Traditional Chinese medicine preparation for treating chronic fatigue syndrome

Abstract

The present invention discloses a Chinese medicine preparation for treating chronic fatigue syndrome. The preparation is prepared from the following raw materials: 25-35 g of raw astragalus, 10-20 g of cinnamon twig, 25-35 g of raw atractylodes macrocephala, 10-20 g of ginger, 2-5 g of processed Chuanwu, 10-20 g of black aconite root, 15-25 g of antler frost, 4-8 g of ginseng, 10-20 g of bupleurum root, 10-20 g of cyperus rotundus, and 15-25 g of immature bitter orange. During treatment, the preparation is taken orally twice a day for a course of 14 days. Generally, significant effects are seen after taking three courses of treatment. The Chinese medicine preparation for treating chronic fatigue syndrome of the present invention can significantly improve the patient's symptoms of fatigue, weakness, poor sleep, etc., has significant efficacy, good safety, low price and simple medicine, and has high clinical promotion value.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine preparation for treating chronic fatigue syndrome, belonging to the technical field of traditional Chinese medicine preparations. Background Art

[0002] Chronic fatigue syndrome (CFS) is a complex clinical syndrome. In 2015, the International Monetary Fund (IOM) redefined it as chronic fatigue lasting for more than six months, unrelieved by rest, accompanied by complex and fluctuating symptoms of post-exertional malaise (PEM), disturbed sleep, cognitive impairment, autonomic dysfunction, and / or muscle or joint pain. In recent years, CFS has experienced a high incidence and disability rate, placing a significant burden on society and families. However, the etiology and pathogenesis of CFS remain unclear, and Western medicine treatments often fail to provide satisfactory results. Traditional Chinese medicine, as a complementary and alternative therapy, offers unique advantages in improving quality of life and alleviating fatigue symptoms.

[0003] To date, research on the pathogenesis of CFS has been conducted across multiple fronts, including the immune system, metabolomics, endocrine system, gut microbiome, and nervous system, to determine the underlying pathophysiology of CFS / ME. Reports suggest that CFS is caused by persistent infection, with high antibody titers against specific viruses. Multiple strains, including Epstein-Barr virus (EBV), human herpesvirus-6, group B coxsackievirus, and human T-cell lymphotrophic virus II, have been proposed as potential etiological agents for CFS. Many patients experience sequelae of CFS, and the theory that viral infection causes CFS has resurfaced. However, to date, no specific infection has been proven to cause CFS. Experimental studies have demonstrated significant defects in NK cell function in CFS patients, with abnormalities in ribonuclease (RNase) L and overactivation of nuclear factor κβ (NF-κB), suggesting immune dysfunction and a possible link between the onset of the disease and immune deficiency. Others have suggested that CFS, often associated with depression, may be a neuropsychiatric disorder, linked to personality and cognition. Currently, there are multiple hypotheses about the etiology of CFS, but there is still no unified conclusion or consensus, and the pathogenesis of chronic fatigue syndrome has not yet been discovered.

[0004] Chronic fatigue syndrome, an emerging disease, can be broadly categorized as "laziness," "exhaustion," "tiredness," "conjunction," and "deficiency" in Traditional Chinese Medicine. The "Golden Chamber Wing: Deficiency and Fatigue General Theory" states: "Conjunction, also known as deficiency and failure, is caused by accumulated fatigue leading to weakness, accumulated weakness leading to damage, and accumulated weakness leading to damage." The disease is located in the heart, spleen, and kidneys, and is generally caused by insufficient heart yang and spleen and kidney deficiency. Therefore, treatments focus on tonifying yang and replenishing qi, strengthening the spleen and promoting circulation, and tonifying the kidneys and replenishing essence. Therefore, based on this theory, the present invention proposes a new traditional Chinese medicine preparation for the treatment of chronic fatigue syndrome. Summary of the Invention

[0005] In view of the above-mentioned prior art, the present invention provides a traditional Chinese medicine preparation for treating chronic fatigue syndrome.

[0006] The present invention is achieved through the following technical solutions:

[0007] A traditional Chinese medicine preparation for treating chronic fatigue syndrome is prepared from the following raw medicinal materials: 25-35 g of raw astragalus, 10-20 g of cinnamon twig, 25-35 g of raw atractylodes macrocephala, 10-20 g of ginger, 2-5 g of processed Chuanwu, 10-20 g of black aconite root, 15-25 g of antler frost, 4-8 g of ginseng, 10-20 g of bupleurum, 10-20 g of cyperus, and 15-25 g of immature bitter orange.

