초록

Objectives: The present study aimed to provide clinical evidence on the effect of herbal medicine
Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia using a sys-tematic review
and meta-analysis of randomized controlled trials (RCTs).

Methods: This study included RCTs that verified the effects of Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia.
Literature searches of English, Chinese and Korean databases were performed, and the selected literature was assessed for investigating the risk of bias.

Results: The analysis included 10 RCTs.
The Chinese Classification of Mental Disorders-3 was most fre-quently used to define the diagnostic criteria for Hyeolbuchukeo-tan
or Xuefu Zhuyu decoction inter-vention in patients with primary insomnia.
The effective rate was the most commonly used outcome measure.
A meta-analysis revealed that the effective rate,
the Pittsburgh Sleep Quality Index, and the Athens Insomnia Scale in the Modified Xuefu Zhuyu decoction (MXZD) group
were higher compared to Western Medicine (WM) group
(RR: 1.17, 95% Cl: 1.08 to 1.26, p＜0.0001, I2=0 / MD: −1.29, 95% Cl: −2.09 to −0.49, p=0.002, I2=0% / MD: −0.99, 95% Cl: −1.81 to −0.18, p=0.02, I2=15%).
The effective rate of the MXZD＋WM group was significantly different compared to the WM group
(RR: 1.28, 95% Cl: 1.11 to 1.47, p=0.0006, I2=2%).
The included RCTs were of relatively poor quality and had small sample sizes.

Conclusions: Treatment with Hyeolbuchukeo-tang or Xuefu Zhuyu decoction was found to be effec-tive in treating primary insomnia.
However, the included RCTs were of relatively poor quality and had small sample sizes.
It is hypothesized that this study could serve as a foundation for further clinical studies on the development of diagnosis
and treatment methods for primary insomnia based on Korean medicine.