A traditional Chinese medicine composition and its preparation method for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women.

Abstract

The application discloses a traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety of perimenopausal women and a preparation method of the traditional Chinese medicine composition. The composition comprises the following components in parts by weight: 20-30 parts of prepared tortoise plastron, 15-20 parts of radix pseudostellariae, 15-30 parts of semen euryales, 8-12 parts of rhizoma anemarrhenae, 8-12 parts of phellodendri cortex, 6-15 parts of fructus gardeniae, 15-30 parts of radix salviae miltiorrhizae, 20-30 parts of fructus jujubae, 15-30 parts of triticum repen, 15-30 parts of semen platycladi, 15-30 parts of semen ziziphi spinosae, and 6-20 parts of honey-fried radix glycyrrhizae. The composition can effectively prevent and treat insomnia accompanied by depression and anxiety of perimenopausal women.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition and preparation method for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women. Background Technology

[0002] Perimenopause is the transitional period for women from their reproductive years to old age. Ovarian function gradually declines, and sex hormone secretion drops sharply, disrupting the homeostasis of the reproductive-age environment within the body. The body's inability to adapt to these changes leads to a series of physical and psychological symptoms, resulting in menopausal syndrome (MPS). Major symptoms include hot flashes, palpitations, insomnia, menstrual irregularities, anxiety, and depression; its incidence is estimated to be as high as 60%–80%. Insomnia is the most common symptom in perimenopausal women, with an incidence rate as high as 76.8%. Among the abnormal emotions that occur during perimenopause, depression and anxiety are the most frequent. Studies have shown that the incidence of depression in women during this period is 36.3%, and the incidence of anxiety symptoms is 23.66%. The "Expert Consensus on the Diagnosis and Treatment of Insomnia with Depression and Anxiety in Chinese Adults" states that insomnia, depression, and anxiety are often mutually causal, inextricably linked in their onset and symptom presentation, and mutually influence each other, seriously affecting the physical and mental health of perimenopausal women and reducing their survival and quality of life. Insomnia accompanied by depression and anxiety in perimenopausal women is receiving increasing attention.

[0003] Modern medicine has explored the mechanisms underlying insomnia accompanied by depression and anxiety in perimenopausal women from multiple perspectives. Currently, it is believed that the condition is primarily caused by a combination of factors, including endocrine axis, neurotransmitter, and immune dysfunction resulting from estrogen withdrawal, as well as genetic factors. Treatment mainly involves hormone replacement therapy, traditional sedative-hypnotic drugs, antidepressants, and anti-anxiety medications, but these treatment methods still have limitations.

[0004] Insomnia accompanied by depression and anxiety in perimenopausal women falls under the categories of "pre- and post-menopausal symptoms," "insomnia," "depression," and "hysteria" in Traditional Chinese Medicine (TCM). TCM has a long history of recognizing and treating this condition, with significant efficacy. While previous studies have reported numerous clinical observations and research on TCM treatment of menopausal syndrome, there are very few reports on the clinical application of TCM in improving insomnia and mood disorders in perimenopausal women. Standardized and systematic research is clearly insufficient, and practical and effective TCM formulas are lacking. Therefore, it is essential to highlight the unique advantages of TCM treatment and seek effective TCM prescriptions.

[0005] Therefore, this invention is proposed. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition and preparation method for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women, which can effectively prevent and treat insomnia accompanied by depression and anxiety in perimenopausal women.

[0007] To achieve the above-mentioned technical objectives, the present invention adopts the following technical solution:

[0008] This invention provides a traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women, comprising the following components by weight: 20-30 parts of prepared tortoise shell, 15-20 parts of Codonopsis pilosula, 15-30 parts of Cuscuta chinensis, 8-12 parts of Anemarrhena asphodeloides, 8-12 parts of Phellodendron chinense, 6-15 parts of Gardenia jasminoides, 15-30 parts of Salvia miltiorrhiza, 20-30 parts of jujube, 15-30 parts of wheat bran, 15-30 parts of Platycladus orientalis seed, 15-30 parts of Ziziphus jujuba seed, and 6-20 parts of prepared licorice root.

