A traditional Chinese medicine composition for treating fibromyalgia syndrome, its preparation and application

Abstract

This invention discloses a traditional Chinese medicine composition for treating fibromyalgia syndrome, its preparation, and its application. The composition includes stir-fried white peony root, angelica root tail, stir-fried jujube seed, bupleurum root, stir-fried gardenia fruit, poria cocos, stir-fried coix seed, tangerine peel, and prepared licorice root. Through careful selection of raw materials and control of additives, the formulation of this traditional Chinese medicine composition is rigorous and can effectively treat patients with fibromyalgia syndrome exhibiting blood deficiency and liver stagnation syndrome. The efficacy is definite, the raw materials are readily available, and a prospective, randomized, parallel-controlled clinical exploratory trial further clarified the effectiveness and safety of this composition, filling a gap in traditional Chinese medicine prescriptions for treating fibromyalgia syndrome with blood deficiency and liver stagnation syndrome.

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 treating fibromyalgia syndrome, its preparation, and its application. Background Technology

[0002] Fibromyalgia syndrome (FMS) is a non-articular soft tissue rheumatic disease characterized by widespread, symmetrical musculoskeletal pain and stiffness, often accompanied by insomnia and psychological disturbances. An epidemiological survey in the United States indicated a prevalence of 2% in the general population. The American College of Rheumatology (ACR) reports FMS as the third most prevalent rheumatic disease. Some scholars in China have estimated that FMS accounts for 4.15% of cases seen in rheumatology clinics, but epidemiological data is currently lacking. This disease primarily affects young and middle-aged women, and patients often present with a wide range of complex and varied complaints, with laboratory tests often yielding negative results, complicating diagnosis and treatment.

[0003] Currently, only three Western medicines are approved internationally for the treatment of fibromyalgia syndrome: the anticonvulsant pregabalin, the serotonin-norepinephrine reuptake inhibitor duloxetine, and mirtazapine. These are relatively expensive, costing between 1300-2000 yuan per month for patients in China, and their efficacy is not entirely satisfactory. Systematic reviews show that pregabalin has a slight effect on improving pain, fatigue, and sleep quality, but no effect on improving physical function; duloxetine has the effect of reducing pain, improving sleep, and improving physical function, but is ineffective in improving fatigue; mirtazapine can reduce pain and has a mild effect on fatigue and physical function, but is ineffective in improving sleep quality. Furthermore, the common adverse reactions of these three drugs, such as dizziness, drowsiness, confusion, and weakness, prevent many patients from using them.

[0004] Traditional Chinese medicine considers fibromyalgia syndrome to fall under the category of "muscle spasm". The external causes of muscle spasm are mostly the invasion of the tendons and meridians by pathogenic factors such as wind, cold, dampness and heat; the internal causes may be liver stagnation and spleen deficiency, resulting in insufficient qi and blood to nourish the tendons and meridians, leading to muscle spasm, or liver qi stagnation, phlegm and blood stasis, which obstruct the flow of qi and blood and cause muscle spasm. The individualized treatment based on syndrome differentiation and the holistic concept of harmony between man and nature in traditional Chinese medicine have shown significant advantages in individualized treatment. In recent years, domestic scholars have tried various treatments, including oral Chinese medicine, external Chinese medicine, acupuncture, massage, and comprehensive Chinese medicine therapies. In terms of oral Chinese medicine, doctors often use treatment methods such as soothing the liver and regulating qi, soothing the liver and strengthening the spleen, warming yang and dispelling cold, clearing heat and promoting diuresis, relieving pain and unblocking collaterals, and harmonizing ying and wei to treat the symptoms based on their own clinical experience. Formulas that have been studied include Xiao Chai Hu Tang, Dan Zhi Xiao Yao San, Huang Qi Gui Zhi Wu Wu Tang, and Wen Dan Tang. However, there are currently no Chinese medicine formulas that use the method of nourishing blood and softening the liver to treat patients with liver stagnation and blood deficiency.

[0005] Currently, there are no clinical studies on the distribution patterns of TCM syndrome types in fibromyalgia syndrome. However, due to the busy work schedules, irregular diets, and unhealthy lifestyles of modern people, such as staying up late, which deplete Yin and blood, coupled with a fast-paced life, high work pressure, and numerous negative life events, leading to excessive thinking, emotional distress, liver dysfunction, and depletion of liver blood, there are a large number of patients with liver stagnation and blood deficiency in clinical practice. To treat patients with blood deficiency and liver stagnation type fibromyalgia syndrome, there is an urgent need to develop formulas with good clinical efficacy and high safety to fill the gap in existing TCM prescriptions. Summary of the Invention

[0006] Based on the above deficiencies, the first objective of this invention is to provide a traditional Chinese medicine composition for treating fibromyalgia syndrome. This composition nourishes blood and softens tendons, soothes the liver and relieves pain. It is suitable for fibromyalgia syndrome belonging to the blood deficiency and liver stagnation syndrome, characterized by: tenderness, soreness, or weakness in multiple muscles throughout the body, aggravated by cold or rainy weather, fatigue, loss of appetite, insomnia, forgetfulness, anxiety, irritability, or shortness of breath, chest and rib pain, frequent sighing, red or pale red tongue, thin white or greasy white tongue coating, and a weak, thready pulse. This composition can effectively fill the gaps in existing traditional Chinese medicine prescriptions.

[0007] A second objective of this invention is to provide a traditional Chinese medicine preparation comprising the traditional Chinese medicine composition described above.

[0008] A third objective of this invention is to provide the application of the Chinese herbal composition or preparation described above in the preparation of a Chinese herbal medicine for treating fibromyalgia syndrome.

[0009] To achieve the first objective mentioned above, this invention discloses a traditional Chinese medicine composition for treating fibromyalgia syndrome, the traditional Chinese medicine composition comprising stir-fried white peony root, angelica root tail, stir-fried jujube seed, bupleurum root, stir-fried gardenia fruit, poria cocos, stir-fried coix seed, tangerine peel, and prepared licorice root.

