Traditional Chinese medicine composition for treating insomnia as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating insomnia as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 25-35 parts of radix bupleuri, 25-35 parts of radix paeoniae alba, 25-35 parts of fructus aurantii, 25-35 parts of rhizoma cyperi, 25-35 parts of radix curcumae, 25-35 parts of herba epimedii, 25-35 parts of semen boitae, 25-35 parts of tuber fleeceflower stem, 25-35 parts of cortex albiziae, 25-35 parts of nacre mother of pearl and 8-15 parts of borneol. The whole formula has the effects of soothing the liver, relieving depression, promoting the circulation of qi, relieving middle energizer and tranquilizing by nourishing the heart. The components of the traditional Chinese medicine synergistically play a role, and the traditional Chinese medicine has obvious curative effect and obvious symptom improvement when used for treating insomnia.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating insomnia, and a preparation method and application thereof. Background Art

[0002] Insomnia refers to a subjective experience in which one is dissatisfied with sleep time and / or sleep quality despite having appropriate sleep opportunities and sleeping environment, and it affects daytime function. Insomnia is usually manifested as difficulty falling asleep, shallow sleep, insufficient sleep time, easy awakening, early awakening, etc. Epidemiology shows that the incidence of insomnia among adults in my country is as high as 38.2%. The prevalence of people suffering from insomnia symptoms or insomnia disorders is between 4% and 50%, and the course of insomnia shows a chronic development. The persistence rate of insomnia in adults is between 30% and 60%, and the overall course of the disease is more persistent. Insomnia is not only a common sleep disorder in clinical practice, but also related to the development of many diseases. It is a risk factor for many diseases such as neurological diseases, cardiovascular and cerebrovascular diseases, etc. The long-term impact of insomnia can reduce the quality of life and work efficiency, while increasing the risk of various health problems. For example, long-term insomnia increases the risk of depression, anxiety, coronary heart disease, diabetes, and cancer.

[0003] Modern medicine believes that sleep is a physiological activity under the control of brain nerves, with the participation of neurotransmitters, hormone secretion and the immune system. The pathological mechanism of insomnia is relatively complex, which may be related to circadian rhythm disorders, abnormal sleep-wake neural circuits, imbalance of neurotransmitter homeostasis, overactive HPA axis, abnormal glial cells, and abnormal cytokines related to sleep and wakefulness. On June 4, 2020, the team of Dragana Rogulja of Harvard Medical School in the United States published a study on the onset of the disease in the journal Cell. The study showed that sleep deprivation can cause intestinal damage, trigger the accumulation of reactive oxygen species (ROS) and aggravate oxidative stress, which in turn causes death. The intestine plays an important role in the process of insomnia. Previous studies have shown that changes in the content of brain gut peptides have a certain regulatory effect on the sleep-wake cycle. Sun Bo and other studies have found that intestinal flora produces neurotransmitters such as GABA, Glu, 5-HT, and DA. Cytokines, endocrine hormones, etc. affect the central nervous system through the blood-brain barrier and the vagus nerve, thereby causing insomnia.

[0004] There are three main treatments for insomnia: Western medicine, traditional Chinese medicine, and non-drug therapy. Western medicine commonly uses benzodiazepines, benzodiazepine receptor agonists, antidepressants, antihistamines, and melatonin. Although sedative hypnotic Western medicines have a quick onset of hypnotic effect in the short term, they are not the best solution for insomnia treatment because they can cause various side effects such as daytime sleepiness, temporary impairment of balance function, drug addiction, or aggravation of insomnia. Cognitive behavioral therapy (CBT) is one of the main non-drug therapies and is usually used as a first-line therapy abroad. Studies have shown that CBT is an effective and safe treatment for long-term insomnia. However, due to the long treatment time of CBT and the fact that the number of professional CBT therapists is affected by regional development, it is not the first choice for patients in actual clinical applications in my country.

[0005] Insomnia belongs to the category of "insomnia" in traditional Chinese medicine. In the thousands of years of development of traditional Chinese medicine, there are many records of insomnia in medical books. Doctors of different generations have different names for insomnia. Insomnia was first called "cannot lie down", "must not lie down" and "cannot lie down", which can be seen in the "Eleven Meridians Moxibustion Classic of Foot and Arm" and "Eleven Meridians Moxibustion Classic of Yin and Yang" unearthed from the Mawangdui Han Tomb. Based on these names, insomnia is also called "no sleep at night, no sleep at night, no sleep and no sleep" in the "Yellow Emperor's Internal Classic". Due to the causes of improper diet, emotional imbalance, and excessive mental fatigue, the heart, liver, spleen, and kidneys are dysfunctional, which in turn leads to the excess of yang and the decline of yin, and the loss of yin and yang, resulting in insomnia.