[0008] Preferably, it is made from the following raw materials: 30 g of raw astragalus, 15 g of cinnamon twig, 30 g of raw white atractylodes, 15 g of ginger, 3 g of processed Chuanwu, 15 g of black aconite root, 20 g of antler powder, 6 g of ginseng, 15 g of bupleurum, 15 g of cyperus, and 20 g of immature bitter orange.

[0009] The method for preparing the traditional Chinese medicine preparation for treating chronic fatigue syndrome comprises the following steps:

[0010] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 20-40 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 20-40 minutes, and set aside;

[0011] (2) Decoction of processed Chuanwu and Heifu Pian for 60-80 minutes (decoction first to reduce toxicity. During the decoction process, Chuanwu converts aconitine into aconitine. Modern Chinese medicine pharmacology research shows that the toxicity of aconitine is one-five thousandth of that of aconitine. Do not add cold water during the decoction. If the water is low during the decoction, add boiling water);

[0012] (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature bitter orange, and boil for 30 to 50 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 30 to 50 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0013] Furthermore, in step (1), the soaking time is 30 minutes.

[0014] Furthermore, in step (2), the decocting time is 60 minutes.

[0015] Furthermore, in step (3), the decocting time is 40 minutes.

[0016] The present invention's traditional Chinese medicine preparation for treating chronic fatigue syndrome (CFS) is based on the following therapeutic principles: Chronic fatigue syndrome (CFS) is a newly diagnosed disease with no known name in Traditional Chinese Medicine (TCM). Based on its symptoms, CFS can be broadly categorized as "asthenia," "insomnia," "laziness," and "dementia." As a clinical syndrome, CFS can be broadly classified as "asthenia." According to TCM theory, the pathogenesis of CFS is primarily based on deficiency, with yang deficiency being the primary cause, and the disease is located within the five internal organs. The Lixu Yuanjian states, "There are six causes of deficiency syndromes: congenital, acquired, caused by smallpox and after illness, caused by external factors, caused by circumstances, and caused by medicine." The mother is the foundation, the father is the shield, and the yin and yang combine to store essence in the kidneys. Kidney yang deficiency leads to this disease; internal damage caused by the seven emotions first harms qi, and qi damage inevitably affects essence. Damage to essence first harms qi, and damage to both yin and yang leads to this disease; external damage to the lungs, over time, damages yin and consumes qi, damaging all five internal organs and causing this disease; adverse circumstances, resulting in depression in the heart and disturbed emotions, damages qi and blood, leading to this disease; and indiscriminate use of medications, which in turn damages vital energy, can also cause this disease. Therefore, the pathogenesis of chronic fatigue syndrome is "six causes leading to disease, first damaging yang qi, then yang damage leading to yin, and thus damaging both yin and yang." Treatment focuses on tonifying deficiency, "essence nourishes the spirit, and suppleness nourishes the tendons." Yang qi is the foundation of life activities, and tonifying qi and nourishing yang are key treatments for chronic fatigue syndrome.

[0017] The Chinese medicine preparation of the present invention is a clinical experience prescription, which is composed of eleven medicinal herbs including raw astragalus, cinnamon twig, raw white atractylodes, ginger, processed Chuanwu, black aconite root, antler powder, ginseng, bupleurum, cyperus, and immature bitter orange. In the prescription, black aconite root and processed Chuanwu are the main herbs, which are very pungent and hot, enter the heart and kidney meridians, and mainly warm and tonify the heart and kidney yang. When used together, they can circulate the twelve meridians; cinnamon twig can circulate yang, move without staying, and circulate the limbs, and when combined with black aconite root, it can strengthen the function of warming and circulating the heart yang; antler powder can "open the qi house of the governor vessel" and has the effect of astringing and consolidating, and when combined with aconite root and aconite root, it can further warm the kidney yang; ginseng can greatly tonify vital energy and can tonify and defend, and when used together with black aconite root, it can assist the heart yang, tonify the kidney yang, and benefit the spleen yang, tonify vital energy, restore yang and consolidate deficiency, and when black aconite root is combined with ginseng, it can restore yang without dryness and heat. To address the disadvantages of Yin damage, ginseng combined with black aconite root can replenish Qi and warm the interior. Astragalus root nourishes the five internal organs, replenishing and promoting circulation, and when combined with ginseng, it replenishes Qi throughout the body. Ginger is pungent, dispersing, warming, and unblocking, promoting Qi and removing stagnation. Atractylodes macrocephala strengthens the spleen and replenishes Qi, and when combined with ginseng, it can dry out dampness and promote fluid production, protecting the acquired foundation and ensuring a viable biochemical source. Bupleurum root is pungent and dispersing, while Citrus aurantium is bitter and descending, one ascending and one descending, one for the liver and one for the spleen. Bupleurum root combined with Citrus aurantium can soothe the liver and regulate Qi, unblocking Yang and relieving stagnation, allowing Yang Qi trapped in the chest and flanks to flow outward to the extremities and downward to the stomach and intestines. Cyperus rotundus promotes Qi in the blood and also promotes blood circulation in the Qi. The combination of these herbs, tonifying both the innate and acquired, warming Yang and nourishing Yin, has the effect of tonifying both Qi and Yang, and warming the five internal organs. The present invention selects deer antler frost (other raw materials with similar effects, such as velvet antlers, deer antler slices, etc.) for its nourishing effect, and prevents the risk of excessive nourishment of the whole formula and obstruction of the spleen and stomach; the deer antler frost is used together with aconite root, Chuanwu and other products that can greatly replenish yang energy, firstly to strengthen the warming and replenishing of the heart and kidney yang energy, and secondly, the deer antler frost, which is a product with blood and flesh, can guide the medicine into the meridians, thereby better exerting the nourishing effect of the whole formula.

