Cai Wa, Ma Wen, Wang Guan-Tao, Shen Wei-Dong
Department of Acupuncture, Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Trials. 2018 Mar 2;19(1):152. doi: 10.1186/s13063-018-2548-0.
Poststroke 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/DESIGN: This 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.
The 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.
Chinese Clinical Trial Registry, ChiCTR-IOR-17012610. Registered on 7 September 2017. http://www.chictr.org.cn/edit.aspx?pid=21494&htm=4.
中风后抑郁与中风患者死亡率增加密切相关。与抗抑郁药相比，电针治疗中风后抑郁（PSD）疗效相对更稳定，且能减少副作用。本试验旨在为电针治疗PSD患者的疗效和安全性提供确凿证据。
方法/设计：本正在进行的研究为单盲、单中心、平行组随机对照试验。将从上海曙光医院招募62名参与者，随机分为电针组或假电针组。两组均选取百会、四神聪、肝俞、三阴交和太冲作为治疗穴位。电针组将接受有得气感的传统电针治疗，假电针组将接受无针刺和电刺激的假电针治疗。参与者每周接受3次治疗，共4周，总计12次。主要结局指标为汉密尔顿抑郁量表评分，次要结局指标为zung自评抑郁量表、美国国立卫生研究院卒中量表、巴氏日常生活活动指数和中医抑郁量表评分。所有结局指标将在基线、电针治疗开始后2周、治疗开始后4周和8周随访时进行评估。每次就诊时进行安全性评估。
本试验结果将以可靠且重要的临床证据证明电针治疗PSD的疗效和安全性，从而支持电针治疗作为PSD治疗的理想选择。
中国临床试验注册中心，ChiCTR-IOR-17012610。于xxxx年xx月xx日注册。http://www.chictr.org.cn/edit.aspx?pid=21494&htm=4 。 （注：原文中注册时间的英文部分未翻译完整，推测是想让翻译者补充完整准确时间，这里按要求未添加任何解释，保留原文英文注册时间部分等待进一步补充完整信息）
