Efficacy of Anshen Jieyu Decoction for Sub-healthy People with Insomnia

Shun ZENG, Nannan LIU, Shuang JIN, Xiong CHEN, Chunqi AI*

1. Mental Health Center, Taihe Hospital of Shiyan City (Affiliated Hospital of Hubei University of Medicine), Shiyan 442000, China; 2. Sleep Disorders Center, Taihe Hospital of Shiyan City (Affiliated Hospital of Hubei University of Medicine), Shiyan 442000, China

Abstract [Objectives] To investigate the efficacy of Anshen Jieyu decoction for sub-healthy people with insomnia. [Methods] A total of 80 sub-healthy insomnia patients admitted to Taihe Hospital of Shiyan City from January, 2020 to December, 2020 were selected as the research objects. All the patients were divided into observation group and control group according to a random number table. The control group was treated with conventional Western medicine, and the observation group was treated with Anshen Jieyu decoction. The clinical treatment effect of the two groups was compared. [Results] Before the intervention, there was no significant difference in Pittsburgh sleep quality index between the two groups. After the intervention, the scores of time required to fall asleep [(1.2±0.3) points], sleep time [(1.2±0.4) points], sleep disorder [(1.2±0.2) points], sleep efficiency [(1.4±0.3 points)], sleep quality [(0.9±0.2) points] and daytime dysfunction [(0.9±0.4) points] of the observation group were significantly lower than those of the control group. There was no significant difference in life quality between the two groups before the intervention. The scores of physical function [(92.3±3.3) points], social function [(91.7±4.1) points], mental health [(92.3±4.1) points] and emotional role [(92.8±5.2) points] after the intervention were significantly higher than those before the intervention. Before the intervention, there was no significant difference in the severity of insomnia between the two groups. After the intervention, the score of insomnia severity index was (10.3±3.0) points in the observation group and was (12.2±2.9) points in the control group. In terms of safety, there were 23 cases of level 1, 15 cases of level 2 and 2 cases of level 3 in the observation group, and there were 20 cases of level 1, 16 cases of level 2 and 4 cases of level 3 in the control group. No significant difference was observed in treatment safety between the two groups. [Conclusions] Anshen Jieyu decoction is effective in treating sub-healthy insomnia and is worthy of promotion.

Key words Anshen Jieyu decoction, Sub-healthy insomnia, Efficacy

1 Introduction

With the rapid increase in social pressure and the acceleration of people’s life rhythm, most people have to bear the tremendous pressure of work, study and life, and more and more people are in sub-health state[1]. According to relevant survey reports, about 75% of the world’s population is facing sub-health conditions, while China’s sub-health population accounts for 60%[2]. People in sub-health state complain of insomnia, loss of concentration, decreased memory, daytime mental exhaustion, difficulty falling asleep, dreaminess and easy waking up and dizziness and fatigue in the morning, which seriously affect the quality of daily life of patients. The wide range and high incidence of sub-healthy insomnia have become an important issue endangering public health and human health[3]. Western medicine treatment methods such as conventional drugs and non-drugs have achieved certain results, but the overall treatment effect is affected by problems such as withdrawal reactions and drug tolerance. Chinese medicine advocates that insomnia belongs to the category of sleeplessness, and it is impossible to get normal sleep for a long time, accompanied by lack of sleep depth and lack of time, ranging from difficulty falling asleep to being insomnia at night[4]. In this study, the effect of Anshen Jieyu decoction in treating sub-healthy insomnia was investigated.

2 Materials and methods

2.1 General informationA total of 80 patients with sub-healthy insomnia admitted to Taihe Hospital of Shiyan City from January, 2020 to December, 2020 were selected as the research object. The inclusion criteria were as follows. (i) The above patients were consistent with the clinical diagnostic criteria for sub-healthy insomnia[5]; (ii) The patients were all consistent with diagnostic criteria for insomnia in theCriteriaofDiagnosisandTherapeuticEffectofDiseasesandSyndromesinTraditionalChineseMedicine[6]; (iii) The patient had a certain understanding and communication skills and volunteers to participate in this study. The exclusion criteria were as follows: breastfeeding women, coagulation dysfunction, severe organ diseases, chronic systemic diseases,etc. All the patients were divided into observation group and control group according to the random number table. In the control group, there were 40 cases, 18 males and 22 females. The patients were 18-65 years old, with an average age of (39.4±3.4) years old. The disease course ranged from one month to 14 years, with an average of (3.0±0.5) years. Among them, 27 patients had mild insomnia and 13 patients had severe insomnia. The observation group also had 40 cases, aged 18-64 years, with an average of (39.6±3.2) years. The disease course ranged from 1.5 months to 12 years, with an average of (3.1±0.2) years. There were 26 cases of mild insomnia and 14 cases of severe insomnia. There was no significant difference in general information between the groups (P>0.05).

2.2 Treatment methods

2.2.1Control group. The control group received conventional Western medicine treatment, taking oryzanol tablets and vitamin B1 orally every day. If necessary, estazolam tablets (Guangdong Taicheng Pharmaceutical Co., Ltd.; batch No. H44021098) were taken before going to bed, strictly following the instructions, and starting from a small dose.

