| BackgroundAccording to the WHO report in2006, there are nearly300million adults are obese, making them more susceptible to obesity-related diseases as cardiovascular disease, cancer, diabetes and so on. As you see, obesity has become a global problem which medicine, nutrition and public health professionals want to solve. Simple Obesity is non-pathological progressive obesity, that is no significant endocrine diseases, metabolic diseases and other diseases, but most of reasons are energy intake exceeds energy consumption, the excess portion changed in the form of fat then stored in the subcutaneous and surround the internal organs which caused obesity, it happens in about95%of the obese population. One of the most insidious is the concentration of fat cells in the abdomen, waist and hip ratio significantly increased central type characterized by simple obesity patients, which were neglected because of the current popular standard measure of obesity, body mass index (BMI). Evidence shows that, starting from the crowd whose BMI were21kg/m2, the corresponding risk of obesity and chronic disease gradually rise. Then we should be more concerned about the central obesity patients whose BMI are relatively low, and to explore the effective measures of its early treatment.To date, numerous methods to treat obesity, various methods have certain suitable crowd, but nowadays acupuncture weight loss treatment is consistent with the principles of "green" therapy. But generally speaking the acupuncture weight loss treatment course is comparatively longer, generally need to experience the following periods:the rapid weight loss period (1-4weeks), the platform adjustment period (4-12weeks) and a slow steady weight loss period (more than12weeks). In order to stimulate for a long time to reach the same site to maximize efficacy, then we use the Tung’s Extra-points therapy as a complementary therapy for the conventional acupuncture therapy, applying to clinical. We found that on the basis of exercise therapy and dietary therapy combined with Tung’s Extra-points therapy to treat simple obesity appear good results. Upon review of the relevant literature and found that although Tung’s Extra-points therapy has begun clinical application, but the specific effect of simple obesity, it is better to conventional acupuncture or not has not been reported yet.In summary, this study by means of evaluating weight, BMI, waistline, hipline, waist-hip ratio, to observe the effect of Tung’s Extra-points therapy on central obesity patients, and compared with conventional acupuncture therapy. To provide the clinical evidence for further promotion of Tung’s Extra-points therapy, and to provide an effective treatment for central obesity.ObjectiveTo explore the therapeutic effect of Tung’s Extra-points therapy on central simple obesity patients, and with the efficacy of conventional acupuncture for comparison, provides a new approach for the treatment of central obesity, and reference for clinicians.Methods(1) Study design and case inclusionNinety central obesity patients from Nanfang Hospital outpatient department in January to July2013, were randomly divided into conventional and Tung’s Extra-points group using parallel randomized controlled trial design, by the random number table,45cases for each group. Blind method was adopted, blind the patients, while the operator, the results assessor, data inputter, and the data statistics were separated. (2) Diagnostic criteriaAccording to standard of "China Working Group on Obesity Collaborative Group pooled analysis of data", male waistline≥85cm, female waistline≥80cm, should be diagnosed with central obesity. TCM differentiation refers to central obesity differentiation on "Zhen Jiu Zhi Liao Xue"("acupuncture and moxibustion therapy") of the new century national planning materials of higher medical institutions.(3) Inclusion criteria①Meet the central obesity standards of "China Working Group on Obesity Collaborative Group pooled analysis of data", male or female.②Aged18to60years old;③Accepted the treatment in this study voluntarily and signed informed consent.(4) Exclusion criteria①Not meet central obesity standards of "China Working Group on Obesity Collaborative Group pooled analysis of data".②Secondary obesity, such as Cushing’s syndrome, hypothyroidism, hypothalamic disease, pancreatic islet cells, etc.③Significant organic disease patients with diseases such as circulatory system, respiratory system, nervous system, urinary system, blood system.④Secondary or primary psychiatric patients.⑤Received any weight loss treatment within the recent three months.⑥Taking the weight loss drugs which have nothing to do with the treatment of this disease.(5) Reject, discontinue and fall off criteria:①Any one who was found out that do not meet the inclusion criteria after inclusion.