[0010] This invention discloses for the first time a traditional Chinese medicine composition for treating fibromyalgia syndrome of blood deficiency and liver stagnation type. It is a formula for nourishing blood, softening the liver, and relieving pain, characterized by its refined and rational formulation, definite efficacy, and readily available raw materials. It can effectively treat patients with fibromyalgia syndrome belonging to the blood deficiency and liver stagnation type, specifically improving symptoms and signs caused by fibromyalgia syndrome such as tenderness, soreness, or weakness in multiple muscles throughout the body, which worsens in cold or rainy weather, fatigue, loss of appetite, insomnia, forgetfulness, anxiety, irritability, or shortness of breath, chest and rib pain, frequent sighing, red or pale red tongue, thin white or greasy white tongue coating, and weak, thready pulse. Furthermore, through a prospective, randomized, parallel-controlled clinical exploratory trial, the efficacy and safety of this traditional Chinese medicine composition were further clarified, filling a gap in traditional Chinese medicine prescriptions for treating fibromyalgia syndrome belonging to the blood deficiency and liver stagnation type.

[0011] The sources and indications of the medicinal materials used in the formulas of this invention are as follows:

[0012] White peony root: The dried root of Paeonia lactiflora Pall, a plant in the Ranunculaceae family. It is bitter, sour, and slightly cold in nature, and enters the liver and spleen meridians. It has the effects of calming the liver and relieving pain, nourishing blood and regulating menstruation, and astringing yin and stopping sweating. It is used for headaches, dizziness, hypochondriac pain, abdominal pain, limb spasms, blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, and night sweats. The *Diannan Materia Medica* states that it "astringes liver qi stagnation and pain, regulates the blood of the heart, liver, and spleen meridians, soothes the meridians and lowers qi, and stops liver qi pain." Therefore, it is heavily used to nourish blood, soften the liver, relax muscles, and relieve pain. Studies have shown that the main active components of white peony root, paeoniflorin and paeoniflorin lactone, can exert anti-inflammatory, antispasmodic, and analgesic effects by reducing the production of PGE2 in the cerebral cortex.

[0013] Angelica sinensis tail: This refers to the tail of Angelica sinensis, the dried root of the plant Angelica sinensis Diels, belonging to the Apiaceae family. It is sweet, pungent, bitter, and warm in nature, and enters the liver, heart, and spleen meridians. It has the effects of nourishing blood, promoting blood circulation, regulating menstruation and relieving pain, and moistening dryness and lubricating the intestines. The volatile oil of Angelica sinensis has sedative, hypnotic, analgesic, and anesthetic effects on the central nervous system.

[0014] Sour jujube seed: the seed of the sour jujube plant (Rhamnaceae family). It is sweet, sour, and neutral in nature, and enters the liver, heart, gallbladder, and spleen meridians. It nourishes the liver, calms the mind, soothes the nerves, and astringes sweat. Water-soluble extracts of sour jujube seed have sedative, hypnotic, and anticonvulsant effects.

[0015] Bupleurum: The dried root of Bupleurum chinense DC. or Bupleurum corzonerifolium Willd, both belonging to the Apiaceae family. It is bitter and slightly cold in nature, and enters the liver and gallbladder meridians. It has the effects of clearing heat from the exterior, soothing the liver and relieving depression, and raising yang qi. The Compendium of Materia Medica states that it can treat yang heat sinking, calm the fire of the liver, gallbladder, triple burner and pericardium, as well as headache, dizziness, heat entering the blood chamber in women, and irregular menstruation. As a commonly used Chinese medicine in clinical practice, Bupleurum is often used in combination with other herbs. It is summarized that it has the functions of relieving depression, raising clear qi, dispelling evil and clearing heat.

[0016] Gardenia: This product is the dried, ripe fruit of *Gardenia jasminoides* Ellis, a plant in the Rubiaceae family. It is bitter and cold in nature, and enters the heart, lung, and triple burner meridians. It has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying. It is used for feverish irritability, jaundice with dark urine, painful hematuria, vomiting due to blood heat, red and swollen eyes, and carbuncles caused by fire toxins; it also treats sprains and contusions.

[0017] Poria cocos: The dried sclerotium of the fungus Poria cocos Wolf (family Polyporaceae). It is sweet, bland, and neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stomach, and calming the mind and soothing the nerves. Poria cocos decoction has a significant sedative effect. According to the *Pharmacopoeia*, it "mainly treats palpitations and muscle twitching, and also treats dizziness and irritability."

[0018] Coix Seed: The dry and ripe semen of Coix lacryma-jobi L. var. ma-yuen Stapf, Gramineae family, is sweet, light, and cool in nature. It acts on the spleen, stomach, and lung meridians. It has the effects of strengthening the spleen and promoting diuresis, expelling wind-dampness and stopping diarrhea, clearing heat and discharging pus, and is used for edema, beriberi, dysuria, wind-damp obstruction with muscle spasm, spleen deficiency diarrhea, lung abscess, intestinal abscess, and flat wart.

[0019] Dried Tangerine Peel: The dry and ripe pericarp of Citrus reticulata Blanco and its cultivated varieties, Rutaceae family, is bitter, pungent, and warm in nature. It acts on the lung and spleen meridians.

[0020] Fried Licorice Root: It is a plant of the Leguminosae family, with the effects of regulating the middle energizer and relieving spasm, moistening the lung, detoxifying, and coordinating various herbs. It is commonly used for spleen and stomach weakness, lassitude and weakness, palpitation, intermittent pulse, and can detoxify the toxicity of aconite root.

