A traditional Chinese medicine composition for tumor-related insomnia, a traditional Chinese medicine preparation and application thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine. More particularly, it relates to a traditional Chinese medicine composition for tumor-related insomnia, a traditional Chinese medicine preparation thereof and application. The traditional Chinese medicine composition comprises the following raw medicinal materials: Baijiangxi, Xiaakucao, Hehuanpi, Wumei, Shouwuteng, Baiwei and Jinqiaomai. The present application also discloses a traditional Chinese medicine preparation of the above-mentioned traditional Chinese medicine composition and application in preparing a medicine for tumor-related insomnia. The traditional Chinese medicine composition provided by the present application has a scientific and reasonable formula and plays a role in communicating Yin and Yang and detoxifying and relieving depression in view of the core pathogenesis of tumor-related insomnia patients, i.e. 'interchange of Yin and Yang and internal accumulation of depression toxin', and has a significant advantage in improving the severity of insomnia and sleep quality of tumor-related insomnia patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology. More specifically, it relates to a traditional Chinese medicine composition for tumor-related insomnia, its preparation, and its application. Background Technology

[0002] According to statistics from the International Agency for Research on Cancer, approximately 4.8247 million new cases of malignant tumors were diagnosed in my country in 2022. Cancer-related insomnia (CRI) is a common complication in the development and treatment of malignant tumors. It refers to common symptoms caused by the tumor itself, other tumor-related symptoms, or tumor treatment-related factors. Symptoms include frequent and persistent difficulty falling asleep and / or sleep maintenance disorders, along with dissatisfaction with sleep duration and quality, often affecting daytime life. CRI has a high incidence rate, occurring throughout all types and stages of cancer, accompanying patients throughout their treatment and prognosis. Studies show that the incidence of insomnia in patients with malignant tumors is three times higher than in the general population. Up to 95% of cancer patients experience sleep disorders throughout the entire course of the disease, during treatment, and at the end of life. Even during the recovery period, 30% to 50% of patients still experience persistent insomnia for ≥3 months. The harm of CRI is multidimensional; at the psychosocial level, insomnia has a bidirectional worsening relationship with anxiety and depression. Insomnia not only affects the physical and mental health of cancer patients but also exacerbates their complications, such as pain, mental disorders, and daytime fatigue, significantly reducing treatment adherence and social functioning. At the biological mechanism level, chronic insomnia can inhibit natural killer cell activity, exacerbate the release of inflammatory factors, and reduce anti-tumor immune responses. Simultaneously, sleep-wake cycle disruption may promote tumor progression by activating the hypothalamus-pituitary-adrenal (HPA) axis, affecting the survival prognosis of cancer patients. From an evidence-based perspective, a large-sample cohort (n=4851) showed that patients with primary brain tumors who developed insomnia after surgery had a 77% increased risk of tumor recurrence and death, and the severity of postoperative insomnia was positively correlated with mortality within 2 years. Therefore, intervention for tumor-related insomnia is crucial for improving patient survival benefits and quality of life.

[0003] The pathogenesis of tumor-related insomnia is complex, resulting from the combined effects of multiple factors, including the pathophysiological changes of the tumor itself, adverse reactions to anti-tumor treatment, physical symptoms, psychological stress, and individual susceptibility factors. Modern medicine has shortcomings in the management of patients with cancer-related insomnia (CRI). Current interventions primarily rely on psychological support and drug therapy, lacking more effective specific treatment strategies. Currently, drug therapy mainly includes benzodiazepines, non-benzodiazepine sedative-hypnotics, antidepressants, antipsychotics, and melatonin receptor agonists. However, these drugs not only have numerous side effects and high dependence rates, but also easily interact with anti-tumor drugs. For example, the use of benzodiazepines and non-benzodiazepines can cause memory loss, dizziness, hypotension, and dependence. When used in combination with platinum-based or taxane-based chemotherapy drugs, it can exacerbate respiratory depression and the risk of hypotension, while potentially reducing the efficacy of anti-tumor drugs. Previous studies have reported that the combined use of chemotherapy and psychotropic drugs may lead to serious drug interactions. For example, the combined use of oxaliplatin and psychotropic drugs increases the risk of QT interval prolongation, while the combined use of paclitaxel and carbamazepine leads to reduced chemotherapy drug levels or effects. These treatment limitations not only affect the effectiveness of anti-tumor therapy but also significantly reduce patients' quality of life. Against this backdrop, the diagnostic and treatment approaches of traditional Chinese medicine offer important insights for the prevention and treatment of CRI (Critical Respiratory Infection).

[0004] CRI falls under the category of "insomnia" in Traditional Chinese Medicine (TCM), and is often explained by its pathogenesis, such as disharmony between Ying and Wei (nutritive and defensive qi), deficiency of vital qi and disturbance of pathogenic factors, or dysfunction of the internal organs. The treatment focuses on harmonizing Ying and Wei and strengthening the body's resistance to pathogenic factors. However, these views mostly remain at the level of static explanations of the body's homeostasis imbalance, failing to fully reflect the dynamic evolution of the tumor's course and lacking targeted analysis of different insomnia symptom clusters. Summary of the Invention

[0005] To address the aforementioned technical problems, one objective of this invention is to provide a traditional Chinese medicine composition for treating tumor-related insomnia. This composition can alleviate the severity of insomnia in cancer patients and significantly improve their sleep quality, particularly suitable for tumor-related insomnia characterized by "imbalance of Yin and Yang and internal accumulation of toxins."

[0006] Another object of the present invention is to provide various traditional Chinese medicine preparations based on the above-mentioned traditional Chinese medicine composition.

[0007] Another object of the present invention is to provide the application of the above-mentioned traditional Chinese medicine composition and preparation in the preparation of a medicine for tumor-related insomnia.