2.2.2Observation group. The observation group was treated with Anshen Jieyu decoction. The prescription consisted of 30 g Caulis Polygoni Multiflori, 30 g Semen Ziziphi Spinosae, 30 g magnetite, 12 g Radix Paeoniae Alba, 10 g Flos Albizzia, 10 g Pericarpium Citri Reticulatae, 10 g Radix Bupleuri, 10 g poria with hostwood, 10 g Radix Polygalae, 10 g Rhizoma Acori Graminei, 10 g Fructus Gardeniae and 10 g tempeh. For those with poor appetite and stomach discomfort, 20 g fried malt is added. For those with dark tongue, 12 g Radix Salviae Miltiorrhizae is added. For those with pale tongue, 12 g Rhizoma Atractylodis is added. For those with partial yang deficiency, 3 g cinnamon is added. For those with partial yin deficiency, 20 g lily is added. All the medicines were decocted in water, one dose a day.

2.3 Observed indicators

2.3.1Comparison of sleep quality between the two groups before and after the intervention. The Pittsburgh sleep quality index was selected to evaluate the sleep quality of the patients. The scale included time required to fall asleep, sleep time, sleep disorder, sleep efficiency, sleep quality, daytime dysfunction and other dimensions. Each dimension was assigned as 0-3 points. The higher the score, the more serious the patient’s sleep disorder[7].

2.3.2Comparison of life quality between the two groups before and after the intervention. The SF-36 Quality of Life Scale developed by the Institute of Medicine, USA was used to assess the quality of life of patients. It was mainly divided into physical function, social function, mental health and emotional role. The size of score was positively correlated with the quality of life[8].

2.3.3Comparison of insomnia severity between the two groups before and after the treatment. The SIS insomnia severity index was selected to assess the severity of insomnia in patients. The scale contained 7 dimensions. The higher the score, the more severe the insomnia of the patient[9].

2.3.4Safety evaluation of the treatment in the two groups. The treatment safety of the above two groups was compared. At safety level of 1, it indicates that there was no adverse reaction, the treatment method was safe, requiring no additional treatment, and the treatment could be continued; at safety level of 2, it indicates that the adverse reaction was mild, the treatment method was relatively safe, requiring no additional treatment, and the treatment could be continued; at safety level of 3, it indicates that the adverse reaction was moderate, there were certain issues in the safety, and the treatment could be continued after routine treatment; and at safety level of 4, it indicates that there were severe adverse reactions, the treatment method was unsafe, and the study must be terminated[10].

3 Results and analysis

3.1 Comparison of Pittsburgh sleep quality index between the two groups before and after the interventionBefore the intervention, there was no significant difference in the Pittsburgh sleep quality index between the two groups (P>0.05). After the intervention, the scores of time required to fall asleep [(1.2±0.3) points], sleep time [(1.2±0.4) points], sleep disorder [(1.2±0.2) points], sleep efficiency [(1.4±0.3) points], sleep quality [(0.9±0.2) points] and daytime dysfunction [(0.9±0.4) points] in the observation group were significantly lower than those in the control group (P<0.05) (Table 1).

Table 1 Comparison of Pittsburgh sleep quality index between the two groups before and after the intervention Points

3.2 Comparison of life quality between the two groups before and after the interventionThere was no significant difference in the quality of life between the two groups before the intervention (P>0.05). After the intervention, the scores of physical function [(92.3±3.3) points], social function [(91.7±4.1) points], mental health [(92.3±4.1) points] and emotional role [(92.8±5.2) points] were significantly higher than those before the nursing (P<0.05) (Table 2).

Table 2 Comparison of life quality between the two groups before and after the intervention Points

3.3 Comparison of insomnia severity between the two groups before and after the interventionBefore the intervention, there was no significant difference in the severity of insomnia between the two groups (P>0.05). After the intervention, the scores of insomnia severity index of the observation group and the control group were (10.3±3.0) and (12.2±2.9) points, respectively (P<0.05) (Table 3).

3.4 Comparison of treatment safety between the two groups

In terms of treatment safety, there were 23 cases of level 1, 15 cases of level 2 and 2 cases of level 3 in the observation group, and there were 20 cases of level 1, 16 cases of level 2 and 4 cases of level 3 in the control group. There was no significant difference in treatment safety between the two groups (P>0.05).

4 Discussion

The sub-health state is the third state between the healthy state and the disease state. It can also become a pre-morbid state. Due to the influence of various internal and external factors such as people’s working environment, interpersonal communication, dietary status, and personal inherent physique, in recent years, the sub-healthy population in the world has increased significantly. The survey of the World Health Organization (WHO) shows that more than 75% of the world’s population is in a sub-healthy state. Sub-healthy insomnia refers to insomnia in patients with sub-health, manifested by difficulty falling asleep, dreaminess, easy waking up, light sleep, persistent fatigue after sleep,etc. Sub-healthy insomnia has not yet reached the diagnostic criteria for organic insomnia[11].

