Moxibustion medicine for preventing and / or treating diarrhea-type irritable bowel syndrome and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a moxibustion medicine for preventing and / or treating diarrhea-type irritable bowel syndrome through moxibustion and a preparation method of the moxibustion medicine. More specifically, the invention provides a moxibustion medicine which comprises moxa, radix paeoniae alba, radix puerariae, cortex phellodendri, radix astragali, radix bupleuri, radix aucklandiae, radix codonopsis, raw rhizoma atractylodis macrocephalae, honey-fried licorice root, pericarpium citri reticulatae, rhizoma cimicifugae and caulis spatholobi. By applying the moxibustion medicine, the diarrhea type irritable bowel syndrome can be effectively prevented and / or treated.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a moxibustion medicine for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome and its preparation method. Background Technology

[0002] Irritable bowel syndrome (IBS) is a functional bowel disorder caused by a variety of factors, leading to abnormal gut-brain interactions. Its main symptoms include abdominal pain, abnormal bowel movements with changes in frequency and / or stool consistency. Common types of IBS include diarrheal, constipation, mixed, and indefinite types. In the general population of China, the prevalence of IBS is approximately 1.4%–11.5%. Although the condition is recurrent, it does not significantly impact normal work or study and may resolve spontaneously after a period of time, resulting in a low rate of medical intervention. This condition can occur in all age groups, but is more common in young and middle-aged adults (18–59 years old). The prevalence decreases in the elderly (≥60 years old), and the prevalence is slightly higher in women than in men.

[0003] Although irritable bowel syndrome (IBS) has a long course and can recur, most patients generally have a relatively good prognosis, with symptoms usually disappearing within one year. However, patients with severe psychological disorders, long disease duration, or a history of surgery generally have a poorer prognosis.

[0004] I. Etiology and Pathogenesis

[0005] Traditional Chinese medicine believes that diarrhea-predominant irritable bowel syndrome (IBS) is often related to emotional distress. The primary location of the disease is in the spleen, stomach, and large and small intestines, with the spleen being the dominant organ. Causes include external pathogens, dietary imbalances, emotional disturbances, spleen and stomach weakness, and spleen and kidney yang deficiency. The main pathogenic factor is dampness, as described in the *Nan Jing* (Classic of Difficult Issues) as "excessive dampness leads to five types of diarrhea." The spleen and stomach are considered the "granaries" of the body, responsible for the transformation and transportation of food and fluids. Anger injures the liver, causing impaired liver function, leading to the liver overacting on the spleen, thus affecting its function. Similarly, worry and anxiety can obstruct spleen function, resulting in undigested food and fluids descending into the intestines as diarrhea. If the individual has a pre-existing spleen deficiency and excessive dampness, weakened digestion, emotional stress, mental tension, or eating while angry can all lead to liver and spleen imbalances, easily resulting in diarrhea.

[0006] II. Clinical Manifestations and Diagnosis

[0007] Diarrhea-predominant irritable bowel syndrome (IBS) is mainly characterized by recurrent episodes of increased bowel movements or loose stools. Symptoms are not fixed and may include abdominal distension and pain, with the pain typically occurring in the lower abdomen, appearing intermittently and often relieved after passing gas or stool. In addition, it may be accompanied by upper gastrointestinal symptoms such as indigestion, heartburn, and reflux, or extraintestinal symptoms such as fatigue, urinary frequency, urgency, and dysmenorrhea. IBS is not a contagious disease; based on the actual condition and symptoms, early medical attention is recommended. Currently, the diagnosis of this disease is mainly based on ruling out other organic diseases, combined with medical history and disease course.

[0008] III. Treatment Methods

[0009] Current clinical treatment for irritable bowel syndrome (IBS) primarily focuses on improving symptoms, enhancing patients' quality of life, and alleviating their anxieties. The main therapies include lifestyle and dietary changes, medication, and psychological and behavioral therapies. Specific treatment strategies are tailored to each patient's individual circumstances by the physician.

[0010] Currently, drug treatment for diarrhea-predominant irritable bowel syndrome (IBS) is mainly symptomatic, requiring long-term oral administration of probiotics, digestive aids, and even antidiarrheal drugs such as montmorillonite powder. Furthermore, relapses are easily triggered by various factors. Long-term use of anti-anxiety and antidepressant medications can lead to difficulties in discontinuing treatment, or even a worsening of the condition after discontinuation, causing patient resistance and decreased adherence. In addition, due to cultural factors and a lack of specialist physicians, the quality of psychotherapy (cognitive behavioral therapy) is low, its content is not standardized, and it is sometimes not even offered in primary care hospitals and general hospitals in my country. Therefore, the clinical treatment outcomes of Western medicine are unsatisfactory, especially for diarrhea-predominant IBS.

