电针对脑卒中后抑郁的疗效和安全性：一项随机对照试验。
Efficacy and safety of electroacupuncture for post-stroke depression: a randomized controlled trial.
机构信息
Department of Acupuncture, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Institute of Acupuncture and Anesthesia, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
Acupunct Med. 2022 Oct;40(5):434-442. doi: 10.1177/09645284221077104. Epub 2022 Mar 2.
OBJECTIVE
The objective of this study is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for post-stroke depression (PSD).
METHODS
This study was a single-center, single-blinded, parallel-arm randomized controlled trial. In total, 65 patients with PSD were randomly allocated into EA and sham EA groups. Treatment was administered at GV20, , SP6, LR3 and BL18 in both groups. The EA group received EA treatment, while the sham EA group received sham EA treatment using the Park device. Treatment was given three times a week for 4 weeks. The primary outcome was the Hamilton Rating Scale for Depression (HRSD). Secondary outcomes included the Zung Self-Rating Depression Scale (SDS), National Institutes of Health Stroke Scale (NIHSS), Barthel Daily Living Index (BI) and depression scale of traditional Chinese medicine (TCM). Primary and secondary outcomes were assessed at baseline, week 2 after treatment, week 4 after treatment and week 8 of follow-up. Safety assessment was conducted at each visit for 4 weeks of treatment.
RESULTS
Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001). Compared with the sham EA group, HRSD scores improved significantly in the EA group at the end of week 2 (F = 31.33, p < 0.001), week 4 (F = 35.58, p < 0.001) and week 8 after treatment onset (F = 25.03, p < 0.001). Similarly, significant improvements were observed in SDS, NIHSS and BI scores. Two participants in the EA group suffered a local hematoma, while no adverse events were reported in the sham EA group.
CONCLUSION
EA appears to be an efficacious and safe treatment for PSD. According to our results, EA may alleviate depressive symptoms, and improve neurological function and capabilities with respect to activities of daily living (ADLs).
TRIAL REGISTRATION NUMBER
ChiCTR-IOR-17012610 (Chinese Clinical Trial Registry).
目的
本研究旨在评估电针（EA）治疗卒中后抑郁（PSD）的疗效和安全性。
方法
这是一项单中心、单盲、平行臂随机对照试验。共纳入 65 例 PSD 患者，随机分为 EA 组和假 EA 组。两组均取 GV20、、SP6、LR3 和 BL18 进行针刺治疗。EA 组给予 EA 治疗，假 EA 组采用 Park 仪给予假 EA 治疗。每周治疗 3 次，共 4 周。主要结局指标为汉密尔顿抑郁量表（HRSD）评分。次要结局指标包括 Zung 抑郁自评量表（SDS）评分、美国国立卫生研究院卒中量表（NIHSS）评分、巴氏日常生活指数（BI）和中医抑郁量表（TCM）评分。于基线、治疗 2 周后、治疗 4 周后及随访 8 周时评估主要和次要结局。在治疗的 4 周内，每次就诊时进行安全性评估。
结果
EA 组针刺治疗前后 HRSD、SDS、NIHSS、BI 和 TCM 量表评分均有显著差异（均 p < 0.001）。与假 EA 组相比，EA 组在治疗后第 2 周（F = 31.33，p < 0.001）、第 4 周（F = 35.58，p < 0.001）及第 8 周（F = 25.03，p < 0.001）时 HRSD 评分显著改善。SDS、NIHSS 和 BI 评分也有显著改善。EA 组有 2 例患者出现局部血肿，假 EA 组无不良事件报告。
结论
EA 治疗 PSD 有效且安全。根据我们的结果，EA 可能减轻抑郁症状，并改善神经功能和日常生活活动能力。
临床试验注册
ChiCTR-IOR-17012610（中国临床试验注册中心）。
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