[0021] According to traditional Chinese medicine theory, white peony root is sour in taste, astringent, nourishing blood and soothing the liver; bupleurum root is pungent in taste, dispersing stagnation and soothing the liver. The combination of the two herbs, one for qi and the other for blood, one for astringing and the other for dispersing, is used as the monarch drug to soothe the liver substance and function, and there is no concern of bupleurum root consuming liver yin. Raw white peony root is slightly cold in nature, and its medicinal property becomes milder after frying, being good at nourishing blood and soothing the liver. When combined with fried licorice root, the two herbs generate yin from sour and sweet, and have a good effect of relieving spasm and pain. Angelica tail, stir-fried gardenia fruit, and wild jujube seed are used as ministerial drugs to assist the monarch drugs white peony root and bupleurum root in exerting the effects of nourishing blood and soothing the liver, and adding the function of relieving restlessness and promoting sleep. Angelica tail is sweet, warm, and moist in nature, capable of both nourishing blood and promoting blood circulation. "Ri Hua Zi Ben Cao" states that it "treats all wind, all blood, and supplements all kinds of fatigue". White peony root is sour in taste, which is in line with the nature of the liver, and can enter the liver meridian to relieve spasm and pain. The combination of the two herbs has a better effect of nourishing blood, making the meridians run smoothly, and nourishing blood to stop the pain of muscles and bones due to blood deficiency. Stir-fried gardenia fruit is bitter and cold, acting on the heart, lung, and triple energizer meridians. "Ben Cao Si Bian Lu" states: "Whenever liver depression leads to the generation of fire, gallbladder fire flares outward while liver fire lies latent inside. Gardenia fruit relieves the stagnant fire, so it treats the liver instead of the gallbladder." It is used to clear away liver fire and relieve restlessness. Wild jujube seed is sour, sweet, and moist in nature, acting on the heart, liver, and gallbladder meridians. "Ben Cao Hui Yan" says: "It astringes qi and soothes the mind, nourishes tendons and marrow, and harmonizes the stomach and promotes the transportation of the spleen", and is used to nourish liver blood, calm the mind, and treat insomnia due to deficiency and restlessness. Modern pharmacological research shows that wild jujube seed can increase the deep sleep time of mice and improve the sleep depth by inhibiting the central nervous system and regulating neurotransmitters. Clinical research also shows that wild jujube seed decoction can reduce the sleep quality score of middle-aged female depression patients and improve the symptoms of neurasthenia. Stir-fried coix seed, poria, dried tangerine peel, and fried licorice root are used as assistant drugs. Stir-fried coix seed is cool in nature, and poria is neutral in nature. Both are sweet and light in taste, and act on the spleen and stomach meridians. Their combination can strengthen the spleen and resolve dampness. Dried tangerine peel is pungent, bitter, and warm in nature, with the functions of regulating qi and promoting appetite, drying dampness. Fried licorice root is sweet, slightly warm, and can strengthen the spleen and boost qi. The combination of the four herbs plays the role of strengthening the spleen and removing dampness. On the one hand, it strengthens the spleen to assist digestion, and when qi and blood are abundant and perfusion into the tendons and vessels, the muscles become firm. On the other hand, it eliminates dampness and relieves wind-damp obstruction, and when pathogenic factors are removed, the meridians become unobstructed. Looking at the whole formula, the combination of various herbs together achieves the effects of nourishing blood, soothing the liver, relieving pain, and promoting sleep. When blood is harmonious, the meridians flow smoothly, nourishing and restoring yin and yang, and the muscles and bones become strong.

[0022] Furthermore, by weight, the traditional Chinese medicine composition includes 30-60 parts of stir-fried white peony root, 15-30 parts of angelica root tail, 30-50 parts of stir-fried jujube seed, 10-15 parts of bupleurum root, 6-10 parts of stir-fried gardenia fruit, 15-30 parts of poria cocos, 30-60 parts of stir-fried coix seed, 6-10 parts of tangerine peel, and 10-20 parts of prepared licorice root.

[0023] Furthermore, by weight, the traditional Chinese medicine composition includes 45-60 parts of stir-fried white peony root, 20-30 parts of angelica root tail, 30-50 parts of stir-fried jujube seed, 10-15 parts of bupleurum root, 6-10 parts of stir-fried gardenia fruit, 15-30 parts of poria cocos, 45-60 parts of stir-fried coix seed, 6-10 parts of tangerine peel, and 15-20 parts of prepared licorice root.

[0024] Furthermore, by weight, the traditional Chinese medicine composition includes 60 parts of stir-fried white peony root, 30 parts of angelica root tail, 50 parts of stir-fried jujube seed, 10 parts of bupleurum root, 10 parts of stir-fried gardenia fruit, 30 parts of poria cocos, 60 parts of stir-fried coix seed, 10 parts of tangerine peel, and 15 parts of prepared licorice root.

[0025] Furthermore, by weight, the traditional Chinese medicine composition includes 45 parts of stir-fried white peony root, 25 parts of angelica root tail, 45 parts of stir-fried jujube seed, 12 parts of bupleurum root, 9 parts of stir-fried gardenia fruit, 20 parts of poria cocos, 45 parts of stir-fried coix seed, 9 parts of tangerine peel, and 15 parts of prepared licorice root.

[0026] To achieve the second objective mentioned above, this invention discloses a traditional Chinese medicine preparation for treating fibromyalgia syndrome.

[0027] In use, the traditional Chinese medicine composition of this invention can be prepared into a decoction according to traditional prescription methods, such as decocting with water and then taking the decoction. Alternatively, the active ingredients of the prescription can be refined with water or other suitable solvents and then prepared into various dosage forms, such as granules, tablets, capsules, pills, powders, and oral liquids, according to conventional pharmaceutical processes. Experimental verification has shown that all the above preparation and usage methods can achieve the therapeutic effect of the drug.

[0028] To achieve the third objective mentioned above, this invention discloses the application of the aforementioned traditional Chinese medicine composition or preparation in the preparation of traditional Chinese medicine for treating fibromyalgia syndrome.

[0029] The beneficial effects of this invention are as follows:

[0030] This invention discloses a traditional Chinese medicine composition for treating fibromyalgia syndrome, its preparation, and its application. The composition includes stir-fried white peony root, angelica root tail, stir-fried jujube seed, bupleurum root, stir-fried gardenia fruit, poria cocos, stir-fried coix seed, tangerine peel, and prepared licorice root. Through careful selection of raw materials and control of additives, the formulation of this traditional Chinese medicine composition is rigorous and can effectively treat patients with fibromyalgia syndrome exhibiting blood deficiency and liver stagnation syndrome. The efficacy is definite, the raw materials are readily available, and a prospective, randomized, parallel-controlled clinical exploratory trial further clarified the effectiveness and safety of this composition, filling a gap in traditional Chinese medicine prescriptions for treating fibromyalgia syndrome with blood deficiency and liver stagnation syndrome. Attached Figure Description

[0031] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0032] Figure 1 The flowchart for patient enrollment in the clinical trial is shown. Detailed Implementation

[0033] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments and accompanying drawings, further clarifies the invention. Those skilled in the art should understand that the specific description below is illustrative rather than restrictive and should not be construed as limiting the scope of protection of the present invention.

