Clinical Research Progress On Traditional Chinese Medicine in Treating Sleep Disorders in Menopausal Women
Jan 07, 2025
Menopause, also known as perimenopause, refers to the period before and after menopause. During this period, women's ovarian function gradually declines and hormone levels decrease, which causes a series of uncomfortable symptoms such as hot flashes, night sweats, and insomnia, which seriously affect the quality of life of menopausal women. Among them, sleep disorders are one of the most important symptoms of menopausal women, mainly manifested as difficulty falling asleep, short sleep time, waking up early in the morning, waking up in the middle of the night, being unable to fall asleep after waking up, or having many dreams and being easily startled [1].

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Long-term sleep disorders can cause endocrine and nervous system dysfunction in the body, and increase the risk of diabetes, hypertension, myocardial infarction, obesity and other diseases [2].
Studies have shown that the incidence of sleep disorders in menopausal women has increased year by year. The incidence rate in my country aged 40 to 65 is about 46.87%, which is much higher than that in Europe and the United States [3]. At present, the main methods of Western medicine for treating sleep disorders in menopausal women are hormone replacement and the use of sedatives and hypnotic drugs. Although there is a certain clinical effect, hormone replacement therapy increases the risk of cancer in women; long-term use of sedatives and hypnotic drugs is prone to drug resistance, and there are many adverse reactions, easy rebound, and poor long-term efficacy [4].
Under the guidance of holistic concepts and syndrome differentiation and treatment, traditional Chinese medicine combines disease and syndrome, adopts syndrome selection, acupuncture, acupoint injection, Chinese medicine massage and other treatment methods, which are diverse in form, have few adverse reactions, and have positive efficacy. They can cooperate with Western medicine basic treatment and have the effect of increasing efficacy and reducing toxicity. This article briefly summarizes the current status of research on the etiology and pathogenesis of sleep disorders in menopausal women, syndrome differentiation treatment, external treatment of Chinese medicine and other therapies, and provides a reference for the clinical treatment of sleep disorders in menopausal women with traditional Chinese medicine.

1. Etiology and pathogenesis
Traditional Chinese medicine does not have a specific record of menopausal sleep disorders, and often classifies them into the categories of "insomnia", "organ dryness", "inability to sleep", "eyes cannot close", etc. in traditional Chinese medicine. "Blood Symptoms and Sleeping" says: "For those who suffer from liver disease and insomnia, the liver stores the soul. When the person is awake, the soul wanders in the eyes, and when the person is asleep, the soul returns to the liver." [5] "Lei Zheng Zhi Cai" says: "Thoughts hurt the spleen, spleen blood is depleted, and insomnia for years." [6] "Shen's Book of Respecting Life" says: "Both the heart and the gallbladder are timid, and the person is easily startled by things. He has many unclear dreams and cannot sleep due to weakness and restlessness." [7] "Golden Chamber Essentials and Heart Classic" says: "When the person is awake, the soul resides in the eyes, and when the person is asleep, the soul is stored in the liver. For those who are exhausted, the liver qi is not prosperous, so the soul cannot be stored. If the soul is not stored, they cannot sleep." [8] The above records show that insomnia is mainly related to the heart, liver, and spleen. Based on their own clinical practice and summarizing the theories and experiences of their predecessors, later generations of doctors further studied and explored the etiology and pathogenesis of menopausal sleep disorders. Professor Wang Ping believes that the etiology of this disease is the deficiency of vital energy, and the key is liver depression, which is not relieved, combined with inappropriate cold and heat, emotional injury, improper diet, excessive work and rest, etc. The deficiency of vital energy leads to the loss of nourishment of the mind, dysfunction of the internal organs, and the deficiency of qi and spirit, resulting in insomnia[9].

Professor Song Jun proposed that insomnia is caused by the invasion of evil into the internal organs, which makes the Shaoyang pivot, which reaches the sun and connects to the yang, unfavorable, and the obstruction of the Wei Qi from the yang to the yin[10].
Professor Lu Shaoguang found in clinical practice that liver depression is the main pathogenesis of chronic insomnia in perimenopausal patients[11]. Professor Liu Zuyi believes that menopausal women often suffer from insomnia due to insufficient kidney essence, liver failure, liver qi stagnation, and spleen and earth disturbance[12]. Professor Zhang Zhiyuan believes that the main cause of menopausal insomnia is the lack of communication between the heart and kidney. The water and fire of the heart and kidney are not connected. The kidney water is insufficient, the heart fire is alone, and the yin and yang are not connected, which disturbs the spirit and causes illness. [13] Professor Zhang Boli believes that this disease is caused by dysfunction of the internal organs, phlegm, blood stasis, and fire are blocked in the body, forcing the yin and yang to be unable to communicate, which aggravates the original condition and forms a vicious cycle. Therefore, the pathological products should not be underestimated. [14]
In summary, the etiology and pathogenesis of sleep disorders in menopausal women are mainly due to dysfunction of zang-fu organs, yang excess and yin deficiency, and the non-interaction of yin and yang. Due to the special physiological stage of menopausal women, kidney essence is insufficient, Tiangui gradually declines, Chong and Ren meridians are damaged, yin is deficient and yang is affected, zang-fu organs fail to warm and nourish, and their functions are abnormal. Yin is deficient and blood is insufficient, the spirit is not used, or qi, blood and body fluids cannot be normally transported and metabolized to form phlegm and blood stasis, which attack the mind and cause this disease.

