A traditional Chinese medicine composition for treating gastroesophageal reflux disease

Abstract

The application belongs to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating gastroesophageal reflux disease. The application is aimed at the core pathogenesis of liver fire invading stomach, adverse stomach qi, and incoordination of fu-qi. The application provides a traditional Chinese medicine composition for clearing and discharging stagnant fire, dredging fu and descending turbidity, soothing liver and stomach, relieving pain, and having rapid effect, simple medicine taste, and treating both symptoms and root causes. The traditional Chinese medicine composition is composed of black radix puerariae, fructus meliae toosendii, prepared ginger, radix paeoniae alba, radix breviflorae and raw rhubarb. The composition of the application is closely related to the core pathogenesis of liver fire invading stomach, adverse stomach qi, incoordination of fu-qi, and meridian and collaterals, has simple and powerful medicine, and can effectively relieve pain and reduce the recurrence rate.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating gastroesophageal reflux disease of the liver-stomach heat stagnation type. Background Technology

[0002] Gastroesophageal reflux disease (GERD) is a common chronic digestive system disease characterized by the reflux of stomach and duodenal contents into the esophagus or mouth, leading to a range of uncomfortable symptoms and potential complications. The clinical manifestations are complex and diverse, with typical symptoms including heartburn, regurgitation, and burning pain in the stomach, often accompanied by atypical symptoms such as chest pain, upper abdominal pain, belching, bloating, a feeling of a foreign body in the throat, and chronic cough, as well as extraesophageal manifestations. Based on endoscopic findings, it can be classified into non-erosive gastroesophageal reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus (BE). GERD has a high prevalence, severely impacting patients' health and significantly reducing their quality of life, while also continuously increasing the burden on social healthcare resources. GERD can induce esophageal cancer; the chronic esophageal inflammation caused by the disease has been proven to be the most significant risk factor for esophageal adenocarcinoma, with BE currently recognized as a precancerous lesion for esophageal adenocarcinoma.

[0003] Western medicine treatment focuses on lifestyle modifications as a fundamental intervention. Commonly used clinical medications include proton pump inhibitors (PPIs), H2 receptor antagonists, and prokinetic drugs. While PPIs are currently the most potent first-line acid-suppressing drugs and can effectively alleviate discomfort in most patients, they still have significant limitations: First, some patients (especially those with NERD) do not respond well to PPIs; second, long-term use of PPIs can easily lead to adverse reactions such as intestinal flora imbalance, increased risk of infection, impaired nutrient absorption, fractures, and kidney damage; and third, the symptom relapse rate is high after discontinuation, requiring long-term continuous medication, which places a heavy economic and psychological burden on patients.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in treating gastroesophageal reflux disease (GERD) through holistic regulation and syndrome differentiation. Based on the core symptoms of this disease, such as acid reflux, heartburn, and epigastric discomfort, it can be categorized under TCM syndromes such as "acid vomiting," "heartburn," "epigastric pain," "esophageal nausea," and "globus hystericus." The *Suwen* (Plain Questions) states, "All vomiting of acid, sudden and forceful diarrhea, belongs to heat," revealing that "heat" is one of the important pathogenic mechanisms of this disease. The liver governs the free flow of Qi, regulating the Qi mechanism throughout the body; the stomach governs the downward flow, with harmonious downward movement being the optimal state. Prolonged emotional imbalance can lead to stagnation of liver Qi, which can transform into fire. This liver fire then attacks the stomach, causing disharmony in the stomach's downward flow and upward reversal of Qi, thus forming a liver-stomach heat syndrome. When stomach heat is accompanied by acid reflux, it burns the esophagus, resulting in symptoms such as acid reflux, heartburn, and burning pain behind the sternum or in the epigastric region. When liver heat is stagnant, symptoms such as bitter taste in the mouth, dry throat, irritability, and chest and rib distension may occur. A red tongue with a yellow coating and a wiry and rapid pulse are all signs of liver and stomach heat stagnation.