[0011] Traditional Chinese medicine (TCM) has a long history of treating diarrhea, and its unique advantages, definite efficacy, fewer adverse reactions, and lack of drug resistance have led to its widespread acceptance and recognition among patients. TCM believes that diarrhea is fundamentally caused by spleen deficiency and dampness accumulation. The spleen, being an earth element organ, is easily affected by excessive liver qi, leading to a deficiency of earth element and the generation of dampness, which in turn causes diarrhea. Through holistic TCM treatment combined with symptomatic treatment from Western medicine, patients' symptoms can be effectively alleviated, improving their quality of life. Furthermore, emphasis on prevention and care is crucial for reducing the occurrence and recurrence of irritable bowel syndrome (IBS).

[0012] However, most of the existing Chinese medicine prescriptions for treating irritable bowel syndrome are decoctions that need to be taken orally. Chinese medicine decoctions usually have an unacceptable taste and are inconvenient to prepare, which can lead to reduced patient compliance and affect the treatment effect.

[0013] Therefore, there is an urgent need in this field for a practical treatment method that is easy to operate clinically and has reliable efficacy to treat diarrhea-predominant irritable bowel syndrome. Summary of the Invention

[0014] In view of this, the present invention provides a moxibustion medicine for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome by moxibustion, which can soothe the liver and regulate qi, warm the meridians and promote blood circulation, strengthen the spleen and resolve dampness, and can effectively prevent and / or treat diarrhea-predominant irritable bowel syndrome.

[0015] In a first aspect, the present invention provides a moxibustion remedy for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome by moxibustion, the moxibustion remedy comprising moxa wool, white peony root, kudzu root, phellodendron bark, astragalus root, bupleurum root, costus root, codonopsis root, atractylodes rhizome, licorice root, tangerine peel, cimicifuga rhizome, and chicken blood vine; preferably, the atractylodes rhizome is raw atractylodes rhizome, and the licorice root is processed licorice root.

[0016] In a second aspect, the present invention provides a method for preparing moxibustion medicine as described in the first aspect of the present invention, comprising the following steps:

[0017] 1) Preparation of mugwort floss: Dry mugwort leaves are crushed and sieved to obtain mugwort floss;

[0018] 2) Mixing: Grind all the other Chinese herbs except the mugwort floss into fine powder and mix them thoroughly with the mugwort floss.

[0019] In a third aspect, the present invention provides the use of the moxibustion medicine of the first aspect of the present invention in the preparation of a medicament for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome.

[0020] The moxibustion medicine of this invention can effectively treat diarrhea-predominant irritable bowel syndrome. It is easy to operate in clinical practice, and patients can also use it for daily prevention and health care, which is very convenient. Detailed Implementation

[0021] The present invention will now be clearly and completely described in conjunction with its embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments that can be obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0022] In this article, all parts refer to parts by weight, with weight calculated based on the weight of the crude drug or raw material. The parts by weight can be well-known pharmaceutical units of weight such as micrograms (μg), milligrams (mg), grams (g), and kilograms (kg), or fractions thereof, such as 1 / 10, 1 / 100, or multiples thereof, such as 10 times, 100 times, etc., and are not limited thereto.

[0023] Moxibustion is a commonly used treatment and health care method in the field of traditional Chinese medicine. It belongs to the external treatment method of traditional Chinese medicine. It is performed by burning the moxibustion medicine and placing it on the corresponding acupoints or diseased areas for fumigation. This method is simple to use, has good effects, and is commonly used in clinical practice.

[0024] Moxibustion medicine is the medicine or material used in moxibustion therapy. It is usually based on mugwort / moxa wool, but other Chinese herbal ingredients may also be added. By burning the moxibustion medicine, it acts on acupoints on the human body to achieve the effects of warming and unblocking the meridians, dispelling dampness and cold, and regulating qi and blood.

[0025] Diarrhea-predominant irritable bowel syndrome (IBS) is related to diet, emotions, and fatigue. Although it can be relieved by controlling diet or adjusting emotions, as a recurrent disease, it still causes many inconveniences for patients. Therefore, the inventors have developed a moxibustion medicine for diarrhea-predominant IBS. Using this medicine to perform moxibustion on corresponding acupoints has both preventive and health-preserving effects as well as good therapeutic effects, effectively preventing and relieving the related symptoms of diarrhea-predominant IBS.

[0026] In a first aspect, the present invention provides a moxibustion remedy for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome by moxibustion, the moxibustion remedy comprising moxa wool, white peony root, kudzu root, phellodendron bark, astragalus root, bupleurum root, costus root, codonopsis root, atractylodes rhizome, licorice root, tangerine peel, cimicifuga rhizome, and chicken blood vine.

[0027] In a preferred embodiment, the Atractylodes macrocephala is raw Atractylodes macrocephala.

[0028] In a preferred embodiment, the licorice is roasted licorice.