②Patients with poor compliance, or serious adverse events happened, or special physiological period variation, or other syndromes appeared which couldn’t continue this treatment, a course of treatment were included in the efficacy of statistics, or as fall off.(6) Treatment1. Basic treatmentAll the patients received basic treatment, namely carry out the relevant standard-setting diet and exercise doctor prescription according to "Chinese adults are overweight and obesity prevention and control guidelines":a normal diet, strict control snacks, change unhealthy diet habits (such as not eat and drink too much, overeating high-fat, high-sugar foods, etc.), not eating two hours before bedtime; balanced diet, ie, protein, carbohydrates and fat to provide energy ratio of15%-20%,60%-65%and25%; eating fresh fruits, vegetables and coarse food grains; limiting alcohol intake. Sports doctor prescription:insisted30-60minutes daily jogging, aerobics, swimming, tai chi and other activities were recommended, according to the age and condition of their own to choose the appropriated sport and exercise activities, not requiring to be continuous, but the total time for each activity can be accumulate, the best time for each activity at least10minutes.2. Tung’s Extra-points therapyAcupuncture points:the "fu chao23points"(1cun above and2cun below umbilicus,2cun bilateral to umbilicus,1cun above and2cun below,6points in total, compose a rectangle), bilateral "huo chuan xue","chang men xue","fu chang xue","si hua xia xue","tong bei xue" and "shen guan xue" were the dominant points. Stomach-intestine excessive heat plus the "tu shui xue", phlegm-dampness stagnation plus "tian huang xue" and "ren huang xue", Yang deficiency of spleen and kidney plus "tai bai xue" and "ling gu xue", liver Qi stagnation plus "mu xue" and "mu yan xue". All the acupuncture points above appropriate changes in need of the patients.Operation:After routine acupuncture points disinfection, insert the needle quickly with a0.30mm×40mm or0.30mm×75mm TianXie brand stainless steel. Take "fu chao23points"1cun above umbilicus and1cun bilateral to it,3in total, horizontal insertion of the needle upward.2cun below umbilicus and1cun bilateral to it,3in total, horizontal insertion of the needle downward.2cun bilateral to the umbilicus and2cun below them,3in each side, horizontal insertion of the needle outward, composed a a rectangle. The other acupuncture points insert0.2-1.5cun according to the obesity degree of patients and acupuncture point locations. After arrival of Qi, treating excess syndrome with purgative method and treating deficiency syndrome with tonifying method. Retention of needle for30minutes, manipulate the needles in every5minutes. 3. Conventional acupuncture treatmentAcupuncture points:RN12, RN9, RN4, ST25, SP15, LI11, SJ6, SP9, ST37, ST40, SP6and ST44were the dominant acupuncture points. Stomach-intestine excessive heat plus the LI4, phlegm-dampness stagnation plus PC6and ST36, Yang deficiency of spleen and kidney plus RN6, BL20, BL23and ST36. Liver Qi stagnation plus LR14and LR3. All the acupuncture points above appropriate changes in need of the patients.Operation:After routine acupuncture points disinfection, insert the needle quickly with a0.30mm x40mm TianXie brand stainless steel. BL20and BL23could not be deep insert, other acupuncture points insert1.0-1.5cun depending on the patient and the degree of obesity and locations. After arrival of Qi, treating excess syndrome with purgative method and treating deficiency syndrome with tonifying method. Retention of needle for30minutes, manipulate the needles in every5minutes.In addition to receive the basic treatment, the Tung’s Extra-points group combined with Tung’s Extra-points therapy and the conventional group combined with regular acupuncture therapy. All the patients were treated once every other day,15times as a course of treatment and7days rest between consecutive completion of three courses. We assessed effects every each completed a course of treatment. Menstrual period stops acupuncture treatment and treatment time is extended accordingly.(7) observation method1. Observation period:3courses as an observation period.2. Observation indicators:(1) Key Indicators①observed the improvement of waistline, hipline, and waist-hip ratio and waistline-height ratio of the two groups of patients. Level of the lower edge of the rib cage and waistline take the midpoint of the iliac crest circumference, hipline take hip largest data in centimeters, readings accurate to0.1mm. Waist-hip ratio is the ratio of waist and hip, waistline-height ratio is the ratio of waistline and height. ②observed the improvement of abdominal line of the two groups of patients. Take the horizontal circumference of RN12, RN10, RN8, RN6, RN4and RN2, measured data in centimeters, readings accurate to0.1mm.(2) Secondary Indicators①observed weight, body mass index (BMI), fat percentage improvement of the two groups. After calibration with the largest weighing is150kg, accuracy of0.1kg of electronic scales to measure weight. BMI=weight (kg)/height2(m2). Fat Percentage=(0.570/volume density-4.142)×100%.