[0018] Modern experiments suggest that the pathological changes of ME / CFS are related to ischemia-hypoxia, inflammation, and viral infection. Pharmacological studies have confirmed that astragalus and its active ingredients, represented by calycosin, can inhibit the expression of NLRP3 / nuclear factor κB, thereby reducing the levels of pro-inflammatory cytokines such as IL-6, IL-1β, IL-18, and TNF-α, thereby counteracting the inflammatory damage caused by ischemia-hypoxia. Combining ginseng with astragalus not only enhances antioxidant activity but also promotes T cell count and activity, thereby increasing phagocytic capacity in mice. Cinnamon twigs primarily exert their antiviral pharmacological effects through their volatile oils and cinnamaldehyde. Cinnamon twig volatile oils and cinnamaldehyde can inhibit influenza virus nucleic acid replication and protein expression through the TLR / IFN signaling pathway, significantly inhibiting influenza virus proliferation. Atractylodes ketone, a major component of Atractylodes macrocephala volatile oil, can reduce TNF-α and NO levels and increase IL-10 levels, an anti-inflammatory factor. It also exhibits strong in vitro antioxidant activity and improves hypoxia tolerance in mice by improving free radical scavenging and reducing the production of lipid peroxidation products. Chuanwu (Aconitum carmichaelii) and Fuzi (Aconitum fuzi) share a common origin, but their pharmacological components differ. The alkaloids and polysaccharides in these two herbs can significantly enhance immunomodulatory effects, increase macrophage phagocytosis, and promote lymphocyte growth. Some studies have shown that Fuzi polysaccharides can improve behavioral responses in depressed mice, possibly related to fatigue. Bupleurum chinense and Citrus aurantium immaturus, a commonly used clinical herbal combination, can inhibit myocardial toxicity and promote ATP synthesis through quercetin, while also protecting endothelial cells by inhibiting inflammatory responses. They have positive effects on the respiratory, endocrine, and cardiovascular systems. Clinical research on antler frost is limited, but it is widely used for hyperplasia and inflammatory conditions. Cyperus rotundus exerts antipyretic and analgesic effects through α-cyperone, while its terpenes and ketones can act on cellular nitric oxide and inflammatory factors, inhibiting inflammation. Ginger, as an adjuvant, regulates other herbs. Its extracts, including gingerol, volatile oils, and diarylheptanes, have broad antibacterial, anti-inflammatory, antioxidant, and immunomodulatory effects.

[0019] The traditional Chinese medicine preparation for treating chronic fatigue syndrome of the present invention is taken orally twice a day during treatment, with 14 days as a course of treatment. Generally, significant effects can be seen after taking 3 courses of treatment.

[0020] Clinical studies have shown that the traditional Chinese medicine preparation for treating chronic fatigue syndrome of the present invention can significantly improve patients' discomfort symptoms such as fatigue, weakness, and poor sleep. The traditional Chinese medicine preparation for treating chronic fatigue syndrome of the present invention has significant efficacy, good safety, low price and simple dosage, and has high clinical promotion value.

[0021] Various terms and phrases used herein have the general meanings that are well known to those skilled in the art. DETAILED DESCRIPTION

[0022] The present invention will be further described below in conjunction with the embodiments. However, the scope of the present invention is not limited to the following embodiments. Those skilled in the art will appreciate that various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention.

[0023] Unless otherwise specified, the instruments, reagents, and materials used in the following examples are all conventional instruments, reagents, and materials available in the prior art and can be obtained through regular commercial channels. The experimental methods and detection methods used in the following examples are all conventional experimental methods and detection methods available in the prior art, unless otherwise specified.

