Hewei Anshe Formula （和胃安神方） for Stress-induced Insomnia in Male Patients： A Randomised Controlled Trial of 52 Cases
10.13288/j.11-2166/r.2024.22.008
- VernacularTitle:和胃安神方治疗应激性失眠男性患者52例随机对照试验
- Author:
Chujiao TIAN
1
;
Liang WANG
1
;
Shuo WANG
1
;
Tao ZOU
1
;
Zihan LIU
1
;
Shaodan LI
1
;
Qi CHEN
1
Author Information
1. Department of Traditional Chinese Medicine，The Sixth Medical Center of Chinese，The People's Liberation Army General Hospital，Beijing，100048
- Publication Type:Journal Article
- Keywords:
stress-induced insomnia;
Hewei Anshen Formula （和胃安神方）;
sleep quality;
Traditional Chinese medicine syndrome;
fatigue;
quality of life;
randomised controlled trial
- From:
Journal of Traditional Chinese Medicine
2024;65(22):2326-2331
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical effectiveness and safety of Hewei Anshen Formula （和胃安神方） for stress-induced insomnia. MethodsA total of 104 male patients with stress-induced insomnia were randomly divided into a treatment group and a control group， with 52 cases in each group. The treatment group was given Hewei Anshen Formula once a day， while the control group was given zolpidem tartrate tablets 10 mg per time and once a day， and both groups were treated for 4 weeks. The Pittsburgh Sleep Quality Index （PSQI） was applied to evaluate sleep quality before and after treatment， Ford Insomnia Response to Stress Test （FIRST） was used to evaluate insomnia susceptibility， MOS 36-tem Short Form Health Survey （SF-36） ［which includes the domains of Physical Component Summary （PCS） and Mental Health Component Summary （MCS）， with the PCS including the General Health （GH）， Physical Functioning （PF）， Role Physical （RP）， and Body Pain （BP）， and the MCS including Role Emotional （RE）， Social Functioning （SF）， Vitality （VT）， Mental Health （MH）］ was used to evaluate the quality of life， and Fatigue Scale 14 （FS-14） ［including somatic fatigue and brain fatigue scores］ to evaluate the degree of fatigue， and the traditional Chinese medicine （TCM） syndrome scores using a self-developed TCM syndrome survey for insomnia. Clinical effectiveness and TCM syndrome improvement were determined after treatment. The occurrence of adverse events and adverse reactions was recorded during treatment. ResultsThe total effective rate of clinical effectiveness was 90.38% （41/52） in the treatment group and 80.77% （42/52） in the control group， and the difference between the two groups was not statistically significant （P＞0.05）. The total effective rate of TCM syndrome effectiveness in the treatment group was 80.77% （42/52）， which was higher than 44.23% （23/52） in the control group， and the difference was statistically significant （P＜0.01）. The TCM syndrome score， FIRST score， brain fatigue scores， brain fatigue score and total score of FS-14 score all reduced after treatment in both groups， and all scores were lower in the treatment group than those in the control group after treatment （P＜0.05）. All transformed scores of SF-36 scores were higher in both groups after treatment than before treatment in this group， and they were better than the control group in the four dimensions of PF， RP， VT， and MH （P＜0.05）. There were no adverse events and adverse reactions in the two groups. ConclusionHewei Anshen Formula can improve patients' sleep quality， effectively relieve clinical symptoms such as fatigue and pain， alleviate TCM syndromes， enhance the quality of life， reduce the susceptibility to insomnia， and shows good safety.
