Clinical Observation on the Treatment of Insomnia in Germany with Deficiency of Heart and Spleen by the Ear Bean Therapy

XIONG Hang (熊 航), MA Shu-hui (马淑惠), LI Yuan-yuan (李媛媛), DAI Jing-zhang (戴京璋)

1. Department of Medical Neurology, Tongzhou District of Dongzhimen Hospital, Beijing University of Chinese Medicine,Beijing 101100, China

2. Bad Koetzting Hospital of Beijing University of Chinese Medicine, Bad Koetzting 93444, Germany

3. Department of Acupuncture, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China

ABSTRACT Objective:To observe the effect of insomnia patients with deficiency of heart and spleen in Germany by the therapy of ear points pressing with bean.Methods:A total of 80 cases of insomnia with deficiency of heart and spleen in Germany were divided into the observation group and the control group, with 40 cases in each group. The patients in the control group were treated with oral modified Guipi Decoction (归脾汤), while the patients in the observation group were treated with oral traditional Chinese medicine (TCM) and the therapy of ear points pressing with bean. The efficacy, sleep quality, the TCM syndromes score and the incidence of adverse reactions were compared between the two groups.Results:The effective rate in the observation group was higher than that in the control group, and there was statistical difference between the two group (P＜0.05). After treatment, the Pittsburgh sleep quality index scale (PSQI) score, insomnia severity index (ISI) score and the TCM syndromes score in the two groups were decreased sharply (P＜0.01), and those scores in the observation group were lower than that in the control group (P＜0.05). There was no adverse reaction between the two groups.Conclusion:The therapy of ear points pressing with bean is effective on insomnia in Germany, which is worth further study and promotion.

KEYWORDS Therapy of ear points pressing with bean; Germany; Insomnia with deficiency of heart and spleen; Pittsburgh sleep quality index; Insomnia severity index

Insomnia is a common and frequently occurring disease and its main manifestations are difficulty in falling asleep, decreased sleep quality or total sleep time[1]. Insomnia seriously affects the work and life of patients, and may lead to the decline of immune function, endocrine disorders, and even lead to other diseases[2]. Benzodiazepine is mainly used to treat insomnia in Western medicine, while some non-benzodiazepine such as zopiclone has also been developed rapidly in recent years[3]. However,patients who take it for a long time still worry about its dependence or other adverse reactions such as dizziness, fatigue. The patient's compliance is not good as a result. In clinical practice, we found that TCM treatment of insomnia had few adverse reactions and good compliance. Our previous study has found that the most common TCM syndrome of insomnia in Germany is heart-spleen deficiency, but there is no data to support the efficacy of auricular points pressing with beans combined with TCM to treat insomnia in Germany. This study intends to analyze the clinical efficacy of auricular points pressing with beans in the adjuvant treatment of German insomnia patients, in order to improve the clinical protocol.

MATERIALS AND METHODS

General Information

From April 2019 to January 2020, 80 inpatients with insomnia who met the inclusion criteria were enrolled in the German Koetzting Hospital of Beijing University of Chinese Medicine. All subjects were randomly divided into the observation group (OG) and the control group (CG), with 40 cases in each group.This study is in accordance with the requirements ofThe Declaration of Helsinki of the World Medical Association(《世界医学协会赫尔辛基宣言》). There was no significant difference in age, gender, course of disease, PSQI, ISI score and TCM syndrome score between the two groups (P＞0.05), suggesting that the two groups are comparable. Detailed information was shown in Table 1.

Table 1. Comparison of General Data between the Two Groups

Diagnostic Criteria

According to the diagnostic criteria of chronic insomnia in the third edition ofInternational Classification of Sleep Disorders（《国际睡眠障碍分类》）[4]. The standard of TCM syndrome differentiation is as follows: According to WHO/WPO[5], the diagnosis standard of deficiency of both heart and spleen was referred.

Inclusion Criteria

(1) The above diagnostic criteria are met.(2) The age ranges from 25 to 75 years old.(3) PSQI score ＞ 7.

Exclusion Criteria

(1) Patients with medical diseases that affect sleep and/or cognitive function test, such as liver and kidney disease, cardiovascular disease, thyroid disease, etc. Neurological disorders (such as dementia), mental illness and other sleep disorders are also included. (2) Pregnancy or lactation. (3)Patients with chronic obstructive sleep apnea syndrome or restless legs syndrome. (4) Sedative hypnotics were used in the last 2 weeks. (5) Allergic to seeds of cowherb.

Therapeutic Methods

The control group: Modified Guipi Decoction was used for treatment. Ingredients:Radix Codonopsis6 g,Poria6 g,Rhizoma Atractylodis Macrocephalae6 g,Radix Astragali seu Hedysari6 g,Radix Angelicae Sinensis6 g,RadixPolygalae6 g,Radix Curcumae6 g,Semen Ziziphi Spinosae6 g,Caulis Bambusae in Taenia6 g,Folium Mori6 g,Semen Sesami Nigri6 g.Decoction 200 mL, Taking 100 mL in the morning and evening was given, 1 dose a day, for 28 days.