[0009] Optionally, the composition comprises, by weight:

[0010] Prepared tortoise shell 20 parts, Codonopsis pilosula 20 parts, Cuscuta chinensis 15 parts, Anemarrhena asphodeloides 12 parts, Phellodendron chinense 8 parts, Gardenia jasminoides 15 parts, Salvia miltiorrhiza 15 parts, Jujube 30 parts, Triticum aestivum 15 parts, Platycladus orientalis seed 30 parts, Ziziphus jujuba seed 15 parts, Prepared licorice root 20 parts.

[0011] Optionally, the composition comprises, by weight:

[0012] Prepared tortoise shell 30 parts, Codonopsis pilosula 15 parts, Cuscuta chinensis 30 parts, Anemarrhena asphodeloides 8 parts, Phellodendron chinense 12 parts, Gardenia jasminoides 6 parts, Salvia miltiorrhiza 30 parts, Jujube 20 parts, Triticum aestivum 30 parts, Platycladus orientalis seed 15 parts, Ziziphus jujuba seed 30 parts, Prepared licorice root 6 parts.

[0013] Optionally, the amount of Anemarrhena asphodeloides is 10 parts and the amount of Platycladus orientalis seed is 10 parts.

[0014] Optionally, the composition comprises, by weight:

[0015] Prepared tortoise shell 20 parts, Codonopsis pilosula 15 parts, Cuscuta chinensis 20 parts, Anemarrhena asphodeloides 10 parts, Phellodendron chinense 10 parts, Gardenia jasminoides 10 parts, Salvia miltiorrhiza 30 parts, Jujube 30 parts, Triticum aestivum 30 parts, Platycladus orientalis seed 30 parts, Ziziphus jujuba seed 30 parts, Prepared licorice root 10 parts.

[0016] This invention also provides a method for preparing a traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women, comprising:

[0017] The above-mentioned traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women is prepared as raw material. The raw material is decocted with water to make a soup or made into granules, ointments, tablets, or capsules.

[0018] The present invention provides a traditional Chinese medicine composition and preparation method for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women. The combination of the medicines prioritizes nourishing the kidneys and replenishing essence, strengthening the spleen and nourishing the blood to nourish the kidney essence, clearing the heart and purging fire, calming the mind and stabilizing the will to help sleep and relieve anxiety. The whole formula works together to harmonize the heart and kidneys and regulate the spirit, which can improve insomnia, depression, anxiety and other symptoms in perimenopausal women. Attached Figure Description

[0019] Figure 1 A comparison chart of PSQI scores before and after treatment for the two groups of patients;

[0020] Figure 2 A comparison chart of HAMD-17 scores before and after treatment in two groups of patients;

[0021] Figure 3 A comparison chart of HAMA scores before and after treatment in two groups of patients;

[0022] Figure 4 A comparison chart of the modified Kupperman Index scores before and after treatment in two groups of patients.

[0023] Figure 5 A comparison chart of TCM syndrome scores before and after treatment for two groups of patients. Detailed Implementation

[0024] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present application, and not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort should fall within the scope of protection of the present application.

[0025] The inventors discovered through research that the key to the disease lies in the disharmony between the heart and kidneys, leading to imbalances in the body's fluids and energy. The heart and kidneys are closely related to a person's mental and emotional activities. However, when a woman reaches the age of 49, her kidney water declines and fails to nourish the heart yin, causing the heart fire to become excessive. This excessive heart fire disturbs the mind, resulting in symptoms such as depression, anxiety, and irritability. When the mind is restless, insomnia occurs.

[0026] In view of this, the present invention provides a traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women, which will be described in detail below.

[0027] This invention provides a traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women, comprising the following components by weight: 20-30 parts of prepared tortoise shell, 15-20 parts of Codonopsis pilosula, 15-30 parts of Cuscuta chinensis, 8-12 parts of Anemarrhena asphodeloides, 8-12 parts of Phellodendron chinense, 6-15 parts of Gardenia jasminoides, 15-30 parts of Salvia miltiorrhiza, 20-30 parts of jujube, 15-30 parts of wheat bran, 15-30 parts of Platycladus orientalis seed, 15-30 parts of Ziziphus jujuba seed, and 6-20 parts of prepared licorice root.