[0024] Example 1 Preparation of a Traditional Chinese Medicine Preparation for Treating Chronic Fatigue Syndrome

[0025] The prescription is as follows: raw astragalus 30 g, cinnamon twig 15 g, raw white atractylodes 30 g, ginger 15 g, processed Chuanwu 3 g, black aconite root 15 g, antler frost 20 g, ginseng 6 g, bupleurum 15 g, cyperus rotundus 15 g, and immature aurantium 20 g.

[0026] The preparation method is as follows:

[0027] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 30 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 30 minutes, and set aside;

[0028] (2) Decoction of processed Chuanwu and Heifupi root for 60 minutes;

[0029] (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature bitter orange, and boil for 40 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 40 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0030] Clinical research data

[0031] Previous studies by the research group of the inventor of the present invention have shown that this prescription can significantly improve the clinical symptoms of patients, including fatigue, weakness, poor sleep and other symptoms of CFS patients, and their quality of life scores are significantly improved, fully demonstrating the advantages of traditional Chinese medicine in treating chronic fatigue syndrome. At the same time, the inventor of the preparation method has summarized its many years of clinical experience, providing safe and effective guarantees for its clinical promotion and application.

[0032] 1. Clinical data

[0033] 1.1 Diagnostic criteria

[0034] 1.1.1 Western medicine diagnostic criteria

[0035] Refer to the 2015 IOM diagnostic criteria for chronic fatigue syndrome (CFS).

[0036] A diagnosis of chronic fatigue syndrome requires the presence of three of the following symptoms for more than six months, with the intensity of the symptoms being moderate or severe at least 50% of the time.

[0037] The three main symptoms include:

[0038] (1) Fatigue: The patient's ability to engage in activities that he or she would have enjoyed before the onset of the disease is significantly reduced or impaired. This impairment persists for more than six months and is associated with new-onset severe fatigue that is not related to exertion and is not relieved by rest;

[0039] (2) Postexertional malaise: patients experience worsening symptoms and functioning after exposure to a physical or cognitive stressor that they previously tolerated well;

[0040] (3) Unrefreshing sleep: The patient feels tired after a night's sleep.

[0041] The diagnostic criteria require the three symptoms listed above plus one of the following additional symptoms:

[0042] (4) Cognitive impairment: problems with thinking or executive function that are exacerbated by fatigue, effort, stress, or time pressure;

[0043] (5) Orthostatic intolerance: Symptoms worsen after adopting and maintaining an upright posture. Lying down or elevating the feet may improve symptoms, although it is not necessarily eliminated.

[0044] 1.1.2 Traditional Chinese Medicine Diagnosis and Quantification Standards

[0045] According to the 2020 "Terms of Clinical Diagnosis and Treatment of Traditional Chinese Medicine" and the 2012 "Guiding Principles for Clinical Research of New Chinese Medicines", Qi Deficiency Syndrome:

[0046] It is caused by Qi deficiency. Clinically, it is characterized by fatigue, weakness, dizziness, palpitations, forgetfulness, loss of appetite, listlessness, sadness, easy fright, dizziness, blurred vision, pale complexion, pale tongue, thin white tongue coating, weak or slow pulse, accompanied by easy fatigue and intolerance to fatigue.

[0047] Main symptoms: fatigue, weakness, dizziness, palpitations, forgetfulness, loss of appetite, listlessness, easy fatigue, intolerance to fatigue, weak or slow pulse.

[0048] Secondary symptoms: dizziness, blurred vision, pale complexion, pale tongue, and thin white tongue coating.

[0049] The diagnosis can be made if two main symptoms and one secondary symptom are present.

[0050] The symptom score was calculated: the main symptoms were 2, 4, and 6 points if they were mild, moderate, and severe, respectively; the secondary symptoms were 1, 2, and 3 points if they were mild, moderate, and severe, respectively; and no symptoms were scored as 0 point.

[0051] 1.2 Inclusion criteria

[0052] (1) Gender is not limited, age is 18 to 80 years old; (2) meet the diagnosis of chronic fatigue syndrome; (3) meet the diagnostic criteria for Qi deficiency syndrome; (4) routine medical auxiliary examinations show no obvious abnormalities. Only those who meet all four of the above conditions can be included.

[0053] 1.3 Exclusion criteria

[0054] (1) Patients with other diseases that may cause fatigue, such as Cushing's syndrome, hypothyroidism, hyperthyroidism, other treatable forms of anemia, iron overload syndrome, diabetes, cancer, treatable sleep disorders, lupus, polymyositis, multiple sclerosis, myasthenia gravis, and severe mental illness; (2) Patients with a history of infection, fever, trauma, burns, or surgery within the past week; (3) Pregnant or breastfeeding women; (4) Those who refuse to participate. Those who meet any of the above conditions will not be included.

