Cui-Mei Liang, Xiao-Man Wang, Song-Ge Sun, Hui Hu*

1Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China. 2Cangzhou Central Hospital, Cangzhou,China. 3Beijing Hospital of Traditional Chinese Medicine Shunyi Hospital, Beijing, China.

Background

Metabolic syndrome (MetS) is a clinical condition associated with abnormal metabolic disorders such as obesity, hypertension, hyperglycemia, and lipoprotein metabolism disorder, which are important risk factors for diabetes and atherosclerosis. In the recent years, its incidence rate in China has reached 25.9% [1], with fast growth rate, which has attracted the attention of scholars.Among the components of MetS, abdominal obesity is the primary and triggering factor for various metabolic disorders [2]. Early intervention in abdominal obesity is an important strategy for the prevention and treatment of MetS and its complications.

In general, the prevention and treatment measures of MetS are individualized or combined with each treatment component [3]. The control of blood pressure, blood sugar, blood lipids, and related cardiovascular risk factors has achieved certain effects; however, insufficient treatment effects on obesity, especially abdominal obesity,were observed. The five weight loss drugs approved by the Food and Drug Administration of the United States are restricted from clinical use as early intervention for abdominal obesity and for prevention and treatment of MetS and its complications because of adverse reactions to varying degrees and strict indications [4]. Therefore,weight loss treatment relies mainly on limiting the caloric intake and increasing exercise. However, studies have shown that only 20% of people can maintain their weight after losing weight for more than a year [5, 6].

The earliest record of obesity in traditional Chinese medicine can be traced back toHuangdi Neijing.Lingshu• WeiQi Shichang, which divides obesity into “Zhiren,”“Gaoren,” and “Rouren.” The main clinical features of“Gaoren” are fat accumulation in the abdomen, loose and soft skin, and weak muscles. It is characterized by excessive adipose tissue deposits in the abdomen or abdominal organs. Fat mainly accumulates in the abdomen, which is consistent with Dai meridian; Dai meridian disharmony is an important pathogenesis of abdominal obesity [10]. In 2002, the World Health Organization published a clinical research report on acupuncture (Review and Analysis of Reports on Controlled Clinical Trial), which has been proven effective against preliminary obesity [7]. In the recent years, systematic review studies have also confirmed the effectiveness of acupuncture in treating obesity [8, 9]. We also emphasized the treatment principle of “Regulating Dai meridian.” Through a series of clinical observations[11, 12] and animal experiments [13, 14], regulating Dai meridian by acupuncture was found to significantly reduce the abdominal fats in patients with abdominal obesity, improve glucose and lipid metabolism disorders,have significant clinical efficacy, and have no side effects.However, after years of clinical practice, some people’s fear of acupuncture and the requirement of acupuncture frequency were found to be limited on its application and promotion.

Cupping is an important part of acupuncturology,which was first recorded inWushier Bing Fangin the Xi Han Dynasty of China (202 B.C.-8 A.D.). Doctors used animal horns as suction and extraction tools, known as“Jiaofa,” which is mainly used to suction and drain pus and treat abscess [15]. During the Sui and Tang Dynasties in China (581 A.D.-907 A.D.), bamboo cans have completely replaced the horns. In the Song, Jin, and Yuan Dynasties of China (960 A.D.-1368 A.D), bamboo pots completely replaced horns, and suction and extraction methods were developed from simple boiling using the“medical cupping.” The medical cupping method is still in use today because of its combination with suction and external treatment. Medical cupping therapy is a kind of treatment method combining cupping therapy with traditional Chinese medicine (TCM) therapy. Through the thermal and mechanical stimulation during cupping, local absorption of TCM can be promoted, in order to improve the treatment effect. Through the literature search,medical cupping therapy was found as one of the comprehensive treatment methods for the treatment of obesity, and no reports on the single medical cupping therapy and research data on the effectiveness of medical cupping therapy for obesity were found. This study aimed to evaluate the efficacy and safety of medical cupping therapy for abdominal obesity associated with MetS,solve the fear of acupuncture in some patients, and reduce the frequency of treatment, in order to determine the advantages of TCM treatment.