[0028] Example 1

[0029] This invention provides a traditional Chinese medicine composition for preventing and treating insomnia accompanied by depression and anxiety in perimenopausal women. The composition consists of: 20g of prepared tortoise shell, 15g of Codonopsis pilosula, 20g of Cuscuta chinensis, 10g of Anemarrhena asphodeloides, 10g of Phellodendron chinense, 10g of Gardenia jasminoides, 30g of Salvia miltiorrhiza, 30g of jujube, 30g of wheat bran, 30g of Platycladus orientalis seed, 30g of Ziziphus jujuba seed, and 10g of prepared licorice root.

[0030] Example 2

[0031] The difference between this embodiment and Implementation 1 is that the proportions of each group are different. Specifically, the ingredients are: 20g of prepared tortoise shell, 15g of Codonopsis pilosula, 20g of Cuscuta chinensis, 10g of Anemarrhena asphodeloides, 10g of Phellodendron chinense, 10g of Gardenia jasminoides, 15g of Salvia miltiorrhiza, 20g of jujube, 30g of wheat bran, 20g of Platycladus orientalis seed, 30g of Ziziphus jujuba seed, and 10g of prepared licorice root.

[0032] Example 3

[0033] The difference between this embodiment and Implementation 1 is that the proportions of each group are different. Specifically, the ingredients are: 20g of prepared tortoise shell, 20g of Codonopsis pilosula, 15g of Cuscuta chinensis, 12g of Anemarrhena asphodeloides, 8g of Phellodendron chinense, 15g of Gardenia jasminoides, 15g of Salvia miltiorrhiza, 30g of jujube, 15g of wheat bran, 30g of Platycladus orientalis seed, 15g of Ziziphus jujuba seed, and 20g of prepared licorice root.

[0034] Example 4

[0035] The difference between this embodiment and Implementation 1 is that the proportions of each group are different. Specifically, the ingredients are: 30g of prepared tortoise shell, 15g of Codonopsis pilosula, 30g of Cuscuta chinensis, 8g of Anemarrhena asphodeloides, 12g of Phellodendron chinense, 6g of Gardenia jasminoides, 30g of Salvia miltiorrhiza, 20g of jujube, 30g of wheat bran, 15g of Platycladus orientalis seed, 30g of Ziziphus jujuba seed, and 6g of prepared licorice root.

[0036] The combined effects of these herbs prioritize nourishing the kidneys and replenishing essence, while also strengthening the spleen and nourishing the blood to replenish the kidney essence. Additionally, they clear the heart and reduce fire, calm the mind and stabilize the spirit to aid sleep and relieve anxiety. The entire formula works to harmonize the heart and kidneys and regulate the spirit.

[0037] The functions and indications are to nourish the kidney, tranquilize the mind and soothe the nerves. It is used for perimenopausal kidney yin deficiency and disharmony between the heart and the kidney. Symptoms include paroxysmal hot flashes and sweating before and after menopause, soreness and weakness of the waist and knees, restlessness, insomnia and多梦, abnormal emotions, palpitations and chest tightness, pale red tongue with little coating, thready or rapid and thready pulse. For those with insomnia accompanied by depressive and anxiety symptoms in menopausal syndrome showing the above syndromes.

[0038] Next, through relevant clinical trials, the effects of the traditional Chinese medicine composition provided in the embodiments of the present invention for preventing and treating insomnia accompanied by depressive and anxiety symptoms in perimenopausal women will be introduced. It should be noted that for the convenience of introduction or description, the "Zishen Anning Prescription" mentioned in the following test examples refers to the traditional Chinese medicine composition for preventing and treating insomnia accompanied by depressive and anxiety symptoms in perimenopausal women in Embodiment 1 of the present invention.

