Bingcong Zhao1, Zhigang Li2, Yuanzheng Wang3, Xuehong Ma4, Xiangqun Wang5, Xueqin Wang6, Yilin Liang7, Xinjing Yang8, Yang Sun2, Meng Song2, Tianwei Guo9, Tuya Bao10, Yutong Fei11. 1. 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. 2. School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029 China. 3. Department of Integrative TCM and Western Medicine, Peking University First Hospital, Xishiku Street 8th, Xicheng District, Beijing, 100034 China. 4. Department of Acupuncture & Moxibustion, Dongfang Hospital, The Second Clinical Medical College of Beijing University of Chinese Medicine, Fengtai District, Beijing, 100078 China. 5. Peking University Sixth Hospital, No. 51, North Huayuan Road, Haidian District, Beijing, 100191 China. 6. Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), No. 51, North Huayuan Road, Haidian District, Beijing, 100191 China. 7. Stritch School of Medicine, Loyola University Chicago, 2160 South First Avenue, Maywood, IL, 60153 USA. 8. School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, 999077 Hong Kong. 9. American Academy of Acupuncture and Oriental Medicine, 1925 County Road B2, Roseville, MN, 55113 USA. 10. School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029 China. Electronic address: tuyab@263.net. 11. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029 China. Electronic address: feiyt@bucm.edu.cn.
Abstract
OBJECTIVES: 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. DESIGN: Pragmatic, parallel, randomized controlled trial. SETTING: 6 hospitals in China. INTERVENTIONS: 6 weeks of manual acupuncture (MA)+selective serotonin reuptake inhibitors (SSRIs), electroacupuncture (EA)+SSRIs, and SSRIs alone. MAIN OUTCOME MEASURES: The primary outcome was response rate of 17-item Hamilton Depression Scale (HAMD-17) total score at 6th week. The secondary outcomes reported in this analysis were HAMD-17 factor scores at 1st, 2nd, 4th, 6th, 10th week and WHO Quality of Life-BREF (WHOQOL-BREF) scores at 6th week. RESULTS:477 patients were randomly assigned into MA + SSRIs (n = 161), EA + SSRIs (n = 160), or SSRIs alone (n = 156) groups. For HAMD-17 (at 6th 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 6th 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). CONCLUSIONS: 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.
RCT Entities:
OBJECTIVES: 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. DESIGN: Pragmatic, parallel, randomized controlled trial. SETTING: 6 hospitals in China. INTERVENTIONS: 6 weeks of manual acupuncture (MA)+selective serotonin reuptake inhibitors (SSRIs), electroacupuncture (EA)+SSRIs, and SSRIs alone. MAIN OUTCOME MEASURES: The primary outcome was response rate of 17-item Hamilton Depression Scale (HAMD-17) total score at 6th week. The secondary outcomes reported in this analysis were HAMD-17 factor scores at 1st, 2nd, 4th, 6th, 10th week and WHO Quality of Life-BREF (WHOQOL-BREF) scores at 6th week. RESULTS: 477 patients were randomly assigned into MA + SSRIs (n = 161), EA + SSRIs (n = 160), or SSRIs alone (n = 156) groups. For HAMD-17 (at 6th 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 6th 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). CONCLUSIONS: 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.