School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029 China; Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No.23, Art Gallery Backstreet, Dongcheng District, Beijing, 100010 China.
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029 China.
Complement Ther Med. 2019 Aug;45:295-302. doi: 10.1016/j.ctim.2019.03.015. Epub 2019 Mar 27.
To explore the effects of acupuncture (manual acupuncture or electroacupuncture) combined with SSRIs for moderate to severe depression improving major clinical symptoms and life quality of the patients on secondary outcomes.
Pragmatic, parallel, randomized controlled trial.
6 hospitals in China.
6 weeks of manual acupuncture (MA)+selective serotonin reuptake inhibitors (SSRIs), electroacupuncture (EA)+SSRIs, and SSRIs alone.
The primary outcome was response rate of 17-item Hamilton Depression Scale (HAMD-17) total score at 6 week. The secondary outcomes reported in this analysis were HAMD-17 factor scores at 1, 2, 4, 6, 10 week and WHO Quality of Life-BREF (WHOQOL-BREF) scores at 6 week.
477 patients were randomly assigned into MA + SSRIs (n = 161), EA + SSRIs (n = 160), or SSRIs alone (n = 156) groups. For HAMD-17 (at 6 week), the MA + SSRIs group was significantly better than the SSRIs alone group in retardation factor (p = 0.008), while the EA+SSRIs group was significantly better than the SSRIs alone group in anxiety/somatization factor (p<0.001) and sleep disturbance factor (p = 0.002). For WHOQOL-BREF (at 6 week), the EA + SSRIs group, compared with the SSRIs alone group, produced a more significant improvement in the overall quality of life, general health, physical health, and psychological health (p<0.05). While, the MA + SSRIs group, compared to the SSRIs alone group, showed significant advantage only in psychological health (p = 0.023).
Either MA or EA combined SSRIs treatment could improve symptoms and quality of life for patients with moderate to severe depression. The main limitation of this trial was not using a sham control therefore the placebo effect could not be excluded.
探索针刺（手动针刺或电针）联合选择性 5-羟色胺再摄取抑制剂（SSRIs）治疗中重度抑郁症对次要结局的影响，改善患者的主要临床症状和生活质量。
实用、平行、随机对照试验。
中国 6 家医院。
6 周的手动针刺（MA）+选择性 5-羟色胺再摄取抑制剂（SSRIs）、电针（EA）+SSRIs 和 SSRIs 单独治疗。
主要结局为 17 项汉密尔顿抑郁量表（HAMD-17）总分在 6 周时的反应率。本分析报告的次要结局包括 HAMD-17 因子评分在 1、2、4、6 和 10 周时和世界卫生组织生活质量简表（WHOQOL-BREF）在 6 周时的评分。
477 例患者被随机分为 MA+SSRIs 组（n=161）、EA+SSRIs 组（n=160）或 SSRIs 单独组（n=156）。对于 HAMD-17（在 6 周时），MA+SSRIs 组在迟滞因子上明显优于 SSRIs 单独组（p=0.008），而 EA+SSRIs 组在焦虑/躯体化因子（p<0.001）和睡眠障碍因子（p=0.002）上明显优于 SSRIs 单独组。对于 WHOQOL-BREF（在 6 周时），与 SSRIs 单独组相比，EA+SSRIs 组在总体生活质量、一般健康、身体健康和心理健康方面的改善更为显著（p<0.05）。而 MA+SSRIs 组与 SSRIs 单独组相比，仅在心理健康方面具有显著优势（p=0.023）。
无论是 MA 还是 EA 联合 SSRIs 治疗都可以改善中重度抑郁症患者的症状和生活质量。本试验的主要局限性是没有使用假对照，因此不能排除安慰剂效应。