[0039] Clinical Observation

[0040] 1. Clinical Data

[0041] 1.1 Case Source

[0042] Adopting a prospective randomized controlled study method, the clinical data of 60 patients who met the diagnostic criteria of MPS insomnia accompanied by depression and anxiety symptoms and were differentiated as disharmony between the heart and the kidney by traditional Chinese medicine during the period from December 2021 to January 2023 in the gynecology outpatient department of the China Academy of Chinese Medical Sciences were collected. These patients were divided into a treatment group of 40 cases and a control group of 20 cases. Treatment group: Given Zishen Anning Prescription for 8 weeks. Control group: Given Kuntai Capsules for 8 weeks.

[0043] The implementation of this study has passed the review and approval of the hospital ethics committee (approval number: 2022XLA105).

[0044] 1.2 Diagnostic Criteria

[0045] 1.2.1 Diagnostic Criteria for MPS

[0046] Referring to the definition of "menopausal syndrome" in the ninth edition of the national higher medical college textbook "Obstetrics and Gynecology" published by People's Medical Publishing House in 2018: Menopausal syndrome: A series of somatic and mental symptoms caused by fluctuations or decreases in sex hormones before and after menopause in women. Age: Women aged 40 - 60. Along with menstrual disorders, the following symptoms are present: ① Vasomotor symptoms, such as hot flashes, sweating, etc. ② Psychoneurological symptoms, such as mood swings, depression, anxiety, restlessness, irritability, etc. ③ Autonomic nervous system disorder symptoms, such as insomnia, palpitations, headache, dizziness, etc. ④ Genitourinary atrophy symptoms, such as vaginal dryness and burning pain, dyspareunia, frequency of urination, urgency of urination, pain during urination, etc. Auxiliary: In reproductive endocrine hormone determination, FSH > 10 U / L (for those with menstruation, it is detected within 2 - 5 days after menstruation stops; for those without menstruation, it is detected at any time). In the above diagnosis, it is necessary to meet items ① and ③, and more than 2 items in item ② to diagnose as menopausal syndrome.

[0047] 1.2.2 Diagnostic Criteria for Non-organic Insomnia

[0048] Refer to the diagnostic criteria for "non-organic insomnia" in the third edition of the Classification and Diagnostic Criteria of Mental Disorders in China (CCMD-3).

[0049] 1.2.3 Judgment Bases for Depression and Anxiety Symptoms

[0050] (1) Hamilton Depression Rating Scale (HAMD-17).

[0051] (2) Hamilton Anxiety Rating Scale (HAMA).

[0052] This study included mild to moderate anxiety patients with HAMA scores between 8 and 29 points.

[0053] 1.2.4 TCM Syndrome Criteria

[0054] Refer to the criteria of "Classification of Syndromes in TCM Clinical Diagnosis and Treatment Terms - Syndromes of Concurrent Disorders of Zang-Fu Organs" issued by the State Bureau of Technical Supervision in 1997, and the diagnostic criteria for "syndrome of disharmony between the heart and kidney" in the textbook of TCM Internal Medicine - Insomnia for Higher Education of Traditional Chinese Medicine.

[0055] 2 Research Methods

[0056] 2.1 Case Collection

[0057] Adopt a prospective randomized controlled research method to collect the clinical data of 60 patients who met the diagnostic criteria of MPS insomnia with depression and anxiety and were dialectically diagnosed as syndrome of disharmony between the heart and kidney during the period from December 2021 to January 2023 in the gynecology outpatient department. These patients were divided into a treatment group of 40 cases and a control group of 20 cases. Treatment group: Given Zishen Anning Decoction for 8 weeks. Control group: Given Kuntai Capsules for 8 weeks.

[0058] 2.2 Treatment Methods

[0059] 2.2.1 Treatment Group

[0060] After the patients met the inclusion and exclusion criteria, the method of tonifying the kidney and nourishing blood, clearing the heart and calming the mind was adopted, and the treatment formula was modified from Zishen Anning Decoction.

[0061] Medication: Zishen Anning Decoction: Prepared by the decoction room of Xiyuan Hospital, 20g of processed tortoise plastron, 15g of heterophylly falsestarwort root, 20g of dodder seed, 30g of floating wheat, 10g of roasted licorice root, 10g of anemarrhena rhizome, 10g of phellodendron bark, 10g of cape jasmine fruit, 20g of semen platycladi, 20g of Chinese date, 15g of salvia miltiorrhiza, 30g of wild jujube seed (decocted twice with 8 times the amount of water, 1 hour for the first time and 0.5 hour for the second time).

