Traditional Chinese medicine composition for treating liver-stomach stasis type functional dyspepsia with anxiety, preparation and application

Abstract

The invention relates to the field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition for treating liver-stomach stasis type functional dyspepsia with anxiety, a preparation and application. The traditional Chinese medicine composition comprises the following active ingredient raw materials in parts by weight: 5-15 parts of radix bupleuri, 5-15 parts of rhizoma cyperi, 2-8-12 parts of fructus aurantii, 5-15 parts of pericarpium citri reticulatae, 5-15 parts of rhizoma pinellinae praeparata, 5-15 parts of fingered citron, 5-15 parts of pericarpium arecae, 5-15 parts of semen raphani, 1-5 parts of liquorice and 2-8-12 parts of rhizoma zingiberis. The traditional Chinese medicine composition and the preparation can effectively treat patients with liver and stomach stasis type functional dyspepsia accompanied with anxiety, can relieve clinical symptoms, can effectively treat patients with liver and stomach stasis type functional dyspepsia accompanied with anxiety, can relieve clinical symptoms and improve life quality, and have good safety.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition, preparation and application for treating liver-stomach stagnation syndrome functional dyspepsia accompanied by anxiety. Background Art

[0002] Functional dyspepsia (FD) is a common functional digestive disease in clinical practice. It is mainly caused by gastrointestinal discomfort symptoms caused by gastric and duodenal dysfunction, and usually there is no organic disease. The main clinical manifestations are abdominal pain after meals, early satiety, upper abdominal burning sensation, upper abdominal pain, etc. Current studies have found that the global prevalence of functional dyspepsia is 11.5% to 14.5%. Long-term suffering from abdominal distension, abdominal pain and other discomforts also brings a series of psychological pressures to patients, which causes patients to become anxious. According to studies, functional dyspepsia is closely related to anxiety. The current treatment method is aimed at alleviating patients' symptoms and improving their quality of life.

[0003] Studies have shown that although the pathogenesis of functional dyspepsia is still unclear, most researchers believe that the disease is caused by a combination of factors, including abnormal gastrointestinal motility, increased visceral sensitivity, psychological factors, Helicobacter pylori infection, brain-gut axis dysfunction, low-grade inflammation of the duodenal mucosa, etc., as follows.

[0004] 1.1 Gastrointestinal motility abnormalities

[0005] Under normal circumstances, gastrointestinal motility is regular and cyclical, while abnormal gastrointestinal motility includes delayed gastric emptying, weakened gastric antral motility, and rhythm disorders. Kusano pointed out through research that most patients experience early satiety symptoms due to delayed gastric emptying. Patients with functional dyspepsia often have irregular intestinal movements and even reverse peristalsis, which eventually leads to weak gastric muscle contraction, and then weakened peristalsis, delaying the process of gastric emptying and causing discomfort.

[0006] 1.2 Increased visceral sensitivity

[0007] At present, many unexplained digestive system symptoms are believed to be related to visceral hypersensitivity. In simple terms, increased visceral sensitivity means that the stomach is stimulated and discomfort occurs. There are many reasons for visceral sensitivity, such as sensitivity to temperature, acidity and alkalinity, and sensitivity to mechanical expansion. Studies have found that patients will experience stomach discomfort or allergies, and more than half will experience symptoms of hypersensitivity to pain.

[0008] 1.3 Psychological factors

[0009] Psychological factors, including anxiety and depression, have a great impact on digestive system diseases. According to most clinical studies, more than half of patients with functional dyspepsia have mental disorders such as anxiety. Ma G et al. found that cold water stress can cause changes in dyspepsia symptoms. When the central nervous system is stimulated in various ways, it will cause gastrointestinal dysfunction at various levels.

[0010] 1.4 Helicobacter pylori infection

[0011] Many studies have shown that Hp-related gastritis caused by Helicobacter pylori infection can lead to stomach discomfort. Therefore, the symptoms of functional dyspepsia can be improved by controlling inflammation and controlling Hp infection. Hp positivity can cause epigastric discomfort from abnormal gastric acid secretion, persistent inflammation of the gastric mucosa and duodenal mucosa, etc. Lan Ling et al. found in clinical studies that after anti-Hp treatment, the improvement rate of abdominal pain in patients with functional dyspepsia reached 77.2%, and the improvement rate of burning sensation was as high as 82%, which indirectly reflects that the treatment of Hp is very effective in improving the symptoms of patients with Hp-related functional dyspepsia.

[0012] 1.5 Dysfunction of the brain-gut axis

[0013] The enteric nervous system transmits gastrointestinal discomfort to the central nervous system, which then integrates the information and transmits it to the enteric nervous system through the nervous system. This two-way interaction is called brain-gut interaction. Liu started from the anatomical aspect and verified that psychological factors lead to gastrointestinal discomfort through the brain-gut axis, showing that functional dyspepsia has a clear relationship with anxiety.

[0014] 1.6 Low-grade inflammation of the duodenal mucosa

[0015] Most current research results show that the main pathophysiological basis of functional dyspepsia is gastric motility disorder and visceral sensitivity. Gastric motility disorder and increased visceral sensitivity are caused by low-grade inflammation of the duodenum. Low-grade inflammation may be caused by gastrointestinal infection, and anxiety can also increase the occurrence of gastrointestinal diseases.

[0016] The onset of functional dyspepsia is related to multiple factors, and the treatment is mainly symptomatic, which is mainly divided into the following three aspects: general treatment, drug treatment and psychotherapy.

[0017] General treatment: Help patients understand their condition, improve their lifestyle and eating habits, eat small meals frequently, reduce fat intake, avoid long-term or large amounts of tobacco and alcohol, remind them to pay attention to their daily routine, avoid excessive fatigue, and try to reduce the tension that induces patients.

[0018] Drug treatment: ① Gastrointestinal motility drugs: Many patients with functional dyspepsia have symptoms of abnormal gastrointestinal regulation, so gastrointestinal motility drugs are the first choice for patients with functional dyspepsia. Common drugs include mosapride, domperidone, metoclopramide tablets, etc. Etsushi Kawamura found that cisapride increases gastrointestinal motility and relieves digestive symptoms by increasing 5-hydroxytryptamine receptors. Mosapride has fewer adverse reactions than cisapride, accelerates gastric motility, and relieves gastroparesis symptoms. Li Wengang found in a trial comparing mosapride and domperidone in the treatment of functional dyspepsia that compared with domperidone, mosapride has better clinical efficacy than domperidone and can significantly improve patient symptoms. ② Acid suppressants: Proton pump inhibitors (PPI) are drugs with good efficacy in treating acid-related diseases. Commonly used drugs include pantoprazole, omeprazole, etc. A meta-analysis showed that PPIs are effective for patients with reflux and ulcerative functional dyspepsia. ③ Central nervous system modulators: Studies have shown that social and psychological factors induce the occurrence of functional dyspepsia through brain-gut axis regulation, so many guidelines use antipsychotic drugs as alternative treatment options for PPIs and prokinetic drugs. For example, anti-anxiety drugs such as amitriptyline and mirtazapine. Studies have shown that compared with the control group, mirtazapine can significantly improve the early satiety and anxiety state of patients with functional dyspepsia and anxiety, and improve the quality of life. ④ Helicobacter pylori eradication treatment: Helicobacter pylori (Hp) infection is the main cause of gastric diseases. The Kyoto Global Consensus Report believes that all Hp patients should receive treatment. Zhang Juan found in the study that after taking quadruple drugs for one month, Hp was eliminated in patients with functional dyspepsia infected with Hp, thereby relieving the patient's sense of fullness, significantly increasing gastric motility, and having a significant effect. ⑤ Other drug treatments: Compound digestive enzyme preparations are often used as adjuvant therapy in the treatment of patients with functional dyspepsia. Probiotics can also be used to improve the symptoms of patients with functional dyspepsia. Wauters et al. randomly divided patients into groups and compared treatments. The results showed that the clinical symptom scores of patients with functional dyspepsia who used probiotic capsules were significantly reduced, while there was no significant change in the control group. The study showed that probiotics have a relieving effect on the improvement of symptoms in patients with functional dyspepsia. However, this type of research is still in its early stages and requires a lot of research to confirm.

[0019] Psychological treatment: Many patients with functional dyspepsia are accompanied by anxiety, so psychological treatment is particularly important. If basic treatment is ineffective, psychological treatment is generally used. There are many ways to treat patients with severe psychological disorders: drug therapy, behavioral therapy, cognitive therapy and psychological intervention, which can effectively relieve patients' symptoms and significantly improve their quality of life.

[0020] Modern medicine believes that anxiety is characterized by widespread, persistent anxiety or recurrent panic attacks, often accompanied by motor tension and autonomic nervous system symptoms. Clinically, most anxiety patients have chronic anxiety disorders, characterized by excessive worry, tension, and anxiety, and accompanied by symptoms of autonomic nervous system dysfunction such as dry mouth, palpitations, and sweating. The course of the disease is mostly more than 6 months. Clinically, patients show excessive worry about trivial matters in life, which leads to a damaged mood, which can induce severe gastrointestinal discomfort and motor anxiety, and gradually affect the quality of life of patients.

[0021] In modern medicine, the causes of anxiety include genetic factors and social and psychological factors.

[0022] Genetic factors: Epidemiological studies have shown that the onset of anxiety is closely related to family genetic factors. Cui Xin pointed out through research that anxiety has a genetic effect, and the inheritance mode is closely related to chromosomal recessive inheritance.

[0023] Social and psychological factors: Anxiety patients have more social and psychological stress disorders than healthy people, and are more likely to develop diseases due to stimulation from trivial matters in life. Social events can easily lead to anxiety. Wang Yi and others conducted an online questionnaire survey of nearly 5,000 citizens in 31 provinces and autonomous regions. The results showed that the anxiety rate was as high as 62.9%, indicating that the occurrence of social events has a great impact on the physical and mental health of residents.

[0024] At present, the pathogenesis of anxiety is still unclear. Changes in the concentration of brain neurotransmitters can make individuals more anxious. When the concentration of monoamine neurotransmitters in the synaptic cleft is abnormal, the individual will also experience anxiety. The stress response will stimulate changes in the human endocrine system, so it is also an important factor leading to anxiety. Meng Junqin found that the plasma cortisol of patients with anxiety disorders was significantly increased, leading to abnormal activation of the thyroid axis. Studies have shown that clinically anxious patients are often accompanied by immune dysfunction, and the degree of anxiety in patients is positively correlated with immune dysfunction.

