Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial
Suzhen Chen,1,2 Zhi Xu,1,2 Yinghui Li,1,2 Tianyu Wang,1,2 Yingying Yue,1,2 Zhenghua Hou,1,2 Linlin You,1,2 Na Lu,1,2 Yingying Yin,1,2 Xiaoyun Liu,1,2 Liangliang Tan,1,2 Houcheng Ji,3 Yaoran Shi,1,2 Xiaoyun Xin,1,2 Wenhao Jiang,1,2 Yonggui Yuan1,2 1Department of Psychosomatics and Psychiatry, ZhongDa...
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Dove Medical Press
2022-03-01
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| Series: | Neuropsychiatric Disease and Treatment |
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| Online Access: | https://www.dovepress.com/clinical-efficacy-of-the-chinese-herbal-medicine-shumian-capsule-for-i-peer-reviewed-fulltext-article-NDT |
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| author | Chen S Xu Z Li Y Wang T Yue Y Hou Z You L Lu N Yin Y Liu X Tan L Ji H Shi Y Xin X Jiang W Yuan Y |
| author_facet | Chen S Xu Z Li Y Wang T Yue Y Hou Z You L Lu N Yin Y Liu X Tan L Ji H Shi Y Xin X Jiang W Yuan Y |
| author_sort | Chen S |
| collection | DOAJ |
| description | Suzhen Chen,1,2 Zhi Xu,1,2 Yinghui Li,1,2 Tianyu Wang,1,2 Yingying Yue,1,2 Zhenghua Hou,1,2 Linlin You,1,2 Na Lu,1,2 Yingying Yin,1,2 Xiaoyun Liu,1,2 Liangliang Tan,1,2 Houcheng Ji,3 Yaoran Shi,1,2 Xiaoyun Xin,1,2 Wenhao Jiang,1,2 Yonggui Yuan1,2 1Department of Psychosomatics and Psychiatry, ZhongDa Hospital, School of Medicine, Southeast University, Nanjing, People’s Republic of China; 2Institute of Psychosomatics, School of Medicine, Southeast University, Nanjing, People’s Republic of China; 3Department of Psychiatry, The Second People’s Hospital of Jiangning District, Nanjing, People’s Republic of ChinaCorrespondence: Yonggui Yuan, Department of Psychosomatics and Psychiatry, ZhongDa Hospital, School of Medicine, Southeast University, No. 87 Dingjiaqiao, Gulou District, Nanjing, 210009, People’s Republic of China, Tel +86-25-83285124, Email yygylh2000@sina.comPurpose: Shumian capsule (SMC) is a patent Chinese herbal medicine that can soothe the liver and relieves depression, quiet the spirit. Here, we aimed to investigate the efficacy of SMC for treating insomnia using both scales and polysomnography (PSG).Patients and Methods: A randomized, double-blind, placebo-controlled trial was performed. Twenty-six insomnia patients randomly received SMC (n = 11) or placebo (n = 15) for four weeks. Pittsburgh Sleep Quality Inventory (PSQI), Insomnia Severity Index (ISI), 9-items Patient Health Questionnaire (PHQ-9), 7-items Generalized Anxiety Disorder (GAD-7), 17-item Hamilton Depression Rating Scale (HAMD-17), and Hamilton Anxiety Rating Scale (HAMA) were applied at the baseline and the 2nd, 4th week after treatment. Treatment Emergent Symptom Scale was used to assess adverse reactions. We used PSG to record and analyze sleep features at baseline and after four weeks.Results: PSQI, ISI, PHQ-9, HAMD-17, and HAMA scores decreased significantly after SMC treatment. Also, the total sleep time, rapid-eye-movement (REM) sleep latency, stage 2 sleep, deep sleep, REM sleep, and sleep efficiency improved significantly after SMC treatment. In the placebo group, the only significant change was the decrease of PHQ-9 at week-2. Furthermore, both SMC and placebo reported no adverse events.Conclusion: SMC could safely improve sleep quality with depression and anxiety remission in insomnia patients.Keywords: Chinese herbal medicine, shumian capsule, insomnia, polysomnography, clinical trial, randomized and double-blind method |
| first_indexed | 2024-04-13T16:40:56Z |
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| institution | Directory Open Access Journal |
| issn | 1178-2021 |
| language | English |
| last_indexed | 2024-04-13T16:40:56Z |
| publishDate | 2022-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Neuropsychiatric Disease and Treatment |
