Journal of Oriental Neuropsychiatry (동의신경정신과학회지)

The Korean Society of Oriental Neuropsychiatry (대한한방신경정신과학회)
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Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) for Insomnia Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

불면장애에 대한 천왕보심단의 체계적 문헌 고찰 및 메타분석 연구

  • Sakong, Jong-Won (Department of Oriental Neuropsychiatry, Dong-Eui University Korean Medical Hospital) ;
  • Kim, Dong-Hee (Department of Oriental Neuropsychiatry, Dong-Eui University Korean Medical Hospital) ;
  • Ha, Ji-Won (Department of Oriental Neuropsychiatry, Graduate School of Korean Medicine, Dong-Eui University) ;
  • Cho, Yun-Song (Department of Oriental Neuropsychiatry, Graduate School of Korean Medicine, Dong-Eui University) ;
  • Kim, Bo-Kyung (Department of Oriental Neuropsychiatry, School of Korean Medicine, Dong-Eui University)
  • 사공종원 (동의대학교 부속한방병원 한방신경정신과) ;
  • 김동희 (동의대학교 부속한방병원 한방신경정신과) ;
  • 하지원 (동의대학교 한의과대학원 한방신경정신과교실) ;
  • 조윤송 (동의대학교 한의과대학원 한방신경정신과교실) ;
  • 김보경 (동의대학교 한의과대학 한방신경정신과교실)
  • Received : 2018.11.30
  • Accepted : 2018.12.12
  • Published : 2018.12.31
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Abstract

Objectives: The objective of this study was to provide clinical evidence to support the use of a herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet (TWBXP)) for insomnia. Methods: Randomized controlled trials that verified effects of Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) treating primary insomnia were carried out. A literature search of English, Chinese, Korean databases was also performed. The selected literature were assessed by Risk of Bias (RoB). Results: The total number of selected trials was 13 RCTs. Among the 13 RCTs, 10 were meta-analyzed. The Chinese Classification of Mental Disorders-3 (CCMD-3) was frequently used as the diagnostic criteria for interventions during the analysis of the use of herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) for management of primary insomnia. As for outcome measurement, the effective rate was used. From the Meta-analysis of the studies, it was established that the insomnia cure effective rate in the TWBXP group was higher than that in the Western Medicine (WM) group (RR: 1.15, 95% CI: 1.07 to 1.24, p<0.0001, $I^2=33%$). Also, the effective rate in the TWBXP+ACU group was significantly different compared to the WM group (RR: 1.32, 95% CI: 1.13 to 1.54, p=0.0004, $I^2=0%$). The quality of the selected RCTs was low. Conclusions: Herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) is effective for treating primary insomnia. It is worth noting that this studies were of relatively poor quality. The sample sizes were also small. Therefore, further investigations into the diagnosis and treatment of insomnia are warranted.

Keywords

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Fig. 1. Flow chart of the trial selection process.

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Fig. 1. Flow chart of the trial selection process.

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Fig. 2. Risk of Bias graph.

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Fig. 2. Risk of Bias graph.

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Fig. 3. Risk of Bias summary.

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Fig. 3. Risk of Bias summary.

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Fig. 4. Forest plot comparison: Tianwangbuxin-Pellet (TWBXP) vs Western Medicine (WM), outcome: effective rate.

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Fig. 4. Forest plot comparison: Tianwangbuxin-Pellet (TWBXP) vs Western Medicine (WM), outcome: effective rate.

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Fig. 5. Forest plot comparison: Tianwangbuxin-Pellet (TWBXP)+Acupuncture (ACU) vs Western Medicine (WM), outcome: effective rate.

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Fig. 5. Forest plot comparison: Tianwangbuxin-Pellet (TWBXP)+Acupuncture (ACU) vs Western Medicine (WM), outcome: effective rate.

Table 2. Adverse Events

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Table 2. Adverse Events

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Table 1. Analysis of Studies

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Table 1. Analysis of Studies

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Table 1. Continued 1

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Table 1. Continued 1

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Table 1. Continued 2

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Table 1. Continued 2

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Table 1. Continued 3

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Table 1. Continued 3

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