[0025] Modern medical treatments for anxiety include both drug therapy and non-drug therapy.

[0026] Drug treatment: At present, there is no particularly standardized treatment in clinical practice. The relatively recognized method is drugs that act on the nervous system. ① Targeting 5-hydroxytryptamine receptors. As the first choice of anxiety drugs, the most commonly used are selective serotonin reuptake inhibitors, which include sertraline, fluvoxamine, etc. in clinical practice. Of course, they can also cause gastrointestinal dysfunction, insomnia and other side effects. ② γ-aminobutyric acid receptor agonists. γ-aminobutyric acid receptor agonists are divided into benzodiazepines and non-benzodiazepines. Benzodiazepines have good sedative and sleep-inducing effects, and have good anti-anxiety effects. They are widely used in clinical practice, mainly including diazepam, lorazepam, estazolam, etc. Non-benzodiazepine drugs include barbiturates and meprobamate, etc. Wang Zhimin proposed that long-term use of benzodiazepines can effectively improve the sleep quality of anxious patients, but the drug dependence is strong and patients are prone to addiction.

[0027] Non-drug treatment: Since drug treatment has side effects such as gastrointestinal dysfunction, insomnia, and strong dependence, anxiety patients are more receptive to non-drug treatment, which has relatively few side effects and is safer. Non-drug treatments include behavioral cognitive therapy, acceptance and commitment therapy, Morita therapy and other psychotherapy, music therapy, and physical therapy. ① Psychological therapy mainly relieves anxiety symptoms by placing patients in a relaxed environment through psychological counseling. Whether modern or traditional, it is a treatment method with high recognition worldwide. Studies have shown that behavioral cognitive therapy can effectively treat adolescent anxiety and reduce the recurrence rate. It is an effective treatment method. ② In addition to psychotherapy, there is also music therapy, which can eliminate anxiety by experiencing music. Studies have shown that music therapy can significantly reduce the release of hormones in the hypothalamus of rats, inhibit overexcitement in rats, and exert anti-anxiety effects. ③ Physical therapy, including repeated transcranial direct current stimulation, etc. NASIRIF et al. have confirmed through research that transcranial direct current stimulation is effective in treating anxiety.

[0028] There is a complex relationship between functional dyspepsia and anxiety. Functional dyspepsia refers to digestive discomfort that occurs in the absence of obvious organic lesions, such as abdominal pain, bloating, indigestion and other symptoms. Anxiety is an emotional state that is often accompanied by tension, uneasiness and worry. Its diagnosis is mainly based on comprehensive clinical evaluation, application of diagnostic criteria and exclusion of other diseases that may cause anxiety symptoms.

[0029] The digestive system is a part controlled by the central nervous system, gastrointestinal system and autonomic nervous system. It has the functions of perception and movement. As the function of the digestive system changes, adrenaline changes accordingly, and the emotional state is easily changed. It is called the second brain of the human body. Functional dyspepsia is mainly manifested as chronic persistent or recurrent upper abdominal pain or discomfort, postprandial fullness, belching, early satiety, etc., which can easily affect the patient's quality of life. Therefore, patients with functional dyspepsia are often accompanied by symptoms such as anxiety and insomnia.

[0030] Current research has found that about 60% of patients with functional dyspepsia have anxiety. There is a close connection between the digestive system and the emotional center, which is also called the gut-brain axis. Anxiety can send signals to the digestive system through this axis, affecting the movement and secretion of the gastrointestinal tract, thereby causing symptoms of dyspepsia. Conversely, the discomfort of dyspepsia can also be transmitted to the brain through the gut-brain axis, aggravating the anxiety state. This proves that there are two-way effects, common neuromodulators, common pathogenesis, and so on between the two. Specifically, first, functional dyspepsia is a chronic disease. Although it will not endanger the patient's life, long-term functional dyspepsia symptoms, such as fullness in the stomach, acid reflux, and heartburn, can cause patients to easily develop an anxious state. When the patient is in an anxious state, the body releases stress hormones such as adrenaline and cortisol, which may affect the function of the digestive system and cause the symptoms related to functional dyspepsia to worsen. The aggravated symptoms can send signals to the brain through neural pathways, aggravating the anxiety state in reverse. The two-way effects form a vicious cycle and aggravate the condition. In addition, studies have found that the two have common pathogenesis, and anxiety and indigestion may have common genetic and biological basis, such as abnormalities of neurotransmitters or disorders of neuroregulatory systems, stress, lifestyle, eating habits, etc. These factors may lead to the co-occurrence of anxiety and indigestion.

[0031] In recent years, society has paid more and more attention to the impact of psychological factors such as anxiety on gastrointestinal symptoms. Studies have shown that emotional stress can easily stimulate inflammatory factors, causing gastric mucosal inflammation, or aggravating inflammation. Experiments have also verified that anxiety, as a serious emotional disorder, can aggravate damage to the gastrointestinal mucosa of mice. Liver depression caused by anxiety can easily damage the spleen and stomach, which is a key link in the development of gastric disease. Therefore, functional dyspepsia and anxiety promote each other. There is currently no specific drug for functional dyspepsia with anxiety in clinical practice, and most of them are symptomatic treatment and anti-anxiety.

[0032] In summary, there is an inseparable relationship between functional dyspepsia and anxiety, and the two influence and interact with each other. Therefore, in the treatment process, in addition to treating digestive system symptoms, it is also necessary to pay attention to the patient's mental health and adopt comprehensive treatment measures, such as psychotherapy, stress management, dietary adjustment, etc., to comprehensively promote the patient's recovery.

[0033] Traditional Chinese medicine's understanding of the name of functional dyspepsia: The Western medical name of functional dyspepsia has no clear record in ancient Chinese medical books and does not fall into the category of disease names in traditional Chinese medicine. Based on the symptoms of functional dyspepsia such as epigastric fullness, flank pain, belching and acid reflux, it can be classified into the category of "fullness" and "epigastric pain" in traditional Chinese medicine.

[0034] The main clinical symptoms of fullness and distension are fullness and distension under the heart, which is invisible to touch, soft to press, and painless to pressure. According to the location of the disease, it can be divided into chest fullness and subcardiac fullness. The Yellow Emperor's Classic of Internal Medicine first recorded "fullness and distension", and the Plain Questions: Five Constant Politics Theory pointed out that "in the period of preparation and transformation...the disease is fullness and distension". Zhang Zhongjing proposed in Treatise on Febrile Diseases: "If there is only fullness but no pain, this is fullness and distension, and Chaihu is not suitable for it. Banxia Xiexin Decoction is the main treatment." He pioneered the Xiexin Decoction treatment method and provided ideas for future doctors.

[0035] The main clinical symptom of epigastric pain is pain in the epigastric region. The Yellow Emperor's Classic of Internal Medicine first recorded "epigastric pain", and the Lingshu: Evil Qi and Organ Disease Forms pointed out that "people with stomach disease have abdominal pain and pain in the abdomen". In the Ming and Qing Dynasties, the difference between heart pain and stomach pain was further pointed out. The Standard of Diagnosis and Treatment said: "Someone asked Danxi if the pain he mentioned was the pain in the stomach? He said: The heart and stomach are each an organ, and their symptoms are not painful. Because the pain in the stomach is under the heart, it is called pain in the heart. Does it mean that the pain in the stomach is heart pain?" This laid the foundation for the differentiation and treatment of stomach pain in later generations.

[0036] TCM's understanding of the name of anxiety: Anxiety, also known as anxiety disorder, is a common psychological disorder with repeated attacks, persistent low mood and emotional anxiety as the main symptoms. Anxiety means wanting something but not getting it; worry means thinking too much. Anxiety can be classified as "visceral agitation" and "depression" in TCM. The main pathogenesis is weak viscera and unfavorable Qi. The main syndromes include deficiency of both heart and spleen, and liver depression and spleen deficiency. Studies have shown that the spleen and stomach are correlated with anxiety in TCM syndrome differentiation and treatment. Fu Lihe et al. found that the anxiety scale scores of patients with functional dyspepsia of spleen deficiency and qi stagnation were higher than those of patients with spleen deficiency and dampness obstruction.

[0037] Traditional Chinese medicine's understanding of the etiology and pathogenesis of functional dyspepsia with anxiety:

[0038] 1. Feeling of external evil

[0039] The "Golden Chamber" states: "... if a woman has pain around the navel, there must be wind and cold... the qi must rush, if it does not rush, there will be a fullness under the heart." Therefore, after being affected by external evil, the surface evil enters the interior, or it is mistakenly injured in the middle, the evil qi enters the interior and gathers in the stomach, blocking the qi mechanism and causing dysfunction of ascending and descending. In the early stage, it is mostly caused by the invasion of external evil into the interior, which leads to dysfunction of the spleen and stomach transportation and ascending and descending, the clear yang does not rise, the turbid yin does not descend, and the qi mechanism of the middle jiao is blocked. The six evils invade the gastrointestinal tract, the meridians have no way to transport qi and blood, the gastrointestinal function is damaged, and various gastrointestinal diseases occur.

[0040] 2. Diet for internal injuries

[0041] "Suwen·Wuchang Zhengdalun" says: "Eating and drinking are also important, and they should not be excessive. Excessive intake will damage the spleen and stomach's normal function." From this, we can know that improper diet can directly affect the normal function of the spleen and stomach and cause this disease. Overeating, or eating too much fatty and sweet food, or excessive drinking, may damage the middle yang, damage the stomach yin, block phlegm and dampness, and cause food stagnation, which will cause the spleen and stomach to rise and fall and cause this disease. Not only that, worrying and thinking hurt the spleen. The spleen plays an important role in regulating emotions. If the disease lasts for a long time, emotions will be disordered and gastrointestinal function will be damaged.

[0042] 3. Emotional disorders

[0043] Among the emotional factors of functional dyspepsia, anger and worry have the most significant effects. The Zhengzhi Huibu states that "violent anger hurts the liver, and qi reversal causes fullness". Therefore, when emotions are not fulfilled, the liver fails to release, liver qi stagnates, and liver qi goes up against the spleen and attacks the stomach, causing spleen and stomach dysfunction. Or worry hurts the spleen, spleen qi is damaged and transportation is unfavorable, stomach and spleen are out of harmony, and qi is not smooth, leading to this disease. Therefore, liver qi stagnation can easily lead to liver and stomach disharmony, causing this disease.