[0006] Traditional Chinese medicine has its own advantages in the treatment of insomnia. Chinese medicine formulas are used to treat patients according to syndrome differentiation, without obvious toxic side effects. Umbilical moxibustion with herbs is a green therapy. This therapy selects the navel (i.e., Shenque point) as the treatment site. Different drug dosage forms are selected according to different diseases and placed in the navel for treatment. The purpose of preventing and curing diseases is achieved by regulating the overall yin and yang of the human body and the qi and blood functions of the internal organs. This therapy is simple to operate, safe and effective. At the same time, it can be coordinated with other therapies for comprehensive treatment. It is one of the important methods for the current clinical treatment of insomnia. However, the therapeutic effect of Chinese medicine umbilical moxibustion with herbs still needs to be improved. Summary of the invention

[0007] The technical problem to be solved by the present invention is to overcome the deficiencies and defects mentioned in the above background technology and provide a Chinese medicine composition for treating insomnia by umbilical moxibustion with medicine separation, and a preparation method and application thereof.

[0008] In order to solve the above technical problems, the technical solution proposed by the present invention is:

[0009] A traditional Chinese medicine composition for treating insomnia is prepared from the following components by weight: 25-35 parts of bupleurum, 25-35 parts of white peony root, 25-35 parts of fructus aurantii, 25-35 parts of cyperus rotundus, 25-35 parts of curcuma, 25-35 parts of epimedium, 25-35 parts of cyperus rotundus, 25-35 parts of platycladus seed, 25-35 parts of smilax china bark, 25-35 parts of mother-of-pearl, and 8-15 parts of borneol.

[0010] Preferably, it is made from the following raw materials in parts by weight: 30 parts of bupleurum, 30 parts of white peony root, 30 parts of fructus aurantii, 30 parts of cyperus rotundus, 30 parts of curcuma, 30 parts of epimedium, 30 parts of cyperus seeds, 30 parts of smilax china, 30 parts of bark of julibrissin, 30 parts of mother of pearl, and 10 parts of borneol.

[0011] The Chinese medicine composition of the invention is used for treating insomnia by umbilical moxibustion.

[0012] The invention also provides a umbilical moxibustion powder for treating insomnia, comprising the Chinese medicine composition.

[0013] The preparation method of the navel moxibustion medicine powder comprises: mixing various component raw materials and grinding them into powder.

[0014] The present invention also provides an application of the traditional Chinese medicine composition in preparing a medicine for treating insomnia.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] The whole prescription of the present invention has the effects of soothing the liver and relieving depression, promoting qi and relieving fullness, and nourishing the heart and calming the mind. The whole prescription promotes qi and soothes the liver and relieves depression and calms the mind at the same time, uses cooling and warming at the same time, and combines dispersion and collection, which are the compatibility characteristics of this prescription. And through the drug-separated navel moxibustion, it can act on the intestines, affect the production of intestinal flora, regulate neurotransmitters and active oxygen, and thus improve insomnia. The components of the present invention work synergistically to treat insomnia, with significant efficacy and obvious symptom improvement. DETAILED DESCRIPTION

[0017] In order to facilitate the understanding of the present invention, the present invention will be described more comprehensively and carefully in combination with preferred embodiments below, but the protection scope of the present invention is not limited to the following specific embodiments.

[0018] Unless otherwise defined, all professional terms used below have the same meanings as those generally understood by those skilled in the art. The professional terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the scope of protection of the present invention.

[0019] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0020] In some specific embodiments, the traditional Chinese medicine composition for treating insomnia of the present invention is made of the following components in parts by weight: 25-35 parts of bupleurum, 25-35 parts of white peony root, 25-35 parts of fructus aurantii, 25-35 parts of cyperus rotundus, 25-35 parts of curcuma, 25-35 parts of epimedium, 25-35 parts of platycladus seed, 25-35 parts of smilax china, 25-35 parts of julibrissin bark, 25-35 parts of mother-of-pearl, and 8-15 parts of borneol.

[0021] In a preferred embodiment, it is made of the following components by weight: 30 parts of bupleurum, 30 parts of white peony root, 30 parts of fructus aurantii, 30 parts of cyperus rotundus, 30 parts of curcuma, 30 parts of epimedium, 30 parts of cyperus rotundus, 30 parts of platycladus seed, 30 parts of smilax china, 30 parts of julibrissin bark, 30 parts of mother of pearl, and 10 parts of borneol.

[0022] In the formula, bupleurum and white peony are the main ingredients. Bupleurum soothes the liver and relieves depression, while white peony nourishes blood, restrains yin and softens the liver. The two are compatible with each other to exert the effects of softening and soothing the liver, relieving depression and soothing the liver. Among them, bupleurum is pungent, bitter, and slightly cold, and enters the liver, gallbladder, and lung meridians to soothe the liver and relieve depression. White peony is sour, bitter, and slightly cold, and enters the liver and spleen meridians to nourish blood and soften the liver. When used with bupleurum, bupleurum is pungent and dispersing, and mainly enters the qi; white peony is sour and astringent, and mainly enters the blood. Bupleurum soothes the liver qi, while white peony nourishes the liver blood. One astringent and one dispersing complement each other.

[0023] The bark of Albizzia julibrissin, Polygonum multiflorum, mother-of-pearl, and cypress seeds are all ministerial drugs, which can invigorate blood circulation, relieve depression, soothe the liver and suppress yang, and nourish the heart and calm the mind. Among them, the bark of Albizzia julibrissin is sweet and flat, enters the heart and liver meridians, relieves depression and calms the mind. Polygonum multiflorum is sweet and flat, enters the heart and liver meridians, nourishes the heart and calms the mind. Mother-of-pearl is salty and cold, enters the heart and liver meridians, soothes the liver and calms the mind. Cypress seeds are sweet and flat, enter the heart, kidney, and large intestine meridians, nourish the heart and calm the mind.

