초록

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, I2=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, I2=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.