[0044] In short, "Lingshu·Zangfu Xieqi Bingxing" believes that gastrointestinal diseases often have symptoms such as abdominal distension and flank pain. Functional dyspepsia is basically located in the stomach and is closely related to the liver and spleen. The basic pathogenesis of this disease is the unfavorable qi movement in the middle jiao and the dysfunction of the spleen and stomach in ascending and descending. "Jingyue Quanshu·Piman" proposes that "Pi means that the stagnation is blocked and cannot be opened; Man means that the bloating is full and cannot move", and proposes that there is a distinction between deficiency and excess. The excess is the internal obstruction of the evil, and the deficiency is the weakness of the spleen and stomach. The deficiency and excess are mixed and both exist. Because the evil is related to the damage of the spleen and stomach and the dysfunction of ascending and descending. Clinically, it is believed that the syndrome differentiation and treatment of this disease should be in line with the idea of ​​holistic view. Patients with liver-stomach disharmony have symptoms of epigastric distension, belching, dry mouth and bitter taste, which are easily induced or aggravated by emotional reasons. The main treatment is to soothe the liver and relieve depression, and harmonize the stomach and reduce adverse reactions.

[0045] Modern doctors also have many unique insights into the etiology and pathogenesis of functional dyspepsia. They draw experience from various ancient medical books and explore the etiology and pathogenesis in more depth. Yu Bin pointed out that functional dyspepsia is located in the stomach and is related to the liver and spleen. The central link of the disease is liver depression and spleen deficiency. Yang Xiaojun pointed out that most female patients with functional dyspepsia are related to liver blood deficiency and liver qi stagnation. The pathogenesis is liver qi stagnation and the spleen and stomach are weak. Therefore, the treatment is mainly to soothe the liver, strengthen the spleen and harmonize the stomach. Gan Chun believes that the causes of functional dyspepsia include external pathogens, food stagnation, and emotional injury. The pathogenesis is mainly spleen deficiency and qi stagnation. The syndrome differentiation and treatment take into account the liver and stomach, and intervene in the relationship between abnormal gastric function and emotions from many aspects.

[0046] According to the 2017 consensus on the diagnosis and treatment of functional dyspepsia using integrated Chinese and Western medicine proposed by the Digestive System Diseases Professional Committee of the Chinese Association of Integrated Traditional Chinese and Western Medicine, functional dyspepsia is divided into the following five different syndromes: spleen deficiency and qi stagnation syndrome, liver-stomach disharmony syndrome, spleen and stomach damp-heat syndrome, spleen and stomach deficiency and cold syndrome, and mixed cold and heat syndrome.

[0047] At present, according to research, the treatment of functional dyspepsia is divided into 5 corresponding syndromes: Spleen deficiency and qi stagnation syndrome, the prescription is Xiangsha Liujunzi Decoction with modifications to strengthen the spleen and stomach, regulate qi and relieve bloating. Qin Huatuo randomly divided 80 patients with spleen deficiency and qi stagnation functional dyspepsia into a study group and a control group. The study group was treated with Houpo Shengjiang Banxia Gancao Renshen Decoction, and the control group was given oral Yigongsan. The results showed that the total effective rate of the study group was 90.0% and the recurrence rate was 10.0%, while the total effective rate of the control group was 85.0% and the recurrence rate was 27.5%, indicating that the clinical effect of Houpo Shengjiang Banxia Gancao Renshen Decoction on patients with spleen deficiency and qi stagnation functional dyspepsia is significant, which can significantly improve the clinical symptoms of functional dyspepsia and reduce the recurrence rate of functional dyspepsia. For liver and stomach disharmony syndrome, the prescription is Chaihu Shugan San with modifications to regulate qi and relieve depression, regulate the stomach and reduce adverse reactions. Wang Chong randomly divided the patients into a treatment group and a control group with 38 cases in each group. The treatment group was treated with Chaihu Shugan San, and the control group was treated with oral Delexin. The total effective rate of the treatment group after treatment was 91.34%, which was higher than the total effective rate of the control group (78.25%) (P<0.05), and the improvement of the Hamilton Depression Rating Scale score in the treatment group was better than that in the control group (P<0.05), indicating that Chaihu Shugan San has an improving effect on anxiety. For spleen and stomach damp-heat syndrome, Lian Pu Yin plus or minus prescriptions are selected to clear away heat and dampness, regulate qi and harmonize the stomach. Xu Jing et al. explored the mechanism of Lian Pu Yin in regulating gastric motility in rats with functional dyspepsia. The 8-day-old SD suckling rats were randomly divided into a normal group, a model group, and a Lian Pu Yin group. Compared with the model group, after intervention with Lian Pu Yin, the responsiveness of gastric antral smooth muscle to acetylcholine and 5-hydroxytryptamine receptors was improved, its contraction activity was enhanced, gastric emptying was promoted, and the effect of promoting gastric motility was played. This indicates that Lian Pu Yin has a relieving effect on patients with functional dyspepsia with spleen deficiency and damp-heat syndrome. For the syndrome of spleen and stomach deficiency and cold, the prescription is Huangqi Jianzhong Decoction with modifications to strengthen the spleen and stomach, warm the middle and dispel the cold. Liu Changyun et al. conducted a study and found that the treatment group was treated with Huangqi Jianzhong Decoction with modifications, and the control group was treated with Western medicine. The effective rate of the treatment group after treatment was as high as 97.2%, while that of the control group was only 78.7% (P < 0.05), indicating that Huangqi Jianzhong Decoction has a significant effect on functional dyspepsia caused by spleen and stomach deficiency and cold. For the syndrome of mixed cold and heat, the prescription is Banxia Xiexin Decoction with modifications to open the spleen and stomach with pungent and bitter herbs, and to harmonize the stomach and eliminate bloating. Li Sai summarized 30 research reports on the treatment of functional dyspepsia with Banxia Xiexin and concluded that Banxia Xiexin Decoction has a significant effect in promoting gastrointestinal motility and improving the quality of life of patients, and the overall clinical cure rate is higher than that of conventional Western medicine treatment.

[0048] Traditional Chinese medicine prescriptions have been around for hundreds of years and still play an important role in clinical practice. Yi Zhizhong studied the effect of Xiao Chaihu Decoction on the anxiety and clinical symptoms of patients with functional dyspepsia. The results showed that Xiao Chaihu Decoction not only relieved clinical symptoms, but also greatly improved the anxiety of patients and improved the quality of life. Compared with the Western medicine treatment group, it had a significant effect. Wu Jintao divided patients with liver depression and spleen deficiency type functional dyspepsia into a Chinese medicine treatment group and a Western medicine control group. The Chinese medicine treatment group was treated with Chaishao Liujunzi Decoction combined with Banxia Xiexin Decoction, and the Western medicine control group was treated with conventional Western medicine. After treatment, it was found that the effective rate of Chinese medicine was much higher than that of the Western medicine group, especially in improving fullness and anxiety. Zhang Hailan et al. summarized Professor Xie Jingri's clinical treatment method of restoring the spleen and strengthening movement, and used ancient prescriptions such as Sijunzi Decoction and Shenling Baizhu San to treat postprandial discomfort syndrome, which had a very important impact on clinical treatment.

[0049] In the process of the development of modern Chinese medicine, modern doctors have created their own unique prescriptions and treatments based on classic prescriptions and medicines, combined with clinical practice, and continuously explored and created them. They have been used in clinical practice and found that the efficacy is very good and the safety is better. Li Hongwei observed the clinical efficacy of the treatment of postprandial discomfort syndrome with the prescription Pi Han Shu Granules prepared by the applicant of the present invention. After comparing the treatment of Chinese and Western medicines in groups, it was found that the Chinese medicine treatment group had a higher efficacy than the Western medicine group, a better TCM syndrome score, and a more significant clinical efficacy. The famous old Chinese medicine doctor Zhou Laixing is good at using medicine and food to treat functional dyspepsia of spleen and stomach weakness or spleen deficiency and qi stagnation type. He prepared "Zhou's Jianpi Yangwei Powder" to treat 150 patients with functional dyspepsia. The results showed that the group used alone or in combination with Western medicine had a higher efficacy than the control group of pure Western medicine (Mosapride) in alleviating the symptoms of patients with functional dyspepsia and improving the quality of life of patients with functional dyspepsia.

[0050] The Suwen Zhizhen Yaoda Lun believes that "internal treatment is internal treatment, and external treatment is external treatment." External treatment is obviously earlier than the development of internal treatment. All methods that use various means on the outside of the body, including plastering, compressing, acupuncture, moxibustion, soaking, fumigation, rubbing, massage, and guidance to relieve diseases are external treatment. ① Acupuncture treatment: Studies have found that acupoints selected from the foot-sun bladder meridian and the foot-yangming stomach meridian are the most effective in treating functional dyspepsia. The improvement of patients' gastrointestinal function is also more obvious. Ye Kaisheng, Chen Mingxian, etc. evaluated the efficacy of transcutaneous acupoint electrical stimulation in the treatment of functional dyspepsia by using the TCM syndrome scale and found that the selected Taichong, Liangmen, Zusanli, etc. are suitable for the treatment of functional dyspepsia liver qi offending the stomach syndrome, and can effectively improve the TCM syndrome of functional dyspepsia liver qi offending the stomach syndrome. ② Acupoint application: Acupoint application therapy can dilate blood vessels, accelerate blood circulation, and play a variety of therapeutic effects such as swelling and pain relief, hemostasis and muscle regeneration. Xie Hongmei et al. conducted a Meta-analysis and found that the total effective rate and cure rate of the Chinese medicine acupoint application therapy group were higher than those of the conventional Western medicine treatment group. Clinically proven, acupoint application can effectively improve symptoms such as indigestion and improve life treatment. ③ Massage therapy: It uses a variety of techniques such as pressing, kneading, and rolling to act on the body surface and skin surface, which has the effects of regulating tendons and veins, unblocking meridians, etc. Zhou Yanzhang et al. summarized that the massage techniques for functional indigestion in recent years mainly include spinal manipulation, abdominal manipulation, and comprehensive manipulation.

[0051] Xie Mingjun used a randomized controlled method to divide patients with functional dyspepsia into a combined Chinese and Western medicine treatment group and a simple Western medicine control group. The combined Chinese and Western medicine treatment group was treated with Chaizhi Pinggan Decoction combined with metoclopramide, and the simple Western medicine group was treated with conventional Western medicine. After treatment, it was found that the symptom improvement of patients in the combined Chinese and Western medicine treatment group was better than that of the simple Western medicine group. Xia Mingwei used Banxia Xiexin Decoction combined with Mosapride Tablets and the control group with simple Mosapride Tablets to treat functional dyspepsia and found that the effect of combined Chinese and Western medicine in the treatment of functional dyspepsia was better than that of simple Western medicine.

