| Objective1. By the investigation of the knowledge, behavior and attitudes of patients with CHF in Guangdong Province towards the proper diet and TCM medicated diet, this research evaluate the patients nutrition status and dietary quality, so as to provide the basis for the treatment of TCM medicated diet for patients with CHF.2. To construct a valid, high-consensus, and easily-promoted TCM medicated diet program combining with modern nutrition theory, by studying the ancient and modern Chinese medicine medicated diet books and literature, applying TCM dialectical logic to select the medicated diet therapy of CHF.3. The prospective randomized controlled test is chosen to evaluate the effect of medicated diet program on CHF, which will promote the TCM medicated diet and provide basis for building the TCM chronic disease management system for CHF.Methods of Research1. The research of CHF patients’ diet statusMake a questionaire on reasonable diet and the knowledge of, attitudes towards, and the respective behavior of TCM medicated diet, and record the food taken in 24 hours. Choose randomly 197 patients with CHF in Guangdong Provincial TCM Hospital and ask them to complete the questionaire face to face. At the mean time, collect and record the data of the patients’ height and weight, serum albumin, hemoglobin and serum uric acid. Track the patients’ eating the same day by telephone interview 3days in a row, and fill the 24-hour food recording table. Calculate the intake of various nutrients from the patients’diet using nutrition calculator software V2.70 (standard version). Input and analyze the data using SPSS17.0 software, comparing with the DRIs formulated by China Nutrition Association and the report of 2002 National Nutrition (diet) Survey to evaluate the CHF patients’ construction and quality of diet.2. Construction of the program of the treatment of TCM medicated diet for CHFIncluding mainly literature data studying and dietary therapy program:(1)Ancient Classic LiteratureUsing the upgraded version of "China Medical Code" as a research tool, and using "edema", "palpitations," "asthma," "heartache," "diuretic", "heart failure" as the key words to search the contents related to CHF below the terms of "Herbal dietary treatment", "comprehensive prescription book", "single prescription test book", "comprehensive medicine", "general study on regimen" and "medicated diet".(2)Modern literature studya:search data from the database such as CBM, VIP, CNKI, WanFang data etc., using "heart failure", "heart-failure", "dysfunction of heart" etc. as the search terms, and using "dietary treatment", "medicated diet", "dialectical medicated diet" as the search terms to do a second search to study the literature on medicated diet treatment for CHF.b:refer to 5 classic work such as China’s medicated diet, Chinese healthy diet canon, traditional Chinese medicine dietary recuperation study, Chinese clinical medicated diet treatment study, dialectical study on Chinese medicated diet, dictionary of Chinese medicated diet, combining the pathogenesis, treating principles and methods of heart failure, look up and record the contents of medicated diet for heart failure. Classify the documents which are in accordance with the inclusion criteria and exclusion criteria, record the information by excels software for descriptive analysis.(3)Document Sorting and filteringAccording to the main symptoms of chronic heart failure, adhering to the principles of "simple, convenient, efficiency, experience, honesty", choose the easy-to-learn medicated prescriptions for the development of medicated diet plan.(4)Construction of TCM medicated diet programCombining modern nutrition theory, make a nutritional assessment on the medicated diet, ultimately develop medicated diet programs of Chronic Heart Failure and print a manual of medicated diet treatment.3. Clinical study on the treatment of TCM medicated diet for CHFSelect 68 CHF inpatients and outpatients from Guangdong Provincial TCM Hospital. Apply the prospective randomized controlled method, divide the patients randomly into medicated diet group and control group. Both groups accepted standard western medication; the patients in the mediated diet group take a TCM dialectical diagnosis, receive chronic heart failure TCM medicated diet nursed Handbook and accept manual interpretation and education. The patients need to make and take the medicated diet according to the recipe made by the prescription following the handbook at least once a week, and every two week there is a follow-up and guidance. The control group of patients discharged from hospital or in the first missionary clinic are instructed about the ordinary diet education, without any intervention during the treatment, make follow-up visit once a month. Observe the patients for 3 months, and compare the two groups patients, as well as the before and after status of each group of patients; evaluate the patients’ dietary pattern, nutrient intake, cardiac function, readmission rates, NT-proBNP, TCM symptom score, Minnesota life quality scores etc. before and after the treatment. Data processing use SPSS17.0 software package, count data use x2 test, measurement data use t test or nonparametric rank sum test.Results1. Study on CHF patients’ diet status quo(1)Social demographic dataCHF patients in this study have a average age of 61.05±9.29 years old, in which male to female ratio is 1.43:1, and 88.3% of patients are in the native place of Guangdong Province, and 74.1% of the patients have secondary school education level and below. The average monthly personal income is of 2000-4999 Yuan range, and the monthly spending is less than 2,000 yuan range. Occupational distribution:manual workers to mental workers ratio is 1.29:1.