[0024] Citrus aurantium, Cyperus rotundus, and Curcuma zedoaria regulate qi and relieve fullness, and are all adjuvants. Citrus aurantium is bitter, pungent, sour, and warm, and enters the spleen, stomach, and large intestine meridians to promote qi and relieve fullness. Cyperus rotundus is pungent, slightly bitter, slightly sweet, and neutral, and enters the liver, spleen, and triple burner meridians to soothe the liver and regulate qi. Curcuma zedoaria is pungent, bitter, and cold, and enters the liver, gallbladder, heart, and lung meridians to promote qi and relieve depression.

[0025] Epimedium harmonizes various medicines and warms and nourishes kidney yang. Epimedium is pungent, sweet, warm, enters the liver and kidney meridians, and warms kidney yang.

[0026] This prescription has the following effects: soothing the liver and relieving depression, nourishing the heart and calming the mind. Indications: Insomnia caused by liver depression and qi stagnation. Symptoms: insomnia, difficulty falling asleep, frequent dreams, waking up easily, difficulty falling asleep again after waking up, excessive thinking, and worsening symptoms when in a bad mood.

[0027] The dosage form of the composition of the invention is navel moxibustion medicine powder, which is used for navel moxibustion with medicine to treat insomnia.

[0028] The preparation method of the Chinese medicinal composition for treating insomnia of the present invention comprises the following steps: mixing and drying various raw materials, and grinding them into powder to obtain the composition.

[0029] Example 1

[0030] The raw materials of the Chinese medicine composition for treating insomnia in this embodiment are: 30g of bupleurum, 30g of white peony root, 30g of fructus aurantii, 30g of cyperus rotundus, 30g of curcuma, 30g of epimedium, 30g of platycladus seed, 30g of smilax china, 30g of bark of julibrissin, 30g of mother of pearl, and 10g of borneol.

[0031] Preparation method: Take the above-mentioned Chinese medicinal materials of each component by weight, mix them evenly after drying, then grind them into powder, and pass them through an 80-100 mesh sieve to make Chinese medicinal powder.

[0032] usage:

[0033] Mix clean water with an appropriate amount of flour and cornmeal to make a noodle bowl of moderate hardness and softness, leaving a small hole in the middle of the bowl; pinch the moxa into a round moxa cone with a diameter of 15mm and a height of 20mm for later use.

[0034] The patient lies on his back and uses 75% medical alcohol to clean the navel. Place the prepared noodle bowl on the patient's navel and take an appropriate amount of medicine powder to fill the navel. Place the moxa cone above the small hole and light it. Replace it with the next one when it burns out. Perform 3 moxibustions in total.

[0035] Example 2

[0036] The raw materials of the Chinese medicine composition for treating insomnia in this embodiment are as follows: 35g of bupleurum, 35g of white peony root, 35g of fructus aurantii, 35g of cyperus, 35g of curcuma, 35g of epimedium, 35g of cyperus, 35g of cyperus, 35g of cyperus, 35g of cyperus, 35g of scutellaria, 35g of julibrissin, 35g of mother-of-pearl, and 15g of borneol. The preparation method is the same as that in Example 1.

[0037] Example 3

[0038] The raw materials of the Chinese medicine composition for treating insomnia in this embodiment are as follows: 25g of bupleurum, 25g of white peony root, 25g of fructus aurantii, 25g of cyperus, 25g of curcuma, 25g of epimedium, 25g of cyperus seeds, 25g of scutellaria baicalensis, 25g of bark of julibrissin, 25g of mother-of-pearl, and 8g of borneol. The preparation method is the same as that in Example 1.

[0039] Clinical Trials

[0040] According to the actual situation and personal wishes of the patients, the insomnia patients who met the inclusion criteria were divided into two groups. The patients who were treated with umbilical moxibustion using the composition of Example 1 were the experimental group, and the patients who were not treated with umbilical moxibustion were the control group. The control group used conventional symptomatic treatment and recorded the number of sleeping pills used. The experimental group was treated with umbilical moxibustion with medicine on the basis of the control group, and the total course of treatment was 2 weeks. The effects of umbilical moxibustion with medicine combined with estazolam on the Pittsburgh Sleep Quality Index (PSQI), clinical efficacy, TCM syndrome score, Insomnia Severity Index Scale (ISI), Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) of patients with insomnia were explored, and the clinical efficacy of umbilical moxibustion with medicine was evaluated for the treatment of insomnia.

[0041] The cases in this study were derived from outpatients and inpatients of Hunan Provincial Hospital of Integrated Traditional Chinese and Western Medicine (Affiliated Hospital of Hunan Institute of Traditional Chinese Medicine) from December 2023 to October 2024.

[0042] The treatment for the control group maintained the original sleep disorder drug treatment plan before enrollment (including frequency of use and type of drug), recorded the type and dosage of medication, and provided lifestyle guidance for adjustment.

