SUMMARY: In this study, 96 patients with treatment-resistant insomnia were randomly divided into the control group and the treatment group, with 48 subjects in each. All subjects met the diagnostic criteria of treatment-resistant insomnia according to the “Essence of Diagnosis and Treatment of Common Diseases and Syndromes in Internal Medicine of Traditional Chinese Medicine” and “Guidelines for the Diagnosis and Treatment of Adult Insomnia in China”. Exclusion criteria of this study were: insomnia caused by physical diseases, history of substance dependence, mental disorders, pregnancy and breastfeeding. There was no significant difference in age, gender, course of diseases and the Pittsburgh Sleep Quality Index (PSQI) scale between the control group and treatment group, and the two groups were therefore statistically comparable (P>0.05).
In the control group, subjects were treated with alprazolam tablets 1.0 mg once a day. In the treatment group, subjects were treated with Modified Suanzaoren Decoction (酸棗仁湯加減), one serving a day in two divided doses (morning and evening); the decoction includes the following ingredients: Suan Zao Ren 15 g (酸棗仁 Semen Ziziphi Spinosae), Fu Ling 12g (茯苓 Poria), Zhi Mu 9g (知母 Rhizoma Anemarrhenae), Chuan Xiong 9g (川芎 Rhizoma Ligustici Chuanxiong), and Gan Cao 5g (甘草 Radix Glycyrrhizae). Additional herbs may be added to the main formula according to the subjects’ symptom and diagnosis. For example, for subjects with palpitation, Ci Shi 15g (磁石 Magnetitum) and Hu Po 15 g (琥珀 Succinum) were added; for subjects with Heart Qi deficient, Dang Shen 15g (黨參 Radix Condonopsis Pilosulae) and Bai Zhu 10g (白朮 Rhizoma Atractylodis Macrocephalae) were added. All subjects received 3 courses of treatment, with 10 days being one course of treatment.
In order to evaluate the clinical efficacy of the treatment, PSQI and the “Chinese Clinical Pharmacy” were used as reference. The results were classified as the following:
- Markedly Effective: clinical symptoms (excessive dreams, easily awakened, pale complexion, thin and weak pulse) significantly improved, duration of sleep significantly increased (more than >6h a day), felt refreshed after sleep, and PSQI scale decreased by >70%.
- Effective: clinical symptoms improved, duration of sleep increased, and PSQI scale decreased by ≥ 30% but ≤ 70%.
- Ineffective: did not meet the criteria of “Markedly Effective” or “Effective”.
The Total Effective Rate = (Markedly Effective cases + Effective cases)/Total number of cases x 100%.
Table 1. Comparison of Clinical Efficacy between Treatment and Control Group
| Group | n | Markedly Effective (n) | Effective (n) | Ineffective (n) | Total Effective Rate |
| Control | 48 | 19 | 21 | 8 | 83.33 |
| Treatment | 48 | 21 | 25 | 2 | 95.83 |
| χ2 | 4.019 | ||||
| P | 0.045 |
In this study, the quality of sleep, time of sleep, duration of sleep, sleep efficiency and total effective rate of the treatment group were significantly higher than the control group (95.83% vs. 83.33%) (P < 0.05). There was no significant difference in terms of side effects in both groups. The result indicated that Modified Suanzaoren Decoction increase clinical efficacy in treatment-resistant insomnia when used in conjunction with conventional treatment and does not cause increase in the incidence of side effects.
Hongli Jia. ZhongYiYao LinChuang ZaZhi. 2020. 32 (3): 552-554