Zhang Yuting, Cao Ziqiong, Ye Junlan, Dai Guoliang, Qin Shan, Wang Xiaoqiu, Wu Wenzhong, Liu Chengyong
Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Front Psychiatry. 2025 Mar 25;16:1499361. doi: 10.3389/fpsyt.2025.1499361. eCollection 2025.
Insomnia is the most prevalent sleep disorder worldwide. Electroacupuncture is effective in improving sleep quality, daytime fatigue status, and anxiety and depression in patients with insomnia, and this study aimed to investigate the metabolic pathways and their possible mechanisms in response to the efficacy of electroacupuncture in the treatment of insomnia.
A single-center, double-blind, clinical trial was the study's design. For this study, a total of 99 participants were enrolled, and they will be split into two groups: one for insomnia and the other for health. There are 33 healthy people in the healthy group and 66 insomnia patients in the insomnia group. Acupuncture treatment will be administered to the intervention group three times a week for four weeks, for a total of twelve treatments, and will be followed up for 3 months. A combination of UPLC-Q/TOF-MS and UPLC-QQQ-MS/MS was used to qualitatively and quantitatively examine the serum of 99 participants. The Pittsburgh Sleep Quality Index (PSQI) and serum metabolomics provided the primary findings. The Insomnia Severity Index (ISI), Hyperarousal Scale (HAS), Fatigue Feverity Scale (FSS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Sleep Diary and The Montreal Cognitive Assessment (MoCA) were the secondary outcomes. For the insomnia group, serum will be collected at baseline, at the end of treatment, and the scale will be collected at baseline, after 4 weeks of treatment, and at 3 months of follow-up. For the healthy group, serum will be collected at baseline.
This study aimed to assess the modulatory effects of electroacupuncture on relevant metabolic markers using serum metabolomics, to explore the potential mechanisms and relevant metabolic pathways of electroacupuncture for the treatment of insomnia, and to provide strong scientific evidence for the treatment of insomnia by electroacupuncture.
ChiCTR2400085660 (China Clinical Trial Registry, http://www.chictr.org.cn, registered on June 14, 2024).
失眠是全球最普遍的睡眠障碍。电针在改善失眠患者的睡眠质量、日间疲劳状态以及焦虑和抑郁方面有效，本研究旨在探讨电针治疗失眠疗效相关的代谢途径及其可能机制。
本研究采用单中心、双盲临床试验设计。共纳入99名参与者，分为两组：一组为失眠组，另一组为健康组。健康组有33名健康人，失眠组有66名失眠患者。干预组每周接受3次针刺治疗，共4周，总计12次治疗，并进行3个月的随访。采用超高效液相色谱-四极杆飞行时间质谱联用仪（UPLC-Q/TOF-MS）和超高效液相色谱-三重四极杆质谱联用仪（UPLC-QQQ-MS/MS）对99名参与者的血清进行定性和定量检测。匹兹堡睡眠质量指数（PSQI）和血清代谢组学提供主要研究结果。失眠严重程度指数（ISI）、觉醒量表（HAS）、疲劳严重程度量表（FSS）、汉密尔顿抑郁量表（HAMD）、汉密尔顿焦虑量表（HAMA）、睡眠日记和蒙特利尔认知评估量表（MoCA）为次要研究结果。对于失眠组，在基线、治疗结束时采集血清，在基线、治疗4周后和随访3个月时采集量表数据。对于健康组，在基线时采集血清。
本研究旨在利用血清代谢组学评估电针对相关代谢标志物的调节作用，探索电针治疗失眠的潜在机制和相关代谢途径，为电针治疗失眠提供有力的科学依据。
ChiCTR2400085660（中国临床试验注册中心，http://www.chictr.org.cn，于2024年6月14日注册）
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