Li Lin, Xu Ping, Wang Mingyue, Pan Lili, Xu Qun, Xu Hongyan
Fund Project: 2023 Provincial Traditional Chinese Medicine Science and Technology Plan (No.: 2023ZL534)
*Corresponding author: Xu Ping,Email:m13505819444@163.com
- Department of Cardiovascular Diseases, Hangzhou Traditional Chinese Medicine Hospital, Zhejiang University of Traditional Chinese Medicine
Abstract: Objective To analyze the clinical effect of gastrointestinal dysfunction in patients with yang deficiency water-based generalized heart failure. Methods 90 patients with gastrointestinal insufficiency were selected from January 2023 to December 2023, and were randomly divided into experimental group, control group, and placebo group by random numerical table method. Finally, 30 cases were included in the test group, 30 cases in the control group and 30 cases in the placebo group. The control group received routine nursing, the experimental group received intervention with traditional Chinese medicine on the basis of routine nursing, and the placebo group received intervention with non-traditional Chinese medicine on the basis of routine nursing. The treatment effect of heart failure, the integration of traditional Chinese medicine syndrome, and the effect of gastrointestinal function were compared among the three groups. Results The baseline data of the three groups of patients before intervention were comparable (P>0.05). After the intervention, the efficacy of heart failure treatment and gastrointestinal function in the experimental group was better than that in the control group and the placebo group, and the difference was statistically significant (P<0.05). The TCM syndrome score in the experimental group was lower than that in the control group, and the difference in the placebo group was statistically significant (P<0.05). Conclusion The gastrointestinal function of the patients with Yang-deficiency water-distinct type heart failure can be improved, and the recovery of the patients is worth promoting.
Key words: heart failure, yang deficiency water-type; Inadequate gastrointestinal function; a cake; Traditional Chinese medicine appropriate techniques; nursing
congestive heart failure (CHF) Heart failure, abbreviated as heart failure, is a group of clinical syndromes caused by impaired ventricular filling or ejection ability due to abnormal heart structure or function. It is a severe and terminal stage of various heart diseases. Recent epidemiological investigations [2-3] have shown that the 5-year mortality rate of heart failure patients is as high as 67%, which is comparable to some malignant tumors. In clinical practice, CHF patients often experience decreased appetite, nausea, vomiting, post-meal bloating, acid reflux, belching, and other digestive system symptoms, which worsen with the severity of heart failure. Dysfunction of the digestive tract in heart failure patients can worsen the patient’s condition, seriously affecting the prognosis, and eventually developing into cachexia. Traditional Chinese medicine believes that heart failure belongs to the category of “asthma” in traditional Chinese medicine, which is a syndrome of deficiency of the essence and deficiency of the essence. The deficiency of the essence is deficiency of qi, yin, and yang, while the deficiency of the essence is blood stasis, water obstruction, and phlegm. The differentiation of the syndrome is mostly the type of yang deficiency and water overflow. The treatment should be warm-yang water. The noodle cake is filled at the Shenque acupoint, which can promote the circulation of various meridians, allowing drugs and properties to be absorbed through the skin. Stimulating this acupoint can regulate the body’s meridians and blood, thereby treating systemic diseases and achieving the therapeutic purpose. This study analyzed the clinical effect of gastrointestinal dysfunction in patients with Yang deficiency and water-induced generalized heart failure, in order to improve the quality of life of heart failure patients and promote recovery.