2 Syndrome differentiation and treatment
Regarding the syndrome differentiation and classification of menopausal women's sleep disorders, each doctor has his own system. At present, there are many types of TCM syndrome differentiation and classification of this disease, and the methods are different. Most of the clinical methods use classical prescriptions and self-made prescriptions. By reviewing the literature and related studies [15], this article divides menopausal women's sleep disorders into kidney deficiency and liver depression syndrome, heart-kidney non-interaction syndrome, liver depression and spleen deficiency syndrome, heart-spleen deficiency syndrome, kidney yin and yang deficiency syndrome, and heart-gallbladder qi deficiency syndrome.
2.1 Kidney deficiency and liver depression syndrome
Ji Mingzhi et al. [16] randomly divided 72 patients with perimenopausal insomnia of kidney deficiency and liver depression into a treatment group and a control group, 36 cases in each group. The treatment group was given Liuwei Dihuang Pills and Xiaoyao Powder with modifications, 1 dose per day, warm before bedtime. The control group was given diazepam tablets 2.5-5.0 mg each time, once a day; oryzanol 10-30 mg each time, 3 times a day, orally. Both groups were treated for 14 days. Results The total effective rate of the treatment group (91.67%) was significantly higher than that of the control group (69.44%) (P<0.05). Wang Feifeng et al. [17] randomly divided 52 patients with perimenopausal insomnia of kidney deficiency and liver depression into a treatment group and a control group, 26 cases in each group. The treatment group was treated with Ganmai Dazao Decoction, 1 dose per day, decocted in water and taken warm twice; the control group was given estazolam tablets (10 mg once a day) combined with oryzanol (20 mg 3 times a day) orally. After 3 months of treatment, the total effective rate of the treatment group (92.3%) was significantly higher than that of the control group (80.8%) (P<0.01).
Yao Zouying et al. [18] randomly divided 113 patients with perimenopausal sleep disorders of kidney deficiency and liver depression into a treatment group and a control group. The 60 patients in the treatment group were treated with a self-made prescription for nourishing kidney yin, clearing liver and relieving depression, removing blood stasis, nourishing the heart and calming the mind, namely, 10 g each of Rehmannia glutinosa, Cornus officinalis, charred Gardenia jasminoides, Paeonia suffruticosa, Angelica sinensis, Red peony root, stir-fried white peony root, 15 g each of Ligustrum lucidum, Ziziphus jujuba seed, Salvia miltiorrhiza, 20 g of Albizzia julibrissin bark, 30 g of Polygonum multiflorum. The prescription was one dose per day, divided into two doses after meals. The 53 patients in the control group were given 2 mg of Estazolam tablets, taken orally 30 min before bedtime every night. Results After 8 weeks of treatment, the total effective rate of the treatment group (91.7%) was significantly higher than that of the control group (73.5%) (P<0.05); the degree of improvement in hormone levels was significantly better than that of the control group (P<0.05); the TCM syndrome score, Pittsburgh Sleep Quality Index (PSQI) scale score, hot flashes, sweating, sexual pain, headache, palpitations and other symptom scores were significantly lower than those of the control group (P<0.05). The results showed that the Zishen Jieyu Ningxin prescription can effectively improve the various indicators of perimenopausal sleep disorders of kidney deficiency and liver depression type, and has a better efficacy than estazolam tablets. Zhang Ya et al. [19] divided 116 perimenopausal insomnia patients with kidney deficiency and liver depression into a control group and a treatment group using a random number table method, with 58 cases in each group.

