Abstract
INTRODUCTION AND AIM: Generalized anxiety disorder (GAD) is a prevalent mental health condition characterized by excessive, often uncontrollable anxiety, frequently accompanied by autonomic dysfunction symptoms. The gut-microbiota-brain axis is implicated in its pathogenesis. Traditional Chinese medicine therapies, including abdominal massage, are increasingly being considered for GAD treatment. This study is designed to evaluate the therapeutic potential of abdominal massage for GAD and its influence on patients' gut microbiota. MATERIALS AND METHODS: A prospective, assessor-blinded, single-center randomized controlled trial involving 70 GAD patients, randomly allocated to either a combined abdominal massage and medication group or a medication-only group will be conducted. An additional 35 healthy individuals will serve as normal controls. RESULTS: The primary outcome measure will be the Hamilton Anxiety Rating Scale (HAMA) score pre- and post-treatment. Participants will undergo electroencephalogram (EEG) assessments and provide stool samples for gut microbiota evaluation. Differences between GAD patients and healthy controls will be compared, and changes in the two GAD groups pre- and post-treatment will be monitored. Subsequently, the correlation between EEG findings, gut microbiota, and clinical efficacy in GAD patients will be analyzed. CONCLUSION: This study seeks to confirm the therapeutic benefits of abdominal massage for GAD and offer preliminary insights into its underlying mechanisms. Changes in these indicators before and after treatment in both the treatment and control groups will be examined to clarify the potential mechanisms by which abdominal massage may benefit GAD patients. Abdominal massage is hypothesized to alleviate clinical symptoms in GAD patients by modulating the gut-brain axis. If our hypothesis is validated, abdominal massage could emerge as a new alternative treatment for GAD and offer fresh insights into the mechanisms underlying massage therapy. The study's findings will be disseminated through peer-reviewed publications.