SUMMARY: 60 patients with insomnia due to heart and gallbladder deficiency were randomly divided into the treatment group and the control group by random number table method, with 30 subjects in each group. All subjects met the diagnostic criteria of insomnia according to the “Guidelines for the Diagnosis and Treatment of Adult Insomnia Disorder in China”, as well as the diagnostic criteria of insomnia due to heart and gallbladder deficiency according to the “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (Trail)” and “Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine”. There was no significant difference in terms of age, gender, and course of disease between the treatment group and control group, and the two groups were therefore statistically comparable (P>0.05).
In the control group, subjects received oral eszopiclone tablet, 3 mg once a day before bed. In addition to the routine treatment, subjects in the treatment group also received Yangxin Ningshen Decoction (養心寧神湯), 200ml 30 minutes after breakfast and dinner. The ingredients of the decoction included: Long Yan Rou 30g (龍眼肉 Arillus Longan), Suan Zao Ren 15g (酸棗仁 Semen Ziziphi Spinosae), Shan Zhu Yu 15 g (山茱萸 Fructus Corni), Bo Zi Ren 12g (柏子仁 Semen Biotae), Sheng Long Gu 12g (生龍骨 Os Draconis), Sheng Mu Li 12g (生牡蠣 Concha Ostreae), Sheng Ru Xiang 3g (生乳香 Olibanum), Sheng Mo Yao 3g (生沒藥Commiphora myrrha), Sheng Dai Zhe Shi 12g (代赭石 Haematitum), Fu Ling 9g (茯苓 Poria), Chuan Huang Lian 9g (川黃連 Rhizoma Coptidis).
To evaluate the efficacy of the treatment, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Scale of Sleep (SRSS), and level of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were monitored. Therapeutic index (n) = (Total Score Before Treatment – Total Score After Treatment)/ Total Score Before Treatment x 100%. The clinical efficacy was considered as: Cured: n ≥ 95%. Markedly effective: 70% ≤ n < 95%. Effective: 30% ≤ n < 70%. Ineffective: n<30%.
Table 1. Comparison of Clinical Efficacy between Treatment and Control Group (n)
| Group | n | Cured | Markedly Effective | Effective | Ineffective | Total Effective Rate |
| Treatment | 30 | 10 | 12 | 7 | 1 | 96.67 1) |
| Control | 30 | 7 | 7 | 5 | 11 | 63.33 |
According to the result of this study, both groups showed a significant decrease in PSQI and SRSS score, with a more significant decrease in the treatment group (P<0.05). In comparison to the control group, the treatment group also showed a more significant reduction in the level of TNF-α and IL-6 (P<0.05). This study shows that Yangxin Ningshen Decoction combined with eszopiclone tablets is effective in the treatment of insomnia due to heart and gallbladder deficiency and can significantly improve sleep quality; the potential mechanism may be related to the reduction of TNF-α and IL-6, which then leads to the decrease in the level of inflammation.
Ge Liu, et al. TCM Research. 2021. 34 (4): 13-16