[0005] Currently, there are several patents for traditional Chinese medicine compound formulas for treating gastroesophageal reflux disease, each with its own focus: Chinese patent CN118217349B discloses a traditional Chinese medicine compound formula composed of gentian root, prunella vulgaris, chrysanthemum, peppermint, scutellaria baicalensis, gardenia, peony bark, trichosanthes fruit, bupleurum root, white peony root, hawthorn, cyperus rhizome, chuanxiong rhizome, angelica root, yam, ginseng, codonopsis root, pseudostellaria root, pinellia tuber, inula flower, perilla seed, and radish seed; this compound formula focuses on comprehensive regulation of multiple organs; Chinese patent CN119656255B discloses a traditional Chinese medicine compound formula composed of gallnut, sophora flower, white peony root, selaginella, burnet root, and bile acid; this compound formula uses the methods of clearing heat and detoxifying, astringing and stopping bleeding; Chinese patent CN116747274B discloses... A traditional Chinese medicine compound is disclosed, consisting of calcined hematite, cuttlebone, ginger-processed pinellia, magnolia bark, stir-fried coptis, evodia, bupleurum, scutellaria, poria, and prepared licorice. This compound focuses on calming the liver, suppressing nausea and vomiting, neutralizing acid, and harmonizing the stomach. Chinese patent CN112717045B discloses a traditional Chinese medicine compound consisting of inula, prepared pinellia, prepared cyperus, perilla stem, raw loquat leaf, tangerine peel, poria, cuttlebone, and stir-fried radish seed. This compound focuses on regulating qi, resolving phlegm, and suppressing nausea and vomiting. Chinese patent CN116603023B discloses a traditional Chinese medicine compound consisting of bupleurum, raw white peony root, immature bitter orange peel, hematite, coptis, evodia, calcined oyster shell, magnolia bark, pinellia, codonopsis, atractylodes, achyranthes, and rehmannia. This compound mainly focuses on soothing the liver, harmonizing the stomach, and promoting downward flow of qi. Existing technologies treat gastroesophageal reflux disease from different perspectives, each with its own characteristics. However, for the core pathogenesis of "liver-stomach stagnation and heat," a common and acutely symptom-prone syndrome, especially for symptoms accompanied by severe burning pain in the epigastrium or behind the sternum, constipation, and obstruction of the bowels, there is still a clinical need for a specialized Chinese medicine formula that is simple in composition, uses simple and potent herbs, clears away stagnant heat, promotes bowel movement and eliminates turbidity, harmonizes the stomach and relieves nausea, and can quickly and effectively relieve pain. Summary of the Invention

[0006] Targeting the core pathogenesis of gastroesophageal reflux disease (GERD) of the liver-stomach stagnation and heat type, characterized by liver fire invading the stomach, qi stagnation and spasms, and obstruction of the bowels, this invention provides a traditional Chinese medicine composition that clears stagnant heat, unblocks the bowels and reduces turbidity, soothes the liver and harmonizes the stomach, relieves spasms and pain, and is fast-acting, simple in composition, and addresses both the root cause and symptoms. This traditional Chinese medicine composition has the effects of relieving pain and reducing the recurrence rate. Based on this, this invention was completed.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating gastroesophageal reflux disease, the traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: 10-20 parts of black gardenia seed, 10-20 parts of Sichuan chinaberry, 1-6 parts of prepared ginger, 10-20 parts of wine-processed white peony root, 3-8 parts of wood butterfly, and 1-6 parts of raw rhubarb.

[0008] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux disease consists of the following traditional Chinese medicines in parts by weight: 12-18 parts of black gardenia seed, 12-18 parts of Sichuan chinaberry, 2-5 parts of prepared ginger, 12-18 parts of wine-processed white peony root, 4-6 parts of wood butterfly, and 1-3 parts of raw rhubarb.

[0009] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux disease consists of the following traditional Chinese medicines in parts by weight: 15 parts of black gardenia seed, 15 parts of Sichuan chinaberry, 3 parts of prepared ginger, 15 parts of wine-processed white peony root, 5 parts of wood butterfly, and 1 part of raw rhubarb.

[0010] Furthermore, the gastroesophageal reflux disease mentioned is a liver-stomach heat stagnation type of gastroesophageal reflux disease.

[0011] Secondly, the present invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating gastroesophageal reflux disease, wherein the traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 10-20 parts of black gardenia seed, 10-20 parts of Sichuan chinaberry, 1-6 parts of prepared ginger, 10-20 parts of wine-processed white peony root, 3-8 parts of wood butterfly, and 1-6 parts of raw rhubarb.