[0029] The following is a detailed description of the various Chinese medicinal herbs used in the moxibustion medicine of this invention:

[0030] Artemisia floss is a medicinal material made by repeatedly pounding and sifting the dried leaves of Artemisia argyi (a plant in the Asteraceae family) to remove leaf veins and impurities while retaining soft fibers. Its properties and channels are: pungent and bitter in taste, warm in nature; it enters the liver, spleen, and kidney channels. Its functions include: warming the channels and stopping bleeding, dispelling cold and relieving pain, regulating menstruation and calming the fetus, and dispelling dampness and relieving itching.

[0031] White peony root (Radix Paeoniae Alba), also known as white peony or golden peony, is the dried root of the Ranunculaceae plant used in traditional Chinese medicine. Its properties and channels are: bitter and sour in taste, slightly cold in nature; it enters the liver and spleen channels. Its functions include: nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening the liver and relieving pain, and calming liver yang.

[0032] Kudzu root (Radix Puerariae Lobatae), also known as dried kudzu, sweet kudzu, powdered kudzu, kudzu vine, or kudzu stem, is the dried root of the legume plant *Pueraria lobata* or *Pueraria lobata*. Its properties and channels are: sweet and pungent, cool in nature; it enters the spleen and stomach channels; its functions include: relieving exterior syndromes with pungent and cool properties, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, generating fluids and quenching thirst, and detoxifying alcohol.

[0033] Phellodendron bark (Phellodendri Chinensis Cortex) is the dried bark of the Phellodendron bark tree, a plant in the Rutaceae family. Its properties and channels are: bitter and cold in nature; it enters the kidney and bladder channels. Its functions include: clearing heat and drying dampness, purging fire and eliminating steaming heat, and detoxifying and healing sores.

[0034] Astragalus (Astragali Radix), also known as Huangqi, is the medicinal part of the root of *Astragalus membranaceus* or *Astragalus mongholicus*, both belonging to the genus *Astragalus* in the legume family. Its properties and channels are: sweet in taste and slightly warm in nature; it enters the spleen and lung channels. Its functions include: strengthening the spleen and replenishing the middle jiao, raising yang and lifting prolapse, benefiting wei qi and consolidating the exterior, promoting diuresis, and promoting tissue regeneration and detoxification.

[0035] Bupleurum (Bupleuri Radix) is the dried root of the plant *Bupleurum chinense* or *Bupleurum angustifolium*, both belonging to the Apiaceae family. Its properties and channels are: pungent and bitter in taste, slightly cold in nature; it enters the liver, gallbladder, pericardium, and triple burner channels. Its functions include: harmonizing the exterior and interior, soothing the liver and relieving depression, raising yang and lifting prolapse, and reducing fever and stopping malaria.

[0036] Costus root (Aucklandiae Radix), also known as Qingmuxiang, Wumuxiang, Nanmuxiang, and Guangmuxiang, is the dried root of the Asteraceae plant. Its properties and channels are: pungent and bitter in taste, warm in nature; it enters the spleen, stomach, large intestine, triple burner, and gallbladder channels. Its functions are: promoting qi circulation and relieving pain, strengthening the spleen and aiding digestion.

[0037] Codonopsis radix, also known as Shangdang, Huangshen, Shitoushen, and Zhonglingcao, is the dried root of several plants in the Campanulaceae family, including Codonopsis pilosula, Codonopsis lanceolata, Codonopsis chuanxiong, Codonopsis lanceolata, Codonopsis pilosula var. tuberosum, Codonopsis lanceolata var. globosum, and Codonopsis pilosula var. huimao. Its properties and channels are: sweet in taste and neutral in nature; it enters the spleen and lung channels. Its functions are: tonifying the middle energizer and replenishing qi, promoting the production of body fluids.

[0038] Raw Atractylodes macrocephalae (Rhizoma Atractylodis Macrocephalae), also known as Yu Shu, Dong Shu, Zhe Shu, and Zhong Shu, is the medicinal part of the rhizome of the Asteraceae plant Atractylodes macrocephalae. Its properties and channels are: bitter, sweet, and warm; it enters the spleen and stomach channels. Its functions include: strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus.

[0039] Prepared licorice root (Glycyrrhizae) is the root and rhizome of the licorice plant (Glycyrrhiza uralensis), belonging to the genus Glycyrrhiza in the legume family. Its properties and channels are: sweet and neutral; it enters the spleen, stomach, and lung channels. Its functions include: harmonizing the middle jiao (digestive system), relieving spasms, moistening the lungs and detoxifying, and harmonizing the effects of other herbs.

