Yu Chuan (于 川), Shen Bin (申 斌), Xu Shiwen (許世聞), Gu Zhaoyi (顧兆一), Xu Linlin (徐林林),Qi Liyue (齊立躍), Wang Yingwei (王迎偉), Han Xiaodan (韓曉丹), Wu Xiangwen (吳香文),Yu Wei (余 威) Xu Yinping (徐寅平)

Beijing Chinese Medicine Hospital Pinggu Hospital, Beijing 101200, China

ABSTRACT OBJECTIVE: To observe the clinical effect of oral traditional Chinese medicine granules combined with health education to regulate phlegm constitution and treat simple obesity. METHODS: According to the method of constitution evaluation in TCM Constitution Classification and Evaluation (Chinese Association of Chinese Medicine), the TCM classification of Chinese medicine was performed on patients who came to the outpatient department of the Traditional Chinese Medicine Hospital of Pinggu District of Beijing and met the diagnostic criteria of simple obesity. One hundred patients with phlegm constitution were selected and those in accordance with the standards, were randomly divided into group with oral TCM granules combined with health education(refer to as treatment group) and health education group(refer to as control group) according to 1:1 ratio. The control group was given health education including diet and exercise instruction. Treatment group: (1) Health education includes diet and exercise instruction. (2) Oral Chinese medicine granules: ingredients: atractylodes rhizome 15g, raw barley 30g, Folium Nelumbinis 10g, Chinese hawthorn fruit 10g,Chinese waxgourd peel 15g, milk-vetch root;15g, kudzuvine root 15g, danshen root10g, 2 times/d. The two groups were intervened for 12 weeks each time, and obesity evaluation indicators such as body weight, body fat, waist circumference,hip circumference, weight index, and score table of TCM constitutional were observed before and after the intervention.Statistical software was used for statistical analysis. RESULTS: The total curative effect of the treatment group was better than that of the control group (P＜0.001). The weight index, body weight, waist and hip circumference decreased significantly after treatment (P ＜0.01). Compared with the two groups, the treatment group is better than the control group in terms of dampness constitution improvement, weight and fat losing and waist and hip circumference reducing. (P＜0.01).CONCLUSION: Oral Chinese medicine granules Jiangzhuo Fang (combined with health education) and simple health education can improve phlegm constitution, and improve the body weight, body fat percentage and other indicators of the patients, but oral granules combined with health education to improve the physical fitness of phlegm is better than simple health education. The thoughts and methods of Chinese medicine granules combined with health education to regulate phlegm constitution is effective for weight losing and is worthy of further research and promotion.

KEY WORDS: Traditional Chinese medicine granules; Health education; Phlegm constitution; Simple obesity

In recent years, the number of people who are overweight and obese in China has gradually increased.At present, there are 150 million people in China, who are overweight, and over 20 million people under the age of 20 are obese[1]. Obesity is the pathogenesis of various diseases such as hyperlipidemia, diabetes,hypertension, coronary heart disease, and sleep apnea syndrome. Obesity not only affects physical health, but also affects people's social behavior. Obese shape leads to slow action, inflexible movement, but also affect the beauty, so that the patients are in low self-esteem, anxiety,depression and other negative emotions.

Modern medicine mainly uses drugs and surgery to lose weight. Each method has its own limitations.Traditional Chinese medicine has become the first choice for many obese people to lose weight because of the flexibility and curative safety of principles, methods,formulas, and medicinals. Since ancient times, there have been old sayings such as "Sweetness leads to more phlegm" and "the fat have more phlegm." From the perspective of Chinese medicine, obesity is closely related to dampness. This study used oral Chinese herbal granules in combination with health education to improve phlegm physique for obesity treatment and achieved good results. The report is as follows.

MATERIALS AND METHODS

General information

A total of 100 cases of obese phlegm and constitution were included in this study, all from the outpatient department of Chinese Medicine Hospital of Pinggu District, Beijing from September 2005 to March 2016.They were randomly divided into oral Chinese medicine group and health education group (referred to as treatment group) using SAS statistical software. And health education group (referred to as the control group). During the experimental observation, the control group was detached in 4 cases, the treatment group was detached in 1 case, and finally included in the statistics in 95 cases. The treatment group consisted of 8 males and 41 females. The youngest was 22 years old and the oldest was 54 years old. The average age was (40.55±8.24) years; the average duration of obesity was (13.41±6.76) years; the degree of obesity was: 16 cases of mild, middle 33 cases. The control group consisted of 6 males and 40 females, youngest 26 years old,maximum age 57 years, mean age (40.02±8.37) years;average obesity duration (15.33±7.74) years; obesity degree: mild 16 patients, moderate 30 cases. There was no statistical difference between the treatment group and the control group in terms of gender, age, course of disease and obesity, and they were comparable.