[0052] The applicant of the present invention, Professor Chen Mingxian, found that the number of patients with functional dyspepsia accompanied by anxiety is increasing in the clinical diagnosis and treatment of spleen and stomach diseases. He found that most patients with functional dyspepsia accompanied by anxiety are related to diet and emotions during the clinical diagnosis and treatment process. He believed that the basic pathogenesis of the disease is liver and stomach qi disorder. The relationship between the liver, spleen and stomach is extremely close. The spleen and stomach qi disorder leads to liver qi stagnation; the liver fails to be smooth and the qi is not well discharged, which affects the stomach. Therefore, patients with liver and stomach diseases are often seen in clinical practice.

[0053] The basic location of this disease is the liver and stomach. It is often caused by invasion of external evil, unclean diet, emotional disorder, spleen and stomach qi deficiency, etc., which cause the middle jiao to fail to function and the spleen and stomach to fail to ascend and descend. From the perspective of the position of the internal organs, the spleen and stomach are mutually exterior and interior, and the liver and the spleen and stomach are closely related. The liver belongs to the wood element in the five elements, and it likes to be smooth and is responsible for dredging. It has the characteristics of dredging, regulating, and ascending. It has the function of regulating the human body's qi. Between the liver and stomach, wood and earth multiply, and liver qi is stagnant, which is easy to invade the stomach, resulting in qi obstruction and "stomach pain". "Medical Biography·Stomach Pain" says: "Wood qi is depressed, and it is too much, so the people's disease has the symptoms of soil defeating wood." If the liver qi is stagnant, the qi will be unfavorable and "fullness" is easy to occur.

[0054] The applicant of the present invention believes that the underlying deficiency and the superficial excess are the nature of the disease, which can also be manifested as a mixed syndrome of deficiency and excess. The disease is caused by abnormal ascending and descending of the spleen and stomach qi, which leads to liver qi stagnation; the liver fails to function properly, and the liver is depressed and qi stagnant, which is easy to attack the stomach. Therefore, during treatment, the deficiency and excess should be treated in the same way, and the cold and heat should be treated in the same way. Therefore, the basic treatment method is to soothe the liver and regulate qi, strengthen the spleen and harmonize the stomach, and take into account the deficiency and excess of the superficial and underlying diseases. Summary of the invention

[0055] The present invention aims at the deficiencies of the prior art and provides a Chinese medicine composition, preparation and application for treating functional dyspepsia with liver and stomach stagnation accompanied by anxiety. The Chinese medicine composition is a prescription for dispersing stagnation and harmonizing the stomach, which can effectively treat patients with functional dyspepsia with liver and stomach stagnation accompanied by anxiety, relieve clinical symptoms, improve quality of life, and improve anxiety and TCM syndromes.

[0056] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0057] A traditional Chinese medicine composition for treating functional dyspepsia accompanied by anxiety due to liver and stomach stagnation syndrome, wherein the active ingredients of the traditional Chinese medicine composition include the following raw materials in parts by weight: 5-15 parts of bupleurum, 5-15 parts of cyperus rotundus, 2-8-12 parts of fructus aurantii, 5-15 parts of dried tangerine peel, 5-15 parts of pinellia, 5-15 parts of citron, 5-15 parts of tangerine peel, 5-15 parts of radish seeds, 1-5 parts of liquorice, and 2-8-12 parts of dried ginger.

[0058] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition include the following raw materials in parts by weight: 8-12 parts of bupleurum, 8-12 parts of cyperus rotundus, 5-7 parts of fructus aurantii, 8-12 parts of tangerine peel, 8-12 parts of pinellia, 8-12 parts of citron, 8-12 parts of tangerine peel, 8-12 parts of radish seeds, 2-4 parts of liquorice, and 4-6 parts of dried ginger.

[0059] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition further include the following raw materials in parts by weight: 1-5 parts of agarwood, 5-15 parts of inula flower, and 5-15 parts of magnetite.

[0060] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition further include the following raw materials in parts by weight: 5-15 parts of Shenqu, 5-15 parts of Zhishi, and 5-15 parts of Areca catechu.

[0061] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition further include the following raw materials in parts by weight: 2-10 parts of Evodia rutaecarpa and 1-5 parts of Coptis chinensis.

[0062] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition further include the following raw materials in parts by weight: 2-10 parts of Corydalis yanhusuo.

[0063] Preferably, the Chinese medicine composition further comprises other Chinese medicine extracts and / or other raw materials.

[0064] Furthermore, the present invention also provides a Chinese medicine composition preparation for treating functional dyspepsia accompanied by anxiety due to liver and stomach stagnation syndrome, wherein the Chinese medicine composition preparation comprises the Chinese medicine composition and / or added pharmaceutical excipients, and / or added food additives.

[0065] Preferably, the Chinese medicine composition preparation is a tablet, chewable tablet, powder, granule, granule, capsule, paste, pill or liquid preparation.

[0066] Furthermore, the present invention also provides the use of the Chinese medicine composition or the Chinese medicine composition preparation in the preparation of a method for treating functional dyspepsia associated with anxiety due to liver and stomach stagnation syndrome.

[0067] Analysis of the formula of Sanzhi Hewei prescription:

[0068] Bupleurum is the main herb, cool in nature and bitter in taste, and enters the liver and gallbladder meridians. It has the effects of regulating liver qi and dispersing depression. According to Shennong's Herbal Classic, Bupleurum can remove gas in the stomach and intestines, dispel cold and heat evil qi, and remove food accumulation, achieving the effect of getting rid of the old and bringing in the new. As an important herb for soothing the liver and relieving depression, Bupleurum also has the effects of relieving exterior symptoms, reducing fever, and raising Yang qi.

[0069] Cyperus rotundus is a minister, with a mild nature, a pungent, slightly bitter, slightly sweet taste, and enters the lung, liver, spleen, and stomach meridians. The "Compendium of Materia Medica" points out that Cyperus rotundus must be used for those with blood and qi deficiency, and can enter the qi division, and qi can produce blood. Cyperus rotundus not only has the effect of soothing the liver and relieving depression, but also can regulate qi and relieve fullness, regulate menstruation and relieve pain. Li Gao pointed out that Cyperus rotundus can cure all qi.

[0070] Citrus aurantium is warm in nature, pungent, bitter and sour in taste, and enters the spleen, stomach, lung and large intestine meridians. The "Compendium of Materia Medica" points out that Citrus aurantium can dissipate phlegm stagnation in the chest, expel water and eliminate fullness. Citrus aurantium not only has the functions of promoting qi, regulating qi and drying dampness, but also can promote digestion, remove dampness and strengthen the spleen, and remove phlegm and relieve asthma. It is more effective for damp-heat in the spleen and stomach, and chest and abdominal fullness. Citrus aurantium itself is sour, which can increase gastric acid and promote digestion.

[0071] Tangerine peel is warm in nature, pungent and bitter in taste, and enters the spleen, stomach, and lung meridians. It has the effect of regulating qi and drying dampness. It can be used with tonics to nourish and with laxatives to purge. It is a good medicine for both nourishing and purging. "Bo Zhai Bian" points out that tangerine peel can relax the diaphragm, lower qi, and eliminate phlegm and fluid, and has special effects. Li Dongyuan believed that spleen and stomach diseases are mainly based on regulating qi, and tangerine peel ranks first. When it encounters tonic medicine, it can prevent it from stagnating the diaphragm and hindering the stomach.

[0072] Banxia is warm in nature and pungent in taste. It enters the spleen, stomach and lung meridians. According to Shennong's Herbal Classic, Banxia can treat cold and heat in typhoid fever, hardness under the heart, and lowering qi. Banxia is good at drying dampness, lowering adverse qi and stopping vomiting, and can also dispel cold and treat stomach qi rising. It is a good medicine for drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting, and eliminating lumps and dispersing knots.

[0073] Dried ginger is warm in nature and pungent in taste. It enters the spleen, stomach, kidney, heart and lung meridians and mainly enters the middle jiao of the spleen and stomach. It can be used with Pinellia ternata to eliminate the abdominal distension. Dried ginger has the effects of warming the middle and dispersing cold, restoring yang and unblocking meridians, and warming the lungs and eliminating phlegm.

[0074] Buddha's hand is warm in nature, pungent, bitter and sour in taste, and enters the liver, spleen and stomach meridians. If Buddha's hand is boiled and drunk with wine, it can cure cough with phlegm and qi. If Buddha's hand is boiled and taken as a decoction, it can cure heart pain. Buddha's hand has the effect of soothing the liver and stomach, regulating qi and relieving pain. It is effective for patients with liver depression and qi stagnation syndrome.

[0075] The radix tangerinae is slightly warm in nature, pungent in taste, and enters the spleen, stomach, large intestine, and small intestine meridians. The "Compendium of Materia Medica" points out that the radix tangerinae can treat edema, fullness and phlegm obstruction, etc. The main effects of the radix tangerinae are to relieve qi and relieve edema, and it has a good therapeutic effect on symptoms such as dampness blocking the qi mechanism and abdominal distension.

[0076] Radish seeds are cold in nature, bitter in taste, and belong to the lung, stomach, and large intestine meridians. "Gu Songyuan Medical Mirror" points out that radish seeds have the effects of lowering qi, treating phlegm and relieving asthma, and digesting food, eliminating bloating and relieving pain. Radish seeds are widely used in the field of traditional Chinese medicine, and are effective in treating food stagnation, chest tightness, abdominal distension, belching, and acid reflux.

[0077] Licorice is mild in nature and sweet in taste. It is good at entering the heart, lung, spleen and stomach meridians. It can nourish the spleen and replenish qi, relieve pain, and harmonize the medicinal properties. Roasting can enhance its nourishing qi. Licorice has the effect of relieving pain, and can relieve spasms of the stomach and internal organs, thereby relieving pain. The various drugs in the Sanzhi Hewei prescription are matched together to achieve the effect of soothing the liver, regulating qi and harmonizing the stomach.

[0078] Pharmacology and clinical application of single herbs in Sanzhi Hewei prescription:

[0079] Bupleurum: It has multiple pharmacological effects, mainly anti-anxiety, anti-inflammatory, immunomodulatory and other pharmacological effects. It is clinically used to treat Shaoyang syndrome, headache caused by liver qi stagnation, qi deficiency and sinking syndrome, bile reflux gastritis, etc. Li Xiangzhong et al. found that Bupleurum saponins can promote the peristalsis of isolated rabbit intestines, and drugs such as atropine have no effect on it.