[0043] Patients in the experimental group were given medicated umbilical moxibustion treatment on the basis of the treatment of the control group. The course of treatment was: once every 2 days, 4 times a week, 1 week as a course of treatment, and the efficacy was observed after 2 consecutive courses of treatment.

[0044] Efficacy indicators: ①Main efficacy indicators: Pittsburgh sleep quality index (PSQI); clinical effective rate; ②Secondary efficacy indicators: TCM syndrome score; Insomnia severity index (ISI); Hamilton depression scale (HAMD); Hamilton Anxiey Scale (HAMA); ③Safety indicators: blood routine, urine routine, liver and kidney function, electrocardiogram. Indicator detection time: Each indicator is detected once before treatment and once after treatment.

[0045] A total of 56 patients with insomnia due to liver depression and qi stagnation were included in this trial, including 36 patients in the experimental group who received umbilical moxibustion treatment and 20 patients in the control group.

[0046] Comparison of baseline data:

[0047] The baseline data of the two groups of patients were compared (see Table 1), P>0.05, and there was no statistically significant difference. Control group: a total of 20 cases, 7 males and 13 females. The youngest age was 27 years old, the oldest was 63 years old, and the average age was 47.83±9.69 years old. The shortest course of disease was 10 months, the longest was 37 months, and the average course of disease was 20.44±6.66 weeks. The total score of PSQI was at least 7 points, the maximum was 15 points, and the average total score was 12.58±2.67 points; experimental group: a total of 36 cases, 15 males and 21 females. The youngest age was 26 years old, the oldest was 62 years old, and the average age was 46.33±9.32 years old. The shortest course of disease was 8 months, the longest was 37 months, and the average course of disease was 20.22±7.28 months. The total score of PSQI was at least 7 points, the maximum was 18 points, and the average total score was 12.66±2.91 points.

[0048] Table 1: Comparison of baseline data

[0049]

[0050]

[0051] The chi-square test was used to compare the gender of the two groups of patients. 2 =0.533, P=0.465, P>0.05, which are comparable; the age, disease course and PSQI total score of the patients were all in line with the normal distribution. Using two independent sample t-tests, the P values ​​were 0.506, 0.893 and 0.900, respectively, with no significant difference, and they were comparable.

[0052] PSQI scale score comparison:

[0053] (1) Comparison of PSQI factor scores between the two groups before treatment (P25, P75)

[0054] Table 2: Comparison of PSQI factor scores between the two groups before treatment

[0055]

[0056] Before treatment, the two groups were compared, and the scores of each factor and the total score of the patients' PSQI did not conform to the normal distribution, so they were expressed as M (P25, P75). Using the non-parametric two-independent sample signed rank test, P>0.05, the difference was not significant and could be compared.

[0057] (2) Intragroup comparison of PSQI factor scores between the two groups before and after treatment (P25, P75)

[0058] Table 3: Comparison of PSQI factor scores before and after treatment in the control group

[0059]

[0060]

[0061] In the comparison of the control group before and after treatment, the scores of each factor of the PSQI of the patients did not conform to the normal distribution, and the difference before and after treatment did not conform to the normal distribution (P<0.05). Therefore, the non-parametric two-correlated sample signed rank test was used, and P<0.01 was obtained, which was statistically significant.

[0062] Table 4: Intra-group comparison of PSQI factor scores before and after treatment in the experimental group

[0063]

[0064] Note: Before and after treatment, the scores of each factor of the PSQI in the treatment group did not conform to the normal distribution, and the difference before and after also did not conform to the normal distribution (P<0.05). Therefore, a nonparametric two-correlated sample signed rank test was used, and P<0.01 was obtained, which was statistically significant.

[0065] (3) Comparison of PSQI factor scores between the two groups after treatment (P25, P75)

[0066] Table 5: Comparison of PSQI factor scores and total scores between the two groups after treatment

[0067]

[0068]

[0069] Note: After treatment, the two groups were compared, and the PSQI factor scores and total scores of the patients did not conform to the normal distribution. The difference between the two groups after treatment also did not conform to the normal distribution (P<0.05). Therefore, two independent sample signed rank test was used. There were statistical differences between the two groups in sleep quality, sleep time, daytime dysfunction factors and PSQI total scores (P<0.05). There was no statistical significance in sleep onset time, sleep efficiency and sleep disorder factors (P>0.05).

[0070] Comparison of ISI scale scores:

[0071] Table 6: Comparison of ISI scale scores ( point)

[0072]

[0073] The ISI scale scores of the two groups before and after treatment were in accordance with normal distribution, so they were expressed as x±s. Intergroup comparison: the scores of the two groups before treatment were compared with t=-1.181, P=0.799, P>0.05, which were comparable; intragroup comparison: the difference between the two groups before and after treatment was in accordance with normal distribution (P>0.05), so the paired sample t test was used, and P<0.01 was obtained, which was statistically significant. Intergroup comparison: the scores of the two groups after treatment were t=2.823, P=0.006, P<0.01, which were significantly different.

