Efficacy of Nortriptyline-Topiramate and Verapamil-Paroxetine in Tinnitus Management: A Randomized Placebo-Controlled Trial.

IF 2.6 3区医学 Q1 OTORHINOLARYNGOLOGY

Otolaryngology- Head and Neck Surgery Pub Date : 2024-11-26 DOI:10.1002/ohn.1063

Mehdi Abouzari, Karen Tawk, Joshua K Kim, Eva D Larson, Harrison W Lin, Hamid R Djalilian

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引用次数: 0

Abstract

Objective: To evaluate the efficacy of 2 drug combinations on tinnitus severity and associated stress, depression, sleep, and anxiety.

Study design: A randomized, double-blind, placebo-controlled clinical trial conducted between 2019 and 2023 for an 8-week duration.

Setting: Single institution tertiary care center.

Methods: The study recruited adult patients with moderate to severe tinnitus for 6 months or more. In total, 81 patients were assessed for eligibility, 78 were enrolled and randomized, and 67 were included in the per-protocol analysis. Patients were randomized into 3 groups (1:1:1). Group NT received nortriptyline-topiramate, group VP received verapamil-paroxetine, and group P received placebo.

Results: A total of 19 patients in group NT, 22 in group VP, and 26 patients in group P were included in the per-protocol analysis. In group NT, the Tinnitus Functional Index (TFI) score decreased from 58.4 ± 13.9 (baseline) to 46.3 ± 17.5 (end-of-trial) (P < .001). Similarly, in group VP, the TFI score decreased from 54.6 ± 17.5 to 42.2 ± 16.1 (P = .004). However, group P did not demonstrate any significant decrease in the TFI score from 51.2 ± 18.6 to 45.2 ± 20.1 (P = .086). The between-arm analysis did not yield any statistical significance decrease in the TFI score (analysis of variance, P = .265).

Conclusion: Both combinations of drugs were promising in improving tinnitus severity. However, larger-scale trials with longer follow-up periods are warranted to validate our findings between groups.

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去甲替林-托吡酯和维拉帕米-帕罗西汀治疗耳鸣的疗效：随机安慰剂对照试验》。

研究目的评估两种药物组合对耳鸣严重程度及相关压力、抑郁、睡眠和焦虑的疗效：随机、双盲、安慰剂对照临床试验，时间为 2019 年至 2023 年，为期 8 周：单一机构三级医疗中心：研究招募了患有中度至重度耳鸣 6 个月或以上的成年患者。共有81名患者接受了资格评估，78名患者入组并进行了随机分组，67名患者纳入了每方案分析。患者被随机分为 3 组（1:1:1）。NT组接受去甲替林-托吡酯治疗，VP组接受维拉帕米-帕罗西汀治疗，P组接受安慰剂治疗：结果：共有 19 名 NT 组患者、22 名 VP 组患者和 26 名 P 组患者接受了按方案分析。NT组的耳鸣功能指数（TFI）从基线（58.4±13.9）分降至试验结束（46.3±17.5）分（P 结论：两种药物的联合治疗均有望改善患者的耳鸣功能：两种药物组合都有望改善耳鸣的严重程度。然而，需要进行更大规模的试验和更长的随访期，以验证我们在不同组别之间的研究结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Otolaryngology- Head and Neck Surgery 医学-耳鼻喉科学

CiteScore

6.70

自引率

2.90%

发文量

250

审稿时长

2-4 weeks

期刊介绍： Otolaryngology–Head and Neck Surgery (OTO-HNS) is the official peer-reviewed publication of the American Academy of Otolaryngology–Head and Neck Surgery Foundation. The mission of Otolaryngology–Head and Neck Surgery is to publish contemporary, ethical, clinically relevant information in otolaryngology, head and neck surgery (ear, nose, throat, head, and neck disorders) that can be used by otolaryngologists, clinicians, scientists, and specialists to improve patient care and public health.