Effects of electroacupuncture therapy for depression: Study protocol for a multicentered, randomized controlled trial.

ABSTRACT

INTRODUCTION: As a major public health problem, depression has a negative impact on individuals and society. The aim of this well-designed trial is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for depression. METHODS/DESIGN: A 3-arm parallel, nonblinded, randomized controlled trial will be performed in 4 hospitals (centers). A total of 144 participants will be divided into 3 groups EA group, manual acupuncture (MA) group, and western medicine group. Participants in EA group and MA group will receive 12 sessions of acupuncture treatment for 4 weeks. Participants allocated to western medicine group will only take 20 mg fluoxetine orally per day for 4 weeks. The primary outcome is Hamilton Depression Scale. Secondary outcomes are Self-Rating Depression Scale, Depression Scale of traditional Chinese medicine (Depression Scale of Traditional Chinese Medicine), brain fMRI and blood biomarkers including neurotransmitters serotonin, dopamine, noradrenaline, inflammatory cytokines inerleukin (IL)-1ß, tumor necrosis factor-α, IL-6, and neurotrophin BDNF. All the outcomes will be assessed at baseline, 4 weeks after EA treatment onset and 6-month follow-up. DISCUSSION: The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence. TRIAL REGISTRATION Chinese Clinical Trial Registry identifier ChiCTR1900023420. Version 1. Registered on 26 May 2019. http//www.chictr.org.cn/edit.aspx?pid=37621&htm=4.