Efficacy and Safety of Electroacupuncture Through Nerve Stimulation in Patients With Anxiety Disorders: Protocol for a Randomized, Assessor-Blind, Three-Arm, Parallel-Group Clinical Trial.

BACKGROUND

Anxiety disorders are among the most common mental health disorders, affecting a significant portion of the population. However, conventional treatments, such as pharmacotherapy and psychotherapy, often have limited effectiveness and may lead to undesirable side effects. Consequently, there is a growing demand for new alternative treatments for anxiety disorders. Recent studies suggest that electroacupuncture may demonstrate therapeutic effects in managing anxiety by mediating nerve stimulation.

OBJECTIVE

This study is designed to assess the efficacy and safety of electroacupuncture in treating anxiety disorders through nerve stimulation. Specifically, it will involve stimulating the median nerve at the PC6 acupoint (Neiguan) and the vagus nerve at the TF4 acupoint (Shenmen of ear acupuncture).

METHODS

This study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. Participants will include patients diagnosed with social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. Eligible participants will be randomly assigned to one of the 3 groups, with each group containing 20 individuals. The electroacupuncture groups will receive treatments at the designated acupoints twice weekly for 8 weeks, totaling 16 sessions. The control group will receive usual care without any treatment interventions through the end of the study period. The primary outcome is the comparison of Hamilton Anxiety Rating Scale scores between the treatment groups and the control group. Secondary outcomes include scores on the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory-II, Patient Health Questionnaire-15, World Health Organization Quality of Life Assessment Instrument abbreviated version, Penn State Worry Questionnaire, Panic Disorder Severity Scale, and Leibowitz Social Anxiety Scale. Safety evaluation variables include the frequency of adverse events, vital signs, and suicide risk assessment. Exploratory variables include performance on the Emotional Reactivity Test, empathy quotient, and heart rate variability.

RESULTS

The first participant was enrolled on December 15, 2022. As of October 2024, a total of 60 participants have been fully registered, and the intervention is currently in progress. We expect the completion of this trial to occur within the year 2025.

CONCLUSIONS

In this study, we will evaluate the safety and efficacy of electroacupuncture for anxiety disorders. By elucidating the therapeutic mechanisms of electroacupuncture through nerve stimulation, this study will provide clinical evidence to support the development of potential interventions for patients with anxiety disorders.

TRIAL REGISTRATION

Clinical Research Information Service of the Republic of Korea KCT0008378; https://cris.nih.go.kr/cris/search/detailSearch.do/24503.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68166.