In China’s traditional Chinese medicine theory, there is no such term as sub-health, but this term has certain similarities with the thoughts of preventing diseases in Chinese medicine. TheInnerCanonofYellowEmperorpoints out that sleep disorders belong to the categories of being unable to sleep, and sub-healthy insomnia belongs to the category of sleeplessness. According to Chinese internal medicine, insomnia is a disease characterized by often not being able to get normal sleep, and it will directly affect people’s study, life and health[12]. The pathogenesis of insomnia is mainly divided into internal injuries and external feelings. Emotional disorders, unclean diet, old age, physical weakness, work-rest disorders and other factors can cause the organism to have a stomach upset and restless. The deficiency of energy will cause the body to suffer from insomnia and other problems, leading to uneasiness and restlessness, and thus insomnia appears. Imbalance between yin and yang and yang excess and yin deficiency will lead to insomnia. The dialectic of insomnia needs to distinguish deficiency and excess. Deficiency is mostly caused by insufficient yin and blood and heart failure. The main manifestations of the patient are heart palpitations, forgetfulness, laziness, dull complexion, and weak physique. Excess mostly refers to evil heat disturbing the heart, and the patients mainly manifested as bitter mouth and dry throat, upset and irritability. On the basis of dialectic of deficiency and excess, it needs to distinguish the location of the disease. The disease is closely related to the liver, kidney, spleen and other organs. The patient has long-term insomnia, poor emotions, and poor circulation of qi and blood, and therefore, the treatment of this disease should be based on the principles of reducing the excess, replenishing the deficiency and regulating the yin and yang[13]. In this study, the observation group was treated with Anshen Jieyu decoction. In the basic prescription, Semen Ziziphi Spinosae is metabolized through liver, gallbladder and heart, and it can calm the mind, nourish the heart, nourish the liver,etc; Caulis Polygoni Multiflori has the effects of nourishing the heart, calming the nerves, dispelling wind, and dredging the collaterals. Magnetite is metabolized through liver, heat and kidney, with effects of deepening yang to soothe the nerves, improving ears and eyesight, soothing breath and relieving asthma. Radix Paeoniae Alba has the effects of calming the liver, relieving pain, restraining yin and stopping sweating, and can also nourish blood, nourish yin, calm liver and relive pain. Flos Albizzia has the effects of calming and tranquilizing, beautifying, clearing away heat and relieving heat. Pericarpium Citri Reticulatae is metabolized through spleen, stomach and lung, and it can invigorate the spleen, regulate qi, and harmonize various medicines. Radix Bupleuri is metabolized through liver and gallbladder, with effects of relieving exterior syndrome, bringing down fever, soothing the liver, relieving depression, and raising Yang[14]. Radix Polygalae has phlegm-excreting, swelling-diminishing, anticonvulsant, sedative, and antibacterial effects. Rhizoma Acori Graminei can dissolve dampness, improve appetite, refresh the mind, resuscitate, relieves phlegm, and nourish the mind. Poria is metabolized through heat, spleen and kidney, with effects of calming the mind and nerves, strengthening the spleen and kidneys. Fructus Gardeniae has the effects of protecting the liver, promoting choleretics, lowering blood pressure, sedation, hemostasis, and reducing swelling. Tempeh can relieve exterior syndrome, clear away heat and detoxify. All the medicines can nourish viscera, nourish qi, nourish yin, relieve depression and calm nerves when used in combination. Cortex Albiziae can promote blood circulation and relive depression; Radix Bupleuri can sooth the liver and regulate qi, and Radix Paeoniae Alba can relieve the urgency of the liver. In short, the prescription can effectively treat liver stagnation and qi stagnation. Modern pharmacology has confirmed that Semen Ziziphi Spinosae has hypnotic and calming effects, and it can effectively inhibit the activity of the central nervous system and can be used for hypnosis and analgesia. The saikosaponins in Radix Bupleuri can effectively inhibit the central nervous system, and extend the sleep time of cyclohexylbarbital. In this study, after the intervention, the scores of time required to fall asleep [(1.2±0.3) points], sleep time [(1.2±0.4) points], sleep disorder [(1.2±0.2) points], sleep efficiency [(1.4±0.3) points], sleep quality [(0.9±0.2) points] and daytime dysfunction [(0.9±0.4) points] of the observation group were significantly lower than those of the control group; the scores of physical function [(92.3±3.3) points], social function [(91.7±4.1) points], mental health [(92.3±4.1) points] and emotional role [(92.8±5.2) points] after the intervention were significantly higher than those before the nursing; after the intervention, the scores of insomnia severity index of the observation group and control group were (10.3±3.0) and (12.2±2.9) points, respectively; and in terms of treatment safety, there were 23 cases of level 1, 15 cases of level 2 and 2 cases of level 3 in the observation group, and there were 20 cases of level 1, 16 cases of level 2 and 4 cases of level 3 in the control group, and no significant difference was observed between the two groups. These were consistent with the findings of Wang Qiaetal[15], suggesting that Anshen Jieyu decoction plays an important role in treating sub-healthy insomnia.

In summary, Anshen Jieyu decoction is effective in treating sub-healthy insomnia. It can effectively improve the quality of sleep and life of patients, is safe and effective, and is worthy of promotion.