[0080] Cyperus rotundus: It can act on the central nervous system, cardiovascular system, digestive system and other aspects, and has anti-anxiety, lipid-lowering, anti-inflammatory, anti-bacterial, anti-tumor and other effects. Zhang Yuefei et al. conducted a study on the effects of Cyperus rotundus volatile oil on gastric residual rate and small intestinal propulsion rate, and showed that Cyperus rotundus volatile oil has a great effect on improving the biological activity of gastrointestinal motility in rats and can promote the proliferation of small intestinal smooth muscle cells.

[0081] Citrus aurantium: It mainly has pharmacological effects such as regulating gastrointestinal function, lowering blood lipids and anti-tumor. Tan Shushu et al. studied the changing patterns of gastrointestinal hormones in rats and found that the flavonoid active substances contained in Citrus aurantium can make Citrus aurantium play a role in regulating gastrointestinal contraction.

[0082] Tangerine peel: It has multiple effects such as antibacterial, anti-oxidant, anti-inflammatory, digestive, expectorant, anti-tumor, liver protection, blood pressure lowering and neuroprotection. Fu Manqin et al. conducted a digestive study on rats using different polar parts of tangerine peel extract and found that the combination of hesperidin, nobiletin and tangeretin has a great effect on promoting the discharge of gastric juice and pepsin, improving the activity of pepsin and enhancing digestive function.

[0083] French Pinellia: It has antiemetic, analgesic, anti-ulcer, anti-diarrhea, anti-inflammatory, and inhibitory effects on the nervous system. Feng Yicong and others conducted an experimental study on total alkaloids of Pinellia on rats subjected to exercise oxidative stress, which showed that Pinellia has an antioxidant effect, reverses damage to the gastric mucosa, and reduces the occurrence of gastric ulcers.

[0084] Buddha's hand: It has a variety of pharmacological effects, such as anti-anxiety, cough and expectorant, anti-infection, hypoglycemic, anti-tumor, and immunity enhancement. Gao Hongyuan et al. found through research that the anti-anxiety mechanism of Buddha's hand volatile oil may be related to regulating serum CORT levels and hippocampal BDNF expression levels. The anti-anxiety effect of Buddha's hand volatile oil shows a significant dose-dependent relationship.

[0085] Cortex Phellodendri: It has gastrointestinal function and antioxidant effects. Li Mei et al.

[94] found that the decoction of Cortex Phellodendri can increase the average amplitude of the contraction wave of the circular muscle strips of the guinea pig gastric body, and it shows a significant dose-dependent relationship. It is speculated that it regulates gastrointestinal function by acting on the cholinergic M3 receptor.

[0086] Radish seeds: It has many functions such as relieving asthma, expectorant, antibacterial, antioxidant, lowering blood lipids, enhancing gastrointestinal motility, and improving the urinary system. Li Hailong et al. studied the contraction activity of guinea pig gastric antral circular muscle strips in vitro and found that radish seed decoction has a significant enhancing effect on the contraction activity of guinea pig gastric antral circular muscle strips in vitro.

[0087] The beneficial effects of the present invention are: 1) It can effectively treat patients with functional dyspepsia accompanied by anxiety due to liver and stomach stagnation, and can relieve clinical symptoms, such as better relieving patients' symptoms such as epigastric distension and belching, and improving the quality of life; 2) It can effectively treat epigastric distension, pain in the flanks, belching, and emotional frustration, and has obvious therapeutic effects; 3) It has good safety. Both groups of patients did not have adverse reactions such as diarrhea and allergies, and the three major routine tests of blood, urine and feces, and liver and kidney functions were all within normal ranges. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] Figure 1 Comparison chart of patient study completion status.

[0089] Figure 2 Figure 2 is a comparison of subjects’ gender (n).

[0090] Figure 3 This is a comparison chart of patient ages (years).

[0091] Figure 4 Comparison of patients' disease course (n) Figure.

[0092] Figure 5 This is a comparison chart of PAGI-SYM symptom scores before treatment.

[0093] Figure 6 This is a comparison chart of TCM syndrome scores before treatment (the control group and the treatment group from left to right are: fullness in the stomach, pain in the flanks, belching, dry and bitter mouth, heartburn and heartburn, and easy induction of emotional frustration).

[0094] Figure 7 This is a comparison chart of Hamilton Anxiety Scale scores before treatment.

[0095] Figure 8 This is a comparison chart of clinical efficacy among patients.

[0096] Figure 9-1 This is a comparison chart of PAGI-SYM symptom scores after treatment.

[0097] Figure 9-2 This is a comparison chart of the difference in PAGI-SYM symptom scores before and after treatment.

[0098] Figure 10-1 This is a comparison chart of the TCM syndrome scores of the two groups after treatment (the control group and the treatment group from left to right are: fullness in the stomach, pain in the flanks, belching, dry and bitter mouth, heartburn and acid reflux, and easy induction of emotional frustration).

[0099] Figure 10-2 This is a comparison chart of the difference in TCM syndrome scores between the two groups before and after treatment (the control group and the treatment group from left to right are: fullness in the stomach, pain in the flanks, belching, dry and bitter mouth, heartburn and acid reflux, and easy induction of emotional frustration).

[0100] Fig.11 This is a comparison chart of the overall efficacy of TCM syndromes in the two groups of patients.

[0101] Figure 12-1 This is a comparison chart of HAMA scores after treatment.

[0102] Figure 12-2 This is a comparison chart of the difference in HAMA scores between the two groups of patients before and after treatment.

[0103] Fig.13 This is a comparison chart of the recurrence rates of the two groups of subjects after treatment. DETAILED DESCRIPTION

[0104] The following is a clear and complete description of the technical solutions in the embodiments of the present invention in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0105] Example 1

[0106] Formula of Chinese medicine composition: 10g of bupleurum, 10g of cyperus rotundus, 6g of fructus aurantii, 10g of pinellia, 10g of tangerine peel, 10g of tangerine peel, 10g of citron, 10g of citron, 10g of radish seed, 3g of liquorice, and 5g of dried ginger.

[0107] Prepare a decoction for oral administration. Take one dose per day, twice a day, morning and evening, 200 ml each time after meals, and continue the Chinese medicine treatment for 4 weeks.

[0108] Research on the beneficial effects of the present invention:

[0109] 1. Research Materials

[0110] 1. Research subjects

[0111] The subjects of this study were all from the outpatient department of gastroenterology of the Affiliated Hospital of Jiangnan University. The case collection time was from January 2023 to January 2024. The subjects all met the Western medicine diagnostic criteria for functional dyspepsia and anxiety state, as well as the Chinese medicine syndrome criteria for liver and stomach stagnation.

[0112] 2. Diagnostic criteria and syndrome differentiation criteria

[0113] 2.1 Western medicine diagnostic criteria

[0114] 2.1.1 Diagnostic criteria for functional dyspepsia

[0115] According to the 2016 Rome IV Diagnostic Criteria for Functional Gastrointestinal Disorders: The diagnostic criteria for functional dyspepsia should include one or more of the following symptoms: ① Postprandial fullness and discomfort; ② Upper abdominal pain; ③ Early satiety; ④ Upper abdominal burning sensation, and there is no evidence of organic disease (including gastroscopy, etc.) that can explain the above symptoms. Symptoms must have occurred for at least 6 months before diagnosis, and the above criteria must have been met in the past 3 months.

[0116] 2.1.2 Diagnostic criteria for anxiety states

[0117] Anxiety is a state of repeated emotional experience of fear, nervousness, and anxiety without clear cause, object, or content, accompanied by physical symptoms such as motor restlessness and autonomic hyperactivity. Personality traits before illness, mental factors, and similar episodes in the family can all help with diagnosis.

[0118] 2.2 Standards for TCM Syndrome Differentiation

[0119] According to the Consensus on Diagnosis and Treatment of Functional Dyspepsia with Integrated Traditional Chinese and Western Medicine, patients with functional dyspepsia who met the criteria of liver and stomach stagnation were selected:

[0120] Main symptoms: ① fullness in the stomach; ② pain in the ribs;

[0121] Secondary symptoms: ① belching; ② dry mouth and bitter taste in the mouth; ③ heartburn and acid reflux; ④ emotional frustration is easily induced or aggravated;

[0122] Tongue and pulse: red tongue, white coating, stringy or thin pulse.

[0123] Syndrome type determination: meet 2 main symptoms and 2 secondary symptoms, or meet the first main symptom and 2 secondary symptoms. Tongue and pulse can be used as reference.

[0124] 3. Inclusion criteria

[0125] ① Patients who meet the diagnostic criteria of functional dyspepsia and anxiety in Western medicine and the diagnostic criteria of liver and stomach stagnation in traditional Chinese medicine;

[0126] ② Patients aged between 18 and 70 years old;

[0127] ③ Patients who have not taken any medication that may affect the results of this study in the past 3 months;

[0128] ④ Patients who have the ability to act independently and voluntarily participate in this study and voluntarily sign the informed consent form;

[0129] 4. Exclusion criteria

[0130] ① Those who do not meet the inclusion criteria;

[0131] ② Patients under 18 years old or over 70 years old;

[0132] ③ Patients with systemic organic diseases that affect drug evaluation;

[0133] ④ Patients with severe liver and kidney dysfunction, or with severe lesions of other systems, or with severe infectious diseases and mental illnesses;

[0134] ⑤ Patients with organic diseases related to the digestive tract, or patients with critical lesions or mental illness;

[0135] ⑥ Patients who are planning to become pregnant or are pregnant or breastfeeding during the study;

[0136] ⑦ Patients with a history of alcohol or drug abuse;

[0137] ⑧ Those who are allergic to the drugs used in the study, or those with allergic constitution;

[0138] ⑨ Currently participating in clinical research of other drugs.

[0139] 5. Elimination criteria

[0140] Those who have been included in the group but meet any of the following conditions should be excluded:

[0141] ① Patients who were misdiagnosed or misadmitted;

[0142] ② Patients who meet the exclusion criteria;

[0143] ③ Patients who fail to take medication as prescribed;

[0144] ④Patients without any test records.

[0145] 6. Shedding criteria

[0146] Patients who have been enrolled but have not completed the clinical study should be considered as dropped out if they meet any of the following conditions:

[0147] ① Patients who withdraw on their own due to various reasons;

[0148] ② Patients whose condition worsens;

[0149] ③Patients with poor compliance.

