Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
BMC Complement Altern Med. 2012 Dec 14;12:255. doi: 10.1186/1472-6882-12-255.
BACKGROUND: Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD) is far from satisfactory. Vagus nerve stimulation (VNS) is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response.This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention. DESIGN: One hundred twenty cases (60 males) of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS) and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period. DISCUSSION: This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of methodologies in clinical trials of acupuncture treatment. TRIALS REGISTRATION: Clinical Trials. ChiCTR-TRC-11001201 http://www.chictr.org/cn/
背景：在社区和医疗保健环境中，抑郁障碍是最常见的精神障碍形式。不幸的是，重度抑郁症（MDD）的治疗远未令人满意。迷走神经刺激（VNS）是一种相对较新且有前途的治疗抑郁障碍的物理治疗方法。VNS 的一个特别吸引人的元素是其在情绪调节方面的长期益处。然而，由于这种干预涉及手术、围手术期风险和潜在的重大副作用，这种治疗方法仅限于那些对药物试验和已建立的重度抑郁症躯体治疗耐受或无反应的治疗抵抗性抑郁症患者。
这项双盲随机临床试验旨在通过引入一种新的刺激耳上迷走神经浅表分支的方法来治疗 MDD，从而克服这些限制。其基本原理是，直接刺激耳区传入迷走神经分布的传入神经纤维，应该产生与经典 VNS 相似的效果，即减轻抑郁症状，而不会带来手术干预的负担。
设计：将 120 例（60 名男性）志愿者轻度和中度抑郁症患者随机分为经皮迷走神经刺激组（tVNS）和假 tVNS 组。治疗期持续 4 个月，在治疗开始和结束时采集所有临床和生理测量值。
讨论：这项研究有可能显著扩展 VNS 治疗 MDD 和其他疾病（包括癫痫、双相情感障碍和病态肥胖）的应用，从而使这些高发性疾病的患者直接受益。此外，这项双盲临床试验的结果将为我们理解穴位特异性和针灸治疗临床试验方法的发展提供新的视角。
试验注册：临床试验。ChiCTR-TRC-11001201 http://www.chictr.org/cn/
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