[0055] 1.4 Elimination criteria

[0056] (1) Patients who were found to not meet the inclusion criteria or met the exclusion criteria after inclusion; (2) Patients who were found to have poor compliance and could not strictly follow the treatment plan after inclusion; (3) Patients who used prohibited drugs arbitrarily during treatment after inclusion. Patients who met any of the above criteria were excluded.

[0057] 1.5 Shedding Standard

[0058] (1) Poor compliance or combined use of drugs outside the prescribed range, which affects the efficacy and safety judgment; (2) Patients who have allergic reactions or serious adverse events and are not suitable for continuing treatment; (3) Patients who cannot continue the clinical trial for various reasons, withdraw from the trial or terminate the trial.

[0059] 1.6 General Information

[0060] Seventy patients, aged 18 to 80 years, diagnosed with chronic fatigue syndrome, were enrolled in the cardiovascular outpatient clinic and inpatient clinic of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, between August 2020 and January 2022. The patients were randomized into a treatment group and a placebo group, each comprising 35 patients.

[0061] 2. Methods

[0062] 2.1 Treatment methods

[0063] Treatment group: Wenyang prescription (i.e., the Chinese medicine preparation of the present invention, prepared in Example 1) was used, twice a day, 14 days as a course of treatment, and 3 courses of treatment were taken.

[0064] Control group: Use placebo (the dosage form, taste and other characteristics of the placebo are similar to those of the test drug, and it contains 10% Wenyang formula), twice a day, 14 days as a course of treatment, and take 3 courses of treatment.

[0065] 2.2 Observation indicators

[0066] (1) FS-14 fatigue symptom score;

[0067] (2) TCM syndrome symptom score;

[0068] (3) Creatine kinase (CK) level.

[0069] 2.3 Criteria for determining efficacy

[0070] 2.3.1 Comprehensive efficacy criteria

[0071] The efficacy evaluation criteria of FS-14 fatigue symptom score were as follows: markedly effective: FS-14 fatigue symptom score decreased by ≥70%; effective: FS-14 fatigue symptom score decreased by ≥30% and <70%; ineffective: FS-14 fatigue symptom score decreased by <30%; ineffective: FS-14 fatigue symptom score decreased by <30%; aggravated: FS-14 fatigue symptom score decreased by <0%.

[0072] 2.3.2 Syndrome efficacy criteria

[0073] This standard was developed with reference to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes." Clinically cured: TCM clinical symptoms and signs disappear or essentially disappear, with a symptom score reduction of ≥95%; markedly effective: TCM clinical symptoms and signs significantly improve, with a symptom score reduction of ≥70% and <95%; effective: TCM clinical symptoms and signs improve, with a symptom score reduction of ≥30% and <70%; ineffective: TCM clinical symptoms and signs show no significant improvement, or even worsen, with a symptom score reduction of <30%.

[0074] 2.3.3 Safety evaluation standards

[0075] Grade 1: Safe, no adverse reactions. Grade 2: Relatively safe, no impact on continued administration, and no special treatment required. Grade 3: Safety issues exist, moderate adverse reactions occur, and administration can continue after treatment. Grade 4: Severe adverse reactions occur, and the trial is terminated.

[0076] 2.3.4 Criteria for judging the severity of adverse events

[0077] Mild: Tolerable, does not affect treatment and recovery, and does not require special treatment. Moderate: Unbearable, requires immediate discontinuation of medication or special treatment, and affects recovery. Severe: Life-threatening, requires immediate discontinuation of medication or emergency treatment.

[0078] 2.4 Medical Ethics Control

[0079] When patients are enrolled in a clinical study, researchers will provide detailed information about their diagnosis using both Traditional Chinese Medicine (TCM) and Western Medicine (WM), TCM syndrome differentiation, treatment options, anticipated treatment goals, and potential adverse reactions. Patients' addresses and phone numbers will be recorded for clinical follow-up. If symptoms worsen or discomfort develops after treatment, patients should contact the researchers promptly to discontinue treatment, address their symptoms, and withdraw from the study. Participation and withdrawal are voluntary throughout the study.

[0080] 2.5 Statistical methods

[0081] Data from this study were collected using paper questionnaires and data records. Observation time points and data were recorded using the CRF form and entered into an Excel spreadsheet for statistical analysis. This study will be based on an intention-to-treat analysis (ITT) approach. Results will be analyzed according to the ITT principle and entered into an information management platform. SPSS 26.0 statistical software was used for data analysis. Enumeration data were expressed as absolute and relative numbers (%). Chi-square tests were used for enumeration data, analysis of variance was used for measurement data, nonparametric tests were used for intergroup comparisons, and multivariate logistic regression was used for correlation analysis. A P < 0.05 was considered statistically significant.