(2) Disease characteristics dataFrom the composition of primary cardiac disease, the highest proportion is coronary heart disease, followed by is hypertension, dilated cardiomyopathy, rheumatic heart disease, hypertrophic cardiomyopathy, valvular heart disease, other heart disease, and heart rhythm disorders. From the Composition of NYHA function, heart function class II take up the highest proportion. The average duration of the patients are 4((1.5,7.0)) years. From the distribution of TCM type, the highest proportion is Qi deficiency and blood stasis syndrome, followed by syndrome of Yang deficiency and blood stasis, deficiency of both Qi and Yin and blood stasis syndrome, Qi deficiency and blood stasis with water stop, and Yang deficiency and blood stasis syndrome with edema. On Western medication, β-blocker usage is up to 74.6%, followed by ACEI or ARB, aldosterone receptor antagonists, and the diuretics has the lowest usage.(3) knowledge of, attitude towards, and behavior of Reasonable dietPatients with chronic heart failure are lack of knowledge of proper diet proper diet on the whole. They have a low degree of understanding of proper diet whereas have a need for and trust in the dietary instruction. When picking food, they tend to choose according to food prices and next the nutrition and function.In daily salt intake,11.8% patients’ daily salt intake is less than 3g,49.2% is 3-5,31.0% is 6-9g, and 8.0% of the patients take in more than 9g salt daily. With respect to the daily water intake,84.2% patients drink more than 1L, most of the patients daily drink 1.5-2L water, basically in accordance with the Recommended Amount of China’s Dietary Guidelines and 2014 China heart failure treatment guidelines. In pickling and the fried food intake, most of the patients said eat them occasionally or never eat, which indicate that patients can recognize the unhealthness of pickled food and fried food, and to consciously reduce their intake. In food arrangement, most of the patients can obey the principle of "meat and non-meat in half". But there is low frequency of eating coarse grains and fruits.(4) knowledge of, attitude towards, and behavior of medicated dietOnly 4.1% of patients in the survey expressed "ignorant" about medicated diet, but in the choice of food there are 59.4% of the patients "usually do not" or "never" pay attention to the nutritional value and special effects of food, which shows that CHF patients have a relatively less understanding of medicated diet. It is likely that they only understand commonsense, but still lack of the knowledge of medicated dietary treatment. There are 87.5% of the patients believing the Chinese medicated diet can improve the condition of heart failure, and among those who express distrust the medicated diet, patients with class IV heart function take up the largest proportion.66.5% of the patients expressed willing to adopt the medicated dietary treatment first while feeling uncomfortable, but this proportion shrinked with the elevation of heart function classification. There are 89.2% of the patients willing to accept the guidance of TCM medicated diet, and regardless of the level of the level of cardiac function; and among those patients, more are willing to accept the dietary interventions than those who do not want so, but this proportion decreases along with the rising of heart function classification.Only 9.1% of the patients in the survey have never had medicated diet. On the consumption frequency, less than 2days per week takes up the largest proportion (39.1%), those who have medicated diet every day is least (1.1%). The daily consumption frequency of 1 meal per day are the most (65.4%). Heart failure patients’knowledge of medicated dietary treatment comes mainly from television programs about health, whereas only 13.4% from the doctors, which suggest that health care professionals often overlook dietary management in the treatment of chronic heart failure. Dietary forms readily accepted by patients are soup, medicated tea, medicated orridge, cream and medicated liquor. Most commonly used medicinal herbs in the production of medicated diet are:wolfberry, ginseng, codonopsis, panax, yam, eucommia, red ginseng, fingers peaches, dates, astragalus, angelica, radix, cistanche, arrowroot, heterophylla, etc.