摘要
背景
据2006年WHO的报告,全球有近3亿成年人过于肥胖,使他们更容易罹患心血管病、癌症、糖尿病等与肥胖有关的疾病。可见,肥胖问题已经成为全球医学、营养学及公共卫生专业人士皆欲解决的问题。单纯性肥胖症是非病理性的渐进性肥胖,即无明显内分泌疾病、代谢性疾病等疾病,而绝大多数是因为摄入的热能超过了消耗的热能,超出的部分以脂肪的形式储存于皮下及内脏器官的周围而引起的肥胖,约占肥胖症人群的95%。其中,最为隐匿的是以脂肪细胞在腹部集聚,腰围和臀围比例显著增大为特点的中心型单纯性肥胖症患者,往往因当下普及的衡量肥胖的标准——体重指数(BMI),而受到忽视。有证据显示,人群中BMI从21kg/m2开始,发生肥胖相应慢性疾病的风险就逐渐上升。遂我们应该更为关注BMI相对较低时的中心型单纯性肥胖症患者,探讨其早期治疗的有效措施。
迄今,治疗肥胖症的方法众多,各种方法均有一定的适宜人群,而针灸疗法是符合时下减肥治疗原则的“绿色”疗法。可是针灸疗法减肥疗程较长,一般需经历快速减重期(1-4周)、平台调整期(4-12周)和稳定缓慢减重期(12周以后)3个阶段。为了长时间地刺激同一部位达到疗效的最大化,遂笔者用董氏奇穴疗法作为常规针刺的补充疗法,应用于临床。发现在运动疗法和饮食疗法的基础上,结合董氏奇穴疗法治疗单纯性肥胖症,效果良好。经查阅相关文献,发现董氏奇穴疗法虽然在临床上已经开始应用,但是对单纯性肥胖症的具体疗效,它与常规针刺疗法孰优孰劣,还未见相关报道。
综上,本研究通过体重、体重指数、腰围、臀围、腰臀比等评价指标,观察董氏奇穴疗法治疗中心型单纯性肥胖的效果,并与常规针刺疗法比较,为董氏奇穴的进一步推广,提供临床证据；为单纯性肥胖的治疗,提供一种有效的治疗手段。
目的
探讨董氏奇穴治疗中心型单纯性肥胖症的临床疗效,并与常规针刺疗法的疗效作比较,为单纯性肥胖症的治疗提供新的方法,以供临床医生参考。
方法
(1)课题设计与病例纳入
本试验采用平行随机对照设计,即按随机数字表法,将90例于2013年1月-7月来自南方医院针灸科门诊的中心型单纯性肥胖症患者随机分成常规组和奇穴组,每组各45例；并采用盲法,盲患者,同时对试验操作者、结果评估者、数据录入和统计者实行三分离。
(2)诊断标准
根据“中国肥胖问题工作组数据汇总分析协作组”制定的标准,以男性腰围≥85cm,女性腰围≥80cm,为中心型单纯性肥胖症。中医辨证分型参照新世纪全国高等中医药院校规划教材《针灸治疗学》中的单纯性肥胖症的辩证分型标准。
(3)纳入标准
①符合“中国肥胖问题工作组数据汇总分析协作组”制定的中心型单纯性肥胖症标准,男女不限；②年龄18～60岁；③自愿接受本研究治疗方法并签署知情同意书。
(4)排除标准
①不符合“中国肥胖问题工作组数据汇总分析协作组”制定的中心型单纯性肥胖症标准；②继发性肥胖症患者,如皮质醇增多症、甲状腺功能减退症、下丘脑病变、胰岛细胞瘤等；③重大器质性疾病患者,如循环系统、呼吸系统、神经系统、泌尿系统、血液系统等疾病患者；④继发性或原发性精神病患者；⑤最近3个月内曾接受其他任何减肥方法治疗者；⑥服用与本病治疗无关但有减肥作用药物者。
(5)剔除、中止和脱落标准：①纳入研究后发现不符合纳入标准者,予以剔除；②患者治疗依从性差,或发生严重不良事件,或特殊生理周期变化、出现其他病证不宜继续接受治疗者,予以中止治疗,其中1个疗程者计入疗效统计,否则视为脱落。
(6)治疗方法
1.基础治疗
所有患者均接受基础治疗,即执行参照《中国成人超重和肥胖症预防控制指南》中相关标准制定的饮食医嘱和运动医嘱：正常饮食,严格节制零食,改变不健康饮食习惯(如不暴饮暴食,过食高脂、高糖食物等),晚睡前两小时不进食；平衡膳食,即蛋白质、碳水化合物和脂肪提供的能量比,应分别占总能量的15%-20%、60%-65%和25%左右；食用新鲜水果,蔬菜和糙粮；限制酒精的摄入。运动医嘱：建议每日坚持30-60分钟慢跑、健身操、游泳、太极拳等活动,依据年龄及自身条件选择合适的运动方式和运动量,活动不要求是连续的,每次活动的总时间可以累加,但每次活动时间最好不少于10分钟。
2.董氏奇穴疗法
取穴：以腑巢二十三穴(取肚脐上1寸及下2寸的2穴,肚脐左右分别旁开2寸及其上1寸、下2寸的6穴,组成矩形),双侧火串穴、肠门穴、腑肠穴、四花下穴、通背穴、肾关穴为主穴。胃肠腑热者加土水穴；痰湿闭阻者加天皇穴、人皇穴；脾肾阳虚者加大白穴、灵骨穴；肝郁气滞者加木穴、木炎穴。以上配穴可依据患者病情酌情增减。