[0074] Comparison of overall clinical efficacy:

[0075] Table 7: Comparison of overall clinical efficacy

[0076]

[0077]

[0078] The Wilcoxon test showed that the overall clinical efficacy of the two groups was Z=-2.902, P=0.004, P<0.01, indicating that there was a significant difference in the efficacy.

[0079] There was no statistically significant difference between the experimental group and the control group in general baseline data, such as gender, age, lifestyle, history of comorbidities, medication history, Pittsburgh Sleep Quality Index (PSQI) score and TCM symptom score (P>0.05).

[0080] After completing two courses of treatment, the PSQI score and Insomnia Severity Index (ISI) score of the experimental group were significantly lower than those of the control group, with significant statistical difference (P<0.05). This indicates that the effect of adjuvant umbilical moxibustion with medicinal herbs on improving insomnia is better than that of using umbilical moxibustion alone on the basis of sleeping pills and lifestyle treatment, and the effect of umbilical moxibustion with medicinal herbs on reducing ISI scores is more obvious.

[0081] The Hamilton Depression Rating Scale (HAMD) scores and Hamilton Anxiety Scale (HAMA) scores of the two groups of patients were analyzed. There were statistically significant differences between the experimental group and the control group before and after treatment (P<0.05), indicating that both sleeping pills and combined umbilical moxibustion can improve patients' anxiety and depression to varying degrees, and there was no significant statistical difference between the two groups of patients (P>0.05).

[0082] The PSQI factor scores of the two groups of patients were analyzed, and there were statistical differences between the experimental group and the control group before and after treatment (P<0.05), indicating that both sleeping pills and combined umbilical moxibustion therapy can reduce the discomfort symptoms of insomnia patients to varying degrees; the PSQI factor scores of the two groups after two courses of treatment were compared, and there were statistical differences (P<0.05), which indicates that combined umbilical moxibustion therapy is more significant in improving the discomfort symptoms of insomnia patients than simple sleeping pills and lifestyle therapy.

[0083] Clinical Case 1

[0084] A, female, 61 years old;

[0085] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0086] Diagnosis: Insomnia

[0087] Current symptoms: insomnia, difficulty falling asleep, easy waking, poor energy during the day, fatigue, irritability, occasional dizziness, paroxysmal, no headache, no chest tightness or pain, good appetite, poor sleep, and normal bowel movements.

[0088] Concomitant diseases: None.

[0089] Relevant examinations during the visit showed: blood pressure: 119 / 81 mmHg, heart rate: 80 times / min, respiration: 21 times / min, body temperature: 36.3℃.

[0090] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 11 points, Insomnia Severity Index (ISI): 13 points, Traditional Chinese Medicine Symptom Score: 8 points, Hamilton Depression Rating Scale (HAMD): 3 points, Hamilton Anxiety Rating Scale (HAMA): 0 points.

[0091] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, was not in good spirits during the day, was weak, upset, had a pale red tongue, a thin white fur, and a stringy pulse. The four examinations combined with the TCM syndrome differentiation showed that he was suffering from liver depression and qi stagnation, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0092] After 14 days of treatment, the following indicators were reviewed: blood pressure: 132 / 76 mmHg, heart rate: 98 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0093] Related scales: Pittsburgh Sleep Quality Index (PSQI): 8 points, Insomnia Severity Index (ISI): 10 points, Traditional Chinese Medicine Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 0 points, Hamilton Anxiety Rating Scale (HAMA): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0094] After umbilical moxibustion with medicine, the patient's PSQI, ISI, HAMD and TCM symptom scores were significantly reduced, and the patient's difficulty in falling asleep was significantly alleviated.

[0095] Clinical Case 2

[0096] A, female, 37 years old;

[0097] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0098] Diagnosis: Insomnia

[0099] Current symptoms: difficulty falling asleep, shallow sleep, easy awakening, frequent dreams, complains that he did not sleep the whole night last night, poor energy during the day, easy fatigue, occasional palpitations at night, good appetite, normal bowel movements and bowel movements.

[0100] Concomitant diseases: None.

[0101] Relevant examinations during the visit showed: blood pressure: 132 / 79 mmHg, heart rate: 78 times / min, respiration: 20 times / min, body temperature: 36.6℃.

[0102] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 12 points, Insomnia Severity Index (ISI): 16 points, Traditional Chinese Medicine Symptom Score: 10 points, Hamilton Depression Rating Scale (HAMD): 8 points, Hamilton Anxiety Rating Scale (HAMA): 5 points.

[0103] When the patient came to the clinic, he had difficulty falling asleep, shallow sleep, easy awakening, many dreams, occasional panic, pale red tongue, thin white fur, and stringy pulse. The four examinations combined with TCM syndrome differentiation were diagnosed as liver depression and qi stagnation syndrome, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0104] After 14 days of treatment, the following indicators were reviewed: blood pressure: 122 / 76 mmHg, heart rate: 97 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0105] Related scales: Pittsburgh Sleep Quality Index (PSQI): 10 points, Insomnia Severity Index (ISI): 13 points, TCM Symptom Score: 7 points, Hamilton Depression Rating Scale (HAMD): 5 points, Hamilton Anxiety Rating Scale (HAMA): 3 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0106] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), HAMD, HAMA and TCM symptom scores were significantly reduced, the patients' sleep quality was improved, the number of early awakenings was reduced, and depression and anxiety were alleviated.