[0034] Example 1

[0035] Softening Muscle Formula: Take 60g of stir-fried white peony root, 30g of angelica root tail, 50g of stir-fried jujube seed, 10g of bupleurum root, 10g of stir-fried gardenia fruit, 30g of poria cocos, 60g of stir-fried coix seed, 10g of dried tangerine peel, and 15g of prepared licorice root. Decocted and taken orally, one packet (150ml) each time, twice a day.

[0036] Example 2

[0037] Softening Muscle Formula: 45 parts stir-fried white peony root, 25 parts angelica root tail, 45 parts stir-fried jujube seed, 12 parts bupleurum root, 9 parts stir-fried gardenia fruit, 20 parts poria cocos, 45 parts stir-fried coix seed, 9 parts dried tangerine peel, and 15 parts prepared licorice root. Decocted and taken orally, one bag (150ml) each time, twice a day.

[0038] Clinical trials

[0039] 1. Overview of Test Methods

[0040] Forty-eight patients with fibromyalgia syndrome who met the 1990 ACR classification criteria for fibromyalgia syndrome and were辨证为血虚肝郁证 (辨证为血虚肝郁证 is not a recognized medical term in English, it should be something like "diagnosed with the syndrome of blood deficiency and liver depression" in a more accurate translation) by traditional Chinese medicine syndrome differentiation were randomly divided into a treatment group of 24 cases and a control group of 24 cases. The treatment group was given 150 ml of the Roujin Recipe prepared in Example 2, twice a day; the control group was given 150 ml of the Roujin Recipe placebo, twice a day. The treatment course for both groups was 8 weeks. The evaluation time points were 0 week, 4 weeks, 8 weeks of treatment, and follow-up until 12 weeks. The FIQR score was used as the main efficacy evaluation index, and the Visual Analogue Scale for pain (VAS score for pain), Pittsburgh Sleep Quality Index (PSQI score), Beck Depression Inventory (BDI score), and Short Form 36 Health Survey (SF-36 score, divided into Physical Component Summary PCS and Mental Component Summary MCS) were used as secondary efficacy evaluation indexes to evaluate the efficacy changes of patients before and after treatment. The examination results of patients at 0 week and 8 weeks of treatment were recorded to evaluate safety. The examination contents mainly included urine routine, liver function, renal function, and blood routine. SPSS 23.0 was used for statistical analysis of the research data.

[0041] 2. Trial protocol

[0042] 1 Research subjects

[0043] 1.1 Case source

[0044] Patients with fibromyalgia syndrome who visited the rheumatology outpatient department of Guang'anmen Hospital, China Academy of Chinese Medical Sciences from October 2018 to August 2019 were selected. After being evaluated by the attending physician, they met the fibromyalgia syndrome classification criteria established by the ACR in 1990 and at the same time met the diagnostic criteria for the traditional Chinese medicine syndrome of blood deficiency and liver depression. A total of 48 cases were included and randomly divided into a Roujin Recipe treatment group and a placebo control group, with 24 cases in each group.

[0045] 1.2 Diagnostic criteria

[0046] 1.2.1 Fibromyalgia syndrome classification criteria

[0047] According to the fibromyalgia syndrome classification criteria established by the ACR in 1990.

[0048] 1.2.2 Diagnostic basis for traditional Chinese medicine syndromes

[0049] Refer to the syndromes of qi and blood deficiency and liver qi stagnation in "Practical Traditional Chinese Medicine Rheumatology" (2009 edition). Symptoms include: muscle pain or soreness, fixed tender points, sallow complexion, weakness of the limbs, emotional discomfort, chest and hypochondrium distending pain, frequent sighing, emaciation, poor sleep and many dreams. The tongue is red or pale, the tongue coating is thin and white, and the pulse is stringy and thready or deep and thready and weak. Diagnosis can be made in combination with actual clinical manifestations.

[0050] 1.3 Inclusion criteria

[0051] ① Met the fibromyalgia syndrome classification criteria established by the American College of Rheumatology in 1990;

[0052] ② It conforms to the diagnostic criteria of traditional Chinese medicine syndromes;

[0053] ③Be 18 years of age or older;

[0054] ④ Sign the informed consent form.

[0055] 1.4 Exclusion Criteria

[0056] ① Patients with rheumatic diseases such as rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, and ankylosing spondylitis;

[0057] ② Other diseases such as severe liver and kidney dysfunction and severe cardiovascular and cerebrovascular diseases;

[0058] ③Pregnant or breastfeeding women;

[0059] ④ You have taken any medication for this disease within the past 4 weeks.

[0060] 1.5 Rejection Criteria

[0061] ① Those who do not meet the case selection criteria;

[0062] ② Patients with poor compliance who have not taken the medication for more than 2 weeks.

[0063] 1.6 Shedding Criteria

[0064] ① Definition of dropout: Patients who have not completed the 8-week clinical trial observation are considered dropout cases.

[0065] ② Handling of dropout cases: When a patient drops out, record the last contact time if possible. Dropouts due to adverse reactions must be recorded in the CRF.

[0066] ③ Reasons for dropout: For any dropout case, the researcher must fill in one of the following reasons for dropout in the CRF form: a. adverse event; b. lack of efficacy; c. violation of the trial protocol (including poor compliance); d. loss to follow-up (including patient withdrawal).

[0067] 1.7 Sample Size

[0068] This study is an exploratory trial. Considering the feasibility of the protocol, the sample size of each group was initially determined to be 20 cases. With an expected loss to follow-up rate of 20%, the sample size of each group would be 24 cases, for a total of 48 cases in both groups.