[0012] Furthermore, the gastroesophageal reflux disease mentioned is the liver-stomach heat stagnation type of gastroesophageal reflux disease.

[0013] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows: Black Gardenia Seed (Roasted Gardenia): Bitter, cold. Enters the Heart, Lung, and Triple Burner meridians. Cools the blood and stops bleeding. Used for hematemesis, epistaxis, hematuria, and metrorrhagia due to blood heat.

[0014] Sichuan Chinaberry: Bitter, cold; slightly toxic. It enters the liver, small intestine, and bladder meridians. It soothes the liver and clears heat, promotes qi circulation and relieves pain, and kills parasites. It is used for liver stagnation transforming into fire, chest and rib pain, abdominal distension and pain, hernia pain, and abdominal pain due to intestinal parasites.

[0015] Prepared ginger: pungent and hot. It enters the spleen, stomach, and kidney meridians. It warms the meridians and stops bleeding, warms the middle jiao and relieves pain. It is used for blood loss due to yang deficiency, hematemesis, epistaxis, metrorrhagia, spleen and stomach deficiency-cold, abdominal pain, vomiting, and diarrhea.

[0016] White peony root (processed with wine): Bitter, sour, slightly cold. Enters the liver and spleen meridians. Nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, calms liver yang. Used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache, and dizziness.

[0017] Wood Orchid: Bitter, sweet, and cool in nature. It enters the lung, liver, and stomach meridians. It clears the lungs and soothes the throat, calms the liver and stomach. Used for cough due to lung heat, sore throat, hoarseness, and liver and stomach pain.

[0018] Raw rhubarb: Bitter, cold. It enters the spleen, stomach, large intestine, liver, and pericardium meridians. It purges stagnation, clears heat and fire, cools the blood and detoxifies, removes blood stasis and promotes menstruation, and promotes diuresis and relieves jaundice. It is used for constipation due to excess heat, hematemesis and epistaxis due to blood heat, red eyes and swollen throat, carbuncles and boils, intestinal abscesses and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, traumatic injuries, damp-heat dysentery, jaundice with dark urine, urinary tract infections, and edema; externally, it is used to treat burns and scalds.

[0019] The formulation and treatment principles of this invention This invention uses Gardenia and Dried Ginger Decoction from the Treatise on Cold Damage as its base formula, and makes precise modifications to address the pathogenesis of liver and stomach stagnation and heat, qi stagnation and spasm, and obstruction of the bowel. Black gardenia seed is the principal herb, clearing away stagnant fire in the triple burner and relieving burning pain in the stomach, irritability, and bitter taste in the mouth. Sichuan chinaberry and wine-processed white peony root are the assistant herbs, working together with black gardenia seed to clear and soothe the liver, dispersing and astringing simultaneously, achieving the effects of clearing liver fire, promoting qi circulation, and relieving stagnation. When liver fire is cleared, stomach heat naturally decreases; when qi flows smoothly, pain naturally subsides. This formula not only helps to soothe the liver and relieve stagnation but also prevents excessive dispersion, effectively alleviating severe pain caused by spasms of the esophagus and gastrointestinal smooth muscles. Raw rhubarb is the adjuvant herb, clearing heat from the bowels, purging stagnant fire, promoting blood circulation and removing blood stasis, improving esophageal mucosal microcirculation, and promoting inflammation absorption and mucosal repair. Prepared ginger and butterfly flower are the guiding herbs, dispersing stagnant fire, protecting the yang qi of the middle burner, restraining bitter and cold properties, preventing damage to the spleen and stomach, and relieving throat discomfort or a foreign body sensation caused by reflux. The entire formula harmonizes ascending and descending functions, closely addressing the core pathogenesis.

[0020] Beneficial effects This invention's herbal formula contains only six ingredients, employing both cold and hot properties, with a focus on cold; it combines clearing and dredging, simultaneously promoting flow and descending; it regulates both qi and blood, and harmonizes ascending and descending functions. Together, they clear stagnant fire in the liver and gallbladder, promote bowel movement and descend turbidity, soothe the liver and harmonize the stomach, and relieve spasms and pain. This invention's formula closely addresses the core pathogenesis of liver fire invading the stomach, stomach qi rising upwards, obstructed bowel qi, and meridian spasms. Its simple yet potent formula achieves rapid effects, relieving pain and reducing the recurrence rate. Detailed Implementation

[0021] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the embodiments described below can be combined with each other as long as they do not conflict with each other.