[0062] Medication administration and course of treatment: After enrollment, patients in the treatment group began taking a modified version of the Zishen Anning formula for a total of 8 weeks, one dose daily, 200ml twice a day (morning and evening). Strict contraception was required during the medication period.

[0063] 2.2.2 Control Group

[0064] After meeting the inclusion criteria, patients were treated with Kuntai capsules.

[0065] Medication: Kuntai Capsules.

[0066] Dosage and course of treatment: 0.5g / capsule, 36 capsules / box, 4 capsules / dose, 3 times a day, for a total of 8 weeks. Strict contraception must be used during medication.

[0067] 2.3 Observation Indicators

[0068] 2.3.1 General Information

[0069] Record the patient's basic information, including age, pregnancy and childbirth history, menstrual status, and past medical history.

[0070] 2.3.2 Therapeutic Indicators

[0071] (1) Main therapeutic indicators

[0072] Pittsburgh Sleep Quality Index (PSQI) score

[0073] (2) Secondary efficacy indicators

[0074] ①HAMD-17 score;

[0075] ②HAMA score;

[0076] ③Domestic improvement of the Kupper Index scoring system;

[0077] ④ Scoring using the Traditional Chinese Medicine Syndrome Recording Scale;

[0078] 2.3.3 Observational Indicators

[0079] Serum sex hormones: estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH);

[0080] 2.3.4 Safety Indicators

[0081] (1) Complete blood count; (2) Complete urine count; (3) Electrocardiogram; (4) Liver function; (5) Kidney function; (6) Endometrial thickness.

[0082] 2.4 Efficacy Evaluation Criteria

[0083] Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)" (2002 edition), the degree of relief of insomnia, depression, anxiety, and perimenopausal symptoms was assessed based on the reduction rate of scores on scales such as PSQI, HAMD-17, HAMA, and the domestically modified Kupperman Index before and after treatment. Clinical efficacy was categorized as cured, significantly effective, effective, and ineffective. The reduction rate was calculated as: (Total score before treatment - Total score after treatment) / Total score before treatment × 100%. The effective rate was calculated as: (Number of cured cases + Number of significantly effective cases + Number of effective cases) / Total number of patients in the group × 100%.

[0084] 2.5 Adverse Events

[0085] Observe whether any adverse events are recorded in the case data. If so, check the occurrence and duration of the adverse events, the severity of the adverse events, the treatment measures, etc., and analyze whether they are related to the drugs used for treatment.

[0086] 2.6 Statistical Analysis

[0087] Statistical processing of data was performed using SPSS 25.0 software. Quantitative data that conform to a normal distribution were... This indicates that comparisons between groups are first performed using a homogeneity of variance test, and then a t-test is used after homogeneity of variance is satisfied; count data are described in terms of number of cases and percentages, and X-rays are applied. 2 The comparisons between groups were performed. Differences between groups were analyzed using one-way ANOVA, with P < 0.05 considered statistically significant.

[0088] 3 Results

[0089] 3.1 Baseline analysis of the two groups before treatment

[0090] 3.1.1 Comparison of General Data

[0091] Age and duration of illness:

[0092] The treatment group consisted of 40 patients, with a mean age of (48.50±2.05) years and a mean disease duration of (1.42±1.77) years; the control group consisted of 20 patients, with a mean age of (48.33±2.54) years and a mean disease duration of (1.07±1.26) years. Before treatment, there were no statistically significant differences in age or disease duration between the two groups (P>0.05), indicating comparability.

