Abstract
BackgroundPoststroke depression is closely related to increased mortality in stroke patients. Compared with antidepressants, electroacupuncture (EA) treatment for poststroke depression (PSD) has relatively more stable effectiveness and can reduce side effects. This trial is designed to provide solid evidence for the efficacy and safety of EA treatment for patients with PSD.Methods/designThis ongoing study is a single-blind, single-center, parallel group, randomized controlled trial. Sixty-two participants will be recruited from Shanghai Shuguang Hospital and randomized into either the EA group or the sham EA group. Baihui, Sishencong, Ganshu, Sanyinjiao, and Taichong are selected as the treatment acupoints in both groups. The EA group will receive the traditional EA treatment with de-qi sensation, and the sham EA group will receive sham EA treatment without needle penetration and electrostimulation. Participants will receive treatment 3 times per week for a total of 12 sessions over 4 weeks. The primary outcome is Hamilton Rating Scale for Depression score, and the secondary outcomes are scores on the Zung Self-Rating Depression Scale, National Institutes of Health Stroke Scale, Barthel Index of Activities of Daily Living, and Depression Scale of traditional Chinese medicine. All of the outcome measures will be assessed at baseline, 2 weeks after EA treatment onset, 4 weeks after treatment onset, and at 8-week follow-up. Safety assessments will be done at each visit.DiscussionThe results of this trial will demonstrate the efficacy and safety of EA treatment for PSD with credible and important clinical evidence, thus supporting EA treatment as an ideal choice for PSD treatment.Trial registrationChinese Clinical Trial Registry, ChiCTR-IOR-17012610. Registered on 7 September 2017. http://www.chictr.org.cn/edit.aspx?pid=21494&htm=4
Highlights
Poststroke depression is closely related to increased mortality in stroke patients
It has been widely verified that the use of antidepressants in patients with poststroke depression (PSD) has an increased risk of adverse events (AEs) that may lead to other problems, including blurry vision, urinary retention, hypotension, sexual dysfunction, tremor, and severe insomnia [4]
Previous trials have verified the effect of acupuncture on alleviating PSD
Summary
Previous trials have verified the effect of acupuncture on alleviating PSD. most of those trials were designed to compare the therapeutic effect between an acupuncture group and a Western medicine group or between groups treated with acupuncture of different types [30,31,32,33,34]. Our present RCT has been designed to use a sham acupuncture method that is based on a Park Sham Device installed with a PG-306 electric pulse generator by which needle penetration and electrostimulation are completely avoided, with the intent being to successfully prevent participants from knowing what their exact treatment is and to which group they belong. In this way can the disturbance of acupuncture treatment’s placebo effect or patients’ psychological factors be effectively reduced.
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