[0069] 1.8 Random Grouping

[0070] Using SAS statistical software, random numbers were generated at a 1:1 ratio, created into random envelopes, sealed, and labeled with serial numbers before being sent for observation. A third party assigned the patients to groups A and B based on the random numbers, keeping this information confidential from the researchers responsible for recruiting patients. The initial values ​​and segment lengths of the random sampling were recorded in a blinded database. The corresponding treatment and control groups for groups A and B were also recorded in the blinded database and kept by the research group leader for future replication.

[0071] 1.9 Treatment Plan

[0072] 1.9.1 Medication Regimen

[0073] To ensure consistency of intervention factors during the treatment process, the provided traditional Chinese medicine decoctions remained unchanged. The medications were uniformly distributed by the same qualified manufacturer of prepared Chinese medicinal herbs and prepared by the decoction room of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (with consistent decoction methods and parameter settings). All researchers responsible for the treatment received standardized training, and enrolled patients were provided with "Medication Instructions." Treatment duration: 8 weeks.

[0074] ① Treatment group:

[0075] Softening Muscle Formula: 45 parts stir-fried white peony root, 25 parts angelica root tail, 45 parts stir-fried jujube seed, 12 parts bupleurum root, 9 parts stir-fried gardenia fruit, 20 parts poria cocos, 45 parts stir-fried coix seed, 9 parts dried tangerine peel, and 15 parts prepared licorice root. Decocted and taken orally, one packet (150ml) each time, twice a day.

[0076] ② Control group:

[0077] Placebo: A placebo was prepared by taking one-tenth the amount of the Roujinfang medicine according to internationally recognized standards. It was identical to the Roujinfang in appearance, color, taste, smell, and packaging. Dosage: Oral administration, one sachet (150ml) twice daily.

[0078] 1.9.2 Combined medication

[0079] During the trial, if a patient's visual analog scale pain score worsens by 30% or more, the patient will be withdrawn, and the reason for withdrawal will be recorded. If a patient needs to take medication due to illnesses such as a cold, the type, method, and total amount of medication taken by each patient during the observation and follow-up periods will be recorded.

[0080] 1.10 Observation Indicators

[0081] 1.10.1 Demographic Data

[0082] Name, gender, age, height, weight, course of illness, etc.

[0083] 1.10.2 Safety Observation and Observation Time Points

[0084] Complete blood count, urinalysis, liver function tests (ALT, AST), and kidney function tests (BUN, Cr);

[0085] Evaluation time points: 0 weeks and 8 weeks.

[0086] 1.10.3 Observation of therapeutic efficacy and observation time points

[0087] ① The revised Fibromyalgia Impact Questionnaire (FIQR) is an internationally recognized indicator for evaluating the treatment efficacy of fibromyalgia syndrome and can comprehensively assess the condition of patients with fibromyalgia syndrome. The scale consists of 21 questions divided into three sections: evaluation of basic living abilities such as combing hair, housework, and shopping; overall evaluation of the impact of the disease; and evaluation of basic symptoms such as pain, stiffness, sleep, depression, and sensitivity to sound, light, and temperature. It can comprehensively reflect the impact of the disease on the patient's life over the past week. Each question is scored from "0" to "9" on a numerical scale, with 0 indicating no symptoms and 9 being the worst. A higher total score indicates a greater impact.

[0088] ② The Pain Visual Analogue Scale / Score (pVAS) consists of a 100 mm vertical line. The doctor tells the patient that no pain corresponds to 0 points, the most severe pain corresponds to 10 points, and moderate pain corresponds to 5 points. The patient describes the intensity of the pain they feel on a scale of 0 to 10 and is asked to describe their pain accordingly.

[0089] ③ The Pittsburgh Sleep Quality Index (PSQI) evaluates patients' sleep status in seven dimensions: sleep quality, time to fall asleep, sleep duration, hypnotic medication, and daytime dysfunction. The higher the score, the worse the sleep quality.

[0090] ④ The Beck Depression Inventory (BDI) is a self-report scale created by A.T. Beck and used clinically to assess the degree of depression in individuals. It consists of 21 questions, each with a four-level rating scale (0-3 points). Patients review their experiences over the past week, selecting the option that best fits them. Based on the total score, they are categorized into four levels: no depression, mild, moderate, and severe depression.

[0091] ⑤ The Short Form-36 Health Status Questionnaire (SF-36) is a self-report scale used to assess health-related quality of life. It consists of 36 items, divided into eight dimensions: Physical Functioning (PF), Role of Physical Activity (RP), Bodily Pain (BP), General Health (GH), Energy Level (VT), Social Functioning (SF), Role of Emotional Activity (RE), and Mental Health (MH). The mean of the scores for the first four dimensions is defined as the Physical Component Summary (PCS), and the mean of the scores for the latter four dimensions is defined as the Mental Component Summary (MCS). Higher scores indicate better quality of life and health.

[0092] Evaluation time points: Recorded once each at weeks 0, 4, and 8. At the end of the study, a final record was made after a 4-week follow-up period.

[0093] 1.11 Efficacy Evaluation Criteria

[0094] 1.11.1 Primary therapeutic indicators

[0095] This study selected the internationally recognized FIQR score as the main efficacy indicator for evaluating the treatment of fibromyalgia syndrome, which can comprehensively assess the condition of patients with fibromyalgia syndrome.

[0096] 1.11.2 Secondary efficacy indicators

[0097] Most patients with fibromyalgia syndrome experience symptoms such as pain, sleep disturbances, and depression. Due to the impact of the disease, their quality of life and health is poor. Therefore, the VAS pain score was selected to evaluate the improvement of pain, the PSQI score was selected to evaluate the improvement of sleep quality, the BDI score was selected to evaluate the improvement of depressive mood, and the SF-36PCS and MCS scores were selected to evaluate the improvement of physical and mental health, in order to comprehensively evaluate the efficacy of Roujinfang on fibromyalgia syndrome.

[0098] 1.12 Data Management

[0099] ① All included cases must complete the case observation form.

[0100] ②For all patients who have passed the screening and entered this trial and have filled out the informed consent form, all items in the observation form must be recorded in detail without any omissions.

[0101] ③ After enrollment, patients may be given symptomatic treatment as needed based on their condition, and all concomitant medications used during the trial should be recorded.