[0093] 3.1.2 Comparison of relevant indicators between the two groups of patients before treatment

[0094] Before treatment, the PSQI score, HAMD-17 score, HAMA score, modified Kupperman Index score (Chinese version), TCM syndrome score, serum sex hormone levels, and endometrial thickness were compared between the two groups. Comparison of PSQI scores before treatment: There was no statistically significant difference (P > 0.05) between the two groups, indicating comparability. Comparison of HAMD-17 and HAMA scores before treatment: There was no statistically significant difference (P > 0.05) between the two groups, indicating comparability. Comparison of TCM syndrome scores before treatment: There was no statistically significant difference (P > 0.05) between the two groups, indicating comparability. Before treatment, there was no statistically significant difference in serum sex hormone levels (E2, FSH, LH) between the two groups (P>0.05). Similarly, there was no statistically significant difference in endometrial thickness between the two groups before treatment, indicating that they were comparable.

[0095] 3.2 Research Results

[0096] 3.2.1 Comparison of PSQI scores before and after treatment in the two groups of patients:

[0097] After treatment, within-group comparisons showed that the PSQI score in the treatment group (5.03±1.58) was significantly lower than the pre-treatment score of 13.6±2.28 (P<0.01), indicating a statistically significant difference. Similarly, the PSQI score in the control group (9.43±1.71) was also lower than the pre-treatment score of 13.4±2.17 (P<0.01), indicating a statistically significant difference. Between-group comparisons showed that the reduction in PSQI score was significantly greater in the treatment group than in the control group (P<0.01), indicating a statistically significant difference. This suggests that the treatment group was significantly more effective than the control group in treating insomnia symptoms in perimenopausal women with heart-kidney disharmony. (See...) Figure 1 ).

[0098] 3.2.2 Comparison of the total effective rate of PSQI scores before and after treatment between the two groups of patients:

[0099] The effective rate in the treatment group was 97.5% (39 / 40), while that in the control group was 85% (17 / 20). Compared with the control group, the treatment group showed a more significant improvement in sleep (P < 0.01), indicating that the treatment group was more effective in relieving insomnia symptoms in perimenopausal women (see Table 1).

[0100] Table 1 Comparison of total effective rate of PSQI score before and after treatment in the two groups of patients.

[0101]

[0102] 3.2.3 Comparison of HAMD-17 scores before and after treatment in the two groups of patients:

[0103] After treatment, within-group comparisons showed that the HAMD-17 score in the treatment group (7.5±2.33) was significantly lower than the pre-treatment score of 20.93±2.95 (P<0.01), indicating a statistically significant difference. The HAMD-17 score in the control group (11.7±3.97) was also lower than the pre-treatment score of 20.53±3.18 (P<0.01), indicating a statistically significant difference. Between-group comparisons showed that the reduction in HAMD-17 score was significantly greater in the treatment group than in the control group (P<0.01), indicating that the treatment group was more effective than the control group in improving depressive symptoms in treating perimenopausal women with insomnia accompanied by depression and anxiety due to heart-kidney disharmony. (See...) Figure 2 ).

[0104] The effective rate in the treatment group was 97.5% (39 / 40), while it was 85% (17 / 20) in the control group. Compared with the control group, the treatment group showed a more significant improvement in HAMD-17 scores (P < 0.01), indicating a statistically significant difference. This suggests that the treatment group was better able to alleviate patients' depressive symptoms than the control group. (See Table 2)

[0105] Table 2 Comparison of the overall effective rate of HAMD-17 scores before and after treatment in the two groups of patients.

[0106]

[0107] 3.2.4 Comparison of HAMA scores before and after treatment in the two groups of patients:

[0108] After treatment, within-group comparisons showed that the HAMA score in the treatment group (6.2±2.46 points) was significantly lower than the pre-treatment score of 19.30±3.09 points (P<0.01), indicating a statistically significant difference. Similarly, the post-treatment HAMA score in the control group (11.5±3.31 points) was also lower than the pre-treatment score of 19.17±4.54 points (P<0.01), indicating a statistically significant difference. Between-group comparisons showed that the reduction in HAMA score was significantly greater in the treatment group than in the control group (P<0.01), indicating that the treatment group was more effective than the control group in improving anxiety symptoms in treating perimenopausal women with insomnia accompanied by depression and anxiety due to heart-kidney disharmony. (See...) Figure 3 ).

