AUDISTIM® 日/夜缓解慢性耳鸣患者与耳鸣相关的障碍:双盲随机安慰剂对照试验。

IF 2.1 Q1 AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY
Didier Portmann, Marie José Esteve-Fraysse, Bruno Frachet, F. Herpin, F. Rigaudier, Christine Juhel
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引用次数: 0

摘要

本研究的目的是根据以往的实际研究,评估每天服用以活性化合物为基础的补充剂(AUDISTIM® Day Night:A D/N)对减轻耳鸣相关残疾的疗效。这项双盲随机安慰剂对照研究的对象是患有轻度至重度耳鸣的成年人,他们将接受为期 3 个月的 A D/N(镁、维生素、植物化学物质)或安慰剂(不含活性成分的辅料)补充剂治疗。在基线和干预期间对耳鸣相关障碍(THI)、心理压力(MSP-9)和睡眠质量(PSQI)进行评估,并在随访结束时对耳鸣改善的感知印象进行评估。全套分析包括 114 名患者(59 名 A D/N,55 名安慰剂),年龄为(53.8 ± 11.4)岁,58% 为女性,患有波动性(45%)或永久性(55%)耳鸣 9.3 ± 9.4 年。补充 D/N 后,THI(-13.2 ± 16.0 vs. -6.2 ± 14.4,p = 0.0158,Cohen's d =0.44)在 3 个月时(主要结果)发生了较大变化,尤其是持续性耳鸣(-15.0 ± 16.3 vs. -6.2 ± 14.4,p = 0.0158,Cohen's d =0.44)。0 ± 16.3 vs. -4.6 ± 12.8,p = 0.0065),1 个月时的改善程度较小(A 为 -9.8 ± 13.1 vs. -4.3 ± 12.1,p = 0.0213)。随着时间的推移,两组患者的 PSQI 均有明显改善,但只有 A D/N 组的 MSP-9 有明显改善。与之前的观察性研究结果一致,临床(THI 评分大于 7 分)和统计(与安慰剂相比)改善在永久性耳鸣中更为明显,这证明了活性化合物组合的有效性,并支持将其用于轻度至重度耳鸣的治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
AUDISTIM® Day/Night Alleviates Tinnitus-Related Handicap in Patients with Chronic Tinnitus: A Double-Blind Randomized Placebo-Controlled Trial.
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.
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来源期刊
Audiology Research
Audiology Research AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY-
CiteScore
2.30
自引率
23.50%
发文量
56
审稿时长
11 weeks
期刊介绍: The mission of Audiology Research is to publish contemporary, ethical, clinically relevant scientific researches related to the basic science and clinical aspects of the auditory and vestibular system and diseases of the ear that can be used by clinicians, scientists and specialists to improve understanding and treatment of patients with audiological and neurotological disorders.
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