[0008] To achieve the first objective mentioned above, the present invention adopts the following technical solution: In a first aspect, the present invention provides a traditional Chinese medicine composition for tumor-related insomnia, the traditional Chinese medicine composition comprising the following raw materials: Pinellia ternata, Prunella vulgaris, Albizia julibrissin bark, Prunus mume, Polygonum multiflorum vine, Cynanchum paniculatum, and Fagopyrum cylindrica.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9-15 parts of processed Pinellia ternata, 10-30 parts of Prunella vulgaris, 10-30 parts of Albizia julibrissin bark, 10-20 parts of Prunus mume, 10-30 parts of Polygonum multiflorum vine, 10-20 parts of Cynanchum paniculatum, and 10-30 parts of Fagopyrum dibotrys.

[0010] Most TCM theories consider tumor-related insomnia to fall under the category of "insomnia." Its pathogenesis mainly involves emotional factors, imbalance between work and rest, improper diet, and physical weakness after illness, leading to disharmony between Ying and Wei, deficiency of vital energy and disturbance of pathogenic factors, or dysfunction of the internal organs. The most common syndrome types are deficiency of heart and gallbladder Qi, deficiency of heart Yin, deficiency of both heart and spleen, disharmony between heart and kidney, and liver stagnation transforming into fire.

[0011] The inventors of this invention have proposed a five-stage evolution theory of malignant tumors and a five-perspective diagnostic and treatment system. Using "deficiency-cold-toxin-closure-decline, with stagnation throughout" as the pathogenesis framework, and from five dimensions—spatial-temporal perspective, core perspective, symptom perspective, precision perspective, and pre-disease perspective—the invention systematically explores the TCM dynamic diagnostic and treatment strategy for CRI (Chronic Inflammatory Respiratory Syndrome), constructing a comprehensive management model of "recognizing the mechanism of stagnation, alleviating depression, and preventing depressive states." Within this theoretical framework, this invention proposes the core pathogenesis of CRI—disharmony of Yin and Yang, and internal accumulation of stagnation and toxins. Malignant tumors are formed by the interaction of pathological products such as "cancer toxins," blood stasis, phlegm, heat, and dampness. Furthermore, anti-tumor treatments such as surgery directly deplete Qi and blood, while chemotherapy, targeted therapy, and immunotherapy cause "drug toxicity," and radiation damage causes "fire toxicity," all intertwining to lead to poor Qi and blood circulation. Over time, this results in the accumulation of stagnation and toxins, depleting Yin and Yang, preventing Yang from interacting with Yin, and causing insomnia. Emotional distress plays a central role in tumor development and insomnia. Cancer patients often experience emotional distress due to fear of the disease, the pressure of treatment, and anxieties about the future, leading to liver qi stagnation. This disrupts the flow of qi, causing blood stasis, depleting liver blood, and disturbing the spirit. Internal stagnation transforms into fire, which in turn disturbs the mind, making it restless. Stagnation of qi and fluids leads to phlegm and blood stasis. The further interaction of phlegm, blood stasis, and fire, accumulating and failing to dissipate, produces internal toxins, further obstructing the flow of yin and yang, disturbing the mind, and forming a vicious cycle of depression-toxin-depression. Therefore, "depression-toxin" is the core pathological product and key link of this disease, promoting tumor progression while emotional distress directly affects sleep.

[0012] Based on this, the applicant establishes the core treatment principle of harmonizing Yin and Yang, resolving toxins and relieving depression, nourishing Yin and calming Yang to support the body's vital energy, and resolving toxins and relieving depression (resolving phlegm, clearing heat, and detoxifying) to address the root cause. In this invention, Pinellia ternata and Prunella vulgaris harmonize Yin and Yang, soothe the liver and relieve depression, clear liver fire, resolve phlegm, detoxify cancer, and harmonize the liver and stomach. Prunus mume, Albizia julibrissin bark, and Polygonum multiflorum vine are added to nourish Yin and blood, relieve depression, and calm the mind. Cynanchum atratum clears deficiency heat in the blood, and Fagopyrum dibotrys clears tumor toxins and phlegm, entering the lung meridian. The liver ascends and the lung descends, jointly governing the Qi mechanism. The lung and brain are connected, jointly regulating emotions, relieving depression, and calming the mind. The entire formula harmonizes Yin and Yang, tonifies while attacking, and treats both the root cause and symptoms. It harmonizes Yin and Yang, resolves toxins, and relieves depression, making it particularly suitable for patients with tumor-related insomnia due to Yin-Yang imbalance and internal accumulation of toxins. It provides a new TCM treatment strategy for the management of tumor-related insomnia patients.

[0013] In this invention, Pinellia ternata (processed) is pungent and warm in nature, and enters the spleen, stomach, and lung meridians. Its functions include drying dampness and resolving phlegm, suppressing nausea and vomiting, and dissipating stagnation and nodules. The *Benjing Shuzheng* states: "Pinellia ternata is pungent and neutral in nature, slippery and dry in nature. Therefore, its use is based on its pungent nature to open stagnation, its neutral nature to stop nausea, its slippery nature to enter yin, and its dryness to assist yang. It grows at the time of yang growth and matures at the time of yin birth, thus its function is to allow the body's vital energy to enter yin from yang..." Pinellia ternata grows precisely in midsummer, the time of yin-yang exchange, a time of transition from yang to yin. Therefore, it can connect yin and yang, taking advantage of its medicinal property of guiding the yang in the heart to be hidden in yin. Furthermore, patients with tumor-related insomnia often experience difficulty falling asleep, shallow sleep, easy awakening, dry mouth, and irritability. Pinellia ternata, being pungent and warm, resolves phlegm, suppresses nausea and dissipates nodules, primarily addressing "tangible evils of phlegm and dampness." It can guide phlegm and heat downwards, resolving phlegm and dissipating nodules to open stagnation. Together with Prunella vulgaris, it serves as the principal herb in the entire formula.

