109568
论文已发表
注册即可获取德孚的最新动态
IF 收录期刊
- 3.4 Breast Cancer (Dove Med Press)
- 3.2 Clin Epidemiol
- 2.6 Cancer Manag Res
- 2.9 Infect Drug Resist
- 3.7 Clin Interv Aging
- 5.1 Drug Des Dev Ther
- 3.1 Int J Chronic Obstr
- 6.6 Int J Nanomed
- 2.6 Int J Women's Health
- 2.9 Neuropsych Dis Treat
- 2.8 OncoTargets Ther
- 2.0 Patient Prefer Adher
- 2.2 Ther Clin Risk Manag
- 2.5 J Pain Res
- 3.0 Diabet Metab Synd Ob
- 3.2 Psychol Res Behav Ma
- 3.4 Nat Sci Sleep
- 1.8 Pharmgenomics Pers Med
- 2.0 Risk Manag Healthc Policy
- 4.1 J Inflamm Res
- 2.0 Int J Gen Med
- 3.4 J Hepatocell Carcinoma
- 3.0 J Asthma Allergy
- 2.2 Clin Cosmet Investig Dermatol
- 2.4 J Multidiscip Healthc
已发表论文
探究经皮耳迷走神经刺激对肥胖患者微生物群-肠-脑轴机制的影响：一项随机对照试验的研究方案
Authors Chen X , Kong W, Song Y, Huang W , Zhang Y, Liu Z, Zhou Z, Fu C
Received 12 August 2025
Accepted for publication 9 October 2025https://www.dovepress.com/article/download/108008
Published 21 October 2025 Volume 2025:18 Pages 3895—3904
DOI https://doi.org/10.2147/DMSO.S558226
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Donald McClain
Xia Chen,1– 3,* Weiqing Kong,4,* Yang Song,5,6,* Wei Huang,1– 3 Yanji Zhang,1– 3 Zhi Liu,1– 3 Zhongyu Zhou,1– 3 Chengwei Fu1– 3
1Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, People’s Republic of China; 2Hubei Provincial Clinical Research Center for Acupuncture and Moxibustion Treatment of Obesity, Wuhan, People’s Republic of China; 3Department of Acupuncture, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, People’s Republic of China; 4College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine, Wuhan, People’s Republic of China; 5Department of Radiology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, People’s Republic of China; 6Department of Radiology, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Zhongyu Zhou; Chengwei Fu, Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, No. 4, Huayanshan, Wuhan, People’s Republic of China, Email 2209447940@qq.com; 405417101@qq.com
Background: Obesity is a common metabolic disorder affecting nearly one-third of the global population. Emerging evidence indicates that the microbiota-gut-brain axis plays a key role in the pathogenesis of obesity. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, may modulate brain function and gut microbiota via vagal pathways. This study aims to evaluate the short-term efficacy of taVNS in reducing body weight in patients with obesity and to explore its underlying mechanisms by assessing changes in neural activity and gut microbial composition.
Methods: This single-center, randomized controlled trial will enroll 74 patients with obesity, who will be randomized in a 1:1 ratio to receive either taVNS (electrical stimulation delivered to the left cymba conchae) or sham taVNS (stimulation at the tail of the helix). The primary outcome will be the percentage change in body weight from baseline to Week 12. Secondary outcomes will include anthropometric measures such as changes in body mass index (BMI), waist circumference, hip circumference, body fat percentage, and visceral fat area. Clinical evaluations will be conducted using validated instruments, including the Impact of Weight on Quality of Life-Lite (IWQOL-Lite), Perceived Stress Scale (PSS), Hamilton Depression Rating Scale (HAMD), Dutch Eating Behavior Questionnaire (DEBQ), International Physical Activity Questionnaire (IPAQ), and the Fatigue Scale-14 (FS-14). To investigate modulation of the microbiota–gut–brain (MGB) axis, assessments will include serum brain–gut peptides, gut microbiota composition, and functional magnetic resonance imaging (fMRI). Adverse events will also be systematically monitored throughout the study period.
Discussion: This study will preliminarily validate the clinical efficacy of taVNS for obesity. And by integrating measures such as gut peptides, microbiota profiling, and brain imaging, it seeks to link therapeutic effects with microbiota-gut-brain axis modulation. The findings may support taVNS as a safe, non-pharmacological approach for obesity management and inform future neuromodulation-based strategies.
Trial Registration Number: ITMCTR2024000518. http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=d4ae9741-2788-433a-9242-a5fe78929bce.
Keywords: obesity, transcutaneous auricular vagus nerve stimulation, randomized controlled trial, microbiota-gut-brain axis, fMRI, gut microbiota
1Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, People’s Republic of China; 2Hubei Provincial Clinical Research Center for Acupuncture and Moxibustion Treatment of Obesity, Wuhan, People’s Republic of China; 3Department of Acupuncture, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, People’s Republic of China; 4College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine, Wuhan, People’s Republic of China; 5Department of Radiology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, People’s Republic of China; 6Department of Radiology, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Zhongyu Zhou; Chengwei Fu, Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, No. 4, Huayanshan, Wuhan, People’s Republic of China, Email 2209447940@qq.com; 405417101@qq.com
Background: Obesity is a common metabolic disorder affecting nearly one-third of the global population. Emerging evidence indicates that the microbiota-gut-brain axis plays a key role in the pathogenesis of obesity. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, may modulate brain function and gut microbiota via vagal pathways. This study aims to evaluate the short-term efficacy of taVNS in reducing body weight in patients with obesity and to explore its underlying mechanisms by assessing changes in neural activity and gut microbial composition.
Methods: This single-center, randomized controlled trial will enroll 74 patients with obesity, who will be randomized in a 1:1 ratio to receive either taVNS (electrical stimulation delivered to the left cymba conchae) or sham taVNS (stimulation at the tail of the helix). The primary outcome will be the percentage change in body weight from baseline to Week 12. Secondary outcomes will include anthropometric measures such as changes in body mass index (BMI), waist circumference, hip circumference, body fat percentage, and visceral fat area. Clinical evaluations will be conducted using validated instruments, including the Impact of Weight on Quality of Life-Lite (IWQOL-Lite), Perceived Stress Scale (PSS), Hamilton Depression Rating Scale (HAMD), Dutch Eating Behavior Questionnaire (DEBQ), International Physical Activity Questionnaire (IPAQ), and the Fatigue Scale-14 (FS-14). To investigate modulation of the microbiota–gut–brain (MGB) axis, assessments will include serum brain–gut peptides, gut microbiota composition, and functional magnetic resonance imaging (fMRI). Adverse events will also be systematically monitored throughout the study period.
Discussion: This study will preliminarily validate the clinical efficacy of taVNS for obesity. And by integrating measures such as gut peptides, microbiota profiling, and brain imaging, it seeks to link therapeutic effects with microbiota-gut-brain axis modulation. The findings may support taVNS as a safe, non-pharmacological approach for obesity management and inform future neuromodulation-based strategies.
Trial Registration Number: ITMCTR2024000518. http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=d4ae9741-2788-433a-9242-a5fe78929bce.
Keywords: obesity, transcutaneous auricular vagus nerve stimulation, randomized controlled trial, microbiota-gut-brain axis, fMRI, gut microbiota