[0022] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, and the experimental materials used in the following embodiments are all available through conventional commercial channels.

[0023] Example 1: Preparation of the traditional Chinese medicine preparation of the present invention The herbal composition consists of: 15g of black gardenia seed, 15g of Sichuan chinaberry, 3g of prepared ginger, 15g of wine-processed white peony root, 5g of wood butterfly, and 1g of raw rhubarb.

[0024] Preparation process: S01. Weigh out the black gardenia seeds, Sichuan chinaberry, prepared ginger, wine-processed white peony root, and wood butterfly according to the specified proportions, remove impurities, wash, drain, and set aside. S02. Mix the Chinese herbs processed in S01 and soak them in water at a ratio of 1:8 for 40 minutes. S03. Boil the mixed soaking solution of Chinese medicine obtained in S02 over high heat, then simmer over low heat for 30 minutes. Add cleaned raw rhubarb and simmer for 5 minutes. Filter out the liquid and keep the dregs. S04. Add 6 times the amount of water to the dregs obtained in S03, simmer over low heat for 20 minutes, and filter out the liquid. S05. Combine the filtered liquids from S03 and S04 to obtain the decoction of the present invention.

[0025] Example 2: Clinical evaluation of the traditional Chinese medicine composition of the present invention Case Source of cases Sixty-two patients who met the diagnostic criteria for gastroesophageal reflux disease of the liver-stomach stagnation and heat type and were admitted to Beijing Chest Hospital, Capital Medical University, between January 2024 and December 2025 were selected.

[0026] 1.2 Research Methods and Grouping A randomized, parallel-controlled, prospective clinical observation method was used to randomly divide patients with gastroesophageal reflux disease of the liver-stomach stagnation and heat type who met the diagnostic criteria into a treatment group and a control group, with 31 patients in each group.

[0027] 2. Diagnostic criteria Referring to the criteria for liver-stomach heat stagnation syndrome in the "Expert Consensus on the Diagnosis and Treatment of Gastroesophageal Reflux Disease with Traditional Chinese Medicine (2023)": Main symptoms: ① Heartburn, ② Acid reflux; Secondary symptoms: ① Burning pain behind the sternum, ② Burning pain in the stomach, ③ Abdominal distension, ④ Belching or regurgitation, ⑤ Irritability, ⑥ Increased hunger; Tongue and pulse: ① Red tongue, ② Yellow coating, ③ Wiry pulse.

[0028] If two of the above symptoms are met, along with two secondary symptoms, and the tongue and pulse conditions are also considered, a diagnosis can be made. The basis for the syndrome of liver and stomach stagnation with heat.

[0029] 3. Discharge Standards 3.1 Inclusion criteria: ① Those who meet the diagnostic criteria; ②Those aged 18-80 years old; ③Those who fully understand the research process, meet the diagnostic criteria, voluntarily participate in the research, and sign an informed consent form; ④ Those who have good compliance and can cooperate to complete the research process.

[0030] 3.2 Exclusion criteria: ① Those who do not meet the diagnostic criteria; ② Individuals with severe complications of GERD, such as Barrett's esophagus; ③ GERD caused by other organic lesions, such as achalasia, radiation esophagitis, etc.; ④ Individuals with untreated or untreated Hp infection; ⑤ Women who are pregnant, trying to conceive, or breastfeeding; ⑥ Individuals allergic to the drugs used in this study; ⑦ Patients with severe mental illness or mental disorder; ⑧ Patients with serious heart, brain, liver, lung, or kidney diseases that affect treatment.

[0031] 4. Rejection, detachment, and termination criteria: 4.1 Exclusion Criteria ① Those who voluntarily withdraw from the research or are lost to follow-up; ②Those who did not take the medication as required after enrollment or failed to complete the course of treatment; ③ Those who cannot clearly express the severity of their illness.

[0032] 4.2 Shedding Criteria ① Participants who voluntarily withdrew from the experiment during the research process; ②Those with incomplete test data.