[0082] 3. Results

[0083] During the trial, 3 patients dropped out because their physical symptoms did not improve significantly. A total of 70 patients were enrolled, 3 of whom dropped out, and 67 completed the trial.

[0084] 3.1 Comparison of comprehensive efficacy among groups

[0085] There was no significant difference in the symptom scores between the groups before treatment. After treatment, the markedly effective rate and total effective rate of the treatment group were significantly better than those of the placebo group (P < 0.05 or 0.01), as shown in Table 1.

[0086] Table 1 Comparison of comprehensive efficacy of each group after treatment (N, %)

[0087]

[0088] Comparison between groups after treatment △ P<0.05, ▲ P < 0.01, P ＃ >0.05.

[0089] 3.2 Comparison of symptom scores in each group before and after treatment

[0090] There were no significant differences in symptom scores before treatment (P>0.05). After treatment, symptom scores decreased to varying degrees in all groups. The degree of symptom improvement in the treatment groups was significantly greater than that in the placebo group (P<0.05 or 0.01), as shown in Table 2.

[0091] Table 2 Comparison of symptom scores in each group before and after treatment (X±S)

[0092]

[0093] Comparison between groups after treatment △ P<0.05, ▲ P < 0.01, P ＃ >0.05.

[0094] 3.3 Comparison of total symptom scores before and after treatment

[0095] The Wilcoxon rank sum test showed that the treatment group had a Z = -2.265, P = 0.008 < 0.01; the placebo group had a Z = -2.358, P = 0.027 < 0.05; both differences were statistically significant. This suggests that treatment in each group improved clinical manifestations. The difference in total symptom scores before and after treatment was significantly better in the treatment group than in the placebo group (P < 0.05 or 0.01), as shown in Table 3.

[0096] Table 3 Comparison of total symptom scores between the two groups before and after treatment (X±S)

[0097]

[0098] Comparison between groups after treatment △ P<0.05, ▲ P < 0.01, P ＃ >0.05.

[0099] 3.4 Comparison of CK improvement rate

[0100] Jing 2 The improvement rate of CK in the two groups was compared by test. The improvement rate in the treatment group was higher than that in the placebo group, but the difference was not significant and not statistically significant, as shown in Table 4.

[0101] Table 4 Comparison of CK improvement rate (U / L)

[0102]

[0103] Comparison between groups after treatment △ P<0.05, ▲ P < 0.01, P ＃ >0.05.

[0104] This indicator varied widely between individuals. Among the 67 patients, 65 had normal initial CK values, ranging from 30 to 70 U / L. In the other two patients, CK values ​​decreased from 192 U / L to 57 U / L and 200 U / L to 68 U / L, respectively.

[0105] 3.5 Occurrence of adverse reactions

[0106] The liver and kidney functions, electrocardiograms, etc. of the patients in each group were normal before and after treatment. No adverse reactions occurred in any group except for the dropout cases.

[0107] 4. Discussion

[0108] In recent years, with the promotion of Traditional Chinese Medicine (TCM), more and more people have benefited from it. The advantages of TCM in treating chronic fatigue syndrome have gradually become apparent, and the clinical manual developed by the International Association for Chronic Fatigue Syndrome (IACFS) recommends Traditional Chinese Medicine (TCM) therapies (including acupuncture and massage).

[0109] RCTs have shown that transcutaneous electrical acupoint stimulation can significantly reduce fatigue syndrome scores in CFS patients, effectively improving fatigue symptoms and, to a certain extent, significantly reducing the ratio of CD4+ to CD8+ T cells, thereby improving immunity. Moxibustion can significantly improve anxiety and depression, enhance sleep quality, and improve intestinal flora structure. It can also improve telomerase activity and alleviate sleep disorders.

[0110] In addition to external treatments in Traditional Chinese Medicine (TCM), research on the use of traditional Chinese medicine (TCM) preparations for the treatment of chronic fatigue syndrome is also gaining momentum. Various active components in traditional Chinese medicine, such as polysaccharides, polyphenols, flavonoids, terpenes, and peptides, have demonstrated efficacy in treating CFS. These TCM formulas have been shown to influence hormone levels and improve immune function in rats, positively impacting their behavior and cognition.