[0014] Prunella vulgaris has a pungent and bitter taste, and is cold in nature. It enters the liver and gallbladder meridians and is effective in clearing liver fire, reducing swelling and dissipating nodules. It is also the chief herb in the whole prescription. The Danxi Xinfa states: "When phlegm and fire are the cause of illness, Pinellia ternata is needed to clear the phlegm, and Prunella vulgaris is needed to disperse the fire. The two herbs combined are like a drum responding to a drumstick." Prunella vulgaris withers at the summer solstice and grows when it receives yang energy. It is paired with Pinellia ternata, taking the principle of "descending its qi is to restrain its yang". It also takes the principle of harmonizing yang and nourishing yin. Its bitter and cold nature clears fire, clears the liver and dissipates nodules. It is mainly used for "intangible heat of stagnant fire" and disperses tangible cancer toxins. Modern pharmacology has confirmed that it has anti-tumor activity. For patients with insomnia caused by tumors, it can soothe the liver and disperse stagnation, and promote the outward flow of heat. Combined with Pinellia ternata, it can harmonize yin and yang, open up stagnation and dissipate toxins.

[0015] Ume plum (dried plum) has a sour and astringent taste, is neutral in nature, and enters the liver, spleen, lung, and large intestine meridians. Its function is to astringe the lungs and generate fluids. The *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) records that it "regulates qi, eliminates heat and vexation, and calms the mind." Ume plum is extremely sour, and its nature is astringent; it can both astringe excessive deficiency fire, guiding yang into yin, and nourish liver yin, astringing liver blood depleted by sluggish qi and blood circulation. Thus, it calms the mind, aids sleep, and harmonizes yin and yang. Tumor-related insomnia is often caused by internal heat and toxins damaging yin, leading to internal deficiency fire, restlessness, insomnia, dry mouth and tongue, and difficulty sleeping. Ume plum not only generates fluids and quenches thirst, replenishes yin fluids, but also helps to reduce deficiency fire. For cancer patients with insomnia due to internal stagnation, it is an auxiliary herb in the formula.

[0016] Albizia bark is sweet in taste and neutral in nature, entering the heart, liver, and lung meridians. Its functions include relieving depression and calming the mind, promoting blood circulation and reducing swelling, and harmonizing yin and yang. As yin and yang enter yin, it is an essential medicine for calming the mind and soothing the spirit. The *Compendium of Materia Medica* records: "Albizia bark is sweet, warm, and mildly nourishing, with the wonderful effect of opening up the five spirits and eliminating the five emotions… Its sweet taste and neutral nature primarily harmonize the heart qi; when the heart qi is harmonized, the spirit naturally becomes clear and joyful without worry." "Depression" permeates the entire course of tumor treatment. Unsatisfied emotions and stagnant liver qi can transform into fire and disturb the mind, or directly affect the spirit, leading to restlessness and difficulty falling asleep. Albizia bark can harmonize the five internal organs, regulate the mind, and clear liver stagnation. It can also promote blood circulation and reduce swelling. For insomnia patients with long-term internal qi stagnation and blood stasis, it plays a role in regulating both qi and blood. Combined with Polygonum multiflorum vine, it promotes the harmony of yin and yang, serving as an adjuvant in the entire formula.

[0017] Polygonum multiflorum vine is sweet in taste and neutral in nature. It enters the heart and liver meridians and is effective in nourishing blood, calming the mind, dispelling wind, and unblocking the meridians. The *Ben Cao Zheng Yi* states that it "treats insomnia." Polygonum multiflorum vine enters the blood aspect of the heart and liver meridians, thus effectively drawing yang into yin, resulting in a significant hypnotic effect. Its mild nature allows for communication between the upper and lower body, causing heart fire to subside, harmonizing yin and yang, and nourishing yin and blood. Sufficient blood nourishes the heart and stores the spirit. Combined with *Huan Pi* (a type of bark), it enhances the calming effect on the mind, serving as an adjuvant in the entire formula.

[0018] Baiwei (Radix Cynanchi Atrati) is bitter, salty, and cold in nature. It enters the stomach, liver, and kidney meridians and is effective in clearing heat, cooling the blood, detoxifying, and healing sores. The *Essential Medicines and Their Dosages* states that it "clears deficiency fire and eliminates blood heat." Baiwei clears heat and nourishes yin, while also possessing a penetrating property. It can clear deficiency heat, cool the blood, relieve irritability, and suppress excessive yang. It targets yin deficiency with internal heat disturbing the mind, allowing pathogenic heat to escape. Once the heat is cleared, irritability is relieved. Combined with He Shou Wu (Radix Polygoni Multiflori) to treat insomnia in cancer patients with shallow sleep and excessive dreaming, it serves as the main ingredient in the entire formula.

[0019] Buckwheat has a slightly pungent and astringent taste, is cool in nature, and enters the lung meridian. Its functions include clearing heat and detoxifying, draining pus and resolving phlegm. The *Compendium of Materia Medica* states that it "treats carbuncles, malignant sores, and toxic swellings..." Buckwheat clears phlegm and heat from the lungs. Combined with Baiwei (a type of herb), it addresses both deficiency and excess, clearing heat and toxins from the lungs, calming internal disturbances, and restoring peace of mind in cancer patients. Secondly, buckwheat is a key herb for clearing the lungs and resolving phlegm. The lungs and heart reside in the upper burner; when the lungs fail to descend properly, the heart is disturbed. Buckwheat can improve insomnia caused by lung disease and heart-related issues. From the perspective of the ascending and descending of Qi, the liver on the left governs ascent, and the lungs on the right govern descent. Stagnation of liver Qi prevents its descent, which in turn affects the ascending of liver Qi, leading to emotional distress and worsening insomnia. In addition, buckwheat can eliminate carbuncles and drain pus. Modern pharmacology shows that it has a certain anti-tumor effect and can detoxify cancer toxins and drug toxicity after treatment. Its "phlegm-removing" effect can clear the toxins caused by phlegm and heat stagnation, making it the main ingredient in the whole formula.