[0102] 1.13 Statistical Methods

[0103] Statistical analysis will be performed using SPSS 23.0 software. All statistical tests will be two-tailed, and a p-value ≤ 0.05 will be considered statistically significant. Quantitative data will be described statistically as mean ± standard deviation. Within-group differences will be compared to baseline values ​​during the screening period using t-tests. Changes before and after treatment in both groups will be compared using t-tests and Wilcoxon rank-sum tests. Categorical data will be described statistically using frequencies (proportions). Changes before and after treatment in both groups will be analyzed using chi-square tests or non-parametric tests.

[0104] 1.14 Quality Control

[0105] ① During the progress of the project, a quality control team was established to train all researchers, with the project leader serving as the team leader.

[0106] ② Establish a specialized clinic for fibromyalgia syndrome, train one clinical researcher to master case collection methods, and train another clinical researcher to master indicator assessment methods. Separate case collection and efficacy indicator evaluation to reduce implementation deviations.

[0107] ③ During the data collection process, the influence of the above-mentioned interference and contamination factors should be excluded during statistical analysis.

[0108] ④ Do a good job of psychological work with patients, gain their cooperation and understanding, improve patient compliance, and control loss to follow-up.

[0109] 1.15 Ethics Approval

[0110] This trial strictly adheres to the ethical review guidelines for biomedical research involving human subjects in my country and other clinical trial standards. It has been reviewed and approved by the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, approval number: 2018-028-KY. Before each participant is enrolled in this study, the researchers are responsible for fully and comprehensively explaining the purpose, procedures, and potential risks of the study to the participant or their representative, and obtaining written informed consent. Medical records will be properly maintained throughout the study process to protect the privacy of the participants.

[0111] Test results

[0112] 1. Baseline Comparison

[0113] This study included 48 patients, of whom 41 actually completed the study after 8 weeks of treatment, with 7 dropouts (14.5%). In the treatment group, 20 patients completed the trial, with 4 dropouts (16.7%); in the control group, 21 patients completed the trial, with 3 dropouts (12.5%). Details are as follows... Figure 1 As shown.

[0114] 1.1 General Comparison

[0115] In the treatment group of 20 patients, there were 3 males and 17 females. The highest body mass index (BMI) was 27.77, and the lowest was 18.82. The oldest patient was 63 years old, and the youngest was 30 years old. The longest course of disease was 360 months, and the shortest was 6 months. In the control group of 21 patients, there were 3 males and 18 females. The highest BMI was 28.54, and the lowest was 17.01. The oldest patient was 63 years old, and the youngest was 32 years old. The longest course of disease was 120 months, and the shortest was 7 months.

[0116] As shown in Table 1, statistical analysis revealed no significant differences in age, gender, disease duration, BMI, etc., between the two groups of patients, indicating comparability. Both groups were predominantly composed of middle-aged and elderly women, consistent with the epidemiological pattern of fibromyalgia syndrome.

[0117] Table 1. General Information of Patients

[0118]

[0119] 1.2 Comparison of various efficacy indicators at baseline

[0120] Comparison of baseline efficacy indicators: Statistical analysis showed no statistically significant differences between the two groups in FIQR scores, VAS pain scores, PSQI scores, BDI scores, SF-36PCS scores, and SF-36MCS scores before treatment, indicating comparability. (See Table 2 for details)

[0121] Table 2 Comparison of efficacy indicators between the two groups at week 0

[0122]

[0123] 2. Results of efficacy index analysis

[0124] 2.1 Comparison of Fibromyalgia Impact Questionnaire (FIQR)

[0125] Table 3 Comparison of FIQR scores between the two groups at each evaluation time point

[0126]

[0127]

[0128] Note: *: P < 0.05 compared to week 0, #: P < 0.01 compared to week 0.

[0129] As shown in Table 3:

[0130] In the treatment group, there was no statistically significant change in FIQR score after 4 weeks of treatment compared with before treatment; however, there were statistically significant changes in FIQR score after 8 weeks of treatment and at the 12-week follow-up compared with before treatment (P<0.01).

[0131] In the control group, there were no statistically significant changes in FIQR scores after 4 weeks, 8 weeks, and 12 weeks of follow-up compared to before treatment.

[0132] Intergroup comparison: After 4 weeks of treatment, there was no statistically significant difference in FIQR scores between the two groups. After 8 weeks of treatment and at 12 weeks of follow-up, there were statistically significant differences in FIQR scores between the two groups (P<0.05). After 4 weeks of treatment, there was no statistically significant difference in the change of FIQR scores from baseline between the two groups. After 8 weeks of treatment and at 12 weeks of follow-up, there were statistically significant differences in the change of FIQR scores from baseline between the two groups (P<0.05).

[0133] 2.2 Comparison of VAS scores for pain

[0134] Table 4 Comparison of VAS scores for pain at different assessment time points

[0135]

[0136] Note: *: P < 0.05 compared to week 0, #: P < 0.01 compared to week 0.

[0137] As shown in Table 4:

[0138] (1) The pain VAS scores at each evaluation time point in the treatment group showed a significant decreasing trend. At 4 weeks, 8 weeks and 12 weeks of follow-up after treatment, the changes in pain VAS scores compared with those before treatment were statistically significant (P<0.01).

[0139] (2) In the control group, there was no statistically significant change in pain VAS score after 4 and 8 weeks of treatment compared with before treatment; after 12 weeks of follow-up, there was a statistically significant change in pain VAS score compared with before treatment (P<0.05).

[0140] (3) Intergroup comparison: There were no statistically significant differences in pain VAS scores between the two groups at 4 weeks, 8 weeks and 12 weeks of follow-up. At 4 weeks, 8 weeks and 12 weeks of follow-up, there were statistically significant differences in the changes in VAS scores from baseline between the two groups (P<0.05).

[0141] 2.3 Comparison of Pittsburgh Sleep Quality Index (PSQI) scores

[0142] Table 5 Comparison of PSQI scores at different evaluation points

[0143]

[0144] Note: *: P < 0.05 compared to week 0, #: P < 0.01 compared to week 0.