(5)CHF patients’ nutritional status and dietary qualitya:Analysis of the nutritional status of patients with CHFThe tested patients’BMI are 22.91+3.87 kg/m2, indicating the CHF patients’overall nutrient level are normal. But with the decrease of heart function, the patients’ BMI index showed a downward trend. According to the laboratory indicators,61.9% of the CHF patients’ serum albumin are less than 40g/L, while the average quantity is 38.28±4.58g/L. In the survey, The prevalence rate of anemia of CHF patients are 37.1%, and the average quantity of hemoglobin in male patients is 124.85±19.98g/L, female patients 120.22±21.84g/L, showing a reduced hemoglobin levels along with a decline in heart function. Hyperuricemia patients account for 56.9% (112/197), and the average level of total serum uric acid is 476.98± 168.09umol/L. The serum uric acid level rises when NYHA heart function classification rises.b. Dietary patterns and nutrient intakesStudies have shown that CHF patients’ daily energy intake is in line with the recommended amount from Chinese dietary requirements. Compared with DIRs, CHF patients’ dietary pattern are characterized as follows:the intake of cereals, vegetables, poultry meat and eggs can meet the requirements of DIRs; intake of beans, fish, fruits, and dairy food is low, together with a high intake of fats and oils. Comparing with the National Nutrition Survey in 2002, CHF patients’ cereal intake basically keep the balance with the population level; beans, vegetables, fruits, dairy intakes are higher than the population level; poultry meat, fish, eggs, oil and fat intake are lower than the population level.Referring to Chinese Dietary Reference Intakes (DRIs), CHF patients’ daily intake of protein, dietary fiber, vitamin A, vitamins B, vitamin E, potassium, magnesium, iron, selenium and other trace element are significantly lower than DRIs requirements, while cholesterol and sodium intake are significantly higher than the DRIs level, among those, vitamin C is slightly higher than DIRs requirements, but no evident statistical significance.As regard to the productivity ration of the three major nutrients, CHF patients’ carbohydrate productivity ratio is higher than the recommended proportion; the ratio of fat meets the recommended proportion, and protein is significantly lower than the average proportion of 15% of the recommended level, only 11.10±1.50%. Compared with the 2002 National Nutrition Survey, the energy ratio of carbohydrates is higher than that of the general population levels, fat and protein significantly lower than that of the general population levels.2. The Construction of Traditional Chinese Medicine Dietary Treatment Program for CHF(1)Results of literature reviewAncient literature screened 36 books and 267 related articles, in which there are 51 kinds of medicated food and 28 medicated dietary prescriptions for the treatment of heart failure. Modern literature research showed inadequance of medicated diet for CHF, with poor quality and low level of evidence, which will not be cited. There are 359 dietary prescriptions for the treatment of CHF found in the collection of books searched in the library, among which delete the ones having 3 kinds of repeated herbs. Choose primarily the ones in the form of porridge, soup and tea as the medicated diet form, combining ancient search results, retain ultimately 95 prescriptions and classify the prescriptions according to its efficacy, which are Qi-tonifying, Yin-nourishing, Yang-tonifying, blood circulation promoting, clearing damp and promoting diuresis, relieving asthma, and nerves soothing; grouped the prescriptions according to the form of diet as:soup, porridge, rice, tea and other forms.(2) Construction of the Programs TCM medicated diet for Chronic Heart FailureCombining with nutritional recommendations for treatment of chronic heart failure and the principles of TCM dialectical treatment, build health programs of TCM medicated diet treatment for Chronic Heart Failure, specific programs see Appendix 2.3. Clinical Research of the medicated diet program for treating Chronic Heart Failure(1) Baseline caseThere are no evident differences among the two groups of patients on the respects of age, gender, education, cardiac protopathy, classification of cardiac function, BMI, and so are the blood pressure, heart rate, dietary structure, nutrients intake, serum ALB, UA, NT-proBNP level, TCM syndrome scores and quality of life scores when the patients were grouped(P<0.05).(2)The implement of the programsPatients who take the dietary prescriptions for 6-7 days according to the recommendations accounted for 12.1%,1-2 days for 21.2%.(3)Evaluation of the effect of the clinical treatmenta. Treatment efficiency:the general efficiency rate of the treatment group is 72.8%, and the control group 40%, there is no statistical significance of the difference (P<0.05).b. The readmission rate:the general efficiency rate of the treatment group is 6.1%, and the control group 17.1%, there is no statistical significance of the difference (P<0.05).c. Diet pattern:both medicated diet and dietary education can promote CHF patients increasing the intake of beans (P<0.05), and both have the same effect on promoting intake of beans (P>0.05). With respect of promoting the intake of fishes, dairy and fruits,milk et, the medicated dietary treatment group does better than the dietary education group (P< 0.05), and on reducing intake of fat, the medicated dietary treatment group also does