[0020] The above-mentioned Chinese herbal medicine composition uses Pinellia ternata and Prunella vulgaris as the principal herbs to detoxify, relieve depression, and regulate the balance of Yin and Yang to calm the mind. Prunus mume is the assistant herb, which astringes and nourishes Yin, calming the spirit. Albizia julibrissin bark and Polygonum multiflorum vine are the adjuvant herbs; Albizia julibrissin bark relieves depression and soothes the mind, while Polygonum multiflorum vine nourishes blood and replenishes Yin. Together, they relieve depression and nourish Yin to strengthen the spirit and promote the harmony of Yin and Yang. Cynanchum atratum clears deficiency heat, and Fagopyrum dibotrys clears toxins and blood stasis, entering the lung meridian to regulate Qi. One is deficient, the other excessive, clearing away stagnant heat to relieve irritability and detoxify, both serving as guiding herbs. The entire formula is well-balanced in its principal, assistant, adjuvant, and guiding herbs, targeting the core pathogenesis of tumor-related insomnia: "disharmony of Yin and Yang and internal accumulation of stagnant toxins." This invention's treatment closely follows the key pathogenesis, focusing on harmonizing Yin and Yang and detoxifying and relieving depression, while also incorporating multiple treatment methods such as phlegm-resolving, heat-clearing, and detoxifying, achieving good therapeutic effects. The entire formula combines tonification and purgation, cold and warm properties, regulates the internal organs, and addresses both the root cause and the symptoms. It works synergistically to harmonize Yin and Yang, and to resolve toxins and relieve depression. It is especially suitable for cancer patients with symptoms of Yin-Yang imbalance and internal accumulation of toxins.

[0021] In this invention, by way of example, the traditional Chinese medicine composition for treating tumor-related insomnia of this invention includes the following raw materials in parts by weight: 9 parts Pinellia ternata, 15 parts Prunella vulgaris, 15 parts Albizia julibrissin bark, 15 parts Prunus mume, 15 parts Polygonum multiflorum vine, 10 parts Cynanchum paniculatum, and 30 parts Fagopyrum dibotrys.

[0022] For example, the traditional Chinese medicine composition for treating tumor-related insomnia includes the following raw materials in parts by weight: 9 parts Pinellia ternata, 15 parts Prunella vulgaris, 20 parts Albizia julibrissin bark, 15 parts Prunus mume, 20 parts Polygonum multiflorum vine, 15 parts Cynanchum paniculatum, and 15 parts Fagopyrum dibotrys.

[0023] For example, the traditional Chinese medicine composition for treating tumor-related insomnia includes the following raw materials in parts by weight: 12 parts Pinellia ternata, 20 parts Prunella vulgaris, 20 parts Albizia julibrissin bark, 20 parts Prunus mume, 20 parts Polygonum multiflorum vine, 20 parts Cynanchum paniculatum, and 20 parts Fagopyrum dibotrys.

[0024] For example, the traditional Chinese medicine composition for treating tumor-related insomnia includes the following raw materials in parts by weight: 15 parts Pinellia ternata, 30 parts Prunella vulgaris, 30 parts Albizia julibrissin bark, 10 parts Prunus mume, 30 parts Polygonum multiflorum vine, 10 parts Cynanchum paniculatum, and 10 parts Fagopyrum dibotrys.

[0025] The basic formula of the above-mentioned traditional Chinese medicine composition of the present invention can be adjusted according to clinical symptoms during specific implementation to improve diabetic cognitive impairment and certain accompanying clinical symptoms, thereby further enhancing the adaptability of the composition of the present invention and improving the therapeutic effect. These adjustments made based on the basic formula of the present invention are also within the scope of protection of this application.

[0026] Secondly, the present invention provides a traditional Chinese medicine preparation for tumor-related insomnia, the raw materials of which include the above-mentioned traditional Chinese medicine composition.

[0027] Depending on actual needs, the traditional Chinese medicine preparations may also include pharmaceutically acceptable excipients. Various dosage forms, such as decoctions, tablets, granules, pills, powders, capsules, or granules, are prepared according to conventional pharmaceutical processes.

[0028] Thirdly, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition and traditional Chinese medicine preparation in the preparation of a drug for treating tumor-related insomnia.

[0029] In addition, unless otherwise specified, all raw materials of the traditional Chinese medicine composition of the present invention can be obtained commercially available. Any range of traditional Chinese medicine composition described in the present invention, including any value between the endpoints and any sub-ranges formed by the endpoints or any value between the endpoints, can inhibit neuroinflammation and thus effectively improve the efficacy of diabetic cognitive impairment.

[0030] The beneficial effects of this invention are as follows: The herbal composition of this invention has been clinically verified to target the core pathogenesis of "yin-yang imbalance and internal accumulation of stagnant toxins" in patients with tumor-related insomnia. It aims to harmonize yin and yang, resolve toxins and relieve stagnation, demonstrating certain advantages in promoting the recovery of patients with tumor-related insomnia, and exhibiting good drug safety. Furthermore, this herbal composition, based on traditional syndrome differentiation and treatment, combines modern pharmacological research of traditional Chinese medicine, employing a disease-syndrome integration approach in its formulation. Its core therapeutic advantage lies in its ability to significantly and persistently reduce the severity of insomnia and improve sleep quality in cancer patients, with efficacy not significantly affected by tumor stage or the severity of insomnia. In addition, this herbal composition has shown significant efficacy in cancer patients with different tumor stages and varying degrees of insomnia, indicating that it has a broad-spectrum effect in improving insomnia, effectively improving sleep patterns and daytime dysfunction in cancer patients, thereby improving their quality of life and demonstrating significant clinical value. Detailed Implementation

[0031] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0032] Example 1 A traditional Chinese medicine composition for tumor-related insomnia is made from the following raw materials: 9g Pinellia ternata, 15g Prunella vulgaris, 15g Albizia julibrissin bark, 15g Prunus mume, 15g Polygonum multiflorum vine, 10g Cynanchum paniculatum, and 30g Fagopyrum dibotrys.

[0033] Example 2 A traditional Chinese medicine composition for tumor-related insomnia is made from the following raw materials: 9g Pinellia ternata, 15g Prunella vulgaris, 20g Albizia julibrissin bark, 15g Prunus mume, 20g Polygonum multiflorum vine, 15g Cynanchum paniculatum, and 15g Fagopyrum dibotrys.

[0034] Example 3 A traditional Chinese medicine composition for tumor-related insomnia is made from the following raw materials: 12g Pinellia ternata, 20g Prunella vulgaris, 20g Albizia julibrissin bark, 20g Prunus mume, 20g Polygonum multiflorum vine, 20g Cynanchum paniculatum, and 20g Fagopyrum cylindrica.