The observation group: On the basis of the control group, patients in the observation group were assisted with auricular points pressing, and unilateral Shenmen, heart, spleen, liver and endocrine points were selected for treatment. The ear was sterilized with 75% ethanol. After natural drying, the seeds were placed on the selected acupoints with tweezers, fixed with medical tape, and gently pressed with finger pulp for 30-40 seconds until the patient has numbness,distension, heat and acid. The patient was asked to press 3 times a day, for 28 days.

Outcome Measures

Comprehensive effects of two groups

The changes of PSQI score, ISI score and TCM syndrome score before and after treatment,as well as the incidence of adverse reactions in the two groups. Among them, TCM syndrome scores refer to theGuiding Principles for Clinical Research of New Chinese Medicine（《中药新药临床研究指导原则》）[6], including 4 points of upset and insomnia,2 points of palpitation, 2 points of dizziness and tinnitus, and 1 point of forgetfulness. Each symptom was calculated as 0, 1, 2 and 3 points according to no, light, medium and heavy, and then multiplied by the symptom score[7]. PSQI score[8]includes 18 items,which are integrated into 7 factors. Each factor is scored 0-3 points according to the 4-level scoring method, and the total score is 0-21 points. ISI score[9]is mainly used to evaluate the sleep quality of patients. The higher the score, the more serious the sleep problem.

Efficacy evaluation criteria

All patients were evaluated after 4 weeks of treatment. If the sleep time is more than 6 hours at night or return to the level before the disease,the clinical recovery is considered. When the total sleep time increased more than 3 hours or the sleep improved significantly, it is markedly effective. The total sleep time increased, but the increase of less than 3 hours is effective. If the total sleep time is reduced,it is invalid. The effective rate of treatment = (clinical recovery + markedly effective + effective)/total number of cases×100%. PSQI, ISI scores and TCM syndrome scores in the two groups were analyzed before and after treatment to evaluate the sleep quality.

Statistical Treatment

SPSS 22.0 statistical software is used. The measurement data are expressed by (mean ± SD).The measurement data in accordance with normal distribution are analyzed byt-test. The count data are analyzed by χ2test.P＜0.05 shown there is statistically significant difference, andP＜0.01 show there is a very significant difference.

RESULTS

Efficacy Comparison

In the observation group, 3 cases were cured,12 cases were markedly effective, 18 cases were effective, 7 cases were ineffective, and the treatment effective rate was 82.50%. While in the control group, 1 case was cured, 10 cases were markedly effective, 13 cases were effective, 16 cases were ineffective, and the effective rate was 60.00%. The effective rate in the observation group was higher than that in the control group (Shown in Table 2).

Table 2. Comparison of Curative Effect between the Two Groups

Changes of PSQI, ISI and TCM Syndrome Score

Before treatment, there was no significant difference in PSQI, ISI and TCM syndrome scores between the two groups. After treatment, PSQI, ISI and TCM syndrome scores in the two groups were far lower than before treatment, and PSQI, ISI and TCM syndrome scores in the observation group were lower than those of the control group, shown in Table 3.

Comparison of Adverse Drug Reactions

No obvious adverse reactions occurred in the two groups during the treatment.

Table 3. Comparison of PSQI, ISI and TCM Syndrome Scores between the Two Groups before and after Treatment (Scores)

DISCUSSION

Insomnia is one of the most common sleep disorders with difficulty in falling asleep and easy to wake up. It is a subjective experience that the quality or quantity of sleep cannot meet the normal demand. With the increase of social competition and the acceleration of life rhythm, insomnia has become a new problem that perplexes people. In Germany,about 6% of people suffer from insomnia, and the main symptoms are problems in falling asleep and maintaining sleep, impaired daytime function and poor attention[10]. The main treatment is sleeping pills, but long-term use of it has serious adverse reactions and poor patient compliance.

In addition to TCM prescriptions, HU Jingliang[11]and others found that acupuncture combined with TCM has a significant effect on insomnia, with an effective rate of 96.88%. ZHOU Wei-xing[12]and others found that Chinese massage combined with Suanzao Decoction (酸枣汤) can significantly reduce the PSQI score of insomnia patients, with significant clinical effects. HE Qi[13]and others found that shallow acupuncture combined with auricular points pressing with beans can significantly improve the sleep quality,depression symptoms and pathological constitution of patients with primary insomnia, and the long-term effect is stable and lasting. In our country, we found that nonmedicine therapy for insomnia has been widely used in clinical practice due to its few side effects and obvious curative effects, among which ear acupoints pressing with bean is one of the commonly used therapies for medicine-free in insomnia[14]. Modern studies have shown that stimulating the corresponding auricular points can activate meridians and collaterals, regulate Yin (阴) and Yang (阳), harmonize the functions of Zang-Fu (脏腑), and play a role in calming the nerves[15], while whether this method is also suitable for German has not been reported. Therefore, this study firstly discussed the clinical efficacy of auricular points pressing with beans combined with modified Guipi Decoction in the treatment of insomnia of deficiency of both heart and spleen.