better than the dietary education group (P<0.05). Above all, the medicated dietary treatment group does better in balancing the dietary patter than the control group.d. Main nutrient intake:the intake of dietary fiber, magnesium, potassium, selenium increased in both the medicated dietary group and the control group after the patients accepted treatment and dietary duidance (P<0.05), and the treatment group increased more compared with the control group (P<0.05). There is no difference in intake of protein and calcium in the control group before and after the patients received dietary guidance (P> 0.05), while medicated group has an obvious increase in the intake of proteins and calcium compared with before grouped(P<0.05). Comparing the intake of protein and calcium in both groups, it is clear that the treatment group is better than the control group (P<0.05). Comparing the intake of fat and sodium, treatment group does better in reducing the intake of fat than the control group (P<0.05); As to sodium intake, there is no evident difference in reducing the sodium intake between the two groups(P> 0.05). In summary, on promoting rationalization in nutrient intake, the medicated dietary treatment group is much better than an ordinary dietary education.e. Body mass index (BMI):BMI differences in the two groups’before and after treatment or intervention have no statistical significance, nor have the differences between the two groups (P>0.05).f. Serum albumin and uric acid:levels of serum ALB in the medicated dietary treatment group elevated compared with the previous untreated (P< 0.05), serum UA level lowered than before (P<0.05), but the differences of ALB and UA level between the two groups after treatment has no statistical significance (P>0.05), indicating that medicated dietary treatment has effect on increasing ALB and lowering UA, but not better than dietary education (P> 0.05).g. NT-proBNP:after treatment and education intervention, NT-proBNP in both groups lowered than before (P<0.05), but treatment group’s effect was more obvious than the control group.h. TCM symptom scores and quality of life in Minnesota Rating:both the scores and ratings of the medicated dietary treatment group lowered evidently after the treatment than before (P< 0.05); comparing the treatment group and the control group after treatment and education, the treatment group’ scores are significantly lower than the control group (P <0.05), indicating that medicated dietary treatment can improve the TCM symptoms and enhance the quality of life.ConclusionOn one hand, Chronic Heart Failure patients lack the knowledge of reasonable diet and traditional Chinese medicated diet, but they trust the dietary guidance and medicated dietary treatment, and they have a strong demand for medicated dietary treatment. On the other hand, the patients respond in behavior to the health-related information actively, and their diet patterns are mostly reasonable, which shows that they have a strong implementing capacity after receiving dietary guidance, so the status mentioned above form the base of our CHF medicated dietary treatment programs. From the relevant inspection it can be seen that the CHF patients’ overall index of BMI take on normal, but their Albumin and hemoglobin in their blood are lower than those of the average of normal people. However, their uric acid are significantly higher than normal level, which indicate abnormal of CHF patients’ nutrition metabolism. From the aspect of diet quality, it can be seen that the CHF patients’diet patterns are out-of-balance, and they don’t get adequate nutrients, which lead to exacerbation of the disease and weakening the medicine effect. In summary, a user-friendly, easy to practice, and significantly effective dietary treatment program is in dire need to regulate the patients dietary behavior.Traditional Chinese medicated dietary treatment program for Chronic Heart Failure is a Chinese characterized program based on the theory of traditional Chinese medicine. Basing on the traditional Chinese medicated dietary and modern nutrition theory, sticking to regulating and improving TCM patients’ dietary behavior, this program expects to balance the patients’ dietary structure, improve nutrients intake, so as to assist the treatment of CHF, improve the heart function and nutritional status as well as enhance the quality of life.This study applied the approach of randomized controlled test, aiming to evaluate the reasonability and practicability of the traditional Chinese medicine medicated dietary treatment for CHF. The results of this study is that the TCM medicated treatment not only increasing the intake of nutrients and balancing the dietary patterns, but also enhance the clinical treatment efficiency, lowering the readmission, improving CHF patients’ heart function, nutrition metabolism and quality of life. Moreover, the implement of the program went well. Above all, the results show preliminarily that the TCM medicated dietary treatment for CHF is reasonable and practical, which can provide reference for the promotion of TCM medicated dietary treatment for CHF program. |
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