Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Erythematotelangiectatic Rosacea: A Randomized Clinical Trial.

IF 11 1区医学 Q1 DERMATOLOGY

JAMA dermatology Pub Date : 2025-10-08 DOI:10.1001/jamadermatol.2025.3796

Jian Li, Jinyu Wei, Mingwang Zhang, Minmin Kong, Lijuan Xie, Mei Wan, Zhifei Pan, Jing Tian, Zuzhen Ou, Shuguang Chen, Aiai Xia, Li Tang, Zhiqiang Song, Jingming Hou, Fei Hao

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引用次数: 0

Abstract

Importance: Treatment of facial flushing and erythema for patients with erythematotelangiectatic rosacea (ETR) is challenging. Transcutaneous auricular vagus nerve stimulation (taVNS) therapy may be beneficial for treating ETR; however, it has not been rigorously evaluated in a randomized clinical trial.

Objective: To evaluate the efficacy of taVNS for ETR compared with sham stimulation (SS).

Design, setting, and participants: Enrollment for this single-center, randomized, double-blind, sham-controlled device clinical trial was initiated in February 2024 and ended in August 2024. The follow-up period ended in February 2025, and data were analyzed in March 2025. Patients with ETR that was accompanied by a Clinician's Erythema Assessment (CEA) score of at least 2 were selected from the Department of Dermatology of Southwest Hospital in China.

Interventions: Patients were allocated to the taVNS group (stimulation pulses at a frequency of 30 Hz and a pulse width of 200 μs for 30 minutes per day) or the SS group at a 1:1 ratio. Both groups received 3 weeks of treatment and 24 weeks of follow-up.

Main outcomes and measures: The primary outcome was CEA score after 3 weeks of treatment. The secondary outcomes included improvements in erythema and facial flushing, sleep disorders, migraine, anxiety, fatigue, and depression, as measured via clinical tools.

Results: Seventy-two participants (67 female individuals [93.1%]; median [IQR] age: 29.5 [24.0-36.0] years) with ETR were randomized into either the taVNS (36 [50.0%]) or SS groups (36 [50.0%]). At 3 weeks, the mean (SD) CEA score was lower in the taVNS group than the SS group (1.56 [0.84] vs 2.47 [0.81]; mean difference, -0.92; 95% CI, -1.3 to -0.53; P < .001). Moreover, taVNS also reduced the severity of anxiety (mean difference, -5.42; 95% CI, -8.11 to -2.73; P < .001) and depression (mean difference, -6.22; 95% CI, -9.69 to -2.75; P < .001). This relief persisted until the follow-up period. The effects on sleep disorders, migraine, and fatigue were consistent with the previously described indicators. Adverse events were not common for taVNS (2 of 36 [5.6%]) and SS (3 of 36 [8.3%]).

Conclusions and relevance: This randomized clinical trial demonstrated that treating ETR with taVNS concurrently ameliorated cutaneous symptoms and systemic comorbidities, and the results suggest that taVNS is a novel therapeutic option for ETR management.

Trial registration: Chinese Clinical Trial Register Identifier: ChiCTR2400080637.

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经皮耳迷走神经刺激治疗红斑毛细血管扩张型酒痤疮：一项随机临床试验。

重要性：红斑毛细血管扩张性酒糟鼻（ETR）患者面部潮红和红斑的治疗是具有挑战性的。经皮耳迷走神经刺激（taVNS）疗法可能有利于治疗ETR；然而，它尚未在随机临床试验中得到严格的评估。目的：比较taVNS与假刺激（SS）治疗ETR的疗效。设计、环境和参与者：这项单中心、随机、双盲、假对照器械临床试验于2024年2月开始招募，并于2024年8月结束。随访期于2025年2月结束，并于2025年3月进行数据分析。选择来自中国西南医院皮肤科且伴有临床医生红斑评估（Clinician’s Erythema Assessment， CEA）评分至少为2分的ETR患者。干预措施：将患者按1:1的比例分为taVNS组（频率为30 Hz，脉宽为200 μs，每天30分钟）和SS组。两组均接受治疗3周，随访24周。主要观察指标：主要观察指标为治疗3周后CEA评分。次要结果包括通过临床工具测量的红斑和面部潮红、睡眠障碍、偏头痛、焦虑、疲劳和抑郁的改善。结果：72名ETR患者（67名女性，占93.1%；中位[IQR]年龄：29.5[24.0-36.0]岁）随机分为taVNS组（36名[50.0%]）和SS组（36名[50.0%]）。在3周时，taVNS组的平均（SD） CEA评分低于SS组(1.56 [0.84]vs 2.47[0.81]；平均差值为-0.92;95% CI, -1.3至-0.53；P结论和相关性：该随机临床试验表明，用taVNS治疗ETR同时改善了皮肤症状和全身合并症，结果表明taVNS是ETR管理的一种新的治疗选择。试验注册：中文临床试验注册号：ChiCTR2400080637。

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来源期刊

JAMA dermatology DERMATOLOGY-

CiteScore

14.10

自引率

5.50%

发文量

300

期刊介绍： JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.