[0150] 7. Ethical requirements

[0151] All patients enrolled in the study were informed of the risks and benefits in advance and signed informed consent before enrollment.

[0152] 2. Research Methods

[0153] 1. Sample size estimation

[0154] Since this study is a clinical trial, the study plan is a randomized, parallel, controlled trial, so the required sample size calculation formula is as follows:

[0155]

[0156] According to the comparative diagnosis and treatment scheme of Chinese and Western medicine for functional dyspepsia in previous literature references, P1 is the treatment group with an effective rate of 94%, and P2 is the Western medicine control group with an effective rate of about 71%. According to the statistical sample size principle, α=0.05, β=80%, then Zα=1.96, Zβ=0.84, P is the mean of P1 and P2, q refers to the mean of 1-P1 and 1-P2, according to the sample size estimation formula, according to the requirements of the "Guidelines for Clinical Research of New Chinese Medicines", and the previous patient visits in our hospital, plus the expected maximum dropout number of 10%, the final calculation can be obtained that n1=n2=47 cases, so a total of at least 94 patients need to be included.

[0157] 2. Grouping scheme

[0158] In this study, 94 patients were randomly divided into treatment group and control group using random numbers generated by statistical software SPSS27.0, and finally 47 patients were included in the treatment group and the control group.

[0159] 3. Treatment options

[0160] The patients in the treatment group were treated with Sanzhi Hewei prescription with additions and subtractions. Sanzhi Hewei prescription consists of: 10g of Bupleurum, 10g of Cyperus, 6g of Citrus aurantium, 10g of Pinellia ternata, 10g of Citrus reticulata, 10g of Citrus grandis, 10g of Citrus citron, 10g of Radish Seed, 3g of Licorice, and 5g of Dry Ginger. In the clinical trial, the prescription was added or subtracted according to the specific condition and symptoms of the subjects. If the belching and nausea were severe, 3g of Agarwood, 10g of Inula, 10g of Hematite, etc. could be added to reduce adverse reactions and stop vomiting; if the appetite was poor and the food intake was poor, 10g of Shenqu, 10g of Citrus aurantium, and 10g of Areca could be added to help digestion and relieve stagnation; if the patient had noisy and acid regurgitation, 6g of Evodia rutaecarpa and 3g of Coptis chinensis could be added to clear the liver and purge fire; if the patient had stomachache, 6g of Corydalis could be added to relieve pain, etc. All the Chinese medicine pieces were purchased from the Chinese medicine pharmacy of the Affiliated Hospital of Jiangnan University, and all of them were qualified pieces after the drug inspection of Suzhou City.

[0161] Dosage: The Chinese medicine is taken once a day, divided into two doses in the morning and evening, 200 ml each time after meals. The course of treatment is 4 weeks, and follow-up is done 8 weeks after the end of the treatment.

[0162] Patients in the control group were given Mosapride Citrate Tablets (trade name: JC4 Anbili, product batch number: Y10000035918, manufacturer: Guangdong Annuo Pharmaceutical, specification: 5 mg / tablet, 36 tablets / box), dosage: 3 times a day, 1 tablet each time, before meals, for 4 weeks. Follow-up was performed 8 weeks after the end of the treatment.

[0163] The two groups of patients were informed that during the treatment period, they should eat a regular and light diet, avoid spicy, greasy, and cold foods, avoid overeating, exercise properly, ensure rest, and have a good mood. Other digestive drugs, gastrointestinal motility drugs, antidiarrheal drugs, etc. should not be taken, as such drugs will affect the results of this study, and other treatments should not be used to relieve symptoms. If any discomfort occurs during the treatment, go to the hospital immediately.

[0164] 4. Observation indicators and evaluation criteria

[0165] 4.1 General observation indicators

[0166] After enrollment, the patient's gender, age, disease course and other baseline conditions were recorded, and statistical analysis was performed to determine whether they affected the research results.

[0167] 4.2 Clinical efficacy observation indicators and evaluation criteria

[0168] According to the TCM syndrome efficacy evaluation criteria in the 2002 "Guidelines for Clinical Research of New Chinese Medicines (Trial)": Syndrome score reduction (%) = (total score before treatment - total score after treatment) / total score before treatment × 100%. The clinical efficacy scoring criteria are as follows:

[0169] ① Cured: symptoms and signs basically disappear, and the syndrome score reduction percentage is ≥ 95%;

[0170] ② Significantly effective: symptoms and signs are significantly improved, 70% ≤, and the percentage reduction of syndrome score is <95%;

[0171] ③Effective: symptoms and signs are improved, 30%≤symptom score reduction percentage<70%;

[0172] ④ Ineffective: There is no significant improvement in symptoms and signs, or they may even worsen, and the percentage reduction in symptom scores is less than 30%.

[0173] The obtained data were statistically processed to explore whether there were differences in the improvement of TCM symptoms between the two groups and draw conclusions.

[0174] 4.3 Clinical symptom observation index standards

[0175] This study scored once before and after treatment. The scoring criteria were based on the PAGI-SYM symptom scale for upper gastrointestinal diseases to score clinical symptom observation indicators. The scale includes 20 symptom items of functional dyspepsia, including 4 main symptoms and 16 secondary symptoms. Each item is assigned 0, 1, 2, and 3 points according to none, mild, moderate, and severe, respectively, and the total clinical symptom score is calculated. The clinical symptom scores of both groups of patients were measured before treatment, and the above-mentioned related indicators were retested after 4 weeks of treatment, and the scores before and after treatment were compared, and charts were made for statistical processing.

[0176] 4.4 TCM Syndrome Scale Indicator Standards

[0177] Each symptom in the TCM syndrome scale is divided into: none, mild, moderate, and severe according to the severity of the symptom. The scoring standards for the main symptoms are: 0, 2, 4, and 6 points, and the scoring standards for the secondary symptoms are: 0, 1, 2, and 3 points. Before treatment, both groups of patients were scored according to the TCM syndrome scale. After 4 weeks of treatment, the above-mentioned related indicators were retested, and the scores before and after treatment were compared. Charts were made and statistical processing was performed.

[0178] 4.5 Comparison criteria for overall efficacy of TCM

[0179] The efficacy of TCM syndrome before and after treatment was compared, and the nimodipine method was used for evaluation: syndrome score reduction (%) = (score before treatment - score after treatment) / score before treatment × 100%. The classification was based on the percentage reduction of syndrome scores before and after treatment, and the standards were as follows: a reduction percentage ≥ 90% was judged as cured; 60% ≤ a reduction percentage < 90% was judged as markedly effective; 30% ≤ a reduction percentage < 60% was judged as effective; and a reduction percentage < 30% was judged as ineffective. Total effective rate = (cured + markedly effective + effective) cases / total number of cases × 100%. Fisher's test was used to calculate the statistics for the obtained counting data to explore whether there was a difference in the improvement of TCM syndromes between the two groups and draw conclusions.

[0180] 4.6 Anxiety Scale Scoring Indicators and Evaluation Criteria

[0181] The Hamilton Anxiety Scale (HAMA) rating scale contains 14 items, all of which are scored on a 5-point scale, with 0, 1, 2, 3, and 4 points corresponding to no symptoms, mild symptoms, moderate symptoms, severe symptoms, and extremely severe symptoms, respectively. The total score is 56 points, and the higher the score, the more severe the anxiety state. A total score of ≥7 points is defined as the presence of anxiety symptoms, and <7 points is defined as the absence of anxiety symptoms.

[0182] 4.7 Relapse assessment and evaluation criteria

[0183] Patients who were effectively treated were followed up for clinical efficacy 8 weeks after the end of treatment. The symptom score at the time of follow-up was calculated and compared with that at the end of treatment to determine the recurrence index and recurrence rate. The calculation formula is as follows:

[0184] Recurrence index = (total score of follow-up patients - total score after treatment) / total score of follow-up patients × 100%;

[0185] Recurrence rate = number of recurrence cases / number of follow-up cases × 100%;

[0186] A recurrence index exceeding 30% was considered a recurrence, and the recurrence rate was calculated based on the number of recurrence cases.

[0187] 4.8 Safety Observation and Evaluation Criteria

[0188] Record the general physical examination items of the two groups of patients: blood pressure, respiration, heart rate, and heart rhythm. Record related examinations including the three routine examinations, liver and kidney function, and routine electrocardiogram examinations. Record the adverse reactions of the patients in the study and the subsequent corresponding measures, and analyze their correlation with the test drugs.

[0189] The evaluation criteria for safety observation were formulated in reference to the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines (Trial)":

[0190] ① Grade I: safe, no adverse reactions occur during treatment;

[0191] ② Grade II: relatively safe. If adverse reactions occur, no special treatment is required and subsequent medication can be given;

[0192] ③Level III: There are safety issues. Certain adverse reactions occur during the test. Subsequent tests can be carried out after appropriate treatment.

[0193] ④Grade IV: Severe adverse reactions occur and the clinical trial needs to be terminated.

[0194] 5. Statistical methods

[0195] SPSS27.0 statistical software was used to analyze the data. Count data were analyzed using t-test, measurement data were analyzed using chi-square test, intra-group comparisons were analyzed using paired t-test, and inter-group comparisons were analyzed using two-sample paired t-test. The results of continuous variable analysis were expressed as mean (x) ± standard deviation (s), and categorical variables were expressed as percentages. In this study, hypothesis tests were all bilateral, with α = 0.05. When P < 0.05, the results of the test were statistically significant. When P > 0.05, there was no statistical difference in the test results.