[0145] As shown in Table 5:

[0146] (1) The PSQI scores of the treatment group showed a significant decreasing trend at all evaluation time points. At 4 weeks, 8 weeks and 12 weeks of follow-up, the PSQI scores were significantly different from those before treatment (P<0.01).

[0147] (2) In the control group, there were no statistically significant differences in PSQI scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0148] (3) Intergroup comparison: There was no statistically significant difference in PSQI scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up. After 4 weeks of treatment, there was no statistically significant difference in the change of PSQI scores from baseline between the two groups. After 8 weeks of treatment and 12 weeks of follow-up, there was a statistically significant difference in the change of PSQI scores from baseline between the two groups (P<0.05).

[0149] 2.4 Comparison of Beck Depression Scale (BDI) scores

[0150] Table 6 Comparison of BDI scores at different evaluation points

[0151]

[0152] As shown in Table 6:

[0153] (1) The BDI scores of the treatment group showed a decreasing trend at all evaluation time points. There were no statistically significant differences in BDI scores between the treatment group at 4 weeks, 8 weeks and 12 weeks after treatment and before treatment.

[0154] (2) In the control group, there were no statistically significant differences in BDI scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0155] (3) Intergroup comparison: There was no statistically significant difference in BDI scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the changes in BDI scores from baseline between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0156] Comparison of scores on the 2,536-item Short Form Health Survey (SF-36)

[0157] 2.5.1 Comparison of Physiological Function (PF) Scores

[0158] Table 7 Comparison of SF-36 "Physiological Function" Scores at Different Assessment Time Points

[0159]

[0160] As shown in Table 7:

[0161] (1) After 4 weeks, 8 weeks and 12 weeks of treatment in the treatment group, there was no statistically significant difference in PF scores compared with those before treatment.

[0162] (2) In the control group, there were no statistically significant differences in PF scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0163] (3) Intergroup comparison: There was no statistically significant difference in PF scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the change of PF scores from baseline between the two groups.

[0164] 2.5.2 Comparison of Functional Responsibility (RP) Scores

[0165] Table 8 Comparison of SF-36 "Physiological Function" scores at different assessment time points

[0166]

[0167]

[0168] Note: #: P < 0.01 compared to week 0.

[0169] As shown in Table 8:

[0170] (1) After 4 weeks of treatment, there was no statistically significant difference in RP score compared with before treatment. After 8 weeks of treatment, there was a statistically significant difference in RP score compared with before treatment (P<0.01). After 12 weeks of follow-up, there was no statistically significant difference in RP score compared with before treatment.

[0171] (2) In the control group, there were no statistically significant differences in RP scores between 4 and 8 weeks after treatment and before treatment. However, after 12 weeks of follow-up, there were statistically significant differences in RP scores compared with before treatment (P<0.05).

[0172] (3) Intergroup comparison: There was no statistically significant difference in RP scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the change of RP scores from baseline between the two groups.

[0173] 2.5.3 Comparison of Body Pain (BP) Scores

[0174] Table 9 Comparison of SF-36 "Body Pain" Scores at Different Assessment Time Points

[0175]

[0176] Note: *: P < 0.05 compared to week 0, #: P < 0.01 compared to week 0.

[0177] As shown in Table 9:

[0178] (1) The BP scores of the treatment group showed a significant upward trend at all evaluation time points. At 4 weeks, 8 weeks and 12 weeks of follow-up, the BP scores were significantly different from those before treatment (P<0.01).

[0179] (2) In the control group, the BP scores after 4 weeks, 8 weeks and 12 weeks of follow-up were significantly different from those before treatment (P<0.05).

[0180] (3) Intergroup comparison: There was no statistically significant difference in BP scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the change of BP scores from baseline between the two groups.

[0181] 2.5.4 Comparison of Overall Health (GH) Scores

[0182] Table 10 Comparison of SF-36 "General Health" scores at different assessment time points

[0183]

[0184] Note: *: P < 0.05 compared to week 0, #: P < 0.01 compared to week 0.

[0185] As shown in Table 10:

[0186] (1) The GH scores of the treatment group showed a significant upward trend at all evaluation time points. After 4 weeks of treatment, there was no statistically significant difference in GH scores compared with those before treatment. After 8 weeks of treatment and at the follow-up period of 12 weeks, the GH scores were statistically significant compared with those before treatment (P<0.01).

[0187] (2) In the control group, there was no statistically significant difference in GH score after 4 weeks of treatment compared with before treatment. After 8 weeks of treatment and at the 12-week follow-up, there were statistically significant differences in GH score compared with before treatment (P<0.05).

[0188] (3) Intergroup comparison: There was no statistically significant difference in GH scores between the two groups after 4 weeks and 8 weeks of treatment. After 12 weeks of follow-up, there was a statistically significant difference in GH scores between the two groups (P<0.05). There was no statistically significant difference in the changes in GH scores from baseline between the two groups after 4 weeks, 8 weeks of treatment and after 12 weeks of follow-up.

[0189] 2.5.5 Comparison of Vital State (VT) Scores

[0190] Table 11 Comparison of SF-36 "Energy Status" scores at different assessment time points

[0191]

[0192] Note: #: P < 0.01 compared to week 0.

[0193] As shown in Table 11:

[0194] (1) The VT scores in the treatment group showed an upward trend at all evaluation time points. After 4 and 8 weeks of treatment, there was no statistically significant difference in VT scores compared with those before treatment. After 12 weeks of follow-up, the VT scores were statistically significant compared with those before treatment (P<0.01).

[0195] (2) In the control group, there was no statistically significant difference in VT score after 4 weeks of treatment compared with before treatment. After 8 weeks of treatment and at the 12-week follow-up, there were statistically significant differences in VT score compared with before treatment (P<0.01).

[0196] (3) Intergroup comparison: There was no statistically significant difference in GH scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the changes in GH scores from baseline between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0197] 2.5.6 Comparison of Social Functioning (SF) Scores

[0198] Table 12 Comparison of SF-36 "Social Functioning" Scores at Different Assessment Time Points

[0199]

[0200] As shown in Table 12:

[0201] (1) After 4 weeks, 8 weeks and 12 weeks of treatment, there were no statistically significant differences in SF scores compared with those before treatment in the treatment group.