②observed adverse reactions during the course of treatment, including fainting, broken needle, hematoma, etc.Indicators above were measured before the start of treatment and treatment of1,2,3courses (or test suspension), the by specially-assigned person who didn’t know the patients’ grouping.(8) Data processingBy specially-assigned person collating data on key variables used to estimate missing values closest to a second observation carried forward (LOCF) method to fill. SPSS20.0software package was adopted for statistical analysis, measurement data such as waistline, hipline, weight and BMI within group applied comparative t-test and independent t-test for the data between groups. count data such as waist-hip ratio and waistline-height ratio applied Friediman test within group and MannWhiteyU test between groups. Data was display to (x±SD). P<0.05was considered statistically significant.Results(1) Case interrupt and fall offThere are three cases of the conventional group,4cases of the Tung’s Extra-points group exit for removal or business trip or other reasons in the first course, considered as fall off. Two groups of15patients because of work or other reasons after the first course of treatment discontinuation of treatment included in the efficacy of statistics. Final conventional group of42patients were included, Tung’s Extra-points group included41patients. Gender, age, height, courses and syndromes showed no statistically significant difference (P>0.05), that is comparable.(2) comparison of waistline, hipline, waist-hip ratio and waist-height ratio before and after treatment between two groupsComparison within group:By repeated measurement data analysis of variance, waistline and hipline of two groups decreased significantly as the treatment time extended (P<0.05). By Friedman test, waist-height of two groups and waist-hip ratio of conventional groups decreased significantly as the treatment time extended (P<0.05); there was no significant statistically difference in comparison of different time periods before and after treatment in waist-hip ratio of Tung’s Extra-points group (P>0.05).Comparison between groups:By independent sample t test, the difference of waistline and hipline after one course, waistline after one and two course show significantly difference(P<0.05), the rest of comparisons show no significantly statistical difference(P>0.05). By Mann-Whitney U test, waist-height ratio after one and two courses, and the difference of waist-height ratio after one course show significantly difference (P<0.05), the rest of comparisons showed no statistical difference (P>0.05); waist-hip ratio showed no significant difference in different periods before and after treatment, difference of one, two and three courses showed no significantly statistical difference(P>0.05).(3) Comparison between two groups of patients’horizontal circumference of RN12, RN10, RN8, RN6, RN4and RN2before and after treatmentComparison between groups:By repeated measurement data analysis of variance, the circumference of RN12, RN10, RN8, RN6, RN4and RN2of two groups decreased significantly as the treatment time extended (P<0.05).Comparison between groups:By independent sample t test, the circumference of RN12, RN10, RN8and RN6after one course show significantly difference (P<0.05), the circumference of RN10and RN8after two courses show significantly difference (P<0.05), the difference of the circumference of RN12, RN10, RN8, RN6, RN4and RN2after one course show significantly difference (P<0.05), the rest of comparisons show no significantly difference (P>0.05).(4) Comparison of weight, body mass index and fat percentage of two groups’ patients before and after treatment.Comparison between groups:Comparison within group:By repeated measurement data analysis of variance, weight and body mass index of two groups decreased significantly as the treatment time extended (P<0.05). By Friedman test, the percentage of fat of two groups decreased significantly as the treatment time extended (P<0.05).Comparison between groups:By independent sample t test, the difference of weight and body mass index after one course show significantly difference (P<0.05), the rest of comparisons show no significantly difference (P>0.05). By Mann-Whitney U test, the percentage of fat showed no significant difference in different periods before and after treatment, difference of one, two and three courses showed no significantly statistical difference(P>0.05).(5)Adverse ReactionsNo post-needling adverse reactions occurred during treatments.ConclusionThis preliminary study shows that Tung’s Extra-points therapy has a certain curative effect on central obesity patients, especially after the first course of treatment, the improvement of weight, body mass index, waist length (including waist and hip) and waist-height ratio significantly better than that of the conventional acupuncture group. |