[0196] 2. Results

[0197] 1. Case completion status

[0198] A total of 94 patients were included in this study. The patients were randomly divided into a treatment group and a control group using a random number method, with 47 patients in each group. During the treatment period, one patient in the treatment group was excluded because he took Jianwei Xiaoshi oral liquid privately, which affected the observation results. One patient in the control group dropped out because he voluntarily terminated the experiment due to work transfer. Therefore, a total of 92 patients completed this study, with 46 patients in both the treatment group and the control group. The specific results are shown in Table 1 and Figure 1 As shown:

[0199] Table 1 Comparison of study completion status of patients (n)

[0200]

[0201] (II) Comparison of general data

[0202] 1. Gender comparison

[0203] There were 36 male patients and 56 female patients in this study, including 19 males and 27 females in the treatment group and 17 males and 29 females in the control group. The male-to-female ratio was 1:1.56. The chi-square test showed that there was no statistical difference in gender between the treatment group and the control group (P>0.05), and the baseline data were comparable. The specific results are shown in Table 2 and Figure 2 As shown:

[0204] Table 2 Comparison of patient gender (n)

[0205]

[0206] 2. Age comparison

[0207] Among the 92 patients who completed the study, the average age of the treatment group was 47.33±15.78 years old, and the average age of the control group was 48.63±15.05 years old. The ages of the two groups of patients were normally distributed. The chi-square test showed that there was no statistical difference in age between the treatment group and the control group (P>0.05), and the baseline data were comparable. The specific results are shown in Table 3 and Figure 3 As shown:

[0208] Table 3 Comparison of patients' age (years)

[0209]

[0210] 3. Comparison of disease course

[0211] Among the 92 patients finally included, the course of the disease was divided into three time periods: 6 to 12 months, 12 to 36 months, and >36 months. The shortest and longest courses of the disease in the two groups were 6 months and 45 months, respectively. According to statistics, the course of disease in both groups was mostly in the time period of 12 to 36 months, followed by 6 to 12 months and >36 months. The chi-square test showed that there was no statistical difference in the course of disease between the two groups (X 2 =0.452, P = 0.798 > 0.05), with comparable baseline data, can be compared, the specific results are shown in Table 4 and Figure 4 As shown:

[0212] Table 4 Comparison of patients' disease course (n)

[0213]

[0214] 4. Comparison of PAGI-SYM symptom scores between the two groups before treatment

[0215] The 92 patients finally included were statistically analyzed, and the PAGI-SYM symptom scores of the two groups of patients before treatment were compared using the t-test of the means of two paired samples. After testing, the PAGI-SYM symptom score data of the two groups before treatment met the normal distribution. The results showed that there was no statistical difference in the total PAGI-SYM symptom scores of the two groups of patients before treatment (P>0.05), and the baseline data were comparable. The specific results are shown in Table 5 and Figure 5 shown.

[0216] Table 5 Comparison of PAGI-SYM symptom scores before treatment

[0217]

[0218] 5. Comparison of TCM syndrome scores between the two groups before treatment

[0219] The individual and total scores of TCM syndromes of the 92 patients finally included before treatment were statistically analyzed. Independent sample t-test was used. Before treatment, there was no statistically significant difference in the individual and total scores of TCM syndromes between the two groups of patients (P>0.05), and the baseline data were comparable. The specific results are shown in Table 6 and Figure 6 shown.

[0220] Table 6 Comparison of TCM syndrome scores before treatment

[0221]

[0222] Note: The comparison of each TCM syndrome score before treatment was performed using t-test

[0223] 6. Comparison of Hamilton Anxiety Scores between the Two Groups Before Treatment

[0224] The Hamilton Anxiety Rating Scale was used to score the 92 patients included in the study. The HAMA scores of the treatment group and the control group before treatment were compared using an independent sample t-test. The results showed that there was no statistical difference in the HAMA scores of the two groups before treatment (P>0.05), and the baseline data were comparable. The specific results are shown in Table 7 and Figure 7 shown.

[0225] Table 7 Comparison of Hamilton anxiety scores between the two groups before treatment

[0226]

[0227] Note: The comparison of Hamilton anxiety scores before treatment was performed using t-test

[0228] 3. Comparison of efficacy

[0229] 1. Comparison of clinical efficacy

[0230] After treatment, 5 patients in the treatment group were cured, 12 were markedly effective, 27 were effective, and 2 were ineffective. The total effective rate of the treatment group was 95.65%; 1 patient in the control group was cured, 8 were markedly effective, 25 were effective, and 12 were ineffective. The total effective rate of the control group was 73.91%. The chi-square test showed that there was a difference in the clinical efficacy results between the two groups, and the difference was statistically significant (P < 0.05), indicating that the treatment group was significantly better than the control group in terms of clinical efficacy. The specific results are shown in Table 8 and Figure 8 shown.

[0231] Table 8 Comparison of clinical efficacy of patients

[0232]

[0233] Note: The clinical efficacy of the two groups of patients was compared using the chi-square test.

[0234] 2. Comparison of PAGI-SYM symptom scores between the two groups before and after treatment

[0235] After treatment, the PAGI-SYM symptom scores of both groups of patients were significantly lower than those before treatment (P < 0.05), and the PAGI-SYM symptom scores of patients in the treatment group decreased more significantly after treatment. The difference was statistically significant (P < 0.05), indicating that the symptoms of both groups of patients were improved after treatment, but the clinical symptoms of patients with functional dyspepsia in the treatment group were more significantly improved than those in the control group. The specific results are shown in Table 9 and Figure 9 (1-2).

[0236] Table 9 Comparison of PAGI-SYM symptom scores between the two groups before and after treatment

[0237]

[0238] Note: * indicates comparison between the two groups, P < 0.05; comparison of PAGI-SYM symptom scores before and after treatment between the two groups was performed using t-test

[0239] 3. Comparison of TCM syndrome scores before and after treatment

[0240] After treatment, the scores of each TCM symptom and the total score of the two groups of patients were significantly reduced compared with those before treatment (P < 0.05), and the scores of each TCM symptom and the total score of the functional dyspepsia patients in the treatment group decreased more significantly after treatment. The difference was statistically significant (P < 0.05), indicating that the treatment group can improve the main clinical symptoms of patients with functional dyspepsia better than the control group. The specific results are shown in Table 10 and Figure 10 (1-2).

[0241] Table 10 Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0242]

[0243]

[0244] Note: * indicates comparison between two groups, P < 0.05. The TCM syndrome scores and total scores of the two groups of patients before and after treatment were compared using t-test

[0245] 4. Comparison of the overall efficacy of TCM syndromes

[0246] After 4 weeks of treatment, the TCM syndrome efficacy of 3 patients in the treatment group was ineffective, 43 patients were effective, and the total effective rate was 93.49%. The TCM syndrome efficacy of 14 patients in the control group was ineffective, 32 patients were effective, and the total effective rate was 69.57%. After testing, there was a difference in the total efficacy of TCM syndrome between the two groups, and the difference was statistically significant (P < 0.05). The specific results are shown in Table 11 and Fig.11 shown.

[0247] Table 11 Comparison of the total efficacy of TCM syndromes in the two groups of patients after treatment

[0248]

[0249]

[0250] Note: The total efficacy of TCM syndromes in the two groups of patients before and after treatment was compared using t-test

[0251] 5. Comparison of anxiety scale scores before and after treatment

[0252] After treatment, the anxiety scale scores of the two groups of patients were significantly reduced compared with those before treatment (P < 0.05), and the Hamilton anxiety score of the patients with functional dyspepsia in the Chinese medicine treatment group decreased more significantly after treatment. After testing, the difference was statistically significant (P < 0.05), indicating that the anxiety symptoms of the two groups of patients were improved after treatment, but the Chinese medicine treatment group was more effective in improving the anxiety symptoms of patients with functional dyspepsia than the Western medicine control group. The specific results are shown in Table 12 and Figure 12 (1-2).

[0253] Table 12 Anxiety scale scores before and after treatment

[0254]

[0255] Note: The HAMA scores of the two groups of patients before and after treatment were compared using t-test

[0256] 6. Comparison of recurrence rates

[0257] Patients who were effectively treated were followed up for clinical efficacy 8 weeks after the end of treatment. Among them, 44 patients with functional dyspepsia and anxiety were effectively treated in the treatment group, 42 patients were followed up, and 3 relapses were found; 34 patients were effectively treated in the control group, 34 patients were followed up, and 9 relapses were found. There was no statistical difference in the relapse rate between the two comparisons (P = 0.068). The specific results are shown in Table 13 and Fig.13 shown.

[0258] Table 13 Comparison of recurrence rates between the two groups of patients

[0259]

[0260] Note: The recurrence rates of the two groups were compared using the chi-square test.

[0261] 7. Comparison of safety and adverse reactions

[0262] This study finally included 92 patients with functional dyspepsia and anxiety due to liver and stomach stagnation. During the intervention period, none of the patients had any discomfort symptoms, their vital signs were stable, no serious adverse reactions or aggravation of the disease occurred, and no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram before and after treatment. The safety of both groups was high, and no adverse reactions or adverse events occurred.

[0263] 3. Analysis of Research Results

[0264] 1. Analysis of case demographic data

[0265] A total of 94 patients with functional dyspepsia and anxiety were included in this study, and 92 patients completed the study. Among them, there were 35 males and 57 females. The number of females was more than that of males. It may be that women are more susceptible to anxiety due to external environmental factors, hormone levels, etc., and it is more common for female patients to have endocrine disorders and anxiety during menopausal syndrome. The main group of patients in the treatment group of this study was middle-aged people. It may be that people at this stage are under greater pressure, and they eat more greasy food and have irregular diets, which leads to gastrointestinal damage and gastrointestinal discomfort symptoms. In general, the samples of this study were all from the outpatient department of the Department of Gastroenterology of the Affiliated Hospital of Jiangnan University. There are certain limitations, and the sample size cannot represent the overall demographic characteristics, but it has certain reference and reference value.

[0266] 2. Comparative analysis of clinical efficacy

[0267] After treatment, the scores of the patients in this study were improved compared with those before treatment, and the difference in efficacy within the group was statistically significant (P < 0.05). After treatment, the total effective rate of the treatment group was 95.65%, and the total effective rate of the control group was 73.91%. After the chi-square test, the total effective rate of the treatment group was higher than that of the control group, and the difference in efficacy between the groups was statistically significant (P = 0.004). Mosapride citrate tablets are gastrointestinal prokinetic agents, which have the effect of promoting gastrointestinal function and motility. From the perspective of traditional Chinese medicine, drugs such as radish seeds and big belly peel have similar efficacy to mosapride citrate tablets. Sanzhi Hewei Fang adds important drugs for soothing liver and relieving depression and regulating qi on the basis of strengthening the spleen and stomach, so it can better relieve patients' symptoms such as epigastric distension and belching. Therefore, the comprehensive efficacy of Sanzhi Hewei Fang is better than that of the control group. This also confirms that traditional Chinese medicine has obvious advantages in treating functional dyspepsia with anxiety caused by liver and stomach stagnation syndrome.

[0268] 3. Comparative analysis of clinical symptom score (PAGI-SYM)

[0269] The PAGI-SYM symptom scores of the two groups of patients before treatment in this study were compared using the t-test of the means of two paired samples. After the test, the PAGI-SYM symptom scores of the two groups of patients met the normal distribution and variance homogeneity. The statistical results showed that there was no statistical difference in the total PAGI-SYM symptom scores of the two groups of patients before treatment (P>0.05), and the baseline data were comparable. After treatment, the total clinical symptom scores (PAGI-SYM) of the two groups were significantly reduced, especially the treatment group was significantly lower than the control group, and the difference was statistically significant (P<0.05). It can be seen that both treatment methods have an improvement effect on the symptoms of functional dyspepsia with anxiety, but the treatment group is significantly better than the control group. This shows that Sanzhi Hewei Fang has a significant effect on the treatment of functional dyspepsia and improving patients' symptoms.