[0202] (2) In the control group, there were no statistically significant differences in SF scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0203] (3) Intergroup comparison: There was no statistically significant difference in SF scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the change of SF scores from baseline between the two groups.

[0204] 2.5.7 Comparison of Affective Functioning (RE) Scores

[0205] Table 13 Comparison of SF-36 "Affective Function" Dimension Scores at Different Assessment Points

[0206]

[0207]

[0208] Note: *: P<0.05 compared with week 0.

[0209] As shown in Table 13:

[0210] (1) After 4 weeks of treatment, there was no statistically significant difference in RE scores compared to pre-treatment scores in the treatment group. After 8 weeks of treatment and at a follow-up period of 12 weeks, the RE scores were statistically significantly different from pre-treatment scores (P<0.05).

[0211] (2) In the control group, there were no statistically significant differences in RE scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0212] (3) Intergroup comparison: There was no statistically significant difference in RE scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the change of RE scores from baseline between the two groups.

[0213] 2.5.8 Comparison of Mental Health (MH) Scores

[0214] Table 14 Comparison of SF-36 "Mental Health" scores at different assessment time points

[0215]

[0216] As shown in Table 14:

[0217] (1) After 4 weeks, 8 weeks and 12 weeks of treatment in the treatment group, there was no statistically significant difference in MH score compared with before treatment.

[0218] (2) In the control group, there were no statistically significant differences in MH scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0219] (3) Intergroup comparison: There was no statistically significant difference in MH scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the change of MH scores from baseline between the two groups.

[0220] 2.5.9 Comparison of Physical Health Assessment (PCS) Scores

[0221] Table 15 Comparison of SF-36 PCS at Different Evaluation Points

[0222]

[0223] Note: *: P < 0.05 compared to week 0, #: P < 0.01 compared to week 0.

[0224] As shown in Table 15:

[0225] (1) The PCS scores in the treatment group showed a significant upward trend at all evaluation time points. After 4 weeks of treatment, the PCS scores were significantly different from those before treatment (P<0.05). After 8 weeks of treatment and at the 12-week follow-up, the PCS scores were significantly different from those before treatment (P<0.01).

[0226] (2) The PCS scores of the control group showed a significant upward trend at all evaluation time points. After 4 weeks of treatment, the PCS scores were significantly different from those before treatment (P<0.05). After 8 weeks of treatment and at the 12-week follow-up, the PCS scores were significantly different from those before treatment (P<0.01).

[0227] (3) Intergroup comparison: There was no statistically significant difference in PCS scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in PCS scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0228] 2.5.10 Comparison of Mental Health Assessment (MCS) Scores

[0229] Table 16 Comparison of SF-36MCS scores at different evaluation points

[0230]

[0231] Note: #: P < 0.01 compared to week 0.

[0232] As shown in Table 16:

[0233] (1) After 4 weeks of treatment, there was no statistically significant difference in MCS scores compared with those before treatment in the treatment group; after 8 weeks of treatment and at the follow-up period of 12 weeks, there were statistically significant differences in MCS scores compared with those before treatment (P<0.01).

[0234] (2) In the control group, there were no statistically significant differences in MCS scores compared with those before treatment after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0235] (3) Intergroup comparison: There was no statistically significant difference in MCS scores between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up; there was no statistically significant difference in the changes in MCS scores from baseline between the two groups after 4 weeks, 8 weeks and 12 weeks of follow-up.

[0236] 3 Security Analysis

[0237] In this study, 48 patients underwent complete blood count, urinalysis, liver function tests (ALT, AST), and kidney function tests (BUN, Cr) at weeks 0 and 8 of treatment, and no abnormalities were found. During the experiment, 4 patients reported adverse events, which were gastrointestinal reactions such as diarrhea and stomach pain; no serious adverse events were observed. Details are as follows:

[0238] Table 18 List of Adverse Events

[0239]

[0240] 4. Compliance Analysis

[0241] A total of 7 patients dropped out in this study, including 4 in the treatment group and 3 in the control group. Among the 4 patients who dropped out in the treatment group, 1 was lost to follow-up and did not complete the trial, 2 withdrew from the trial due to adverse events, and 1 withdrew from the trial because the patient did not want to continue participating. Among the 3 patients who dropped out in the control group, 2 were lost to follow-up and did not complete the trial, and 1 withdrew from the trial because the patient did not want to continue participating.

[0242] 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 fibromyalgia syndrome, characterized in that, The traditional Chinese medicine composition is made from 45-60 parts of stir-fried white peony root, 20-30 parts of angelica root tail, 30-50 parts of stir-fried jujube seed, 10-15 parts of bupleurum root, 6-10 parts of stir-fried gardenia fruit, 15-30 parts of poria cocos, 45-60 parts of stir-fried coix seed, 6-10 parts of tangerine peel, and 15-20 parts of prepared licorice root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from 60 parts of stir-fried white peony root, 30 parts of angelica root tail, 50 parts of stir-fried jujube seed, 10 parts of bupleurum root, 10 parts of stir-fried gardenia fruit, 30 parts of poria cocos, 60 parts of stir-fried coix seed, 10 parts of tangerine peel, and 15 parts of prepared licorice root.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from 45 parts of stir-fried white peony root, 25 parts of angelica root tail, 45 parts of stir-fried jujube seed, 12 parts of bupleurum root, 9 parts of stir-fried gardenia fruit, 20 parts of poria cocos, 45 parts of stir-fried coix seed, 9 parts of tangerine peel, and 15 parts of prepared licorice root.

4. A traditional Chinese medicine preparation for treating fibromyalgia syndrome, characterized in that, The traditional Chinese medicine composition according to any one of claims 1-3 may be prepared into decoction, granules, capsules, tablets, powders, pills or oral liquids.

5. The use of the traditional Chinese medicine composition as described in any one of claims 1-3 or the traditional Chinese medicine preparation as described in claim 4 in the preparation of a traditional Chinese medicine for treating fibromyalgia syndrome.

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