1 Information and methods
1.1 General information
A total of 90 patients with Yang-deficiency water generalized heart failure were selected from the cardiovascular department of our hospital from January 2023 to December 2023. They were randomly divided into experimental group, control group, and placebo group by random numerical table method, with 30 cases in each group. Diagnostic criteria: 1 Diagnostic criteria for heart failure: Refer to the “Framingham Standard” [5] formulated by the Cardiovascular Disease Branch of the Chinese Medical Association and the Editorial Committee of the Chinese Journal of Cardiovascular Diseases. Main criteria: paroxysmal nocturnal dyspnea; Jugular veins are raged; lung rales; Acute pulmonary edema; cardiac enlargement; Third heart sound: horse-running rhythm; Increased venous pressure (>16 cmH2O). Minor criteria: ankle edema; Nighttime coughing; difficulty breathing after activity; Hepatic enlargement; pleural effusion, lung capacity decreased to 1/3 of the maximum lung capacity; Tachycardia (> 120 beats/min). The primary or secondary criteria are: Weight loss of ≥4.5Kg after 5 days of heart failure treatment. The diagnosis is established if two primary criteria are met, or if one primary criterion and two secondary criteria are met. 2 Diagnostic criteria for gastrointestinal dysfunction: Based on the 1995 re-examination of multiple organ dysfunction (MODSE) disease staging diagnosis and severity scoring criteria and the diagnostic criteria for elderly multiple organ dysfunction syndrome (Trial Draft, 2003), the following are comprehensively formulated: (1) Abdominal bloating and reduced or absent bowel sounds; (2) Symptoms of indigestion such as bloating, poor appetite, nausea, vomiting, belching, diarrhea, and constipation; (3) Paralytic intestinal obstruction; (4) For stress ulcer bleeding or perforation, the diagnostic criteria are gastric fluid occult blood test +++ or above, excluding ulcer bleeding, gastrointestinal mechanical damage, and oral and pharyngeal bleeding. (5) Necrotizing enteritis, spontaneous gallbladder perforation. If one of the above conditions is met, it can be diagnosed as gastrointestinal insufficiency. 3 Traditional Chinese medicine diagnostic criteria: Referring to the “Guiding Principles for Clinical Research of Traditional Chinese Medicine New Drugs” diagnostic criteria for Yang-deficiency water-type generalized heart failure [6]: Main symptoms: (1) Lower limb edema; (2) Chest tightness and pain; (3) Palpitations; (4) Shortness of breath. Second, (1) oliguria; (2) Exposure of neck veins; (3) The underside of the block; (4) Bluish lips; (5) Fatigue and weakness; (6) Abdominal distension and poor appetite; (7) Fear of cold and cold limbs; (8) Dark complexion; (9) Occasionally coughing with white sputum. Tongue veins, with stasis, bruises, or dull tongue texture, deep, thin, or astringent pulse. It is necessary to have at least 2 main and secondary symptoms, and the diagnosis can be confirmed by combining the tongue and pulse. Inclusion criteria: 1 Meet the above-mentioned Western medical diagnostic criteria and traditional Chinese medicine diagnostic criteria; 2 Age between 18 and 85 years old; 3 The patient or family members give informed consent and sign the informed consent form. Exclusion criteria: 1 Chest pain caused by trauma or other reasons; 2 Those with other malignant diseases or severe liver and kidney dysfunction; 3 Pregnant or lactating women; 4 Allergic to umbilical therapy; 5 Those with skin damage, scars, or lumps on the abdomen; 6 Patients with neurological, hematopoietic, and immune system diseases; 7 Those who have recently received other medications; 8 Those who cannot communicate normally or have mental illness; 9 Not willing to cooperate with the researchers. This study was approved by the Ethics Committee of Hangzhou Traditional Chinese Medicine Hospital (Approval No. 202211242207000028580)
1.2 method
1.2.1 Control group: Routine treatment and care for heart failure, such as cardiotonic drugs, diuretics, and coronavirus expansion, guidance on a low-salt, low-oil healthy diet, quitting smoking and drinking, and ensuring proper sleep. If the patient has primary hypertension and diabetes, appropriate antihypertensive and hypoglycemic drugs should be given for treatment.
1.2.2 Test group: On the basis of routine treatment and care for heart failure, a noodle-cake umbilical therapy is given, and the formula is composed of: Dried ginger, cinnamon, fennel, tangerine peel, assine, etc. Select the Shenque acupoint, disinfect the local acupoint (with 75% alcohol), fill the navel hole with powder, place a temperature controller (pay attention to the temperature controller in contact with the heated part), place a navel bowl (adjust the remote control according to the size of the navel), and fill the medicine hole with powder. Ignite the mugwort column (ignite the bottom) and place it above the medicine hole of the navel bowl, burning three mugwort columns in total. (When adding moxa stakes, directly use the ignited moxa stake to push down the moxa ash and place it above the medicine hole. The moxa ash does not need to be cleaned) Infra-red light on the abdomen. Pay attention to observing the patient’s treatment during the burning process of the moxa stake: Facial expression, local skin heat sensation, bloating, abdominal pain, chest tightness, palpitations, etc. Record the process of the patient’s gas absorption during the treatment. After the treatment, seal the powder on the navel with a patch for 2 hours, and clean it up after 2 hours. Once a day, moxibustion on two columns each time, a total of 60 minutes, a course of 3 days, rest for 1 day after the end of one course of treatment, and continue for 2 courses of treatment, a total of 7 days.
