Clinical Efficacy of Auricular Vagus Nerve Stimulation in the Treatment of Chronic and Acute Pain: A Systematic Review and Meta-analysis.

IF 4.1 2区 医学 Q1 CLINICAL NEUROLOGY Pain and Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-09 DOI:10.1007/s40122-024-00657-8
Irina T Duff, Rudolf Likar, Christophe Perruchoud, Stefan Kampusch, Markus Köstenberger, Sabine Sator, Caroline Stremnitzer, Andreas Wolf, Stefan Neuwersch-Sommeregger, Alaa Abd-Elsayed
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Abstract

Introduction: Current guidelines for pain treatment recommend a personalized, multimodal and interdisciplinary approach as well as the use of a combination of drug and non-drug therapies. Risk factors for chronification should already be reduced in patients with acute pain, e.g., after surgery or trauma. Auricular vagus nerve stimulation (aVNS) could be an effective non-drug therapy in the multimodal treatment of chronic and acute pain. The aim of this systematic review and meta-analysis is to evaluate the clinical efficacy and safety of aVNS in treating chronic and acute pain conditions.

Methods: A systematic literature search was performed regarding the application of auricular electrical stimulation in chronic and acute pain. Studies were classified according to their level of evidence (Jadad scale), scientific validity and risk of bias (RoB 2 tool) and analyzed regarding indication, method, stimulation parameters, duration of treatment and efficacy and safety. A meta-analysis on (randomized) controlled trials (using different comparators) was performed for chronic and acute pain conditions, respectively, including subgroup analysis for percutaneous (pVNS-needle electrodes) and transcutaneous (tVNS-surface electrodes) aVNS. The visual analog pain scale (VAS) was defined as primary efficacy endpoint.

Results: A total of n = 1496 patients were treated with aVNS in 23 identified and analyzed studies in chronic pain, 12 studies in acute postoperative pain and 7 studies in experimental acute pain. Of these, seven studies for chronic pain and six studies for acute postoperative pain were included in the meta-analysis. In chronic pain conditions, including back pain, migraine and abdominal pain, a statistically significant reduction in VAS pain intensity for active compared to sham aVNS or control treatment with an effect size Hedges' g/mean difference of - 1.95 (95% confidence interval [CI]: - 3.94 to 0.04, p = 0.008) could be shown and a more favorable effect in pVNS compared to tVNS (- 5.40 [- 8.94; - 1.85] vs. - 1.00 [- 1.55; - 0.44]; p = 0.015). In acute pain conditions, single studies showed significant improvements with aVNS, e.g., in kidney donor surgery or tonsillectomy but, overall, a non-statistically significant reduction in VAS pain intensity for active compared to sham aVNS or control with - 0.70 [- 2.34; 0.93] (p = 0.15) could be observed in the meta-analysis. In acute pain results vary greatly between studies depending especially on co-medication and timepoints of assessment after surgery. A significant reduction in analgesics or opiate intake was documented in most studies evaluating this effect in chronic and acute pain. In 3 of the 12 randomized controlled trials in patients with chronic pain, a sustainable pain reduction over a period of up to 12 months was shown. Overall, aVNS was very well tolerated.

Conclusion: This systematic review and meta-analysis indicate that aVNS can be an effective and safe non-drug treatment in patients with specific chronic and acute postoperative pain conditions. Further research is needed to identify the influence of simulation parameters and find optimal and standardized treatment protocols while considering quality-of-life outcome parameters and prolonged follow-up periods. A more standardized approach and harmonization in study designs would improve comparability and robustness of outcomes.

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耳廓迷走神经刺激在治疗慢性和急性疼痛中的临床疗效:系统综述和元分析》(A Systematic Review and Meta-analysis)。
导言:目前的疼痛治疗指南建议采用个性化、多模式和跨学科的方法,并综合使用药物和非药物疗法。对于急性疼痛患者,如手术或创伤后患者,应减少慢性化的风险因素。耳迷走神经刺激疗法(aVNS)是一种有效的非药物疗法,可用于慢性和急性疼痛的多模式治疗。本系统综述和荟萃分析旨在评估耳迷走神经刺激治疗慢性和急性疼痛的临床疗效和安全性:方法:对应用耳穴电刺激治疗慢性和急性疼痛的相关文献进行了系统性检索。根据证据级别(Jadad 量表)、科学有效性和偏倚风险(RoB 2 工具)对研究进行分类,并就适应症、方法、刺激参数、治疗持续时间以及疗效和安全性进行分析。针对慢性疼痛和急性疼痛分别进行了(随机)对照试验(使用不同的比较对象)的荟萃分析,包括经皮(pVNS-针电极)和经皮(tVNS-表面电极)aVNS 的亚组分析。视觉模拟疼痛量表(VAS)被定义为主要疗效终点:结果:在已确定和分析的 23 项慢性疼痛研究、12 项急性术后疼痛研究和 7 项实验性急性疼痛研究中,共有 n = 1496 名患者接受了 aVNS 治疗。其中,7 项慢性疼痛研究和 6 项急性术后疼痛研究被纳入荟萃分析。在慢性疼痛(包括背痛、偏头痛和腹痛)方面,与假的 aVNS 或对照治疗相比,积极的 aVNS 治疗可在统计学上显著降低 VAS 疼痛强度,其效应大小 Hedges' g/mean difference 为 - 1.95(95% 置信区间 [CI]:- 3.94 至 0.04,p = 0.008),与 tVNS 相比,pVNS 的效果更佳(- 5.40 [- 8.94; - 1.85] vs. - 1.00 [- 1.55; - 0.44];p = 0.015)。在急性疼痛方面,有单项研究显示 aVNS 有显著改善,例如在肾脏捐献手术或扁桃体切除术中,但总体而言,与假 aVNS 或对照组相比,主动 aVNS 在 VAS 疼痛强度方面有 - 0.70 [- 2.34; 0.93] (p = 0.15) 的无统计学意义的显著降低。在急性疼痛方面,不同研究的结果差异很大,尤其取决于术后的联合用药和评估时间点。在大多数评估慢性和急性疼痛疗效的研究中,镇痛剂或阿片类药物的摄入量都有明显减少。在 12 项针对慢性疼痛患者的随机对照试验中,有 3 项显示疼痛可在长达 12 个月的时间内持续减轻。总体而言,aVNS 的耐受性非常好:本系统综述和荟萃分析表明,对于特定的慢性和急性术后疼痛患者,aVNS 是一种有效、安全的非药物治疗方法。需要进一步开展研究,以确定模拟参数的影响,并找到最佳的标准化治疗方案,同时考虑生活质量结果参数和延长随访时间。更标准化的方法和统一的研究设计将提高结果的可比性和稳健性。
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来源期刊
Pain and Therapy
Pain and Therapy CLINICAL NEUROLOGY-
CiteScore
6.60
自引率
5.00%
发文量
110
审稿时长
6 weeks
期刊介绍: Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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