[0035] Example 4 A traditional Chinese medicine composition for tumor-related insomnia is made from the following raw materials: 15g Pinellia ternata, 30g Prunella vulgaris, 30g Albizia julibrissin bark, 10g Prunus mume, 30g Polygonum multiflorum vine, 10g Cynanchum paniculatum, and 10g Fagopyrum dibotrys.

[0036] Example 5 A study on the improvement of insomnia in patients with tumor-related insomnia using traditional Chinese medicine intervention. 1. Research Design Thirty patients with malignant tumors who received traditional Chinese medicine (TCM) treatment for insomnia at the Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, between August 2025 and January 2026 were included in this study. They were classified as stage I-IV according to the AJCC 8th edition TNM staging system. There were 15 males and 15 females, with an average age of 57.7 (48.0, 67.25) years. All patients had no prior diagnosis of insomnia before being diagnosed with malignant tumors and met the criteria for chronic insomnia as defined in the "Guidelines for the Diagnosis and Treatment of Insomnia in China (2023 Edition)" published by the Chinese Sleep Research Society at enrollment. Patients with severe mental illness or taking sedatives, hypnotics, or psychotropic drugs were excluded. A decoction prepared from the TCM composition of this invention was administered orally twice daily for 12 weeks. The improvement in insomnia was assessed at weeks 4, 8, and 12 to compare the efficacy of the TCM composition of this invention and a control drug in patients with tumor-related insomnia.

[0037] 2. Research Standards (1) Insomnia Assessment Scale ①Indicators of insomnia severity Insomnia Severity Index (ISI) scores: scores at enrollment and at 4, 8, and 12 weeks after traditional Chinese medicine intervention.

[0038] ② Sleep quality indicators Pittsburgh Sleep Quality Index (PSQI): Scale scores at enrollment and at 4, 8, and 12 weeks after traditional Chinese medicine intervention.

[0039] (1) Statistical methods Baseline data analysis: For count data, the basic statistical description uses frequency tables, percentages or proportions; for continuous data that conforms to a normal distribution, the mean ± standard deviation (SD) is used; for non-normally distributed data, the median and interquartiles (P75, P25) are used. Within-group comparisons: For normally distributed continuous data, paired-samples t-tests are used for within-group comparisons; for non-normally distributed continuous data, non-parametric tests (such as Wilcoxon signed-rank test) are used, with α = 0.05 as the significance level, and P > 0.05 is considered statistically insignificant.

[0040] Between-group comparisons: For normally distributed continuous data, the independent t-test is used for comparisons between two groups; for comparisons among multiple groups, analysis of variance is used, and further pairwise comparisons are performed using the Tukey test. For non-normally distributed continuous data, the Mann test is used for comparisons between two groups. Whitney U test; Kruskal test was used for comparisons among multiple groups. The Wallis H test was used, and the Dunn test was used for further pairwise comparisons. An α of 0.05 was used as the significance level, and P > 0.05 was considered statistically insignificant.

[0041] 3. Research Results (1) Baseline data A total of 30 patients with tumor-related insomnia who received traditional Chinese medicine treatment in our department from August 2025 to January 2026 were included (see Table 1).

[0042] Table 1. Baseline information of included patients

[0043] Note: *Insomnia Severity Index (ISI): Clinically insignificant insomnia: 0-7 points; Subclinical or mild insomnia: 8-14 points; Moderate insomnia: 15-21 points; Severe insomnia: 22-28 points.

[0044] (2) Changes in Insomnia Severity Score (ISI) The Insomnia Severity Index (ISI) consists of seven self-report items used to assess the severity of insomnia symptoms and their impact on daytime functioning over the past two weeks. Developed in 2001 by Charles M. Morin et al. in Canada, based on a cognitive-behavioral model and clinical diagnostic criteria for insomnia, the scale covers core characteristics of insomnia: difficulty falling asleep, difficulty maintaining sleep, early awakening, satisfaction with sleep quality, impaired daytime functioning, the degree to which insomnia symptoms are noticed by others, and distress caused by insomnia. All seven items are scored using a 5-point Likert scale (0-4), and the scores are summed to obtain a total score (range 0-28). The total score is summarized into a core observation indicator: the total insomnia severity score, and insomnia severity is categorized into four levels based on the total score range: "no clinically significant insomnia," "mild insomnia," "moderate insomnia," and "severe insomnia." This scale is concise and efficient, and is widely used in clinical screening, efficacy evaluation, and epidemiological studies. The results are shown in the table below.

[0045] Table 2 Changes in ISI scores before and after treatment (4 weeks)

[0046] Table 3. Changes in ISI symptom scores before and after treatment (4 weeks)

[0047] Table 4-1 Changes in ISI scores before and after treatment in patients with different tumor stages (4 weeks)

[0048] Table 4-2 Differences in ISI scores between patients with different tumor stages before and after treatment (4 weeks)

[0049] Table 5-1 Changes in ISI scores based on "Insomnia Severity Grading" (4 weeks)

[0050] Table 5-2 Inter-group differences in ISI scores based on “Insomnia Severity Grading” (4 weeks)

[0051] After 4 weeks of treatment, the severity of the patient's sleep significantly decreased. The ISI score before treatment was 15.33±3.75, and after treatment it was 12.20±3.74. The parametric test result was t=6.861. P <0.001, the difference was statistically significant (Table 2). Scores for difficulty falling asleep, difficulty maintaining sleep, and early awakening symptoms all significantly decreased after treatment (see Table 3). Further analysis showed that ISI scores decreased after treatment in patients with tumors at different stages, especially in patients with stage I and II malignant tumors. There was no statistically significant difference in the treatment efficacy for decreased sleep severity across different stages (F=1.731, ...). P =0.185), both groups achieved good therapeutic effects (see Tables 4-1 and 4-2). Furthermore, based on the "Insomnia Severity Grading" system, the severity of insomnia at baseline was determined. Both groups showed a significant decrease in ISI scores after treatment, especially for patients with moderate insomnia. There was no statistically significant difference in the degree of improvement in treatment efficacy between the two groups of patients with different ISI scores (F=1.725, F=0.185). P =0.200), all yielded good therapeutic effects. (See Tables 5-1 and 5-2) Table 6. Changes in insomnia severity before and after treatment (8 weeks)