[0040] Dried tangerine peel (Citri Reticulatae Pericarpiu), also known as Guangchenpi, Chenjupi, Jupi, Hongpi, and Guangjupi, is the dried, mature pericarp of the Rutaceae plant and its cultivated varieties. Its properties and channels are: bitter and pungent in taste, warm in nature; it enters the lung and spleen channels. Its functions are: regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0041] Cimicifugae Rhizoma, also known as Longan Root, Zhouma, and Kulongya Root, is the rhizome of the Ranunculaceae plant Cimicifuga dahurica, Cimicifuga dahurica, or Cimicifuga dahurica. Its properties and channels are: pungent, sweet, and slightly cold; it enters the Lung, Spleen, Large Intestine, and Stomach channels. Its functions include: releasing exterior pathogens and promoting rash eruption, clearing heat and detoxifying, and raising Yang and lifting prolapse.

[0042] Chicken blood vine (Callerya reticulata (Benth) Schott), also known as blood wind vine, blood vine, or blood wind vine, is the dried stem of the legume *Callerya reticulata*. Its properties and channels are: bitter, sweet, and warm; it enters the liver and kidney channels. Its functions include: promoting blood circulation and nourishing blood, regulating menstruation and relieving pain, and relaxing muscles and tendons.

[0043] In the moxibustion medicine of this invention, the principal herbs are Astragalus membranaceus and Codonopsis pilosula, which can invigorate the spleen, replenish qi, and resolve dampness; the assistant herbs include two groups: one group of assistant herbs is Bupleurum chinense and Pueraria lobata, which can assist the principal herbs in soothing the liver and promoting qi circulation; the other group of assistant herbs is Atractylodes macrocephala and Citrus reticulata, which can relieve depression and invigorate the spleen; the adjuvant herbs include three groups: the first group is Cimicifuga foetida and Spatholobus suberectus, which can assist the assistant herbs in raising yang and invigorating the spleen; the second group is Paeonia lactiflora and Aucklandia lappa, which can remove the heaviness by promoting qi circulation and dispelling dampness; the third group is Artemisia argyi and Glycyrrhiza uralensis, which can harmonize the herbs; the guiding herb is Phellodendron chinense.

[0044] Those skilled in the art will understand that: adjuvant medicine is an auxiliary medicine, that is, it assists the principal and assistant medicines to enhance the therapeutic effect; guide medicine can be 1) a guiding medicine, which can guide the other medicines in the prescription to the affected area; or 2) a harmonizing medicine, that is, a medicine that has the function of harmonizing the other medicines. In this invention, the guide medicine is the guiding medicine. The adjuvant medicine or guide medicine can also be replaced by other Chinese medicines with the same medicinal properties, and it can be expected that the replaced Chinese medicine composition will still have the same efficacy.

[0045] In one embodiment, the moxibustion medicine of the present invention comprises 40-60 parts of moxa wool, 5-10 parts of white peony root, 5-7 parts of kudzu root, 5-8 parts of phellodendron bark, 10-15 parts of astragalus root, 12-15 parts of bupleurum root, 8-10 parts of costus root, 8-15 parts of codonopsis root, 10-15 parts of atractylodes rhizome, 6-8 parts of licorice root, 10-12 parts of tangerine peel, 4-6 parts of cimicifuga rhizome, and 10-12 parts of chicken blood vine, wherein the parts of each Chinese herb are by weight.

[0046] More specifically, in the moxibustion medicine, by weight, the moxa wool can be 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 parts; white peony root can be 5, 6, 7, 8, 9, or 10 parts; kudzu root can be 5, 6, or 7 parts; phellodendron bark can be 5, 6, 7, or 8 parts; and astragalus root can be 10, 11, 12, or 10 parts. 3, 14, 15 parts; Bupleurum can be 12, 13, 14, 15 parts; Costus root can be 8, 9, 10 parts; Codonopsis can be 8, 9, 10, 11, 12, 13, 14, 15 parts; Atractylodes macrocephala can be 10, 11, 12, 13, 14, 15 parts; Licorice can be 6, 7, 8 parts; Tangerine peel can be 10, 11, 12 parts; Cimicifuga can be 4, 5, 6 parts; Spatholobus suberectus can be 10, 11, 12 parts.

[0047] In one specific implementation, the moxibustion medicine of the present invention comprises 60 parts of moxa wool, 5 parts of white peony root, 5 parts of kudzu root, 5 parts of phellodendron bark, 15 parts of astragalus root, 12 parts of bupleurum root, 8 parts of costus root, 8 parts of codonopsis root, 10 parts of atractylodes rhizome, 6 parts of licorice root, 10 parts of tangerine peel, 4 parts of cimicifuga rhizome, and 10 parts of chicken blood vine.

[0048] In one embodiment, the moxibustion medicine can be a loose moxa wool ball, or it can be conical, cylindrical, disc-shaped, or sheet-shaped. When the moxibustion medicine is conical, it is called a moxa cone; when it is cylindrical, it is called a moxa stick; when it is disc-shaped, it is called a moxa tower; and when it is sheet-shaped, it is called a moxa wool sheet.

[0049] In one specific implementation, the moxibustion medicine is cylindrical.