操作：穴位常规消毒后,用0.30mm×40mm或0.30mm×75mm天协牌不锈钢毫针快速进针。取腑巢二十三穴中脐上1寸及其左右各旁开1寸,共3针,向上平刺；脐下2寸及其左右各旁开1寸,共3针,向下平刺；脐旁开2寸及其上1寸和其下2寸,左右各3针向外平刺,组成矩形；其他腧穴视患者肥胖程度及取穴部位而深刺0.2-1.5寸。诸穴得气后,实证患者用泻法,虚证患者用补法；共留针30min,行针1次/5min。
3.常规针刺治疗
取穴：以中脘,水分,关元,及双侧天枢、大横、曲池、支沟、阴陵泉、上巨虚、丰隆、三阴交和内庭为主穴。胃肠腑热者加合谷；痰湿闭阻者加内关、足三里；脾肾阳虚者加气海、脾俞、肾俞、足三里；肝郁气滞者加期门、太冲。以上穴位可依据患者病情酌情增减。
操作：穴位常规消毒后,用0.30mm×40mm天协牌不锈钢毫针快速进针。脾俞、肾俞不可深刺,其他腧穴视患者肥胖程度及取穴部位而深刺1.0～1.5寸；诸穴得气后,实证患者用泻法,虚证患者用补法；共留针30min,行针1次/5min。
两组患者除接受基础治疗外,奇穴组配合董氏奇穴疗法,常规组配合常规针刺治疗,两组患者均隔日治疗1次,15次为1疗程,疗程之间休息7天,连续完成3个疗程。每完成1个疗程均评估治疗效果1次。女性月经期停止针刺,治疗时间相应延长。
(7)观察方法
1.观察周期：以3个疗程为观察期限。
2.观察指标
(1)主要指标
①观察两组患者腰围、臀围、腰臀比和腰围身高比的改善情况。腰围取肋弓下缘和髂嵴连线中点的水平周径,臀围取臀部最大周径,数据以厘米为单位,读数精确至0.1毫米。腰臀比为腰围和臀围的比值,腰围身高比为腰围和身高的比值。
②观察两组患者腹围的改善情况。取中脘穴、下脘穴、神阙穴、气海穴、关元穴、曲骨穴的水平周径,测量数据以厘米为单位,读数准确至0.1毫米。
(2)次要指标：
①观察两组患者体重、体重指数(BMI)、脂肪百分率改善情况。用经过校正的最大称量为150kg,确度为0.1kg的电子体重计测量体重。BMI=体重(kg)/身高2(m2)。脂肪百分率=(0.570／体密度-4.142)×100%。
②治疗过程中两组患者不良反应的观察,包括晕针、断针、血肿等。
上述指标均在治疗开始前和治疗第1、2、3个疗程后(或试验中止)时,由专人在不知道患者分组的情况下,各测量1次。
(8)数据处理
由专人整理数据,对主要变量缺失值的估计采用最接近1次观察的结转(LOCF)法来填补。采用SPSS20.0软件包进行统计学处理,腰围、臀围、体重、体重指数等计量资料组内比较使用配对t检验,组间比较使用独立t检验；腰臀比、腰围身高比等计数资料组内比较使用Friedman检验,组间比较使用Mann-Whitney U检验。数据以(x±SD)表示,以P<0.05为差异有统计学意义。
结果
(1)病例中断与脱落情况
常规组有3例,奇穴组有4例因搬迁、出差等原因在第1个疗程内就选择退出试验,视为脱落；两组共15例患者因工作等原因在第1疗程之后中止治疗,计入疗效统计。最终常规组共纳入42例患者,奇穴组共纳入41例患者,两组患者的性别、年龄、身高、病程、证型比较,差异均无统计学意义(P>0.05),具有可比性。
(2)两组患者治疗前后腰围、臀围、腰臀比和腰围身高比的比较
组内比较：经重复测量数据方差分析检验,两组患者腰围和臀围随着治疗时间延长,其值均有显著性下降(P<0.05)。经Friedman检验,两组患者腰围身高比和常规组腰臀比随着治疗时间延长,其值均有显著性下降(P<0.05),奇穴组腰臀比治疗前和治疗中不同时间段两两比较均无统计学差异(P>0.05)。
组间比较：经独立样本t检验,两组患者除腰围和臀围1疗程后差值,及1疗程后和2疗程后腰围数值比较均有显著性差异(P<0.05),余比较均无统计学差异(P>0.05)。经Mann-Whitney U检验,两组患者除1疗程后和2疗程后腰围身高比,及腰围身高比1疗程后差值比较均有显著性差异(P<0.05),余比较均无统计学差异(P>0.05)；腰臀比在治疗前、治疗中不同时间段、1疗程差、2疗程差和3疗程差比较均无统计学差异(P>0.05)。
(3)两组患者治疗前后中脘腹围、下脘腹围、神阙腹围、气海腹围、关元腹围和曲骨腹围的比较情况
组内比较：经重复测量数据方差分析检验,两组患者中脘腹围、下脘腹围、神阙腹围、气海腹围、关元腹围和曲骨腹围随着治疗时间延长,其值均有显著性下降(P<0.05)。