[0107] Clinical Case 3

[0108] A, female, 43 years old;

[0109] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0110] Diagnosis: Insomnia

[0111] Current symptoms: insomnia, difficulty falling asleep, easy waking, low mood, irritability, heavy thoughts, occasional dizziness, occasional dull pain in the epigastric area, and normal appetite.

[0112] Comorbidities: Mild depression.

[0113] Relevant examinations during the visit showed: blood pressure: 127 / 83 mmHg, heart rate: 81 times / min, respiration: 20 times / min, body temperature: 36.3℃.

[0114] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 10 points, Insomnia Severity Index (ISI): 13 points, Traditional Chinese Medicine Symptom Score: 7 points, Hamilton Depression Rating Scale (HAMD): 19 points, Hamilton Anxiety Rating Scale (HAMA): 15 points.

[0115] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, was in a low mood, had a red tongue, a thin white fur, and a stringy pulse. The four examinations combined with the TCM syndrome differentiation showed that he was suffering from liver depression and qi stagnation, and was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0116] After 14 days of treatment, the following indicators were reviewed: blood pressure: 131 / 76 mmHg, heart rate: 83 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0117] Related scales: Pittsburgh Sleep Quality Index (PSQI): 8 points, Insomnia Severity Index (ISI): 9 points, TCM Symptom Score: 6 points, Hamilton Depression Rating Scale (HAMD): 16 points, Hamilton Anxiety Rating Scale (HAMA): 13 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0118] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), HAMD, HAMA and TCM symptom scores were significantly reduced, the patients' difficulty in falling asleep was alleviated, and their depression and anxiety were alleviated.

[0119] Clinical Case 4

[0120] A, female, 51 years old;

[0121] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0122] Diagnosis: Insomnia

[0123] Current symptoms: poor sleep, difficulty falling asleep, easy waking, frequent dreams, fatigue, irritability, no headache, no chest tightness or pain, good appetite, poor sleep, and normal bowel movements.

[0124] Concomitant diseases: Hypertension stage 3 (high risk).

[0125] Relevant examinations during the visit showed: blood pressure: 156 / 96 mmHg, heart rate: 90 beats / min, respiration: 20 times / min, body temperature: 36.1℃.

[0126] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 11 points, Insomnia Severity Index (ISI): 14 points, Traditional Chinese Medicine Symptom Score: 6 points, Hamilton Depression Rating Scale (HAMD): 12 points, Hamilton Anxiety Rating Scale (HAMA): 10 points.

[0127] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, had many dreams, was weak, upset, had a red tongue, a thin yellow fur, and a stringy pulse. The four examinations combined with the TCM syndrome differentiation showed that he was suffering from liver depression and qi stagnation, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0128] After 14 days of treatment, the following indicators were reviewed: blood pressure: 145 / 76 mmHg, heart rate: 98 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0129] Related scales: Pittsburgh Sleep Quality Index (PSQI): 9 points, Insomnia Severity Index (ISI): 10 points, TCM Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 9 points, Hamilton Anxiety Rating Scale (HAMA): 10 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0130] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), HAMD, and TCM symptom scores were significantly reduced, the patients' sleep quality was improved, and their depression was alleviated.

[0131] Clinical Case 5

[0132] A, male, 69 years old;

[0133] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0134] Diagnosis: Insomnia

[0135] Current symptoms: Can fall asleep after taking sleeping pills, dream a lot, sleep shallowly, wake up easily, occasionally feel panic, chest tightness, irritable personality, good appetite, occasional constipation, urinate 3-4 times at night, not much, and have a lot of foam in the urine.

[0136] Concomitant diseases: hypertension stage 2 (high risk), hyperlipidemia.

[0137] Relevant examinations during the visit showed: blood pressure: 139 / 81 mmHg, heart rate: 81 times / min, respiration: 20 times / min, body temperature: 36.1℃.

[0138] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 13 points, Insomnia Severity Index (ISI): 17 points, Traditional Chinese Medicine Symptom Score: 8 points, Hamilton Depression Rating Scale (HAMD): 9 points, Hamilton Anxiety Rating Scale (HAMA): 7 points.

[0139] When the patient came to the clinic, he had difficulty falling asleep, dreaming a lot, sleeping lightly, waking up easily, occasionally panicking, feeling stuffy in the chest, pale red tongue, greasy white fur, and slow pulse. The four examinations combined with TCM syndrome differentiation showed liver depression and qi stagnation syndrome, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0140] After 14 days of treatment, the following indicators were reviewed: blood pressure: 137 / 81 mmHg, heart rate: 87 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0141] Related scales: Pittsburgh Sleep Quality Index (PSQI): 11 points, Insomnia Severity Index (ISI): 15 points, TCM Symptom Score: 6 points, Hamilton Depression Rating Scale (HAMD): 9 points, Hamilton Anxiety Rating Scale (HAMA): 5 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0142] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), HAMA and TCM symptom scores were significantly reduced, the patients' difficulty in falling asleep was alleviated, their anxiety was reduced, and the dosage of sleeping pills was reduced.

