life. However, given the retrospective, uncontrolled design of this study, randomized controlled trials are warranted to confirm these preliminary findings.