[0111] The Yang-warming prescription of the present invention is a clinical experience prescription, which is applied to patients with chronic fatigue syndrome and has a good effect. It is composed of eleven medicinal herbs including raw astragalus, cinnamon twig, raw white atractylodes, ginger, processed Chuanwu, black aconite root, antler powder, ginseng, bupleurum, cyperus, and immature bitter orange. In the prescription, aconite and processed Chuanwu are the main drugs, which are very pungent and hot, enter the heart and kidney meridians, and are mainly used to warm and nourish the heart and kidney yang. The two are used together to circulate through the twelve meridians; cinnamon twig can promote yang, move but not stay, and circulate through the limbs, and is combined with aconite to strengthen the function of warming and promoting the heart yang; antler powder "opens the Qi house of the Governor Vessel" and has the effect of astringing and consolidating, and combined with aconite and aconite, it can warm the kidney yang even more; ginseng greatly replenishes the vital energy, replenishes and can protect, and is used together with aconite to help the heart yang, replenish the kidney yang, and benefit the spleen yang, replenish the vital energy, restore yang and consolidate deficiency, and aconite with ginseng can restore yang without dryness and heat damaging yin. The disadvantages of ginseng are that it can replenish qi and warm the interior when combined with aconite; astragalus can replenish the deficiencies of the five internal organs, replenishing them while enabling them to move, and when combined with ginseng, it can replenish qi throughout the body; ginger is pungent, dispersing, warming, and unblocking, promoting qi and removing stagnation; white atractylodes can strengthen the spleen and replenish qi, and when combined with ginseng, it can dry out dampness and promote fluid production, consolidating the foundation of the acquired constitution and ensuring a source of biochemical activity; bupleurum is pungent and dispersing, while tangerine peel is bitter and descending, one ascending and one descending, one for the liver and one for the spleen; bupleurum combined with tangerine peel can soothe the liver and regulate qi, promote yang and relieve depression, allowing yang qi trapped in the chest and ribs to flow outward to the extremities and downward to the stomach and intestines; cyperus can promote qi in the blood and promote blood circulation in the qi. All these herbs are used together to replenish both the innate and acquired constitutions, warming yang and nourishing yin, achieving the effects of replenishing both qi and yang and warming the five internal organs.

[0112] Clinical studies have demonstrated the potential efficacy of Wenyang Formula in significantly improving patients' symptoms of fatigue, weakness, and insomnia, using the FS-14 fatigue symptom score and Traditional Chinese Medicine (TCM) syndrome score as primary evaluation criteria. Although the improvement in creatine kinase (CK) levels in the subjects did not reach statistical significance, the before-and-after comparison of two patients with abnormal CK levels in this study suggests that Wenyang Formula can significantly improve CK levels.

[0113] 5. Conclusion

[0114] The Yang-warming prescription of the present invention has obvious clinical application effect and good safety. In addition, it is simple, easy to use, inexpensive and simple in medicine, which provides a guarantee for its clinical promotion.

[0115] Example 2 Preparation of a Traditional Chinese Medicine Preparation for Treating Chronic Fatigue Syndrome

[0116] The prescription is as follows: raw astragalus 25 g, cinnamon twig 20 g, raw white atractylodes 25 g, ginger 20 g, processed Chuanwu 2 g, black aconite root 20 g, antler frost 15 g, ginseng 8 g, bupleurum 10 g, cyperus rotundus 20 g, and immature bitter orange 15 g.

[0117] The preparation method is as follows:

[0118] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 20 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 20 minutes, and set aside;

[0119] (2) Boil the processed Chuanwu and Heifupi root for 70 minutes;

[0120] (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature aurantium, and boil for 30 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 30 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0121] Example 3 Preparation of a Traditional Chinese Medicine Preparation for Treating Chronic Fatigue Syndrome

[0122] The prescription is as follows: raw astragalus 35 g, cinnamon twig 10 g, raw white atractylodes 35 g, ginger 10 g, processed Chuanwu 5 g, black aconite root 10 g, antler frost 25 g, ginseng 4 g, bupleurum 20 g, cyperus rotundus 10 g, and immature bitter orange 25 g.

[0123] The preparation method is as follows:

[0124] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 40 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 40 minutes, and set aside;

[0125] (2) Decoction of processed Chuanwu and Heifupi root for 80 minutes;

[0126] (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature bitter orange, and boil for 50 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 50 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0127] Example 4 Preparation of a Traditional Chinese Medicine Preparation for Treating Chronic Fatigue Syndrome

[0128] The prescription is as follows: raw astragalus 28 g, cinnamon twig 18 g, raw white atractylodes 28 g, ginger 18 g, processed Chuanwu 3 g, black aconite root 18 g, antler frost 18 g, ginseng 7 g, bupleurum 13 g, cyperus rotundus 18 g, and immature bitter orange 18 g.