[0050] In a second aspect, the present invention provides a method for preparing moxibustion medicine as described in the first aspect of the present invention, comprising the following steps:

[0051] 1) Preparation of mugwort floss: Dry mugwort leaves are crushed and sieved to obtain mugwort floss;

[0052] 2) Mixing: Grind all the other Chinese herbs except the mugwort floss into fine powder and mix them thoroughly with the mugwort floss.

[0053] In one embodiment, the preparation method of the moxibustion medicine further includes step 3): shaping the mixed Chinese medicine obtained in step 2).

[0054] In a preferred embodiment, the mixed Chinese medicine is shaped into a cone, cylinder, disc, or sheet.

[0055] In one specific implementation, the preparation method of the moxibustion medicine further includes step 4): further drying the moxibustion medicine; preferably, the drying treatment is sun-drying or oven-drying.

[0056] In a more specific embodiment, step 3) includes rolling the mixture obtained in step 2) into a cylindrical shape, then wrapping the moxa stick with moxa paper and pressing it firmly, and then gluing the edges of the moxa paper to secure it, ensuring that the moxa stick will not come apart, thus obtaining the product.

[0057] In a more specific embodiment, the rolling is performed using a wooden strip rolling machine or an moxa stick machine; the moxa stick paper is mulberry bark paper or pure cotton paper.

[0058] In a more specific embodiment, the adhesive fixing of the moxa stick paper is performed using an adhesive such as flour glue or paste.

[0059] In a third aspect, the present invention provides the use of the moxibustion medicine of the first aspect of the present invention in the preparation of a medicament for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome.

[0060] In one embodiment, the moxibustion medicine is used for warm moxibustion on Zusanli, Shenque, and Guanyuan acupoints; preferably, the warm moxibustion time is 10-30 minutes, more preferably 30 minutes.

[0061] The moxibustion medicine of this application can be used for warming moxibustion on Zusanli, Shenque and Guanyuan acupoints. Moxibustion on Zusanli helps to strengthen the spleen and stomach and replenish the middle qi; moxibustion on Shenque helps to warm the kidneys and consolidate the original qi; moxibustion on Guanyuan helps to replenish the original qi and strengthen the spleen and kidneys.

[0062] In one implementation, the moxibustion medicine is applied 2-3 times a week.

[0063] In a preferred embodiment, the moxibustion medicine is applied three times a week.

[0064] In one embodiment, the moxibustion medicine can also be mixed with water after peeling and used as an acupoint patch, applied to Zusanli, Shenque, and Guanyuan acupoints.

[0065] Example

[0066] Example 1: Preparation of moxa sticks

[0067] I. Preparation of Artemisia argyi

[0068] ① Screening: Based on the size, color, texture and other indicators of the mugwort leaves, they are screened and graded to remove impurities, yellow leaves and large branches, and select mugwort leaves of excellent quality.

[0069] ②Pulverizing: Pulverize the dried mugwort leaves. You can use tools such as a mortar and pestle to pulverize them by hand or by machine to break them into small pieces.

[0070] ③ Sieving: Pour the crushed mugwort powder into a sieve for sieving to obtain pure and fine mugwort floss, removing large particles, impurities, and dust.

[0071] II. Drug Compatibility and Mixing

[0072] Grind 5g of white peony root, 5g of kudzu root, 5g of phellodendron bark, 15g of astragalus root, 12g of bupleurum root, 8g of costus root, 8g of codonopsis root, 10g of raw atractylodes rhizome, 6g of prepared licorice root, 10g of dried tangerine peel, 4g of cimicifuga rhizome, and 10g of chicken blood vine into a fine powder, and mix it thoroughly with 60g of mugwort floss.

[0073] III. Molding of Moxa Sticks

[0074] ① Rolling: Place the mixed moxa wool and Chinese medicine powder into a special moxa stick mold, or use tools such as a wooden rolling machine to roll the moxa wool into a cylindrical shape. Alternatively, you can wrap the moxa wool by hand with mulberry paper or pure cotton paper, and press it appropriately during the rolling process to make the moxa stick tight and firm.

[0075] ② Adhesion: Use flour glue or similar adhesives to glue and fix the edges of the moxa stick paper to ensure that the moxa stick will not fall apart.

[0076] IV. Drying and Packaging of Moxa Sticks

[0077] - Drying: Place the prepared moxa sticks in a well-ventilated and dry place to dry, turning them over once a day until they harden and dry. You can also use methods such as baking to speed up the drying process.

[0078] - Packaging: Pack the dried moxa sticks in plastic bags or cardboard boxes and store them in a cool, dry place to prevent them from getting damp, moldy, or infested by insects.

[0079] Example 2: Clinical Trial

[0080] 1. Research Design

[0081] 1.1 Types of Research Design

[0082] This section employs a randomized, parallel-controlled, interventional study design.