Diagnostic criteria

Diagnostic Criteria for Western Medicine Diagnostic Criteria for Obesity According to the weight grading criteria established by the Western Asia Pacific Region Obesity Working Group according to Asian characteristics, obesity can be diagnosed when the body mass index (BMI) is greater than or equal to 25 kg/m2.[2]

Judgment Criteria for TCM Phlegm Constitution:According to the "Standard for the Identification and Identification of TCM Constitutions" issued by the State Administration of Traditional Chinese Medicine in 2009[3], the phlegm condition score is40 points.

Inclusion criteria

1. Meet the diagnostic criteria of simple obesity. 2.Meet the criteria for phlegm constitution. 3. Age18 years and60 years old. 4. BMI25 and39.9; 5. Understand and actively observe and follow-up. 6. Sign the informed consent form and volunteer to participate in the researcher.

Exclusion criteria

1. Secondary obesity caused by other diseases.2.With diseases such as cardiovascular, liver, kidney,endocrine and hematopoietic systems. 3. Suffering from severe mental illness. 4. Pregnancy or preparation of pregnant women, lactating women. 5. Chinese medicine allergy. 6. Other relevant treatments that have been received may affect the efficacy of this study.

Treatment

Therapy group

(1) Health education: 1. Dietary guidance. The nutritionist in nutrition department, in our hospital formulates the daily recommended intake for patients of different genders, age, and physical labor to help the patient to form a healthy dietary habits, with sufficient intake of protein, vitamins, minerals, the appropriate amount of carbohydrates, low fat etc. Three meals a day would be served at a rate of 2/5, 2/5, and 1/5. The law of eating three meals a day should be abide by and they should not eat or drink too much. Dinner should be more than 4 hours away from sleep. When eating, they were asked to eat slowly.2. Sports instruction. According to different ages and gender, individualized exercise programs were developed to encourage the patient to adhere to the principle of gradual and orderly progress. The daily exercise time is 45min-60min, and at least 3 times a week. The heart rate of each exercise can be set as (220-age)×(0.6-0.8).

During period of the patients' medication, if there was an adverse reaction, the research team would take effective measures in time to minimize the incidence rate of adverse reactions.

Control group

Only health education was given, according to the treatment group.

Both groups of patients filled out the diary of weight loss, produced by the project group, during the observation period, including three meals and the amount of exercise, which were handed in each week.Nutritionists and physicians promptly intervened when it was necessary.

(2) Oral Chinese herbal granules (produced by Beijing Kangrentang Pharmaceutical Co., Ltd.)Intervention treatment, herbal granules: 15g of Cangshu,30g of raw Yiyiren, 10g of lotus leaf, 10g of raw Hawthorn,15g of melon skin, 15g of raw Astragalus membranaceus,Radix Puerariae 15g, Salvia miltiorrhiza 10g, 2 times per day, daily dose. Served for a total of 12 weeks.

Efficacy indicators and efficacy evaluation

Shape indicators

(1) The same tester used the body fat meter of OMRON brand (maximum weighing 150 kg, accuracy 0.1 kg) to determine the weight, body fat percentage and BMI of patients emptying, secondly emptying shit, wearing of single-layer clothing after and before intervention.

(2) A tape was used to measure waist and hip circumference and calculate waist-to-hip ratio. When measuring waist and hip circumference, participants only wore a thin piece of clothing with arms perpendicular to the sides of the body, palms inward, and feet standing together. The weight of the legs was evenly distributed.When measuring, the tester breathed gently. Do not abdomen or hold your breath. The waist circumference was the value of the horizontal circumference around the upper edge of the navel at the edge of the scale. The hip circumference was the value at the level of the widest part of the hip. When measure the tape close to the skin, avoid the tape to be trapped inside the skin.

Score of Phlegm Constitution

The changing value in phlegm constitution scores before and after intervention.

Evaluation Time

Week 4, Week 8 and Week 12.

Efficacy Evaluation

According to "The diagnosis of simple obesity,evaluation criteria for efficacy, and requirements for medical records writing, the third revision"[4]we draw up as follows:

(1) Significantly Effective: after the course of treatment, the body weight decreased by more than 5kg,or the percentage of fat decreased by more than 5%.

(2) Valid: After the course of treatment, the body weight decreased by more than 3kg, or the percentage of fat decreased by 5%.

(3) Invalid: The body weight and fat percentage did not decrease.

Statistical analysis

SPSS17.0 was used for statistical analysis. Measured material are expressed as mean ± standard deviation(±s). If the normal distribution is met, the paired t-test is used before and after treatment. Two groups of independent samples t-test are used for comparison between groups.If the normal distribution is not met, rank sum test of the non-parametric test is used. The counting material is expressed in terms of rate, and the χ2test is used. The difference is statistically significant at P＜0.05.

RESULTS

Comparison of body weight, body fat rate and body mass index (BMI) in two groups, see table 1.

Comparison of waist and hip circumference in two groups, see table 2.

Table 1. Comparison of body weight, body fat rate, body mass index (BMI) in two groups

Table 2. Comparison of waist and hip circumference in two groups

Comparison of the scores of patients with phlegm and dampness constitution in both groups, See Table 3.

Table 3. Comparison of the scores of patients with phlegm and dampness constitution in both groups

Comparison of clinical efficacy between the 2 groups See Table 4.