[0052] Table 7. Changes in ISI symptom scores before and after treatment (8 weeks)

[0053] Table 8-1 Changes in ISI scores before and after treatment in patients with different tumor stages (8 weeks)

[0054] Table 8-2 Differences in ISI scores between patients with different tumor stages before and after treatment (8 weeks)

[0055] Table 9-1 Changes in ISI scores based on "Insomnia Severity Grading" (8 weeks)

[0056] Table 9-2 Inter-group differences in ISI scores based on "Insomnia Severity Grading" (8 weeks)

[0057] After 8 weeks of treatment, the patients' sleep severity significantly decreased. The baseline ISI score was 15.33±3.75, and after treatment it was 10.56±3.90. The parametric test result was t=2.75. P= The difference was 0.010, which was statistically significant (see Table 6). Scores for difficulty falling asleep, difficulty maintaining sleep, and early awakening symptoms all decreased significantly after treatment, especially for difficulty falling asleep (see Table 7). Further analysis showed that ISI scores decreased after treatment in patients with tumors at different stages, particularly in patients with stage I and IV malignant tumors. There was no statistically significant difference in the treatment efficacy for decreased sleep severity across different stages (F=2.337). P =0.138), both groups achieved good therapeutic effects (see Tables 8-1 and 8-2). Furthermore, based on the "Insomnia Severity Grading" to determine the severity of insomnia at baseline, both groups showed a significant decrease in ISI scores after treatment. Especially for patients with moderate insomnia, there was no statistically significant difference in the degree of improvement in treatment efficacy between the two groups of patients with different ISI grades (F=2.337, P=0.138), both achieving good therapeutic effects (see Tables 9-1 and 9-2).

[0058] Table 10 Changes in insomnia severity before and after treatment (12 weeks)

[0059] Table 11 Changes in ISI symptom scores before and after treatment (12 weeks)

[0060] Table 12-1 Changes in ISI scores before and after treatment in patients with different tumor stages (12 weeks)

[0061] Table 12-2 Differences in ISI scores between patients with different tumor stages before and after treatment (12 weeks)

[0062] Table 13-1 Changes in ISI scores based on "Insomnia Severity Grading" (12 weeks)

[0063] Table 13-2 Inter-group differences in ISI scores based on “Insomnia Severity Grading” (12 weeks)

[0064] After 12 weeks of treatment, the patients' sleep severity significantly decreased. The baseline ISI score was 15.33±3.75, and after treatment it was 8.86±3.01. The parametric test result was t=3.08. P= The difference was 0.004, which was statistically significant (see Table 10). Scores for difficulty falling asleep, difficulty maintaining sleep, and early awakening symptoms all decreased significantly after treatment, especially for difficulty falling asleep (see Table 11). Further analysis showed that ISI scores decreased after treatment in patients with different tumor stages, particularly in stage I and II malignant tumors. There was no statistically significant difference in the treatment efficacy for decreased sleep severity across different stages (F=0.542, ...). P =0.658), both groups achieved good therapeutic effects (see Tables 12-1 and 12-2). Furthermore, based on the "Insomnia Severity Grading" system, the severity of insomnia at baseline was determined. Both groups showed a significant decrease in ISI scores after treatment, especially for patients with moderate insomnia. There was no statistically significant difference in the degree of improvement in treatment efficacy between the two groups of patients with different ISI scores (F=0.134, P=0.939), indicating good therapeutic effects in both groups (see Tables 13-1 and 13-2).

[0065] (3) Changes in the Pittsburgh Sleep Quality Index (PSQI) The Pittsburgh Sleep Quality Index (PSQI) comprises 18 self-report items to assess a subject's subjective sleep quality over the past month. These items are categorized into seven components (dimensions). Developed in 1989 by Dr. Buysse and colleagues, psychiatrists at the University of Pittsburgh, the scale's item design incorporates multidimensional considerations of sleep quality in sleep medicine. The 18 items are ultimately integrated into seven components, each scored from 0 to 3: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of hypnotics, and daytime dysfunction. The scores of the seven components are summed to obtain the overall PSQI score (range 0-21), with a higher score indicating poorer sleep quality. This scale not only provides a quantitative assessment of overall sleep quality but also reflects different aspects of sleep problems through component scores, making it one of the most widely used comprehensive sleep quality assessment tools in clinical practice. The results are as follows.

[0066] Table 14 Changes in PSQI scores before and after treatment (4 weeks)

[0067] Table 15-1 Changes in PSQI scores before and after treatment in patients with different tumor stages (4 weeks)

[0068] Table 15-2 Differences in PSQI scores between different tumor stages before and after treatment (4 weeks)

[0069] Table 16. Changes in scores of each component of the PSQI scale before and after treatment (4 weeks)

[0070] After 4 weeks of treatment, patients' sleep quality significantly improved. The pre-treatment PSQI score was 13.06±2.89, and the post-treatment score was 10.86±3.37. The parametric test result was t=4.469, P<0.001, indicating a statistically significant difference (see Table 14). Further analysis showed that PSQI scores decreased after treatment in patients with tumors at different stages, especially for patients with stage II and IV malignant tumors. There was no significant difference in treatment efficacy among patients with different stages (F=1.643). P =0.204), all of which showed good therapeutic effects (see Tables 15-1 and 15-2). Furthermore, based on the changes in scores of each component of the PSQI scale before and after treatment, the sleep duration component score significantly improved after treatment (Z=-3.30, P＜ 0.001), sleep efficiency was significantly improved (Z=-1.99, P= 0.046), indicating that it effectively prolongs the patient's actual sleep time and improves sleep efficiency and sleep quality. P= 0.090), daytime dysfunction ( P= The value of 0.073 shows an improving trend (see Table 16).