| spelling | doaj.art-7f99d1c4cc7540c6bd58a7a80bb7658b2022-12-22T02:39:14ZengDove Medical PressNeuropsychiatric Disease and Treatment1178-20212022-03-01Volume 1866967973996Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled TrialChen SXu ZLi YWang TYue YHou ZYou LLu NYin YLiu XTan LJi HShi YXin XJiang WYuan YSuzhen Chen,1,2 Zhi Xu,1,2 Yinghui Li,1,2 Tianyu Wang,1,2 Yingying Yue,1,2 Zhenghua Hou,1,2 Linlin You,1,2 Na Lu,1,2 Yingying Yin,1,2 Xiaoyun Liu,1,2 Liangliang Tan,1,2 Houcheng Ji,3 Yaoran Shi,1,2 Xiaoyun Xin,1,2 Wenhao Jiang,1,2 Yonggui Yuan1,2 1Department of Psychosomatics and Psychiatry, ZhongDa Hospital, School of Medicine, Southeast University, Nanjing, People’s Republic of China; 2Institute of Psychosomatics, School of Medicine, Southeast University, Nanjing, People’s Republic of China; 3Department of Psychiatry, The Second People’s Hospital of Jiangning District, Nanjing, People’s Republic of ChinaCorrespondence: Yonggui Yuan, Department of Psychosomatics and Psychiatry, ZhongDa Hospital, School of Medicine, Southeast University, No. 87 Dingjiaqiao, Gulou District, Nanjing, 210009, People’s Republic of China, Tel +86-25-83285124, Email yygylh2000@sina.comPurpose: Shumian capsule (SMC) is a patent Chinese herbal medicine that can soothe the liver and relieves depression, quiet the spirit. Here, we aimed to investigate the efficacy of SMC for treating insomnia using both scales and polysomnography (PSG).Patients and Methods: A randomized, double-blind, placebo-controlled trial was performed. Twenty-six insomnia patients randomly received SMC (n = 11) or placebo (n = 15) for four weeks. Pittsburgh Sleep Quality Inventory (PSQI), Insomnia Severity Index (ISI), 9-items Patient Health Questionnaire (PHQ-9), 7-items Generalized Anxiety Disorder (GAD-7), 17-item Hamilton Depression Rating Scale (HAMD-17), and Hamilton Anxiety Rating Scale (HAMA) were applied at the baseline and the 2nd, 4th week after treatment. Treatment Emergent Symptom Scale was used to assess adverse reactions. We used PSG to record and analyze sleep features at baseline and after four weeks.Results: PSQI, ISI, PHQ-9, HAMD-17, and HAMA scores decreased significantly after SMC treatment. Also, the total sleep time, rapid-eye-movement (REM) sleep latency, stage 2 sleep, deep sleep, REM sleep, and sleep efficiency improved significantly after SMC treatment. In the placebo group, the only significant change was the decrease of PHQ-9 at week-2. Furthermore, both SMC and placebo reported no adverse events.Conclusion: SMC could safely improve sleep quality with depression and anxiety remission in insomnia patients.Keywords: Chinese herbal medicine, shumian capsule, insomnia, polysomnography, clinical trial, randomized and double-blind methodhttps://www.dovepress.com/clinical-efficacy-of-the-chinese-herbal-medicine-shumian-capsule-for-i-peer-reviewed-fulltext-article-NDTchinese herbal medicineshumian capsuleinsomniapolysomnographyclinical trialrandomized and double-blind method |
| spellingShingle | Chen S Xu Z Li Y Wang T Yue Y Hou Z You L Lu N Yin Y Liu X Tan L Ji H Shi Y Xin X Jiang W Yuan Y Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial Neuropsychiatric Disease and Treatment chinese herbal medicine shumian capsule insomnia polysomnography clinical trial randomized and double-blind method |
| title | Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_full | Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_fullStr | Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_full_unstemmed | Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_short | Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_sort | clinical efficacy of the chinese herbal medicine shumian capsule for insomnia a randomized double blind placebo controlled trial |
| topic | chinese herbal medicine shumian capsule insomnia polysomnography clinical trial randomized and double-blind method |
| url | https://www.dovepress.com/clinical-efficacy-of-the-chinese-herbal-medicine-shumian-capsule-for-i-peer-reviewed-fulltext-article-NDT |
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