[0129] The preparation method is as follows:

[0130] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 30 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 30 minutes, and set aside;

[0131] (2) Decoction of processed Chuanwu and Heifupi root for 60 minutes;

[0132] (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature bitter orange, and boil for 40 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 40 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0133] Example 5 Preparation of a Traditional Chinese Medicine Preparation for Treating Chronic Fatigue Syndrome

[0134] The prescription is as follows: raw astragalus 33 g, cinnamon twig 13 g, raw white atractylodes 33 g, ginger 13 g, processed Chuanwu 4 g, black aconite root 13 g, antler frost 22 g, ginseng 5 g, bupleurum 18 g, cyperus rotundus 13 g, and immature bitter orange 22 g.

[0135] The preparation method is as follows:

[0136] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 30 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 30 minutes, and set aside;

[0137] (2) Decoction of processed Chuanwu and Heifupi root for 60 minutes;

[0138] (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature bitter orange, and boil for 40 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 40 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0139] The above examples are provided to those skilled in the art to fully disclose and describe how to implement and use the claimed embodiments, rather than to limit the scope of the disclosure herein. Modifications that are obvious to those skilled in the art will fall within the scope of the appended claims.

Claims

1. A Chinese medicine preparation for treating chronic fatigue syndrome, characterized in that: It is made from the following raw materials: 25-35 g of raw astragalus, 10-20 g of cinnamon twig, 25-35 g of raw white atractylodes, 10-20 g of ginger, 2-5 g of processed Chuanwu, 10-20 g of black aconite root, 15-25 g of antler frost, 4-8 g of ginseng, 10-20 g of bupleurum, 10-20 g of cyperus, and 15-25 g of immature bitter orange.

2. The Chinese medicine preparation for treating chronic fatigue syndrome according to claim 1, characterized in that It is made from the following raw materials: raw astragalus 30 g, cinnamon twig 15 g, raw white atractylodes 30 g, ginger 15 g, processed Chuanwu 3 g, black aconite root 15 g, antler frost 20 g, ginseng 6 g, bupleurum 15 g, cyperus rotundus 15 g, and immature aurantium 20 g.

3. The Chinese medicine preparation for treating chronic fatigue syndrome according to claim 1, characterized in that It is made from the following raw materials: raw astragalus 25 g, cinnamon twig 20 g, raw white atractylodes 25 g, ginger 20 g, processed Chuanwu 2 g, black aconite root 20 g, antler frost 15 g, ginseng 8 g, bupleurum 10 g, cyperus rotundus 20 g, and immature aurantium 15 g.

4. The Chinese medicine preparation for treating chronic fatigue syndrome according to claim 1, characterized in that It is made from the following raw materials: raw astragalus 35 g, cinnamon twig 10 g, raw white atractylodes 35 g, ginger 10 g, processed Chuanwu 5 g, black aconite root 10 g, antler frost 25 g, ginseng 4 g, bupleurum 20 g, cyperus rotundus 10 g, and immature aurantium 25 g.

5. The Chinese medicine preparation for treating chronic fatigue syndrome according to claim 1, characterized in that It is made from the following raw materials: raw astragalus 28 g, cinnamon twig 18 g, raw white atractylodes 28 g, ginger 18 g, processed Chuanwu 3 g, black aconite root 18 g, antler frost 18 g, ginseng 7 g, bupleurum 13 g, cyperus rotundus 18 g, and immature bitter orange 18 g.

6. The Chinese medicine preparation for treating chronic fatigue syndrome according to claim 1, characterized in that It is made from the following raw materials: raw astragalus 33 g, cinnamon twig 13 g, raw white atractylodes 33 g, ginger 13 g, processed Chuanwu 4 g, black aconite root 13 g, antler frost 22 g, ginseng 5 g, bupleurum 18 g, cyperus rotundus 13 g, and immature aurantium 22 g.

7. The method for preparing the traditional Chinese medicine preparation for treating chronic fatigue syndrome according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 20-40 minutes, and set aside; mix the raw Astragalus, cinnamon twig, raw Atractylodes macrocephala, ginger, antler powder, ginseng, bupleurum, cyperus and immature aurantium, soak them in water for 20-40 minutes, and set aside; (2) Decoction of processed Chuanwu and Heifupi root for 60-80 minutes; (3) Add raw astragalus, cinnamon twig, raw white atractylodes, ginger, antler frost, ginseng, bupleurum, cyperus and immature bitter orange, and boil for 30 to 50 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 30 to 50 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

8. The preparation method according to claim 7, characterized in that: In the step (1), the soaking time is 30 minutes.

9. The preparation method according to claim 7, characterized in that: In the step (2), the decocting time is 60 minutes.

10. The preparation method according to claim 7, characterized in that: In the step (3), the decocting time is 40 minutes.

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