[0109] The effective rate in the treatment group was 95% (38 / 40), while it was 80% (16 / 20) in the control group. Compared with the control group, the treatment group showed a more significant improvement in HAMA scores (P < 0.01), indicating a statistically significant difference. This suggests that the treatment group was better able to alleviate patients' anxiety symptoms than the control group. (See Table 3.)

[0110] Table 3 Comparison of total effective rate of HAMA score before and after treatment in the two groups of patients.

[0111]

[0112] 3.2.5 Comparison of the modified Kupperman Index scores before and after treatment in the two groups of patients:

[0113] After treatment, within-group comparisons showed that the modified Kupperman Index (MKI) score in the treatment group (11.9±4.77) was significantly lower than the pre-treatment score of 28.37±7.09 (P<0.01), indicating a statistically significant difference. Similarly, the modified Kupperman Index score in the control group (16.46±5.48) was also lower than the pre-treatment score of 28.77±6.86 (P<0.01), indicating a statistically significant difference. Between-group comparisons showed that the reduction in the modified Kupperman Index score in the treatment group was significantly greater than that in the control group (P<0.01), indicating that the treatment group was more effective than the control group in alleviating MPS symptoms in treating perimenopausal women with insomnia accompanied by depression and anxiety due to heart-kidney disharmony. (See...) Figure 4 ).

[0114] The effective rate in the treatment group was 95% (38 / 40), while that in the control group was 80% (16 / 20). Compared with the control group, the treatment group showed a more significant improvement in the domestic modified Kupperman Index score (P < 0.01), indicating a statistically significant difference. This suggests that the treatment group was better able to alleviate MPS symptoms (see Table 4).

[0115] Table 4 Comparison of the overall effectiveness of the modified Kupperman Index score before and after treatment in the two groups of patients.

[0116]

[0117] 3.2.6 Comparison of changes in TCM syndrome scores before and after treatment in the two groups of patients:

[0118] After treatment, within-group comparisons showed that the TCM syndrome score in the treatment group (10.43±4.01 points) was significantly lower than the pre-treatment score of 26.67±7.57 points (P<0.01), indicating a statistically significant difference. Similarly, the TCM syndrome score in the control group (14.73±5.14 points) was also lower than the pre-treatment score of 27.03±4.81 points (P<0.01), indicating a statistically significant difference. Between-group comparisons showed that the reduction in TCM syndrome score was significantly greater in the treatment group than in the control group (P<0.01), indicating that the treatment group was more effective than the control group in alleviating TCM symptoms in perimenopausal women with insomnia accompanied by depression and anxiety due to heart-kidney disharmony. (See...) Figure 5 ).

[0119] The effective rate in the treatment group was 95% (38 / 40), while that in the control group was 90% (18 / 20). Compared with the control group, the treatment group showed a more significant improvement in TCM syndrome scores (P < 0.01), indicating a statistically significant difference. This suggests that the treatment group had a better therapeutic effect on improving TCM syndromes (see Table 5).

[0120] Table 5 Comparison of the total effective rate of TCM syndrome scores before and after treatment in the two groups of patients.

[0121]

[0122] 3.2.7 Changes in serum sex hormone levels before and after treatment in both groups of patients

[0123] E2: Treatment group: Post-treatment: 146.06±83.23 pmol / ml, Pre-treatment: 125.43±71.55 pmol / ml; Control group: Post-treatment: 146.30±90.59 pmol / ml, Pre-treatment: 123.68±72.94 pmol / ml. Within-group comparisons before and after treatment showed no statistically significant difference (P>0.01). Between-group comparisons showed no statistically significant difference (P>0.01).

[0124] FSH: Treatment group: Post-treatment: 31.43±11.85 mIU / ml, Pre-treatment: 48.41±22.47 mIU / ml; Control group: Post-treatment: 37.09±19.3 mIU / ml, Pre-treatment: 46.57±19.14 mIU / ml. Within-group comparisons before and after treatment, the treatment group showed a statistically significant difference (P<0.01), while the control group showed no statistically significant difference (P>0.01). Between-group comparisons before and after treatment, the difference was also statistically significant (P>0.01).

[0125] In summary, Kuntai capsules have no effect on ovarian sex hormone levels; Zishen Anning formula has no effect on E2 levels, but has a certain regulatory effect on serum FSH (see Table 6).