1.2.3 Placebo group: On the basis of the conventional treatment, the navel therapy without medication was given, and the usage and treatment course were the same as those of the test group.
1.3 evaluation index
1 Evaluation criteria for the efficacy of heart failure treatment [7]:
Significant effect: Complete disappearance of clinical manifestations, normal electrocardiogram.
Effective: Clinical manifestations improve, and electrocardiograms tend to be normal.
Ineffective: No significant improvement in clinical manifestations, abnormal electrocardiogram.
2 Traditional Chinese medicine syndrome score [8]:
The evaluation was conducted according to the “Evaluation Method for Clinical Symptoms of Traditional Chinese Medicine”. The symptoms of traditional Chinese medicine include chest tightness, chest pain, shortness of breath, palpitations, and fatigue. Each symptom is divided into 4 levels from mild to severe, with a score of 0 to 6.
3 Evaluation criteria for gastrointestinal function efficacy: It was formulated in accordance with the 1995 re-adjusted MODS disease staging diagnosis and severity rating criteria and the “Clinical Research Guidelines for the Treatment of Pymang with Traditional Chinese Medicine New Drugs”. The scores are based on the severity of six major symptoms: abdominal distension, bowel sounds, nausea and vomiting, gastric fluid occult blood test, loss of appetite, and constipation. Each item is worth 1-3 points, and the higher the score, the more severe the symptoms.
1.4 Mass Control
The study subjects were selected strictly according to the inclusion criteria and exclusion criteria set by the study. A random number was generated by an independent researcher through a computer, placed in a sealed opaque envelope, and registered and assigned patients according to the order of hospitalization, according to the random number table method. Find out possible problems in the scheme through pre-test and further improve it; At the same time, in the clinical trial process, the three groups should ensure that the other routine treatment and nursing measures are as consistent as possible except for the different umbilical therapy, and reduce the confusion bias. The researchers should supervise the work to ensure the smooth implementation of the research plan, and check and verify the collected original data to ensure the accuracy and completeness of the data.
1.5 statistical method
Use SPSS25.0 Perform statistical analysis, and describe the category data in general data such as gender and cardiac function classification by frequency and percentage; The quantitative data, such as age, are described by means and standard error; The paired t-test was used for comparison before and after the intervention. The measurement data of the comparison between groups were analyzed by variance or the rank sum test of multiple samples. The comparison between two groups was corrected by Bonferroni, and the counting data were tested by chi-square test. The comparison of grade data was performed by Kruskal-Wallis rank sum test, and the difference was statistically significant with P<0.05.
- results
(I) Baseline comparison of general patient data
One case was dropped out due to treatment refusal in the placebo group and one case was dropped out due to allergies in the control group. A total of 88 patients were finally included in this study. The general data baseline is balanced and comparable, as shown in Table 1.
Table 1: Baseline comparison of general data of three groups of patients [cases (percentage,%)]
| Project | Category | Test group (n = 30) | Control group (n = 29) | placebo group
（n=29） |
Statistic value | P |
| sex | Man | 21(70) | 17 (58.6) | 14(48.3) | 2.883a) | 0.237 |
| Woman | 9(30) | 12(41.4) | 15(51.7) | |||
| Age (years) | 74.00±9.91 | 74.69±7.77 | 76.76±8.01 | 0.810b) | 0.448 | |
| Course of disease (years) | 2.07±2.24 | 3.31±3.33 | 3.38±4.48 | 1.184b) | 0.311 | |
| cardiac function classification | I | 0(0) | 0(0) | 0(0) | 1.596c) | 0.450 |
| II | 0(0) | 0(0) | 0(0) | |||
| III | 23(76.7) | 23(79.3) | 19(65.5) | |||
| Ⅳ | 7(23.3) | 6(20.7) | 10(34.5) |
Note: a) The value of γ2 isb) F value,c) H value
()二)The comparison of the treatment effect of heart failure in three groups after intervention
The effect of heart failure treatment after intervention in the three groups is shown in Table 2, and the difference is statistically significant (Z=59.255, P<0).001). Further comparison of the three sets of data shows that: The difference between the experimental group and the control group and the placebo group in the effective rate of intervention was statistically significant (P=0.02<0.01, P<0).001 () The difference between the control group and the placebo group was statistically significant (P<0.001).