Research method

Diagnostic criteria

The MetS [16] diagnostic criteria in the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China issued by the Diabetes Branch of the Chinese Medical Association in 2013 are as follows: (1) abdominal obesity is defined as waist circumference (WC) of > 90 cm in men and 85 cm in women; (2) high blood sugar is characterized by fasting blood glucose (FBG) of ≥ 6.1 mmol/L and (or) postprandial 2-h blood glucose (2hBG)level of ≥ 7.8 mmol/L or diabetes diagnosis and treatment;(3) hypertension is characterized by systolic pressure(SBP)/diastolic pressure (DBP) of ≥ 130/85 mmHg or has been diagnosed with hypertension and treatment; (4)fasting triglycerides (TG) of ≥ 1.7 mmol/L; and (5)high-density lipoprotein cholesterol (HDL-C) level of <1.04 mmol/L in fasting blood. The patient was diagnosed as having MetS if three or more of these five components were present.

Inclusion criteria

Patients who (1) met the diagnostic criteria of MetS and abdominal obesity; (2) aged 25-70 years; and (3)voluntarily participated and signed the informed consent book were included in this study.

Exclusion criteria

Patients (1) with secondary metabolic diseases, such as hypothalamic lesions, hypothyroidism, polycystic ovary syndrome, and Cushing syndrome; (2) with broken local skin surface; (3) who used other methods to control weight and WC, such as surgery and drugs; (4) receiving antihypertensive, hypoglycemic, lipid-lowering drugs,adjusted the drug type and/or dose within 3 months; (5)who were pregnant or nursing; (6) who were critically ill or had liver and kidney function damage and had cancer;and (7) who were severely visually impaired or mentally ill were excluded.

Therapeutic method

One-on-one health education was conducted after enrolling all the subjects in the group. The Chinese Dietary Guidelines (2013 edition) [17] recommended the development of a diet program to educate patients on dietary conditioning and change bad habits, record the patient’s diet and exercise volume, and provide relevant guidance. The corresponding treatment was then performed according to different groups.

Drug cupping therapy group

Preparation of TCM ointment. Based on clinical experience, the author formulated Huazuo Xiaoman Formulae ointment with the following preparation method: 9 g of Fuling (Rhizoma Smilacis Glabrae),Baizhu (Rhizoma Atractylodis Macrocephalae), Banxia(Rhizoma Pinelliae), Zhishi (Fructus Aurantii Immaturus),Peilan (HerbaEupatorii), Cangzhu (Rhizoma Atractylodis), Houpo (Cortex Magnoliae Officinalis),Dahuang (Radix et Rhizoma Rhei), Chaihu (Radix Bupleuri), Caodoukou (Semen Alpiniae Katsumadai),Heye (Folium Nelumbinis), Wuyao (Radix Linderae),Rougui (Cortex Cinnamomi), Honghua (Flos Carthami),Danggui (Radix Angelicae Sinensis), Baishao (Radix Paeoniae Alba), Chuanxiong (Rhizoma Ligustici Chuanxiong), Chuanjiao (Zanthoxylumbungeanum)respectively, 15 g of Huangqi (Radix Astragali seu Hedysari), 20 g of Zexie (Rhizoma Alismatis), and 6 g of Sharen (Fructus Amomi Villosi). The above Chinese medicines were crushed to pieces, 10 g capsaicin was added, and the appropriate amount of vegetable oil and yellow wax were added; the mixture was finally combined with a paste to form the Huazuo Xiaoman Formulae ointment.

Operation method of medical cupping group.The appropriate amount of Huazuo Xiaoman Formulae ointment was applied evenly on the waist and abdomen;thereafter, the suction was created with the glass jar on the abdominal skin using the flash fire method. The jar was then held and pushed and pulled back and forth several times, until the waist and abdominal skin was flushed; the jar was then lifted up. The glass jar was retained on the following acupoints: Zhongwan (CV12),Tianshu (ST25, double side), Qihai (CV6), Daimai(GB26, double side), Liangmen (ST21, double side), and Shuidao (ST28, double-side). According to the degree of patient’s abdominal bulge, 6-8 glass jars were left for 5 min; the waist and abdomen were wiped with toilet paper,and the patient was instructed to take a bath 4 h later.Swimming and the use of hot springs were prohibited on the day of treatment. Treatment was performed once every 2-3 days, twice a week, for a total of 8 weeks.

Acupuncture group

Acupoint.Using the theory of syndrome differentiation of TCM guideline, the method of “Regulating Dai meridian” was adopted, and the following points were selected: Daimai (GB26, double), Tianshu (ST25, double),Daheng (SP15, double), Shuidao (ST28, double),Zhongwan (CV12), Waiguan (SJ5, double), and Zulinqi(GB41, double).