[0033] 4.3 Termination Criteria ① Other critical illnesses suddenly occurred during the research process; ②Those who refuse treatment or examination in this study; ③ Those who make requests unrelated to the research.

[0034] 5. Treatment methods Treatment group: The decoction prepared according to Example 1 of this invention was used, one dose per day, 400 mL, taken warm twice after meals, for two weeks as one course of treatment.

[0035] Control group: Oral administration of esomeprazole sodium enteric-coated tablets (Jiangxi Shanxiang Pharmaceutical Co., Ltd., National Drug Approval Number H20203298), 40 mg / time, once a day, for 4 weeks as one course of treatment.

[0036] 6. Observation Indicators Symptoms of gastroesophageal reflux disease with liver and stomach heat syndrome include burning pain in the stomach, acid reflux, heartburn, bitter taste in the mouth, dry mouth, irritability, chest and rib distension, and constipation. Among these, burning pain in the stomach, acid reflux, and heartburn are the main symptoms and are assigned a score of 0-5, while the other symptoms are assigned a score of 0-3.

[0037] 7. Efficacy Evaluation Criteria The efficacy of TCM syndromes is evaluated based on the "Guiding Principles for Clinical Research of New Chinese Medicines".

[0038] The efficacy index was calculated using the nimodipine method: Therapeutic effect index = [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100% Table 1 Evaluation of therapeutic effects

[0039] 8. Research Results 8.1 Comparison of total clinical symptom scores after 4 weeks of treatment The total clinical symptom score was compared by assigning a score of 0-5 to the main symptoms of burning stomach pain, acid reflux, and heartburn, and a score of 0-3 to the symptoms of bitter taste in the mouth, dry mouth, irritability, chest and rib distension, and constipation.

[0040] Table 2 Comparison of total clinical symptom scores between the treatment group and the control group after 4 weeks of treatment (x±s)

[0041] Note: a) Compared with the control group, the treatment group had a P>0.05; b) Compared with the control group, the treatment group had a P<0.05.

[0042] As shown in Table 2, there was no significant difference in the total symptom scores between the two groups before treatment. However, after 4 weeks of treatment, the total symptom score in the treatment group was significantly lower than that in the control group (P < 0.05). Therefore, the herbal composition of this invention can effectively alleviate the clinical symptoms of gastroesophageal reflux disease of the liver-stomach heat stagnation type.

[0043] Comparison of the scores of major symptoms such as burning pain, acid reflux, and heartburn in patients with gastroesophageal reflux disease of the liver-stomach stagnation and heat type before and after treatment.

[0044] Table 3 Comparison of main symptom scores between the two groups after 4 weeks of treatment (x±s)

[0045] Note: a) Compared with the control group, the treatment group showed P>0.05; b) Compared with the control group, the treatment group showed P<0.05.

[0046] As shown in Table 3, after 4 weeks of treatment, the scores of the main symptoms of gastroesophageal reflux disease (GERD) of the liver-stomach heat stagnation type, such as burning pain, acid reflux, and heartburn, were significantly lower than those of the control group (P < 0.05). This indicates that the preparation of the present invention can effectively treat the main symptoms of GERD of the liver-stomach heat stagnation type, such as burning pain, acid reflux, and heartburn.

[0047] 8.2 Comparison of clinical efficacy after 4 weeks of treatment Four weeks after treatment, the efficacy of TCM syndrome was evaluated in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine".

[0048] Table 4 Comparison of clinical efficacy between the treatment group and the control group after 4 weeks of treatment.

[0049] Note: The treatment group was significantly different from the control group (P<0.05).

[0050] As shown in Table 4, after 4 weeks of treatment, the effective rate and cure rate of the treatment group were significantly higher than those of the control group (P < 0.05). This indicates that the traditional Chinese medicine composition of the present invention has good clinical efficacy in improving the TCM syndrome of patients with gastroesophageal reflux disease of the liver-stomach heat stagnation type.