Table 2 Comparison of the treatment effect of heart failure after intervention in three groups (n,%)
| Group | apparent effect | effective | Not valid | total efficiency |
| Test group (n = 30) | 22 (73.3) | 8 (26.7) | 0 (0) | 30 (100) |
| Control group (n = 29) | 5(17.2) | 20(69.0) | 4(13.8) | 25（86.2）a |
| Placebo group (n=29) | 0(0) | 10(34.5) | 19(65.5) | 10（34.5）a）b） |
| Z/χ2 | 49.721 | 36.201 | ||
| P | ＜0.01 | ＜0.01 |
Note: a) represents a ratio of P<0.01 compared to the test group, b) represents a ratio of P<0.001 compared to the control group.
(III) The comparison of TCM syndrome scores before and after the intervention of the three groups
Before the intervention, there were no statistically significant differences in the three groups of patients with palpitations, frequent coughing, short urine output, facial floating and tarsal swelling, cold shape, cold aversion, and low back pain and loose stools (P>0).05 After the intervention, the scores of palpitations, frequent cough, short urination, facial floating and tarsal swelling, cold shape, and low back pain and loose stools in the experimental group were all lower than those in the control group and the placebo group, and the difference was statistically significant (P<0.05).
Table 3 Comparison of TCM syndrome scores before and after intervention in the three groups
| Group | shortness of breath | Chest tightness pain | palpitations | mental fatigue | Low urine | facial limb swelling | |
| Test group (n = 30) | Before the intervention | 3.93±0.83 | 3.33±1.21 | 3.07±1.55 | 5.2±1 | 2±1.05 | 3.4±1.3 |
| After the intervention | 1.80±0.81b | 0.93±1.26b | 0.80±1.00 ab | 2.6±1.19b | 0.53±1.17b | 0.4±0.81ab | |
| Control group (n = 29) | Before the intervention | 3.93±0.65 | 3.10±1.47 | 3.24±1.24 | 4.83±1 | 1.86±1.3 | 3.38±1.42 |
| After the intervention | 2.28±0.88 | 1.52±1.02 | 1.66±1.32 | 3.1±1.01c | 0.83±1.14 | 1.17±1.14 | |
| Placebo group (n=29) | Before the intervention | 3.72±1.03 | 3.10±1.26 | 3.1±1.37 | 5.03±1.48 | 1.86±1.41 | 2.9±1.65 |
| After the intervention | 2.76±0.99 | 2.07±1.00 | 2±1.31 | 3.93±1.36 | 1.52±1.57 | 1.72±1.49 | |
| Statistics (before 3 groups of interventions) | 0.582 | 0.300 | 0.127 | 0.739 | 0.119 | 1.102 | |
| P | 0.561 | 0.742 | 0.881 | 0.480 | 0.888 | 0.337 | |
| Statistics (after 3 groups of interventions) | 8.481 | 7.854 | 7.663 | 9.274 | 4.393 | 9.485 | |
| P | ＜0.01 | ＜0.01 | ＜0.01 | ＜0.01 | ＜0.05 | ＜0.01 | |
Note: a indicates that the ratio between the test group and the control group is P<0.05, b indicates that the comparison between the test group and the blank control group is P<0.05, and c indicates that the comparison between the control group and the blank control group is P<0.05.
(IV) The comparison of gastrointestinal function effect after the intervention of three groups
The efficacy of gastrointestinal function after intervention in the three groups of patients is shown in Table 4. The effective rate of treatment in the experimental group (100%) is greater than that in the control group (64.8%) and the placebo group (14.7%), with statistically significant differences (Z=57.443, P<0.001). Further comparison of the three sets of data shows that: The difference in the effective rate of gastrointestinal function after intervention was significant between the test group and the control group and the placebo group (P<0.001). The difference between the control group and the placebo group in the effective rate of gastrointestinal function after intervention was statistically significant (P<0.01).