[0126] Table 6 Comparison of serum hormone levels in the two groups before and after treatment

[0127]

[0128] 3.2.9 Safety Indicator Analysis

[0129] After the course of treatment, follow-up examinations of the patients in the treatment group showed normal blood routine, urine routine, and electrocardiogram results, and their liver and kidney functions were all within the normal range. Their body temperature, pulse, respiration, and blood pressure were also normal, and no adverse reactions were observed in the patients in the treatment group while taking the medication.

[0130] in conclusion

[0131] (1) Nourishing the kidneys and calming the mind can improve insomnia symptoms in perimenopausal women.

[0132] In the treatment group of 40 patients, 39 showed improvement and 1 showed no improvement. In the control group of 20 patients, 17 showed improvement and 3 showed no improvement. The total effective rate of the PSQI scale in the treatment group was 97.5%, significantly higher than that in the control group (85%). This indicates that the application of Zishen Anning Formula can significantly improve insomnia symptoms in perimenopausal women, showing a significant advantage over the Kuntai Capsule group, improving sleep quality and prolonging sleep time.

[0133] (2) Nourishing Kidney and Calming Formula can improve depressive symptoms in perimenopausal women.

[0134] In the treatment group of 40 patients, 39 showed improvement and 1 showed no improvement. In the control group of 20 patients, 17 showed improvement and 3 showed no improvement. The total effective rate of the HAMD-17 Depression Scale in the treatment group was 97.5%, significantly higher than that in the control group (85%). This indicates that the application of Zishen Anning Formula can significantly improve depressive symptoms of insomnia accompanied by depression and anxiety in perimenopausal women, showing a significant advantage and more significant efficacy compared to the Kuntai Capsule group.

[0135] (3) Nourishing the kidneys and calming the mind can improve anxiety symptoms in perimenopausal women.

[0136] In the treatment group of 40 patients, 38 showed improvement and 2 showed no improvement. In the control group of 20 patients, 16 showed improvement and 4 showed no improvement. The total effective rate of the HAMA score in the treatment group was 95%, which was significantly higher than that in the control group (80%). This indicates that the application of Zishen Anning Formula can significantly improve anxiety symptoms in perimenopausal women with insomnia accompanied by depression and anxiety, and has a significant advantage and more significant efficacy compared with the Kuntai Capsule group.

[0137] (4) The Zishen Anning Formula significantly relieved the symptoms of menopausal syndrome in patients.

[0138] In the treatment group of 40 patients, 38 showed improvement and 2 showed no improvement. In the control group of 20 patients, 16 showed improvement and 4 showed no improvement. The total effective rate of the treatment group using the modified Kupperman Index (MRI) was 95%, significantly higher than that of the control group (80%). This indicates that the application of Zishen Anning Formula can significantly improve insomnia accompanied by depression and anxiety symptoms in perimenopausal women, showing a significant advantage compared to the Kuntai Capsule group. It can significantly alleviate symptoms such as hot flashes, sweating, insomnia, depression, and anxiety.

[0139] (5) Nourishing the kidneys and calming the mind can improve TCM syndromes.

[0140] In the treatment group of 40 patients, 38 showed improvement and 2 showed no improvement. In the control group of 20 patients, 18 showed improvement and 2 showed no improvement. The total effective rate of TCM syndrome scores in the treatment group was 95%, significantly higher than that in the control group (90%). This indicates that the application of Zishen Anning Formula can significantly improve insomnia accompanied by depression and anxiety symptoms in perimenopausal women, showing a significant advantage compared to the Kuntai Capsule group. It can better relieve symptoms such as hot flashes, sweating, irritability, and sadness.

[0141] (6) The Zishen Anning Formula has no adverse effects on safety indicators.

[0142] After treatment, the liver and kidney function results of the patients in the treatment group were normal, with no allergies or adverse reactions. Blood routine, urine routine, electrocardiogram, body temperature, pulse, respiration and blood pressure were all normal, and there was no adverse effect on endometrial thickness.

[0143] The above description is only a preferred embodiment of this application. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

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