Bai Lu, Zou Wei, Wang Long, Yu Xueping, Lou Hongjun, Dai Xiaohong, Teng Wei, Yu Weiwei, Li Mingyue, Cao Hongtao, Zheng Lei
Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
The third department of Acupuncture, the First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
Heliyon. 2024 Mar 30;10(7):e28889. doi: 10.1016/j.heliyon.2024.e28889. eCollection 2024 Apr 15.
Mild depression is not just a mental disease, but also a serious and long-term public health issue. It affects the quality of life of patients and can quickly develop into major depression. There are currently no effective drug treatments with high efficacy and few adverse reactions. Acupuncture may be an alternative treatment option. Preliminary experiments and practices have demonstrated that "Tiaoshen" acupuncture improves symptoms in patients who have depression, however the underlying data and method remain unclear at present.
This is a prospective, single-center, single-blind, randomized controlled trial. We plan to recruit 70 participants and randomly assign them to receive "Tiaoshen" acupuncture or traditional acupuncture at a ratio of 1:1. Then, all the participants will receive the appropriate acupuncture treatment for four weeks. The results of the Hamilton Depression Rating Scale (HDSR-24) will serve as the primary outcome, while the results of the Patient Health Questionnaire-9 (PHQ-9) and the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will serve as secondary outcomes. Evaluations will be conducted at baseline, 1, 2, and 4 weeks after treatment initiation, and 1 and 3 months after treatment completion. The safety of the intervention will be evaluated every week using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Treatment Emergent Symptoms Scale (TESS). Serum levels of oxidative stress markers 8-iso-prostaglandin F2α (8-iso-PGF2α), superoxide dismutase (SOD), uric acid (UA), and total bilirubin (TBIL) will be measured at baseline and the end of the treatment. We will conduct a statistical analysis of intention to treat (ITT) and conformance to protocol set (PPS) data.
This research aims to provide high-quality evidence for the efficacy and safety of "Tiaoshen" acupuncture as a treatment for mild depression. In addition, the mechanism through which acupuncture heals mild depression will be investigated.
轻度抑郁症不仅是一种精神疾病，也是一个严重且长期的公共卫生问题。它影响患者的生活质量，并可能迅速发展为重度抑郁症。目前尚无高效且不良反应少的有效药物治疗方法。针灸可能是一种替代治疗选择。初步实验和实践表明，“调神”针法可改善抑郁症患者的症状，但目前其潜在数据和方法仍不明确。
这是一项前瞻性、单中心、单盲、随机对照试验。我们计划招募70名参与者，并按1:1的比例将他们随机分配接受“调神”针法或传统针法治疗。然后，所有参与者将接受为期四周的适当针刺治疗。汉密尔顿抑郁量表（HDSR - 24）的结果将作为主要结局，而患者健康问卷 - 9（PHQ - 9）和世界卫生组织生活质量简表（WHOQOL - BREF）的结果将作为次要结局。评估将在基线、治疗开始后1周、2周和4周以及治疗完成后1个月和3个月进行。使用哥伦比亚自杀严重程度评定量表（C - SSRS）和治疗中出现的症状量表（TESS）每周评估干预措施的安全性。在基线和治疗结束时测量氧化应激标志物8 - 异前列腺素F2α（8 - iso - PGF2α）、超氧化物歧化酶（SOD）、尿酸（UA）和总胆红素（TBIL）的血清水平。我们将对意向性分析（ITT）和符合方案集（PPS）数据进行统计分析。
本研究旨在为“调神”针法治疗轻度抑郁症的疗效和安全性提供高质量证据。此外，还将研究针刺治愈轻度抑郁症的机制。