Table 4 Comparison of gastrointestinal function effects after intervention in three groups
| Group | apparent effect | effective | Not valid | efficient |
| Test group (n = 30) | 16 (53.3%) | 14 (46.7%) | 0 (0) | 30 (100%) |
| Control group (n = 29) | 2 (6.9 per cent) | 14 (48.3%) | 13 (44.8%) | 16（55.2%）a |
| Placebo group (n=29) | 0 (0) | 3 (10.3%) | 26 (89.7%) | 3（10.3%）b |
| Z/χ2 | 52.792 | 48.036 | ||
| P | <0.01 | <0.01 |
Note: a represents the ratio of P<0.01 to the test group, and b represents the ratio of P<0.01 to the control group.
3 discussion
Heart failure belongs to the category of “asthma” in traditional Chinese medicine. Traditional Chinese medicine believes that the basic pathogenesis of heart failure is the deficiency of heart yang and qi, with blood stasis and water stagnation as the standard. Weakness of the heart’s yang qi can cause weak heartbeat, leading to blood stasis and poor circulation of qi, resulting in internal water intake. At the same time, blood stasis and water consumption can further damage yang qi, forming a vicious cycle. Therefore, the deficiency of heart yang qi is the foundation, and blood stasis and water cessation are the standard, which is the etiology and pathogenesis of heart failure [9]. Chinese medicine often conducts disease differentiation and treatment from the perspective of the overall view of the five viscera [10]. According to the theory of intergeneration, fire produces earth, and the heart and spleen are mother-child relationships. “The heart is the mother of the spleen, and the heart is weak, and the spleen is thin, and the flesh is thin” [12]. From this, it can be seen that the heart and spleen are closely related, and the spleen relies on the nourishment of the heart and blood. A deficiency of heart qi can lead to the loss of spleen health and inability to nourish the limbs. If the function of the spleen’s water transport and fluid is abnormal, it will produce the pathological products of water-damp phlegm, and the phlegm and water-damp stagnation of the heart meridian is one of the pathogenic factors of heart failure.
The heart and the small intestine are intertwined [13]. The heart is the yang organ, the main blood vessels, and is conducive to the normal operation of the physiological functions of the small intestine; The small intestine is filled with substances and secretes clear and turbid, and it turns red to the heart, ensuring “heart yin” and “heart yang”. Conversely, there is inflammation under the heart fire, and red urine and even bloody stools can be seen; Small intestinal heat can be caused by menstrual inflammation, and symptoms such as irritability and red tongue can be seen. The small intestine is weak and cold, and there is a lack of water and grains. Over time, the heart and blood are insufficient, and the mind and spirit are not nourished. Symptoms such as palpitations, lack of appetite, and fatigue may occur. It can be seen that heart failure can cause symptoms of gastrointestinal discomfort.
According to the principle of “the meridians pass through, and the treatment reaches”, the Shenque acupoint can connect all the meridians, so stimulating this acupoint can regulate the meridians and blood of the whole body, thereby treating systemic diseases. The traditional Chinese medicine composition of the noodle cake is dried ginger, cinnamon, fennel, tangerine peel, and assin. Dried ginger [14] belongs to the heart meridian and has the effects of revitalizing yang, saving rebelliousness, warming the middle, and dispelling cold. fennel and cinnamon are warm in nature, bitter in taste, promote the twelve meridians, and have the effects of tonifying fire and dispelling yang, warming and dispelling cold, regulating qi and blood, and dispelling dampness and cold. Chenpi [16] has the function of regulating qi, invigorating the spleen, and removing dampness and phlegm. The firepower of the cone-shaped moxibustion stick increases from small to large, and then decreases from large to small, which can make the qi and blood of a person rise and fall like the sea, and the firepower of moxibustion is slow and deep. Wheat nourishes deficiency and has the functions of nourishing the heart, nourishing the kidneys, promoting blood circulation, and invigorating the spleen. Therefore, this study can relieve the symptoms of gastrointestinal discomfort in the gastrointestinal function of Yang deficiency and water-induced generalized heart failure.
- summary
The incidence and mortality rate of heart failure are high, and patients with heart failure often have gastrointestinal dysfunction, which seriously affects the patient’s condition and prognosis. Western medicine treatment mainly involves oral medication, but severe gastrointestinal dysfunction can affect the effectiveness of oral medication. Even if the dosage is increased, the therapeutic effect cannot be achieved. Therefore, this study uses the noodle cake to improve the gastrointestinal function of patients with Yang deficiency and water-based heart failure, and promote the recovery of patients, which is worth promoting.
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