[0051] 9. Conclusion The traditional Chinese medicine composition provided by this invention originates from classical texts and is based on clinical practice. Its formulation is rigorous, and the ingredients are concise. The entire formula primarily clears heat from the liver and stomach, while also addressing bowel-regulating, liver-soothing, qi-regulating, pain-relieving, and cold-protecting effects, thus targeting the core pathogenesis of gastroesophageal reflux disease (GERD) of the liver-stomach heat type. Clinical studies have shown that this traditional Chinese medicine composition can rapidly relieve burning pain in the epigastric region and behind the sternum, significantly improve core symptoms of liver-stomach heat such as acid reflux and heartburn, and has a low recurrence rate and good safety profile. Its preparation method is mature and can be formulated into various dosage forms, facilitating clinical application and promotion. This provides a new, effective, and distinctive traditional Chinese medicine treatment option for GERD of the liver-stomach heat type, especially for patients with significant pain.

[0052] Example 3 Typical Case

[0053] Case 1 (Acute attack with constipation): Xiao, male, 35 years old.

[0054] Chief complaint: The patient presented with "severe pain in the epigastric region and behind the sternum for 3 days, accompanied by constipation".

[0055] The patient is usually irritable. Three days ago, after arguing with someone, he experienced severe burning pain in his stomach and behind his sternum, which was especially bad at night. Conventional painkillers and acupuncture were ineffective.

[0056] Current symptoms: The patient presented with a pained expression, experiencing severe pain in the epigastric region and behind the sternum, which was aggravated by pressure and radiated to both sides of the ribs. Other symptoms included a bitter taste in the mouth, irritability, occasional acid reflux and heartburn, yellow urine, and constipation for three days, with stools that were dry and hard like sheep pellets.

[0057] The tongue is red with a dry, yellow coating, and the pulse is wiry, rapid, and forceful.

[0058] examine: Gastroscopy revealed erosive esophagitis (LA-B grade).

[0059] Traditional Chinese Medicine Diagnosis: Acid reflux and stomach pain (due to liver and stomach heat stagnation and obstruction of the internal organs).

[0060] treat: I urgently need to administer one dose of the decoction of this invention (15g of black gardenia seed, 15g of Sichuan pepper, 3g of prepared ginger, 15g of white peony root cooked in wine, 5g of oroxylum indicum, and 1g of raw rhubarb added later). Each dose is 400mL, to be taken warm in two divided doses after meals.

[0061] Therapeutic effects: I took the medicine in the afternoon, and by evening I had a bowel movement, the pain was greatly reduced, and I slept soundly through the night.

[0062] After taking two more doses (removing the raw rhubarb), the pain completely disappeared, and the acid reflux and heartburn also subsided.

[0063] Case 2 (Chronic and recurrent, accompanied by sore throat): Ms. Zhang, female, 48 years old.

[0064] Chief complaint: The patient has a 5-year history of gastroesophageal reflux disease (GERD), which often recurs due to emotional stress or dietary indiscretions. Endoscopic examination revealed NERD.

[0065] Due to high work pressure, I experienced a recurrence of acid reflux, heartburn, and unbearable burning pain in the epigastric region and behind the sternum, accompanied by distending pain in the hypochondrium, dry mouth and bitter taste, restless sleep, and a pronounced foreign body sensation in the throat (what Traditional Chinese Medicine calls "plum pit qi"). My stools were sticky and unsatisfactory. My tongue was crimson with a yellow and greasy coating, and my pulse was wiry, strong, and rapid.

[0066] diagnosis: The diagnosis is that the liver meridian is stagnant and fire is rebellious, which invades the stomach and intestines, accompanied by damp heat, qi stagnation and phlegm accumulation.

[0067] treat: The decoction of this invention (15g of black gardenia seed, 15g of Sichuan pepper, 3g of dried ginger, 15g of white peony root, 5g of oroxylum indicum, and 1g of raw rhubarb) was used for treatment.

[0068] Therapeutic effects: After taking one dose of the medicine, the pain was greatly reduced, bowel movements became regular, and the feeling of a foreign object in the throat was alleviated; after taking two doses day and night, the pain was basically under control and the throat felt comfortable.

[0069] At the follow-up visit, the original prescription was modified by removing raw rhubarb and adding 10g of turmeric, 12g of trichosanthes peel, 15g of stir-fried atractylodes macrocephala, and 10g of magnolia bark to enhance the spleen-strengthening, dampness-resolving, chest-relieving, depression-relieving, qi-regulating, and phlegm-resolving effects. Five more doses were prescribed. A six-month follow-up showed no serious relapse, only occasional mild discomfort, and a significantly improved quality of life.