[0083] 1.2 Sample size

[0084] The sample size for this study was the minimum number of cases required for clinical trials, 60 cases. Considering a dropout rate of 20%, this study used N1=N2=72 cases, for a total of 144 cases.

[0085] 1.3 Randomization Methods

[0086] A computer-generated randomization method was used, generating 144 random integers using the randbetween function in an Excel spreadsheet. Patients with odd-numbered visits were assigned to the experimental group, and those with even-numbered visits were assigned to the control group.

[0087] 1.4 Covert Grouping Methods and Processes

[0088] The randomization scheme was kept in an opaque envelope. The envelopes were opened in the order of enrollment, and the patients were assigned to groups according to the allocation scheme inside the envelopes.

[0089] 1.5 Blindness

[0090] This study is a randomized controlled clinical trial. During the study, the researchers, operators, and statisticians adhered to the principle of separation of duties.

[0091] 2. Research Subjects

[0092] 2.1 Subject Recruitment

[0093] 144 patients with diarrhea-predominant irritable bowel syndrome were recruited by posting recruitment advertisements at the Spleen and Stomach Diseases Clinic of Shaanxi Provincial Hospital of Traditional Chinese Medicine and by posting on WeChat Moments.

[0094] Recruitment period: August 2020 to February 2022.

[0095] 2.2 Diagnostic criteria

[0096] Based on the Rome IV criteria (irritable bowel syndrome), the diagnostic criteria for diarrhea-predominant irritable bowel syndrome are as follows:

[0097] 1. Recurrent abdominal pain or discomfort, with symptoms occurring for at least 3 days each month for the past 3 months.

[0098] 2. Combine two or more of the following:

[0099] - Symptoms are relieved after defecation;

[0100] - Changes in bowel movement frequency are accompanied by attacks;

[0101] - The condition is accompanied by changes in the appearance of the stool during an attack.

[0102] Symptoms that support a diagnosis of IBS include:

[0103] - Abnormal bowel movement frequency (less than 3 bowel movements per week, or more than 3 bowel movements per day);

[0104] - Abnormal stool characteristics (dry or hard stool, or pasty / watery stool);

[0105] - Difficulty defecating;

[0106] - Urgency to defecate, incomplete bowel movement, mucus in stool, and bloating.

[0107] 2.3 Inclusion Criteria

[0108] ① Meets the diagnostic criteria for diarrhea-predominant irritable bowel syndrome as described above in the Rome IV (Irritable Bowel Syndrome) criteria;

[0109] ② Age 18-60 years old;

[0110] ③ ≥ 12 years of education;

[0111] ④ Sign the informed consent form;

[0112] ⑤ Patients with no history of smoking.

[0113] 2.4 Exclusion Criteria

[0114] Insomnia can be associated with other mental illnesses (depression, anxiety, schizophrenia, bipolar disorder, etc.) or physical illnesses (pain, stroke, coronary heart disease, tumors, etc.).

[0115] Comorbid severe depression and anxiety (PHQ-9 depression screening ≥20; GAD-7 anxiety screening ≥19);

[0116] Those with serious or unstable, poorly controlled chronic diseases;

[0117] Patients with severe gastroesophageal reflux disease;

[0118] Patients with severe cardiopulmonary dysfunction;

[0119] A history of central nervous system diseases such as epilepsy, brain tumors, hemangiomas, encephalitis, and acute brain injury.

[0120] 3. Research Methods

[0121] 3.1 Intervention Measures

[0122] 3.1.1 Grouping

[0123] ① Traditional Chinese medicine moxa stick set, wherein the traditional Chinese medicine moxa stick is used three times a week, and each time it is used for moxibustion on one or more of the following acupoints: Zusanli, Shenque, Guanyuan for 30 minutes.

[0124] ②Waiting for treatment group: No intervention was given during the observation period, and intervention was given after the observation period ended.

[0125] 3.1.2 Basic Treatment

[0126] Both groups received basic education based on the diagnostic criteria for diarrhea-predominant irritable bowel syndrome (IBS) in the Rome IV (Irritable Bowel Syndrome) criteria:

[0127] During the first treatment, the therapist distributed an educational booklet on diarrhea-predominant irritable bowel syndrome to the patient and conducted approximately 30 minutes of education and communication to ensure the patient understood the content. The patient was then asked to try to follow the educational content during the study period.

[0128] 3.1.3 Treatment Course

[0129] Both groups were given 2 weeks of treatment / observation.

[0130] 3.1.4 Emergency Plan

[0131] During the study, all antidepressants, anxiolytics, antipsychotics, and mood stabilizers are prohibited. In the event of worsening diarrhea or abdominal pain during the study, the alternative treatment, based on ethical requirements, is Bacillus licheniformis tablets (manufacturer: Zhejiang Jingxin Pharmaceutical Co., Ltd.; batch number: S20083112; specification: 0.25g*6 tablets*4 blisters / box).

[0132] If subjects use alternative drugs during the study, the number of times and dosage of the alternative regimen must be recorded in detail.