DISCUSSION

At present, exercise and dietary guidance are mostly used for the intervention of obese lifestyle use.Exercise improves energy expenditure and maintains energy and material metabolism of the body in a state of balance[5]Meanwhile, it combines with dietary intervention to reduce energy intake. It is believed by traditional Chinese medicine that obesity is closely related to dampness. The inability of meridians and blood in the body and dysfunction of the organs, etc.result in loss of body fluids, and dampness and phlegm result in obesity. Famous doctors in ancient times mostly used phlegm and dampness to discuss the pathogenesis of obesity. In the Yuan Dynasty, Zhu Danxi said: "The fat and the white have more phlegm." Wang Ang in the Qing Dynasty said "The Fat have more phlegm and are more obstructed." Chen Shizhao said: "Fat people have more phlegm." Chen Xiuyuan: "Most of us have never suffered from dampness and phlegm." Luo Yuankai said"The obese people are bigger in shape and do not enough Qi and spleen deficiency leads to phlegm and dampness.Zhang Lu: "persons with too thick fat have more phlegm.Wang Yanchang: "If the person is not sick, then the body fluid is a fat. If the person is sick, it is result of phlegm and dampness." From the discussion of ancient famous doctors, we can conclude that phlegm and dampness,which are pathogenic factor and a pathological product,are the main pathogenesis of obesity. According to TCM constitution, phlegm constitution is gradually formed on the basis of congenital endowments, with the in fluence of internal and external environment, such as improper diet,improper work and clothing, and emotional injury etc.

The prescription of traditional Chinese medicine used in this research has been continuously studied and explored by Xu Yinping, the vice president and the chief physician, in a long-term clinical experience. Xu Yinping,believed that the occurrence of dampness was related to the dysfunction of the lungs, spleen and kidneys.Lung controls body fluids, freeing and regulating the waterways, and dredging bladder. If the lungs lose blood and the water does not spread, the water will stop and condense into phlegm.If the spleen is transported, the spleen and yang will be cleared and the turbidity will be reduced. If the spleen yang is damaged and the operation is neglected, the water will not wet, and it will stop for the sputum to drink. Kidneys mainly steamed water into fluid. If the kidney yang is insuf ficient, with unfavorable opening and closing, water will rise and gather togetheras phlegm. Phlegm and dampness are yin pathogen,which will damage the yang for a long time, causing the spleen yang to be trapped. Atractylodes rhizome and raw barley are dampness and are good to spleen,promoting urination and percolate dampness."Ear Pearl Capsule": Atractylodes can fortify stomach and calm the spleen. All kinds of dampness and swelling can not be eliminated. "New Materia Medica": atractylodes rhizome is good for draining water, not consuming the air of true yang. Chinese waxgourd peel and Folium Nelumbinis is good for eliminating swelling. Folium Nelumbinis has the function of sending up the lucid yang. Chinese hawthorn fruit can improve digestion, eliminating dampness, lowering fat, promoting the circulation of qi,and dissipating blood stasis. In Compendium of Materia Medica, Chinese hawthorn fruit can improve digestion,eliminate fat and remove lump phlegm retention...stopping bleeding and distending pain. danshen root can invigorate blood and dissolve stasis, unblocking the channels and quickening the collaterals. Chinese hawthorn fruit, with danshen root, can invigorate blood and collateral channels, n promoting the smooth flow of water. Milkvetch root and kudzuvine root are good for spleen and lungs, lifting yang, innovating spleen yang, boosting kidney yang to steam. Thus dampness gradually removed."Earth capsule" milk-vetch root is sweet, mild and Yang,with five functions: one, complement Qinxu deficiency...third, strengthen spleen and stomach, three also; ...

Table 4. Comparison of clinical efficacy between the 2 groups

With a comprehensive view of the wholeness,drying dampness and draining water provide temporary solutions to the problems while fortifying the spleen and boosting lung provide fundamental solutions to the problems, invigorating blood and unblocking the collaterals. The two are complementary to each other,regulating phlegm and dampness constitution, and having a function of losing weight.

The results of the study shows that after intervention, all the indexes of the 2 groups of patients are lower than those before treatment (P＜0.01), indicating that health education could change lifestyles and improve various indicators of obesity. Traditional Chinese Medicine Granules and Jiangzhuo Formula combined with health education is better than the control group in improving phlegm constitution, (P＜0.01), indicating that oral granules is better than only health education, improve phlegm constitution.During the trial, the treatment group was detached in 1 case and the control group was detached in 4 cases. The reason was analyzed by using intervention group of traditional Chinese medicine granules. The patients came to the hospital regularly,which helped improve the obese patients' reliance. In the treatment group, 5 patients who were ineffective at the age of 50 years or older had longer duration of obesity.Considering the changes in body weight and constitution,the treatment cycle of the study was short. In the future study, the treatment cycle can be appropriately increased.Long-term observation and follow-up could be carried out to better evaluate the clinical efficacy of the obesity treatment by improving the phlegm and dampness constitution.