[0143] Clinical Case 6

[0144] A, female, 48 years old;

[0145] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0146] Diagnosis: Insomnia

[0147] Current symptoms: difficulty falling asleep, easy to wake up, difficult to fall asleep again after waking up, still energetic during the day, can sleep for 5 hours, occasional headaches, back pain on both sides, sweating a lot at night and soaking clothes, urinating 1-2 times / night, normal bowel movements, easy hair loss, easy to be afraid of cold.

[0148] Concomitant diseases: None.

[0149] Relevant examinations during the visit showed: blood pressure: 118 / 83 mmHg, heart rate: 73 times / min, respiration: 21 times / min, body temperature: 36.3℃.

[0150] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 9 points, Insomnia Severity Index (ISI): 12 points, Traditional Chinese Medicine Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 3 points, Hamilton Anxiety Rating Scale (HAMA): 4 points.

[0151] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, had difficulty falling asleep again after waking up, was upset, had a pale red tongue, a thin white fur, and a stringy and thin pulse. The four examinations combined with the TCM syndrome differentiation were diagnosed as liver depression and qi stagnation syndrome, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0152] After 14 days of treatment, the following indicators were reviewed: blood pressure: 122 / 76 mmHg, heart rate: 98 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0153] Related scales: Pittsburgh Sleep Quality Index (PSQI): 7 points, Insomnia Severity Index (ISI): 10 points, TCM Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 3 points, Hamilton Anxiety Rating Scale (HAMA): 4 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0154] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and TCM symptom scores were significantly reduced, the patients' difficulty in falling asleep was alleviated, and their sleep quality was improved.

[0155] Clinical Case 7

[0156] A, female, 41 years old;

[0157] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0158] Diagnosis: Insomnia

[0159] Current symptoms: difficulty falling asleep, easy to wake up, difficulty falling asleep after waking up, about 6 hours / night, occasional abdominal pain and bloating, occasional tightness in the shoulders and neck, no dizziness or headache, no chest tightness or palpitations, anxiety, heavy thoughts, dry mouth without bitter taste, good appetite, and normal bowel movements.

[0160] Concomitant diseases: None.

[0161] Relevant examinations during the visit showed: blood pressure: 131 / 83 mmHg, heart rate: 81 times / min, respiration: 21 times / min, body temperature: 36.3℃.

[0162] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 10 points, Insomnia Severity Index (ISI): 13 points, Traditional Chinese Medicine Symptom Score: 7 points, Hamilton Depression Rating Scale (HAMD): 11 points, Hamilton Anxiety Rating Scale (HAMA): 10 points.

[0163] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, had difficulty falling asleep after waking up, was anxious, had a pale red tongue, a thin white fur, and a stringy pulse. The four examinations combined with the TCM syndrome differentiation were diagnosed as liver depression and qi stagnation syndrome, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0164] After 14 days of treatment, the following indicators were reviewed: blood pressure: 127 / 76 mmHg, heart rate: 98 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0165] Related scales: Pittsburgh Sleep Quality Index (PSQI): 8 points, Insomnia Severity Index (ISI): 10 points, TCM Symptom Score: 6 points, Hamilton Depression Rating Scale (HAMD): 9 points, Hamilton Anxiety Rating Scale (HAMA): 9 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0166] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), HAMD, HAMA and TCM symptom scores were significantly reduced, the patients' sleep quality was improved, and their depression and anxiety were alleviated.

[0167] Clinical Case 8

[0168] A, female, 50 years old;

[0169] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0170] Diagnosis: Insomnia

[0171] Current symptoms: insomnia, difficulty falling asleep, easy waking, difficulty falling asleep after waking up, poor spirits during the day, memory loss, prone to anxiety, headache when tired or not well rested, weakness in both lower limbs, pain in the calves, poor appetite, irregular bowel movements, and dry and bitter mouth.

[0172] Concomitant diseases: None.

[0173] Relevant examinations during the visit showed: blood pressure: 129 / 81 mmHg, heart rate: 80 times / min, respiration: 20 times / min, body temperature: 36.3℃.

[0174] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 12 points, Insomnia Severity Index (ISI): 16 points, Traditional Chinese Medicine Symptom Score: 8 points, Hamilton Depression Rating Scale (HAMD): 10 points, Hamilton Anxiety Rating Scale (HAMA): 10 points.

[0175] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, had difficulty falling asleep after waking up, was in poor spirits during the day, had memory loss, was prone to anxiety, had a red tongue, a white and greasy coating, and a stringy pulse. The four examinations combined with the TCM syndrome differentiation showed that the patient was a syndrome of liver depression and qi stagnation, and was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0176] After 14 days of treatment, the following indicators were reviewed: blood pressure: 132 / 78 mmHg, heart rate: 87 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0177] Related scales: Pittsburgh Sleep Quality Index (PSQI): 11 points, Insomnia Severity Index (ISI): 14 points, TCM Symptom Score: 6 points, Hamilton Depression Rating Scale (HAMD): 8 points, Hamilton Anxiety Rating Scale (HAMA): 10 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0178] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), HAMD and TCM symptom scores were significantly reduced, and the patients' sleep quality was improved.