[0133] 3.2 Observation Indicators (Symptom and Therapeutic Efficacy Evaluation Criteria)

[0134] 3.2.1 Recording and evaluation of main symptoms: Symptom assessment criteria:

[0135] ① Score for the degree of abdominal pain and bloating: 0 points for no symptoms; 1 point for symptoms only after being prompted, mild; 2 points for symptoms without prompting, moderate; 3 points for patients reporting the main symptom, severe.

[0136] ② Frequency of diarrhea score: 0 points for no symptoms; 1 point for less than 3 times a day, mild; 2 points for 3-5 times a day, moderate; 3 points for 6 times a day, severe.

[0137] ③ Ineffective: No improvement in symptoms. Improvement includes significant effect, effective, and progress; the overall improvement rate of each major symptom is calculated for symptom evaluation.

[0138] 3.2.2 The comprehensive efficacy evaluation criteria for main symptoms are as follows: The improvement percentage is calculated as: (Total score before treatment - Total score after treatment) / Total score before treatment × 100%. Symptom disappearance is considered a cure, with a symptom improvement percentage of 100%. A symptom improvement percentage ≥ 80% is considered significantly effective; 50% ≤ symptom improvement percentage < 80% is considered improvement; a symptom improvement percentage < 50% is considered ineffective; and a negative symptom improvement percentage indicates deterioration. The total effective rate is calculated using the number of cured cases and the number of significantly effective cases.

[0139] ① Clinical cure: The main symptoms and signs have disappeared or basically disappeared, and the efficacy index is ≥95%.

[0140] ②Significant effect: Major symptoms and signs are significantly improved, with 70% ≤ efficacy index < 95%.

[0141] ③ Effective: Major symptoms and signs show significant improvement, with 30% ≤ efficacy index < 70%.

[0142] ④ Ineffective: The main symptoms and signs show no significant improvement or even worsen, and the efficacy index is <30%.

[0143] 3.3.4 Evaluation Methods and Timing

[0144] Evaluation methods: Evaluation was conducted on the first outpatient visit, at weekly follow-up visits, and at the end of the experiment, based on the recording and evaluation of individual main symptoms, the comprehensive efficacy evaluation criteria for main symptoms, and the efficacy evaluation criteria for syndrome differentiation.

[0145] 3.4 Statistical Analysis

[0146] Data analysis was performed using SPSS 22.0 software. A two-sided α = 0.05 was used as the significance level, and P < 0.05 was considered statistically significant.

[0147] Descriptive analysis of baseline data: calculation of continuous data Median, interquartile range (P75-P25), minimum and maximum values; calculation of proportions and rates for count data.

[0148] Analysis of effect indicators: For quantitative data analysis, the mean and standard deviation of each test indicator were calculated. For comparisons within the same group (treatment and control), paired t-tests (or paired signed rank tests using the Wilcoxon Signed Ranks Test) were used. For comparisons between groups of quantitative data, t-tests (or calculations using 95% confidence intervals) were used. When data were not normally distributed and had unequal variances, the Mann-Whitney U rank-sum test was used.

[0149] 4. Research Results

[0150] 4.1 Baseline Data Analysis

[0151] This study included 144 participants, of whom 130 completed the entire trial.

[0152] Group 1: Experimental group (traditional Chinese medicine moxa stick group) 66 cases; Group 2: Control group (waiting for treatment group) 64 cases.

[0153] Table 1. Baseline Data Overview

[0154]

[0155] Note: ■ Chi-square test; ▲ Independent samples t-test;

[0156] The chi-square test results indicated that there was no statistically significant difference in gender distribution between the two groups.

[0157] The results of the two independent samples t-test indicated that there was no statistically significant age difference between the two groups.

[0158] The results of the Mann-Whitney U test indicated that there were no statistically significant differences in years of education or disease duration between the two groups.

[0159] 4.2 Evaluation of the efficacy of treatment for symptoms and syndromes of irritable bowel syndrome

[0160] 4.2.1 Comparison of main symptoms of irritable bowel syndrome between the two groups

[0161] Table 2. Analysis of Irritable Bowel Syndrome Before and After Treatment and Changes in Values

[0162]

[0163] Note: *Independent samples t-test, comparing data from the two groups after treatment / spontaneous remission, the difference is statistically significant.

[0164] △ Paired-samples t-test showed that the difference was statistically significant compared with the pre-treatment group.

[0165] The independent samples t-test was used, and the results showed that the baseline symptoms of the two groups were similar. The scores of the two groups of patients with irritable bowel syndrome before and after treatment were statistically significant. In addition, the scores of the experimental group and the control group after treatment were also statistically significant. This indicates that although irritable bowel syndrome can be improved by spontaneous remission, the use of the moxa sticks of traditional Chinese medicine in this application can more effectively relieve the related symptoms.

