Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis.
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis.
复制标题
DOI：
10.1038/s41598-022-25864-1
复制
发表时间：
2022-12-21
影响因子：
4.6
通讯作者：
Fregni, Felipe
中科院分区：
文献类型：
--
作者：
Kim, Angela Yun;Marduy, Anna;de Melo, Paulo S.;Gianlorenco, Anna Carolyna;Kim, Chi Kyung;Choi, Hyuk;Song, Jae-Jun;Fregni, Felipe
经皮耳迷走神经刺激(TaVNS)作为一种新的神经调节工具已被研究。虽然taVNS通常被认为是安全的，只有轻微和短暂的不良反应(AEs)，但那些由taVNS具体引起的不良反应尚未被调查。本研究旨在(1)系统地分析研究特点和不良反应评估，(2)描述和分析可能发生的不良反应及其发生率，(3)寻找可预测的危险因素，(4)分析不良反应的严重程度，(5)提出基于证据的不良事件调查问卷，用于安全监测。搜索的文章发表到2022年4月7日，在Medline、Embase、Web of Science、Cochrane和Lilacs数据库中发表。总的来说，我们评估了177项研究，评估了6322名受试者。在这些研究中，55.37%的研究没有提到任何不良反应的存在或不存在；只有24.86%的研究描述了至少发生过一次不良事件。在报告至少有一种不良事件的受试者数量的35项研究中，使用了荟萃分析方法来计算活动期TAVNS和对照组之间发生不良事件的风险差异。根据100,000人-分钟-天报告的不良事件总数计算荟萃分析的总体不良事件发生率。在活动的taVNS和对照组之间，发生不良事件的风险没有差异。一般来说，耳声发射的发生率为12.84/100,000人-分钟-天，最常见的报告是耳痛、头痛和刺痛。几乎一半的研究没有报告是否存在任何AEs。我们将这归因于那些研究中没有声发射。TAVNS与严重不良事件之间没有因果关系。这是首次系统回顾和荟萃分析经皮耳穴刺激的安全性。总体而言，TAVNS是一种安全可行的临床干预选择。
Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
登录
查看更多内容
影响因子：
5.1
作者：
Ben-Menachem E;Revesz D;Simon BJ;Silberstein S
通讯作者：
Silberstein S
影响因子：
4.3
作者：
Bonaz B;Bazin T;Pellissier S
通讯作者：
Pellissier S
影响因子：
--
作者：
Bursac, Zoran;Gauss, C Heath;Williams, David Keith;Hosmer, David W
通讯作者：
Hosmer, David W
影响因子：
7.7
作者：
Frangos, Eleni;Ellrich, Jens;Komisaruk, Barry R.
通讯作者：
Komisaruk, Barry R.
影响因子：
4.5
作者：
Johnson RL;Wilson CG
通讯作者：
Wilson CG