[0270] 4. Comparative analysis of TCM syndrome scores

[0271] 4.1 Comparative analysis of total score of TCM syndromes

[0272] After treatment, the total score of TCM syndrome in both groups was lower than that before treatment (P<0.05), and the difference in the total score of TCM syndrome within the group was statistically significant (P<0.05). After treatment, the total effective rate of TCM syndrome in the treatment group was 93.49%, and the total effective rate of TCM syndrome in the control group was 69.57%. The total effective rate of TCM syndrome in the treatment group was significantly higher than that in the control group, and the difference in efficacy between the groups was statistically significant (P<0.05). This shows that both the treatment group and the control group have an improvement effect on TCM syndrome, and the effect of Sanzhi Hewei Fang is significantly better than that of Mosapride Citrate Tablets.

[0273] 4.2 Comparative analysis of individual scores of TCM syndromes

[0274] The statistical results showed that before treatment, the TCM syndrome scores of the two groups of patients included the main symptoms: fullness in the stomach and pain in the two flanks. Secondary symptoms: belching, dry mouth and bitter mouth, heartburn and acid reflux, and emotional frustration easily induced symptoms. After t test, P>0.05, indicating that there was no statistical significance and comparability. After treatment, the single score and total score of TCM syndrome in the two groups were compared within the group, including the main symptoms (fullness in the stomach and pain in the two flanks), secondary symptoms (belching, dry mouth and bitter mouth, heartburn and acid reflux, and emotional frustration easily induced) and other symptoms. All improved (P<0.05), but the treatment group was significantly better than the control group, and there was a statistical difference between the treatment group and the control group (P<0.05), indicating that TCM treatment has more advantages in the treatment of functional dyspepsia with anxiety due to liver and stomach stagnation syndrome. Judging from the difference, Sanzhi Hewei prescription has obvious therapeutic effect on the main symptoms (epigastric fullness and pain in the flanks) and secondary symptoms (belching and emotional frustration) (P < 0.05). It can be seen that Sanzhi Hewei prescription is more effective in improving the symptoms of epigastric fullness, pain in the flanks, emotional frustration and belching.

[0275] It can be seen that TCM syndrome differentiation and treatment of functional dyspepsia with anxiety has a good effect. Sanzhi Hewei Fang is a clinical practice prescription based on the spleen and stomach theory. The instructor believes that liver and stomach diseases should take into account both heat relief and fullness. The liver is strong and impatient, and the stomach likes moisture and hates dryness, so its disease is prone to dryness and heat. The liver is too much, or the qi is stagnant for a long time and turns into fire, the liver fire invades the stomach, the stomach loses harmony and descends, and the liver and stomach are stagnant. Therefore, clinically, patients often have symptoms such as fullness in the stomach, belching, flank pain, dry mouth and bitter mouth, heartburn and acid reflux, and emotional frustration. The tongue and pulse are often red, with thin yellow fur and stringy pulse. In treatment, the focus is on soothing the liver and relieving depression, regulating qi and harmonizing the stomach.

[0276] 5. Comparative analysis of Hamilton anxiety state scores

[0277] In this study, there was no statistical difference in HAMA scores between the two groups before treatment (P>0.05). After treatment, the HAMA scores of both groups were improved (P<0.05), and the score comparison between the two groups was also statistically significant (P<0.05). This shows that both the Chinese medicine treatment group and the Western medicine control group can improve the anxiety symptoms of patients, but the efficacy of anxiety symptoms in the Chinese medicine treatment group is better than that in the control group. This proves that the self-prepared Sanzhi Hewei prescription is significantly better than Mosapride Citrate Tablets in treating patients with functional dyspepsia and anxiety caused by liver and stomach stagnation, reflecting the accuracy of the treatment method of regulating the liver and stomach. Soothing the liver and regulating qi, strengthening the spleen and harmonizing the stomach, making the human body's qi run smoothly, alleviating the symptoms of fullness and improving the anxiety state of patients. This is also closely related to the anti-anxiety effects of drugs such as Bupleurum for soothing the liver and promoting gallbladder, Cyperus rotundus, Foshou for regulating qi and relieving depression, and Licorice for nourishing the spleen and replenishing qi in the Sanzhi Hewei prescription. The Sanzhi Hewei prescription is good at soothing the liver and regulating qi, harmonizing the stomach and relieving the middle. The middle burner is the pivot of the ascending and descending of qi. When wood is strong and earth is healthy, the qi is unobstructed, so the emotions are regulated. Therefore, the effect of Sanzhi Hewei prescription in improving anxiety is significantly better than that of Mosapride Citrate Tablets. Therefore, the effect of Sanzhi Hewei prescription in improving patients' uncomfortable symptoms such as fullness in the stomach, dry mouth and bitter taste is also better than that of Mosapride Citrate Tablets.

[0278] 6. Comparative analysis of recurrence rate

[0279] All patients were followed up 8 weeks after the end of treatment. There were 42 patients in the treatment group who were followed up, 3 relapsed, and the relapse rate was 7.14%. There were 34 patients in the control group who were effectively treated and successfully followed up, 9 relapsed, and the relapse rate was 26.47%. There was no statistical difference in the relapse rate between the two groups (P = 0.068). Although there was no significant difference in the relapse rate between the two groups, the results showed that the relapse rate of patients with functional dyspepsia and anxiety due to liver and stomach stagnation syndrome treated with Sanzhi Hewei prescription was lower (7.14% VS 26.47%), which may be due to insufficient sample size. In the future, we will conduct a large sample, multicenter randomized controlled trial, and extend the follow-up period to verify the research results, and provide high-quality evidence-based medicine evidence for the long-term efficacy of Sanzhi Hewei prescription in treating functional dyspepsia and anxiety due to liver and stomach stagnation syndrome.

[0280] 7. Comparative safety analysis

[0281] During the study, the vital signs of the two groups of patients were stable, and no abnormalities were found in the three routine tests of blood, urine and stool, liver and kidney function and electrocardiogram. No adverse reactions or allergic symptoms occurred in the two groups of patients, indicating that the clinical application of Sanzhi Hewei Decoction is relatively safe and reliable, and has a definite effect on functional dyspepsia with anxiety caused by liver and stomach stagnation, and is worthy of promotion and application.

[0282] The above is a description of the embodiments of the present invention. Through the above description of the disclosed embodiments, professionals and technicians in the field can implement or use the present invention. Various modifications to these embodiments will be apparent to professionals and technicians in the field. The general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown in this article, but will conform to the widest range consistent with the principles and novelties disclosed herein.

Claims

1. A Chinese medicine composition for treating functional dyspepsia with anxiety due to liver and stomach stagnation syndrome, characterized in that: The active ingredient raw materials of the traditional Chinese medicine composition include the following raw materials by weight: 5-15 parts of bupleurum, 5-15 parts of cyperus rotundus, 2-8-12 parts of fructus aurantii, 5-15 parts of dried tangerine peel, 5-15 parts of pinellia, 5-15 parts of citron, 5-15 parts of tangerine peel, 5-15 parts of radish seeds, 1-5 parts of liquorice, and 2-8-12 parts of dried ginger.

2. A Chinese medicine composition for treating liver-stomach stagnation syndrome functional dyspepsia accompanied by anxiety according to claim 1, characterized in that: The active ingredient raw materials of the traditional Chinese medicine composition include the following raw materials by weight: 8-12 parts of bupleurum, 8-12 parts of cyperus rotundus, 5-7 parts of fructus aurantii, 8-12 parts of dried tangerine peel, 8-12 parts of pinellia, 8-12 parts of citron, 8-12 parts of tangerine peel, 8-12 parts of radish seeds, 2-4 parts of liquorice, and 4-6 parts of dried ginger.

3. A Chinese medicine composition for treating functional dyspepsia with anxiety due to liver and stomach stagnation according to claim 1 or 2, characterized in that: The active ingredient raw materials of the traditional Chinese medicine composition also include the following raw materials in parts by weight: 1-5 parts of agarwood, 5-15 parts of inula flower, and 5-15 parts of magnetite.

4. A Chinese medicine composition for treating liver-stomach stagnation syndrome functional dyspepsia accompanied by anxiety according to claim 1 or 2, characterized in that: The active ingredient raw materials of the traditional Chinese medicine composition also include the following raw materials in parts by weight: 5-15 parts of Shenqu, 5-15 parts of Zhishi, and 5-15 parts of Areca.

5. A Chinese medicine composition for treating functional dyspepsia with anxiety due to liver and stomach stagnation syndrome according to claim 1 or 2, characterized in that: The active ingredient raw materials of the Chinese medicine composition also include the following raw materials by weight: 2-10 parts of Evodia rutaecarpa and 1-5 parts of Coptis chinensis.

6. A Chinese medicine composition for treating functional dyspepsia with anxiety due to liver and stomach stagnation syndrome according to claim 1 or 2, characterized in that: The active ingredients of the Chinese medicine composition are also calculated by weight. The invention comprises the following raw materials: 2-10 portions of Corydalis yanhusuo.

7. A Chinese medicine composition for treating functional dyspepsia associated with anxiety due to liver and stomach stagnation syndrome according to any one of claims 1 to 6, characterized in that: The Chinese medicine composition also includes adding other Chinese medicine extracts and / or adding other raw materials.

8. A Chinese medicine composition preparation for treating functional dyspepsia with anxiety due to liver and stomach stagnation syndrome, characterized in that: The Chinese medicine composition preparation comprises the Chinese medicine composition according to any one of claims 1 to 7 and / or added pharmaceutical excipients and / or added food additives.

9. A Chinese medicine composition preparation for treating liver-stomach stagnation syndrome functional dyspepsia accompanied by anxiety according to claim 8, characterized in that: The Chinese medicine composition preparation is in the form of tablets, chewable tablets, powders, granules, granules, capsules, ointments, pills or liquid preparations.

10. Use of the Chinese medicine composition according to any one of claims 1 to 7 or the Chinese medicine composition preparation according to any one of claims 8 to 7 in the preparation of a treatment for functional dyspepsia associated with anxiety due to liver and stomach stagnation syndrome.

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