[0166] Furthermore, statistics show that among 66 patients who received continuous treatment with the herbal composition of this invention for one course (14 days): 42 cases achieved clinical cure, 9 cases showed significant improvement, 11 cases showed improvement, and 4 cases showed no improvement, with an overall effective rate of 77.27%. No recurrence cases were observed during the three-month observation period. In contrast, among the 64 patients in the control group who experienced spontaneous remission, 2 cases achieved clinical cure, 12 cases showed significant improvement, 23 cases showed improvement, and 27 cases showed no improvement, with an overall effective rate of 21.88%. Fifty of these patients experienced recurrence symptoms during the three-month observation period.

[0167] The above results all indicate that using the moxa sticks of traditional Chinese medicine described in this application can achieve a better therapeutic effect and can greatly reduce the recurrence rate.

[0168] 5. Summary

[0169] ① Baseline data

[0170] The baseline characteristics of the irritable bowel syndrome (IBS) group treated with moxibustion sticks were as follows: most patients were in their late 20s or early 30s, with a mean age of 40.77 ± 11.30 years and a median years of education of 14.70 ± 1.96 years. The baseline characteristics of the IBS control group were also as follows: most patients were in their late 20s or early 30s, with a mean age of 41.25 ± 10.95 years and a median years of education of 14.67 ± 1.99 years.

[0171] ② Therapeutic indicators

[0172] The intervention (using moxa sticks) reduced the symptom scores, syndromes, and recurrence rate within the experimental group.

[0173] in conclusion

[0174] Using the moxa sticks of the present invention can effectively improve the clinical symptoms of patients with irritable bowel syndrome and reduce the recurrence rate of irritable bowel syndrome.

Claims

1. A moxibustion remedy for preventing and / or treating diarrhea-predominant irritable bowel syndrome by moxibustion, said moxibustion remedy comprising: Artemisia argyi, Paeonia lactiflora, Pueraria lobata, Phellodendron chinense, Astragalus membranaceus, Bupleurum chinense, Aucklandia lappa, Codonopsis pilosula, Atractylodes macrocephala, Glycyrrhiza uralensis, Citrus reticulata, Cimicifuga foetida, and Spatholobus suberectus; preferably, the Atractylodes macrocephala is raw Atractylodes macrocephala; Preferably, the licorice is roasted licorice.

2. The moxibustion medicine as described in claim 1, wherein the moxibustion medicine comprises: Artemisia floss 40-60 parts, white peony root 5-10 parts, kudzu root 5-7 parts, phellodendron bark 5-8 parts, astragalus root 10-15 parts, bupleurum root 12-15 parts, costus root 8-10 parts, codonopsis root 8-15 parts, atractylodes rhizome 10-15 parts, licorice root 6-8 parts, tangerine peel 10-12 parts, Cimicifuga rhizome 4-6 parts, and Spatholobus suberectus 10-12 parts, where the number of each Chinese herb is by weight.

3. The moxibustion medicine as described in claim 1 or 2, wherein the moxibustion medicine comprises: The ingredients are: 60 parts Artemisia argyi, 5 parts Paeonia lactiflora, 5 parts Pueraria lobata, 5 parts Phellodendron chinense, 15 parts Astragalus membranaceus, 12 parts Bupleurum chinense, 8 parts Aucklandia lappa, 8 parts Codonopsis pilosula, 10 parts Atractylodes macrocephala, 6 parts Glycyrrhiza uralensis, 10 parts Citrus reticulata, 4 parts Cimicifuga foetida, and 10 parts Spatholobus suberectus. The number of parts for each Chinese herb is by weight.

4. The moxibustion medicine according to any one of claims 1-3, wherein the moxibustion medicine is conical, cylindrical, disc-shaped, or sheet-shaped.

5. The method for preparing the moxibustion medicine according to any one of claims 1-4, comprising the following steps: 1) Preparation of mugwort floss: Dry mugwort leaves are crushed and sieved to obtain mugwort floss; 2) Mixing: Grind all the other Chinese herbs except the mugwort floss into fine powder and mix them thoroughly with the mugwort floss.

6. The method as described in claim 5 further includes step 3): shaping the mixed Chinese medicine obtained in step 2).

7. The method of claim 6, wherein the mixed Chinese medicine is shaped into a conical, cylindrical, disc-shaped, or sheet-like shape.

8. Use of the moxibustion medicine as described in any one of claims 1-4 in the preparation of a medicament for the prevention and / or treatment of diarrhea-predominant irritable bowel syndrome.

9. The use as described in claim 8, wherein the moxibustion medicine is used for warm moxibustion on Zusanli, Shenque, and Guanyuan acupoints; preferably, the warm moxibustion time is 10-30 minutes, more preferably 30 minutes.

10. The use as described in claim 8 or 9, wherein the moxibustion medicine is applied 2-3 times a week; preferably, the moxibustion medicine is applied 3 times a week.

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