PDF(Pubmed)
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.
摘要：
这项研究的目的是评估基于活性化合物（AUDISTIM®DayNight：AD/N）的每日补充剂在减轻耳鸣相关残疾方面的功效，正如以前的现实生活研究所建议的那样。这项双盲随机安慰剂对照研究是在轻度至重度耳鸣的成年人中进行的，接受了3个月的AD/N（镁，维生素,植物化学物质）或安慰剂（不含活性成分的赋形剂）。耳鸣相关障碍（THI），心理压力（MSP-9），在基线和干预期间评估睡眠质量（PSQI），在随访结束时感觉到耳鸣改善的印象。全套分析包括114例患者(59AD/N，55安慰剂）年龄53.8±11.4岁，58%的女性，波动（45％）或永久性（55％）耳鸣从9.3±9.4年。D/N补充导致THI发生更大的变化（-13.2±16.0vs.-6.2±14.4，p=0.0158，科恩d=0.44）在3个月时（主要结果），尤其是持续耳鸣（-15.0±16.3vs.-4.6±12.8，p=0.0065），and,在较小程度上，在1个月时（A与-9.8±13.1-4.3±12.1,p=0.0213)。随着时间的推移，两组的PSQI显著改善，但MSP-9仅带有AD/N。与以前的观察性研究一致，临床(THI评分>7分)和统计学(与安慰剂)改善，在永久性耳鸣中更明显，证明活性化合物组合的有效性，并支持其用于治疗轻度至重度耳鸣。