The control group was given oral estazolam tablets, 1 mg each time, once a day; the treatment group was given Songyu Yinxu prescription (10 g each of Adenophora acuta, Gnaphalium wilfordii, Citrus aurantium, Bupleurum chinense, Cortex Lycii, 20 g of Radix Rehmanniae, 15 g each of Fructus Corni, Paeonia lactiflora, Curcuma aromatica, Cortex Albizziae, Rhizoma Alismatis, 6 g of Licorice) on the basis of the treatment method of the control group, 1 dose per day, twice orally in the morning and evening. After 4 weeks of treatment, the scores of PSQI scale, self-rating depression scale (SDS), self-rating anxiety scale (SAS) and TCM symptoms and signs in the treatment group were significantly lower than those in the control group (P<0.05), and the scores of 8 quality of life items and serum estradiol (E2) level were significantly higher than those in the control group (P<0.05). The results showed that Songyu Yinxu prescription combined with estazolam tablets was superior to estazolam tablets alone in improving sleep quality, alleviating depression and anxiety, and improving clinical symptoms in the treatment of perimenopausal insomnia with kidney deficiency and liver depression. Li Ying et al. [20] randomly divided 103 patients with perimenopausal insomnia of kidney deficiency and liver depression into a control group and a treatment group. The control group received estazolam tablets, and the treatment group received Chaihu Jia Longgu Muli Decoction combined with auricular acupoint pressing on the basis of the treatment method of the control group. Both groups took 7 days as one course of treatment, and a total of 3 courses of treatment were given. Results After treatment, the PSQI, SDS, SAS scores and TCM symptom scores of the treatment group were significantly lower than those of the control group (P < 0.05); the serum 5-hydroxytryptamine (5-HT) and dopamine (DA) levels were significantly higher than those of the control group (P < 0.05). This indicates that Chaihu Jia Longgu Muli Decoction, auricular acupoint pressing beans combined with estazolam tablets can improve the sleep quality of perimenopausal insomnia patients with kidney deficiency and liver depression, and the efficacy is better than that of simple estazolam tablets.
2.2 Heart-kidney disharmony
Qiao Wei et al. [21] randomly divided 60 patients with perimenopausal hypertension and insomnia into a control group and a treatment group, 30 cases in each group. The control group was treated with estazolam tablets, 2 mg once a day, before bedtime; the treatment group was treated with Tianwang Buxin Dan and Jiaotai Wan plus or minus pills on the basis of the treatment method of the control group, 1 dose per day, warmed at 3-4 pm and 2 h before bedtime, 200 mL each time.
After 4 weeks of treatment, the total effective rate of the treatment group (86.21%) was significantly higher than that of the control group (75.86%) (P < 0.05); after treatment, the PSQI scores, Kupperman scores and 24-h dynamic blood pressure of the two groups were significantly lower than those before treatment, and the PSQI scores and Kupperman scores of the treatment group were significantly lower than those of the control group (P < 0.05); the serum E2 level of the treatment group was significantly higher than that of the control group, and the serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels were significantly lower than those of the control group (P < 0.05); the incidence of adverse reactions in the treatment group (17.24%) was significantly lower than that of the control group (44.82%); after 2 weeks of follow-up, the recurrence rate of the treatment group (10.34%) was significantly lower than that of the control group (31.03%) (P < 0.05).

The results showed that Tianwang Buxin Dan combined with Jiaotai Wan plus or minus treatment was effective in treating perimenopausal hypertension with insomnia and heart-kidney disharmony, and the clinical symptoms and hormone levels of the patients were significantly improved, with few adverse reactions. Li Yang [22] randomly divided 98 patients with menopausal sleep disorders and heart-kidney disharmony into a western medicine group and a combined group, 49 cases in each group. The western medicine group was treated with estazolam tablets, 1 mg each time, 30 minutes before bedtime every night; the combined group was treated with Zixin Yangshen Decoction (10 g each of Cistanche deserticola, Asparagus cochinchinensis, Ophiopogon japonicus, Cornus officinalis, Ziziphus jujuba, Polygonum multiflorum, and Radix Glycyrrhizae, 15 g each of Rehmannia glutinosa, Dragon Bone, Oyster, Dioscorea opposita, Poria, Salvia miltiorrhiza, and Codonopsis pilosula, and 6 g of Schisandra chinensis) on the basis of the treatment methods of the western medicine group, 1 dose per day, twice a day, morning and evening. After 30 days of treatment, the total effective rate of the combined group (91.84%) was significantly higher than that of the western medicine group (75.51%) (P<0.05), and the PSQI score, Spiege sleep score, Kupperman score and TCM syndrome score of the combined group were significantly lower than those of the western medicine group (P<0.05). The results showed that the effect of estazolam tablets combined with Zixin Yangshen Decoction in treating menopausal patients with sleep disorders and heart-kidney disharmony was better.
Hu Ning [23] randomly divided 72 menopausal women with sleep disorders into a control group and a treatment group, with 36 cases in each group. The control group was given 10 mg of tartaric acid tablets, taken orally before going to bed every night; the treatment group was given self-made Ziyin Xiexin Decoction (12 g each of Angelica sinensis, Platycladus orientalis, Ophiopogon japonicus, Semen jujuba, Coptis chinensis, Poria cocos, 20 g each of Scrophularia ningpoensis and Radix Rehmanniae, 1 dose per day, warm in the morning and evening) combined with moxibustion on Yongquan acupoint (15 min each time, once a day). After 4 weeks of treatment, the total effective rate of the treatment group (83.3%) was significantly higher than that of the control group (58.3%) (P<0.05). Professor Xiao Chengcong treated menopausal insomnia from the perspective of the heart, kidney and liver. He believed that the key to the pathogenesis of insomnia lies in the disharmony between the heart and kidney and the deficiency of liver and kidney yin. He created the Gengxin prescription (15 g each of Ligustrum lucidum, Ecliptae macrophylla, Radix Rehmanniae, Paeonia lactiflora, Fructus Lycii, Lilium, Salvia miltiorrhiza, Tribulus terrestris, Cortex Albizziae, Caulis Polygoni Multiflori, 10 g of Tribulus terrestris, 30 g each of Raw Dragon Bone and Raw Oyster, 3 g of Lotus Seed Heart, 12 g of Rhizoma Anemarrhenae) to connect the heart and kidney and nourish the kidney and liver. The prescription was adjusted according to the symptoms and the clinical efficacy was significant [24].






