# AUDISTIM® Day/Night Alleviates Tinnitus-Related Handicap in Patients with Chronic Tinnitus: A Double-Blind Randomized Placebo-Controlled Trial

## TL;DR

A supplement called AUDISTIM® Day/Night reduced tinnitus-related disability in patients with chronic tinnitus over three months compared to a placebo.

## Contribution

This study provides clinical evidence that a combination of magnesium, vitamins, and phytochemicals alleviates tinnitus-related handicap in a placebo-controlled trial.

## Key findings

- AUDISTIM® Day/Night supplementation led to greater improvement in tinnitus-related handicap (THI) compared to placebo.
- Improvement was more pronounced in patients with permanent tinnitus.
- Psychological stress (MSP-9) improved only in the active treatment group.

## Abstract

The aim of this study is to evaluate the efficacy of taking a daily supplement based on active compounds (AUDISTIM® Day Night: A D/N) in alleviating tinnitus-related disability, as suggested by previous real-life studies. This double-blind randomized placebo-controlled study was conducted in adults with mild to severe tinnitus receiving a 3-month supplementation with A D/N (magnesium, vitamins, phytochemicals) or placebo (excipients without active ingredients). Tinnitus-related handicap (THI), psychological stress (MSP-9), and sleep quality (PSQI) were assessed at baseline and during intervention, perceived impression of tinnitus improvement at the end of the follow-up. The full set analysis included 114 patients (59 A D/N, 55 placebo) aged 53.8 ± 11.4 years, 58% women, with fluctuating (45%) or permanent (55%) tinnitus from 9.3 ± 9.4 years. A D/N supplementation led to greater changes in THI (−13.2 ± 16.0 vs. −6.2 ± 14.4, p = 0.0158, Cohen’s d = 0.44) at 3 months (primary outcome), especially with continuous tinnitus (−15.0 ± 16.3 vs. −4.6 ± 12.8, p = 0.0065), and, to a lesser extent, at 1 month (−9.8 ± 13.1 for A vs. −4.3 ± 12.1, p = 0.0213). PSQI significantly improved over time in both groups, but MSP-9 only with A D/N. In lines with previous observational studies, both clinical (THI score > 7 pts) and statistical (vs. placebo) improvement, more pronounced in permanent tinnitus, demonstrate the effectiveness of the combination of active compounds and support its use in the management of mild to severe tinnitus.