[0071] Table 17 Changes in PSQI scores before and after treatment (8 weeks)

[0072] Table 18-1 Changes in PSQI scores before and after treatment in patients with different tumor stages (8 weeks)

[0073] Table 18-2 Differences in PSQI scores before and after treatment in patients with different tumor stages (8 weeks)

[0074] Table 19 Changes in scores of each component of the PSQI scale before and after treatment (8 weeks)

[0075] After 8 weeks of treatment, patients' sleep quality significantly improved. The pre-treatment PSQI score was 13.06±2.89, and the post-treatment score was 9.76±3.58. The parametric test result was t=5.349, P<0.001, indicating a statistically significant difference (see Table 17). Further analysis showed that PSQI scores decreased after treatment in patients with tumors at different stages, especially for patients with stage II and IV malignant tumors. There was no significant difference in treatment efficacy among patients with different stages (F=0.850, ...). P =0.479), all of which showed good therapeutic effects (see Tables 18-1 and 18-2). Furthermore, based on the changes in scores of each component of the PSQI scale before and after treatment, the sleep time after treatment (Z=-4.39, P＜ 0.001), sleep efficiency (Z=-2.72, P= 0.006) and daytime dysfunction ( P= The sleep quality score (Z=-3.30) showed significant improvement (0.002). P＜ Significant improvement (0.001) indicates effective prolongation of actual sleep time and duration, improved sleep efficiency, improved daytime function, and reduced sleep onset time. P= The score (0.020) showed a significant improvement (see Table 19).

[0076] Table 20 Changes in PSQI scores before and after treatment (12 weeks)

[0077] Table 21-1 Changes in PSQI scores before and after treatment in patients with different tumor stages (12 weeks)

[0078] Table 21-2 Differences in PSQI scores between different tumor stages before and after treatment (12 weeks)

[0079] Table 22 Changes in scores of each component of the PSQI scale before and after treatment (12 weeks)

[0080] After 12 weeks of treatment, patients' sleep quality significantly improved. The pre-treatment PSQI score was 13.06±2.89, and the post-treatment score was 8.23±3.42. The parametric test result was t=8.312, P<0.001, indicating a statistically significant difference (see Table 20). Further analysis showed that PSQI scores decreased after treatment in patients with tumors at different stages, especially for patients with stage II and IV malignant tumors. There was no significant difference in treatment efficacy among patients with different stages (F=1.798). P=0.172), all of which showed good therapeutic effects (see Tables 21-1 and 21-2). Furthermore, based on the changes in scores of each component of the PSQI scale before and after treatment, the sleep quality after treatment (Z=-4.12, P <0.001), sleep time (Z=-4.15, P <0.001), sleep efficiency (Z=-3.67, P <0.001), daytime dysfunction ( P= Scores <0.001) all showed significant improvement, and sleep onset time ( P= (0.009) showed improvement, effectively prolonging the patient's actual sleep time and sleep duration and improving sleep efficiency, and improving daytime function (see Table 22).

[0081] 4. Conclusion The herbal composition of this invention can significantly improve insomnia in patients with multiple types of cancer, different stages, and different degrees of insomnia severity. P <0.05). This result suggests that this traditional Chinese medicine composition can effectively reduce the severity of insomnia in cancer patients, improve sleep quality conditions such as daytime dysfunction, thereby improving patients' quality of life and having clinical application value.

[0082] Example 6: Typical Cases and Therapeutic Effects Case 1: Postoperative insomnia after endometrial cancer surgery Ms. Li, female, 50 years old. First visit on August 27, 2025. She underwent endometrial resection in July 2025. Postoperative pathology showed adenocarcinoma. Pathological stage: IB stage. Immunohistochemistry: ER (+), PR (+), P53 (+), Ki-67 (40%), PD-L1 [22C3] (CPS=2), MLH1 (+), MSH-2 (+). No anti-tumor treatment was administered postoperatively. Current symptoms: lower abdominal pain and heaviness, occasional palpitations, hot flashes, generally good mood, good appetite, recurrent insomnia for over 3 months, difficulty falling asleep, falling asleep about an hour after lying down, shallow sleep, easily awakened, difficulty falling back asleep, many dreams, prone to anxiety, bowel movements every 2-3 days, normal urination. Red tongue, little coating, teeth marks on the edges, thready pulse. ISI score: 18 points, PSQI score: 13 points. Western medicine diagnosis: Postoperative insomnia following endometrial malignancy. Traditional Chinese Medicine Diagnosis: Abdominal masses and insomnia are diagnosed as a syndrome of Yin-Yang imbalance and internal accumulation of toxins. Treatment Principle: Harmonize Yin and Yang, resolve toxins and relieve stagnation.

[0083] Prescription: Pinellia ternata 9g, Prunella vulgaris 15g, Albizia julibrissin bark 15g, Prunus mume 15g, Polygonum multiflorum vine 15g, Cynanchum paniculatum 10g, Fagopyrum dibotrys 30g, Curcuma zedoaria (processed with vinegar) 9g, Angelica dahurica 10g, Achyranthes bidentata 15g. 28 doses in total, one dose daily, decocted in water and taken warm in the morning and evening.

[0084] Second visit: Difficulty falling asleep significantly improved, falling asleep in less than half an hour, fewer dreams, still light sleep, easier to fall back asleep after waking, abdominal pain relieved, hot flashes and sweating, normal bowel movements, no other discomfort. ISI score: 14 points, PSQI: 12 points. The above prescription was continued.

[0085] Third visit: The patient falls asleep within half an hour each day, has fewer nighttime urinations, has improved daytime energy, and is in better spirits. Abdominal distension and regular bowel movements are present. Tongue is pale and dark, with a red tip and slight teeth marks; coating is thin and white; pulse is wiry and thready. ISI score: 9 points; PSQI score: 11 points. The above prescription was modified accordingly. The patient was followed up at the outpatient clinic, and their quality of life significantly improved.

