SUMMARY: 124 patients with insomnia were randomly divided into the treatment group and control group, with 62 subjects in each group. All subjects met the diagnostic criteria of “Guidelines for the Diagnosis and Treatment of Insomnia in China”, as well as the diagnostic criteria of phlegm heat with liver stagnation type of insomnia according to “Criteria of Diagnosis and Therapeutic Effect of Internal Diseases and Syndromes in Traditional Chinese Medicine”. The main symptoms include: difficulty falling asleep, dreaming and waking up easily, chest tightness, epigastrium distress, depressive mood; associated symptoms include: excessive phlegm, dizziness, depression, bitter taste in the mouth, sighing, fullness and tightness in the chest and costal area; tongue red with yellow and greasy coating, pulse rapid and wiry. There was no significant difference between the treatment and control in gender, age, course of disease, and Pittsburgh Sleep Quality Index (PSQI) (P>0.05), and the two groups were statistically comparable.
In the control group, subjects received 7.5mg oral zopiclone before bed. In the treatment group, subjects received Huang Lian Wen Dan Decoction (黃連溫膽湯) with Shong Yu An Shen Decoction (松郁安神湯), 180ml twice a day (after breakfast and dinner). The ingredients of the formula included: Huang Lian 6g (黃連 Rhizoma Coptidis), Fa Ban Xia 10g (法半夏 Rhizoma Pinelliae Preparatum), Zhu Ru 10g (竹茹Caulis Bambusae in Taeniam), Zhi Shi 6g (枳實Fructus Aurantii Immaturus), Chen Pi 10g (陳皮 Pericarpium Citri Reticulatae), Gan Shon 10g (甘松 Nardostachys chinensis), Yu Jin 10g (郁金Radix Curcumae), Fu Ling 10g (茯苓 Poria), Bei Chai Hu 10g (北柴胡 Bupleurum chinense), He Huan Pi 15 g (合歡皮 Cortex Albizziae), Suan Zao Ren 15g (酸棗仁 Semen Ziziphi Spinosae), Ye Jiao Teng 30g (夜交藤 Caulis Polygoni Multiflori), and Zhi Gan Cao 6g (炙甘草 Radix Glycyrrhizae Preparata). The course of treatment was 2 weeks for both groups. 3 subjects dropped out from the study in the treatment group, and 2 subjects dropped from the control group.
To evaluate the efficacy and safety of the treatment, the PSQI, time required to fall sleep, duration of sleep, frequency of night waking, liver, kidney function and blood routine were monitored before and after treatment. A subject was considered as:
- Cured: Sleep returned to normal or duration of sleep increased by > 6 hours, deep sleep and felt refreshed upon waking; clinical symptoms resolved.
- Markedly effective: Duration of sleep significantly improved, or duration of sleep increased by > 3h; clinical symptoms significantly improved
- Effective: Quality of sleep improved, but the duration of sleep was increased by < 3h; clinical symptoms improved
- Ineffective: No significant improvement or insomnia exacerbated; no improvement in clinical symptoms.
Table 1. Comparison of Treatment Efficacy between Treatment and Control Group
| Group | n | Cured | Markedly Effective | Effective | Ineffective | Total Effective Rate |
| Treatment | 59 | 22 | 24 | 11 | 2 | 96.61 1) |
| Control | 60 | 15 | 19 | 16 | 10 | 83.33 |
According to the result, the treatment group showed a more significant improvement in PSQI, time required to fall sleep, duration of sleep, and frequency of night waking (P<0.05). The total effective rate for treatment group was 96.1%, which was significantly higher than the control group (83.33%). In both groups, liver, kidney function and blood routine were normal before and after the treatment, and no significant adverse reaction was noted. The result indicated that Huang Lian Wen Dan Decoction with Shong Yu An Shen Decoction is effective and safe in treating phlegm heat with liver stagnation type of insomnia.
Xiao Shaojian. Fujian Journal of TCM November 2020. 51(6): 9-11.