Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial

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=4Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2548-0) contains supplementary material, which is available to authorized users.

Efficacy and safety of electroacupuncture for post-stroke depression: a randomized controlled trial

“…It was considered that an increase of 8.5 points in the EA group relative to the sham EA group would represent a clinically meaningful difference. 23 Considering a 5% false positive error (α = 0.05, two-sided) and 80% power (β = 0.2), the sample size was calculated as (5) verified in the pilot study), a total sample size of at least 64 participants was needed for the trial.…”

The Therapeutic Effect of Electroacupuncture Therapy for Ischemic Stroke

“…Poststroke depression (PSD) is characterized by anxiety, disordered sleep, hopelessness, and lowered responsiveness and is a common stroke complication [ 46 ]. Cai et al show that EA stimulation might be safe and effective for treating poststroke depression (PSD) in clinic [ 8 ]. Acupuncture plus auricular point sticking are effective and safe for poststroke depression (PSD).…”

“…As a relatively feasible, simple, and cheap therapy, it is commonly accepted by stroke patients in clinic [ 7 ]. The clinical effectiveness of EA in stroke rehabilitation has been demonstrated in numerous studies [ 8 – 10 ].…”

Effectiveness and safety of auricular therapy for post-stroke depression

“…In the treatment of PSD, antidepressants such as citalopram, escitalopram, nortriptyline, milnacipran, mirtazapine, piracetam, and fluoxetine are most commonly used. [ 12 ] However, adverse effects of antidepressants were evident, including blurred vision, urinary retention, low blood pressure, sexual dysfunction, tremors, and severe insomnia. [ 13 ] And 1 study showed that up to 60% of patients do not respond adequately to antidepressant treatment.…”