[0086] Case 2: Insomnia following chemotherapy after sigmoid colon cancer surgery Ms. Nie, female, 45 years old, first visit on September 2, 2025. She underwent laparoscopic radical resection of sigmoid colon cancer on April 1, 2025. Postoperative pathology revealed moderately differentiated adenocarcinoma of the sigmoid colon, pT3N0Mx. Immunohistochemical results: MLH-1 (+), PMS-2 (+1), MSH-2 (+), MSH-b (+), HER-2 (+). Postoperative recovery was good, and she underwent 4 cycles of oxaliplatin + capecitabine chemotherapy. Current symptoms: fatigue, decreased attention, numbness in hands and feet, lower limb pain, light sleep with frequent awakenings, difficulty falling back asleep, early awakening, good appetite, normal bowel movements. Pale and dark tongue, obese body, thin yellow coating, slippery and rapid pulse. ISI score: 13 points, PSQI score: 9 points. Western medicine diagnosis: Postoperative insomnia due to malignant tumor of the sigmoid colon; Traditional Chinese medicine diagnosis: Intestinal tumor, insomnia, yin-yang imbalance, internal accumulation of toxins. Traditional Chinese medicine treatment principle: Harmonize yin and yang, resolve toxins and relieve depression.

[0087] Prescription: Pinellia ternata 9g, Prunella vulgaris 15g, Albizia julibrissin bark 15g, Prunus mume 15g, Polygonum multiflorum vine 15g, Cynanchum paniculatum 10g, Fagopyrum dibotrys 30g, Morus alba twig 15g, Lycopodium clavatum 15g, Saposhnikovia divaricata 15g. 28 doses in total, one dose daily, decocted in water and taken warm in the morning and evening.

[0088] At the second visit, the patient reported no longer waking up early, fewer nighttime awakenings, and improved physical strength. Numbness in the hands and feet persisted, bowel movements were normal, and there were no other significant discomforts. ISI score: 6 points, PSQI score: 5 points. The above prescription was modified accordingly. The patient was followed up at the outpatient clinic and achieved the clinical diagnostic criteria for normal sleep (ISI < 8 points), with a significant improvement in quality of life.

[0089] Case 3: Postoperative insomnia after esophageal cancer surgery Mr. Yue, male, 59 years old. First visit on August 26, 2025. On June 21, 2024, the patient underwent endoscopic mucosal dissection of the esophagus due to esophageal malignancy. Postoperatively, esophageal dilation was performed due to esophageal stricture. He did not receive radiotherapy or chemotherapy postoperatively. Current symptoms: choking while eating, occasional acid reflux, a foreign body sensation in the throat, difficulty falling asleep (approximately 40 minutes to fall asleep), shallow sleep, frequent awakenings, vivid dreams, and early awakening. Tongue: red with fissures, white and greasy coating; pulse: deep and slippery. ISI score: 13 points; PSQI score: 12 points. Western medicine diagnosis: Postoperative insomnia following esophageal malignancy. Traditional Chinese medicine diagnosis: esophageal obstruction, insomnia, differentiated as Yin-Yang imbalance and internal accumulation of toxins. Treatment principle: Harmonize Yin and Yang, resolve toxins and relieve stagnation.

[0090] Prescription: Pinellia ternata 9g, Prunella vulgaris 15g, Albizia julibrissin bark 15g, Prunus mume 15g, Polygonum multiflorum vine 15g, Cynanchum paniculatum 10g, Fagopyrum dibotrys 30g, Clematis chinensis 15g, Hedyotis diffusa 15g, Paeonia lactiflora 10g. A total of 28 doses, one dose daily, decocted in water and taken warm in the morning and evening.

[0091] Second visit: Difficulty falling asleep significantly improved, with sleep onset time shortened to within 30 minutes. The number of awakenings decreased, but early awakenings, choking, and occasional acid reflux remained. Bowel movements were normal, with no other discomfort. ISI score: 8 points, PSQI: 9 points. The above prescription was modified accordingly. The patient was subsequently followed up at the outpatient clinic, and their quality of life significantly improved.

[0092] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is impossible to exhaustively list all the implementation methods here. All obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating tumor-related insomnia, characterized in that, The traditional Chinese medicine composition includes the following raw materials: Pinellia ternata, Prunella vulgaris, Albizia julibrissin bark, Prunus mume, Polygonum multiflorum vine, Cynanchum paniculatum, and Fagopyrum cylindrica.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9-15 parts Pinellia ternata, 10-30 parts Prunella vulgaris, 10-30 parts Albizia julibrissin bark, 10-20 parts Prunus mume, 10-30 parts Polygonum multiflorum vine, 10-20 parts Cynanchum paniculatum, and 10-30 parts Fagopyrum cylindrica.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9 parts Pinellia ternata, 15 parts Prunella vulgaris, 15 parts Albizia julibrissin bark, 15 parts Prunus mume, 15 parts Polygonum multiflorum vine, 10 parts Cynanchum paniculatum, and 30 parts Fagopyrum dibotrys.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9 parts Pinellia ternata, 15 parts Prunella vulgaris, 20 parts Albizia julibrissin bark, 15 parts Prunus mume, 20 parts Polygonum multiflorum vine, 15 parts Cynanchum paniculatum, and 15 parts Fagopyrum dibotrys.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition includes the following raw materials in parts by weight: 12 parts Pinellia ternata, 20 parts Prunella vulgaris, 20 parts Albizia julibrissin bark, 20 parts Prunus mume, 20 parts Polygonum multiflorum vine, 20 parts Cynanchum paniculatum, and 20 parts Fagopyrum dibotrys.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition includes the following raw materials in parts by weight: 15 parts Pinellia ternata, 30 parts Prunella vulgaris, 30 parts Albizia julibrissin bark, 10 parts Prunus mume, 30 parts Polygonum multiflorum vine, 10 parts Cynanchum paniculatum, and 10 parts Fagopyrum dibotrys.

7. A traditional Chinese medicine preparation for tumor-related insomnia, characterized in that, The raw materials for the traditional Chinese medicine preparation include the traditional Chinese medicine composition according to any one of claims 1-6.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The raw materials for the traditional Chinese medicine preparations also include pharmaceutically acceptable excipients.

9. The traditional Chinese medicine preparation according to claim 7 or 8, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, tablets, granules, pills, powders, capsules, or powders.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-6 or the traditional Chinese medicine preparation according to any one of claims 7-9 in the preparation of a medicament for tumor-related insomnia.

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