[0070] Case 3 (Intractable reflux, accompanied by anxiety and insomnia): Ms. Wang, 52 years old.

[0071] Chief complaint: The patient presented with symptoms of "recurrent acid reflux, heartburn, and insomnia for more than 2 years, which has worsened in the past week".

[0072] The patient had a history of gastroesophageal reflux disease for more than 2 years and had been taking PPI drugs such as omeprazole and rabeprazole for a long time. They were effective at first, but gradually became ineffective and the symptoms recurred.

[0073] Over the past week, due to high work pressure, my symptoms have worsened dramatically. I experience frequent acid reflux, unbearable heartburn, especially at night, which severely affects my sleep. I can only sleep for 2-3 hours each night, accompanied by irritability, bitter taste in my mouth, dry throat, chest and rib distension, and constipation.

[0074] I tried taking more PPIs on my own, but it was still ineffective.

[0075] Current symptoms: Symptoms include anxiety, flushed face, red tongue with dry yellow coating, and a wiry, slippery, and rapid pulse.

[0076] examine: Gastroscopy revealed erosive esophagitis (LA-A grade).

[0077] diagnosis: Acid reflux and insomnia (due to liver and stomach heat disturbing the mind).

[0078] treat: The patient was treated with the decoction of this invention (15g of black gardenia seed, 15g of Sichuan chinaberry, 3g of prepared ginger, 15g of wine-processed white peony root, 5g of wood butterfly, and 1g of raw rhubarb added later), and was instructed to discontinue Western medicine.

[0079] Therapeutic effects: After taking one dose of the medication, the patient had a bowel movement that night, and the acid reflux and heartburn were significantly reduced. The patient was able to sleep for about 4 hours. After taking three doses of the medication, the acid reflux and heartburn were basically under control, the patient's sleep returned to more than 6 hours, and the patient's mood was significantly stable.

[0080] During the follow-up visit, the rhubarb was removed, and 15g of jujube seed and 15g of albizia bark were added to nourish the heart and calm the mind. Seven more doses were administered to consolidate the therapeutic effect.

[0081] During the subsequent 3-month follow-up, the patient occasionally experienced mild acid reflux due to emotional fluctuations. This was relieved by self-medicating with the original prescription for 2-3 doses, and no severe episodes occurred again.

Claims

1. A traditional Chinese medicine composition for treating gastroesophageal reflux disease, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 10-20 parts of black gardenia seed, 10-20 parts of Sichuan chinaberry, 1-6 parts of prepared ginger, 10-20 parts of wine-processed white peony root, 3-8 parts of wood butterfly, and 1-6 parts of raw rhubarb.

2. The traditional Chinese medicine composition for treating gastroesophageal reflux disease as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 12-18 parts of black gardenia seed, 12-18 parts of Sichuan chinaberry, 2-5 parts of prepared ginger, 12-18 parts of wine-processed white peony root, 4-6 parts of wood butterfly, and 1-3 parts of raw rhubarb.

3. The traditional Chinese medicine composition for treating gastroesophageal reflux disease as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 15 parts black gardenia seed, 15 parts Sichuan chinaberry, 3 parts prepared ginger, 15 parts wine-processed white peony root, 5 parts wood butterfly, and 1 part raw rhubarb.

4. The traditional Chinese medicine composition for treating gastroesophageal reflux disease as described in claim 1, characterized in that, The gastroesophageal reflux disease mentioned is the liver-stomach heat stagnation type of gastroesophageal reflux disease.

5. The application of a traditional Chinese medicine composition in the preparation of a drug for treating gastroesophageal reflux disease, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 10-20 parts of black gardenia seed, 10-20 parts of Sichuan chinaberry, 1-6 parts of prepared ginger, 10-20 parts of wine-processed white peony root, 3-8 parts of wood butterfly, and 1-6 parts of raw rhubarb.

6. The use in the medicament for treating gastroesophageal reflux disease as described in claim 5, characterized in that, The gastroesophageal reflux disease mentioned is the liver-stomach heat stagnation type of gastroesophageal reflux disease.

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