组间比较：经独立样本t检验,两组患者中脘腹围、下脘腹围、神阙腹围和气海腹围1疗程后的数值比较均有显著性差异(P<0.05),两组患者下脘腹围和神阙腹围2疗程后的数值比较均有显著性差异(P<0.05),两组患者中脘腹围、下脘腹围、神阙腹围、气海腹围、关元腹围、曲骨腹围治疗1疗程差值比较均有显著性差异(P<0.05),余比较均无统计学差异(P>0.05)。
(4)两组患者治疗前后体重、体重指数和脂肪百分率的比较
组内比较：经重复测量数据方差分析检验,两组患者体重和体重指数随着治疗时间延长,其值均有显著性下降(P<0.05)。经Friedman检验,两组患者脂肪百分率随着治疗时间延长,其值均有显著性下降(P<0.05)。
组间比较：经独立样本t检验,两组患者体重和体重指数除1疗程后差值比较均有显著性差异(P<0.05),余比较均无统计学差异(P>0.05)。经Mann-Whitney U检验,两组患者脂肪百分率在治疗前、治疗中不同时间段、1疗程差、2疗程差和3疗程差比较均无统计学差异(P>0.05)。
(5)不良反应
治疗过程中两组患者均未发生晕针、断针、血肿等不良反应。
结论
本研究初步表明,董氏奇穴治疗中心型单纯性肥胖症疗效确切,特别在第一个疗程结束后,其对体重、体重指数、腹围长度(包括腰围和臀围)、腰围身高比的改善较常规针刺疗法更为明显。
Background
According 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.
Objective
To 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 inclusion
Ninety 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 criteria
According 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 criteria
①Meet 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 criteria
①Not 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) Treatment
1. Basic treatment
All 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 therapy
Acupuncture 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 treatment
Acupuncture 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 method
1. Observation period:3courses as an observation period.
2. Observation indicators:
(1) Key Indicators
①observed 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 Indicators
①observed 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 processing
By 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 off
There 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 groups
Comparison 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 treatment
Comparison 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 Reactions
No post-needling adverse reactions occurred during treatments.
Conclusion
This 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.
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