[0179] Clinical Case 9

[0180] A, female, 60 years old;

[0181] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0182] Diagnosis: Insomnia

[0183] Current symptoms: difficulty falling asleep, taking alprazolam to aid sleeping, waking up easily, difficulty falling asleep again after waking up, dizziness and headache from time to time, mental state is OK during the day, but sometimes not, swelling and pain in the neck, no dryness or bitter taste in the mouth, good appetite, and normal bowel movements.

[0184] Concomitant diseases: mixed cervical spondylosis.

[0185] Relevant examinations during the visit showed: blood pressure: 131 / 81 mmHg, heart rate: 76 times / min, respiration: 20 times / min, body temperature: 36.3℃.

[0186] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 12 points, Insomnia Severity Index (ISI): 16 points, Traditional Chinese Medicine Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 0 points, Hamilton Anxiety Rating Scale (HAMA): 0 points.

[0187] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, was not in good spirits during the day, had a pale red tongue, a thin white fur, and a stringy and thin pulse. The four examinations combined with the TCM syndrome differentiation were diagnosed as liver depression and qi stagnation syndrome, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0188] After 14 days of treatment, the following indicators were reviewed: blood pressure: 133 / 76 mmHg, heart rate: 75 beats / min, respiration: 20 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0189] Related scales: Pittsburgh Sleep Quality Index (PSQI): 9 points, Insomnia Severity Index (ISI): 11 points, TCM Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 0 points, Hamilton Anxiety Rating Scale (HAMA): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0190] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and TCM symptom scores were significantly reduced, the patients' difficulty in falling asleep was alleviated, and the number of sleeping pills they took was reduced.

[0191] Clinical Case 10

[0192] A, male, 52 years old;

[0193] The patient came for insomnia and was given the composition of Example 1 for 14 days of umbilical moxibustion.

[0194] Diagnosis: Insomnia

[0195] Current symptoms: difficulty falling asleep, but acceptable sleep quality. The patient complained of waking up at 5 a.m. recently, occasional dizziness when getting up in the morning, left-sided headache, fatigue during the day, soreness and swelling in both lower limbs, good appetite, nocturia 1-2 times / night, and normal bowel movements.

[0196] Concomitant diseases: None.

[0197] Relevant examinations during the visit showed: blood pressure: 129 / 81 mmHg, heart rate: 80 times / min, respiration: 20 times / min, body temperature: 36.1℃.

[0198] Related scale assessment: Pittsburgh Sleep Quality Index (PSQI): 12 points, Insomnia Severity Index (ISI): 16 points, Traditional Chinese Medicine Symptom Score: 6 points, Hamilton Depression Rating Scale (HAMD): 0 points, Hamilton Anxiety Rating Scale (HAMA): 0 points.

[0199] When the patient came to the clinic, he had difficulty falling asleep, woke up easily, had occasional dizziness, fatigue, pale red tongue, thin white fur, and stringy pulse. The four examinations combined with TCM syndrome differentiation were diagnosed as liver depression and qi stagnation syndrome, and he was treated with umbilical moxibustion with medicine. The treatment lasted for 14 days.

[0200] After 14 days of treatment, the following indicators were reviewed: blood pressure: 122 / 81 mmHg, heart rate: 78 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's insomnia symptoms were significantly improved.

[0201] Related scales: Pittsburgh Sleep Quality Index (PSQI): 9 points, Insomnia Severity Index (ISI): 11 points, TCM Symptom Score: 5 points, Hamilton Depression Rating Scale (HAMD): 0 points, Hamilton Anxiety Rating Scale (HAMA): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0202] After umbilical moxibustion with medicine, the patients' Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and TCM symptom scores were significantly reduced, and the patients' difficulty in falling asleep was alleviated.

[0203] The above is only a preferred embodiment of the present invention and does not limit the present invention in any form. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the content of the technical solution of the present invention shall fall within the scope of protection of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating insomnia, characterized in that: The invention is prepared from the following components in parts by weight: 25-35 parts of bupleurum, 25-35 parts of white peony root, 25-35 parts of fructus aurantii, 25-35 parts of cyperus rotundus, 25-35 parts of curcuma, 25-35 parts of epimedium, 25-35 parts of cyperus seeds, 25-35 parts of polyphylla, 25-35 parts of julibrissin bark, 25-35 parts of mother of pearl and 8-15 parts of borneol.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 30 parts of bupleurum, 30 parts of white peony root, 30 parts of fructus aurantii, 30 parts of cyperus rotundus, 30 parts of curcuma, 30 parts of epimedium, 30 parts of cyperus seeds, 30 parts of smilax china, 30 parts of bark of julibrissin, 30 parts of mother-of-pearl and 10 parts of borneol.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The Chinese medicine composition is used for treating insomnia by umbilical moxibustion.

4. A umbilical moxibustion powder for treating insomnia, characterized in that: Including the Chinese medicine composition according to claim 1 or 2.

5. A method for preparing the umbilical moxibustion powder according to claim 4, characterized in that: include: Mix and grind the raw materials into powder.

6. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicine for treating insomnia.

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