Most of the hospitalized patients in Bad Koetzting Hospital of Beijing University of Chinese Medicine in Germany are middle-aged and elderly people with long-term and complex conditions. Our previous studies found that insomnia mainly manifested as easy to wake up, tired, difficult to fall asleep, wake up early, difficult to sleep again after waking up. The tongue is fat and dark, the fur is thin and white, and the pulse is thin. It is suggested that the heart and spleen are responsible for the location of insomnia. Heart governing blood vessels is an important physiological function of the heart and the material basis for the heart to store the spirit. It is because the heart controls the blood vessels that it is able to control the mind."The heart and brain are closely connected, and their gods and spirits wake up from each other."(Records of Tradition Chinese and Western Medicine in Combination 《医学衷中参西录》). The heart stores the spirit, and the brain is the organ of the original spirit. The heart controls the blood, and the superior supply is to the brain, and the brain is full of blood; therefore, the heart and brain are interlinked and can be treated together. The heart governs the activities of spirit, thinking and consciousness, and the mind is out of balance. Yang cannot enter into Yin, and the mind is not conservative, which can lead to insomnia. There are many reasons for the disorder of mind and spirit, such as spleen deficiency,stagnation of the liver and fire, illness of mother viscera affecting the child one[16]. Therefore, the treatment of nourishing the heart and strengthening the spleen should be treated with modified Guipi Decoction.Radix Astragali seu HedysariandRadix Codonopsisare the main herbs for invigorating Qi (气)and strengthening spleen.Radix Angelicae Sinensistonifies Ying blood, with the main medicine to tonify Qi and blood.Rhizoma Atractylodis Macrocephalaecan invigorating spleen and regulating Qi, so that it can be tonified without stagnation.Poria,Radix PolygalaeandSemen Ziziphi Spinosaecan nourish and calm the mind, helping the main medicine to play a role. Spleen deficiency and liver depression is easy to cause phlegm heat, disturbance of mind and leads to insomnia.Bambusae in Taenia, taking its sweet and slightly cold, is used to clear away heat, resolve phlegm and calm nerves[17].Folium Moriclears internal heat and calms heart[18].Semen Sesami Nigrinourishes blood and kidney. Both of them, one is responsible for ascending and the other is responsible for descending, clearing the upper and nourishing the lower, enriching the Yin and blood.When all the herbs are used together, the spleen and heart can be invigorated and the blood can be invigorated. Then insomnia and fatigue can be cured.

The results showed that the sleep quality of the 2 groups was significantly improved after 4 weeks of treatment. The effective rate of the observation group was as high as 82.50%, which was much higher than that of the traditional prescription group(60.00%), indicating that auricular points pressing with bean therapy has a certain effect on insomnia. Some studies have found that ears are related to viscera and meridians. When the human body has diseases,the corresponding parts of the auricle often have"positive reaction points". Therefore, stimulating the corresponding auricular points to treat diseases can dredge the channels and collaterals, strengthen the body and eliminate pathogens, coordinating Yin and Yang, and regulating the viscera[19]. It is reported that the commonly used ear points for insomnia are Shenmen, heart, subcortical, kidney, sympathetic,pillow, spleen, endocrine, liver, etc.[20]. The heart stores the spirit and governs the spirit. The spleen controls the movement and transformation of Qi and blood. The liver governs the dispersion and regulation of Qi and blood. The heart belongs to fire,spleen to soil, liver to wood, wood to fire and fire to soil, so the three are closely related and influence each other. Shenmen (HT 7) is the gate of Yuan Shen, which has the meaning of dominating people's thinking, consciousness and spirit. Endocrine balance neurohumoral was regulated by hormone secretion[21]. According to our previous experience,we selected the acupoints of heart, Shenmen,spleen, endocrine and liver, all of which have the effect of invigorating the spleen and nourishing the heart, calming the mind.

To sum up, compared with TCM treatment,the auricular points pressing method assisted with modified Guipi Decoction in the treatment of insomnia patients with heart and spleen deficiency syndrome in Germany was significantly better than that in the control group in improving sleep quality and decreasing the scores of sleep disorder,severity and TCM syndrome. Moreover, the ear points pressing with bean therapy is easy to operate,without the disadvantages of traditional acupuncture pain, and no obvious adverse reactions, no dependence and addiction. It is welcomed by the majority of German insomnia patients, which is worthy of further application and research.