The central response of electroacupuncture for anxiety in people with obesity based on resting-state functional magnetic resonance imaging: a protocol for a randomized, blinded, sham-controlled trial

Abstract

Introduction Obesity is a problem that is increasing worldwide and anxiety is a major psychological disorder associated with obesity. Electroacupuncture (EA) has been proved to be a feasible treatment for obesity and anxiety respectively in clinical practice. However, to date, there are no data on EA's effectiveness on anxiety for people with obesity. Therefore, this study aims to evaluate the efficacy and safety of EA for anxiety in people with obesity, and to observe the brain functional status of patients and the intervention effects of EA on brain function by functional magnetic resonance imaging (fMRI). Methods and analysis This study is a randomized, blinded, sham-controlled and clinical trial. 72 obesity patients from two hospitals with anxiety will be randomly divided into EA group and control group in 1:1 ratio by using a random number table. Patients in EA group will receive EA treatment at specific acupoints with penetrating needling for 8 weeks. The control group will receive Park's acupuncture with non-penetrating needling. Weight, waist, BMI (Body Mass Index), SAS (Self-rating Anxiety Scale), STAI (State-Trait Anxiety Inventory) and PSQI (Pittsburgh Sleep Quality Index) will be performed before, after 8-week treatments and at one-month follow-up in patients. Objective metabolic parameters such as triglyceride, total cholesterol, fasting blood glucose, ghrelin, leptin, cortisol and adrenocorticotropic hormone will also be detected before and after 8-week intervention. 20 patients will be randomly selected from EA group and control group, respectively, before treatment, and 20 paired healthy participants will be recruited at the same time. The 20 patients will be scanned by fMRI before and after treatment while the other 20 healthy participants will be scanned only at baseline. Regional homogeneity, amplitude of low-frequency fluctuation and resting-state-functional-connectivity will be carried out to compare the dysfunctional brain regions between patients and healthy participants, as well as the differences between two groups of patients after treatment. Ethics and dissemination The study protocol has been approved by the Hospital Ethics Committee of Second Affiliated Hospital of Anhui University of Chinese Medicine (2023-zj-42). Informed consent will be obtained prior to starting study-ralated procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences. Trail Registration number Chinese Clinical Trail Registry. ChiCTR2400083594, registered 29 April 2024. Keywords: Electro-acupuncture, Obesity, Anxiety, Randomized controlled trial