Clinical effect of abdominal Tuina on patients with generalized anxiety disorder: A randomized controlled study and evaluation of event-related potentials

Abstract

Background Generalized anxiety disorder (GAD) is a highly prevalent disorder that affects patients’ physical and mental health and overall quality of life. GAD is often accompanied by palpitations, chest tightness, muscle tension, restlessness, and other autonomic nervous disorders and symptoms, but its underlying mechanism is incompletely understood. Abdominal Tuina is effective in relieving the clinical symptoms of patients with GAD; therefore, to objectively evaluate the efficacy of abdominal Tuina, which is essential to make appropriate treatment decisions, we will use event-related potentials to assess cognitive function in patients with GAD. Methods We will enroll 114 patients diagnosed with GAD who will be randomly assigned to either the abdominal Tuina or drug group at a 1:1 ratio. The main outcome indicator will be the Hamilton Anxiety Scale (HAMA), while secondary outcome indicators will include the Self-rating Anxiety Scale (SAS), the Traditional Chinese Medicine (TCM) syndrome scale, the Chinese Attention to Positive and Negative Information Scale (APNI), attention to deviation index changes, negative potential (N1), vertex positive potential (VPP) amplitude, and latency. We will use the German Brain Products electroencephalogram (EEG) collection device to perform one EEG session before and after treatment for both the treatment and control groups. Through the changes in N1, VPP amplitude, and the latency of event-related potentials, we will analyze the specific neural mechanism by which abdominal Tuina affects the attention bias of negative stimuli in patients with GAD. Discussion The results of this randomized controlled clinical trial will help to demonstrate the efficacy of abdominal Tuina. Trial registration: ClinicalTrials.gov ChiCTR2300068257. Registered on February 13, 2023.