Operation method.The acupoint skin was disinfected using a 75% alcohol, and 0.30 × 100-mm needle was used to puncture obliquely toward the homolateral Wushu point (GB27). Puncture perpendicularly Zhongwan(CV12), Tianshu (ST25), Daheng (SP15), and Shuidao(ST28) points using a 0.30×40-mm filiform needle as well as Waiguan (SJ5) and Zulinqi (GB41) points using a 0.25×25-mm filiform needle. After inserting, the reinforcing-reducing method was performed by twirling and rotating the needle until a sensation of numbness and distension was produced. The treatment was performed once every other day, three times a week, for 8 weeks.

Waiting group

The waiting group was observed without any intervention for 8 weeks. Interviews were conducted every 2 weeks or by telephone or WeChat. If aggravation or special physiological and pathological changes were noted during the observation period, patients could terminate the trial and seek medical advice at any time. After the observation, the medical cupping or acupuncture compensatory treatment could be given as required.

Observation index

Metabolic index

According to the MetS diagnostic criteria, the WC, SBP,DBP, FBG, 2hBG, TG, and HDL-C measurements were collected. FBG, 2hBG, TG, and HDL-C measurements were collected in the morning after fasting.

WC.When measuring the waistline, the subjects were asked to stand upright, with feet shoulder-width apart and weight evenly distributed on their legs. At the end of natural exhalation, the midpoint circumference of the line between the iliac crest and the inferior edge of the 12th rib was measured.

Blood pressure.Measurements were taken with the subject lying flat on the treatment bed and breathing evenly in a quiet state. The above data were collected in the morning after fasting.

Subcutaneous fat thickness

Subcutaneous fat thickness was measured using a JOINFIT skinfold caliper (JAT028).

Thickness of the above umbilical fat.The skin approximately 5 cm from the midpoint of the line between the breast-sword union and umbilicus was lifted and measured using the caliper. The value obtained is divided by 2, which is the thickness of the umbilical fat.

Umbilical right fat thickness.The skin at the right side of the umbilicus was lifted up to 10 cm and measured using the caliper; the obtained value was divided by 2 to get the thickness of the umbilical right fat.

Side waist fat thickness.The skin 5 cm before and after the horizontal intersection of left axillary midline and umbilical cord was lifted and measured using the caliper.The value obtained is divided by 2, which is the thickness of the side waist fat.

Subjects lie flat on the treatment bed, breathe evenly,and measured at the end of natural exhalation. Measured by the same person, averaged three times per measurement. The above data were collected before and after treatment, after morning fasting and defecation.

Comparison of the MetS prevalence in the three groups after treatment

According to the MetS diagnostic criteria, subjects who met 0-2 items were diagnosed as non-MetS and those meeting 3-5 items were diagnosed as MetS. The number of MetS and non-MetS in each group was calculated.MetS prevalence = NMetS/(NMetS+Nnon-MetS)×100%.

Statistical analysis

Results

Baseline data

A total of 75 patients with MetS abdominal obesity who met the criteria in the acupuncture department of Oriental Hospital of Beijing University of Traditional Chinese Medicine from July 2015 to February 2016 were randomly divided into the medical cupping (N = 25),acupuncture (N = 25), and waiting groups (N = 25). At the end of treatment, 11 patients dropped out owing to work or family, and the drop-out rate was 14.67%. No significant difference in gender and age were observed among the 64 patients. The three groups were comparable(see Table 1).

Comparison of metabolic indicators before and after treatment

No differences were observed between the three groups before treatment. After the treatment, the WC, TG, FBG,and 2hBG in the medical cupping (AllP< 0.001) and acupuncture groups (P= 0.004,P< 0.001,P< 0.001,P<0.001) were lower than those in the waiting group, and no difference was observed between the medical cupping and acupuncture groups (see Table 2).

Comparison of subcutaneous fat thickness before and after treatment

No difference in subcutaneous fat thickness was observed between the three groups before treatment. After the treatment, the subcutaneous fat thickness in the above umbilicus, umbilical right, and lateral waist in the medical cupping (AllP< 0.001) and acupuncture groups(P< 0.001,P= 0.002,P= 0.001) were lower than those in the waiting group; the subcutaneous fat thickness in the above umbilicus and lateral waist of the medical cupping group was lower than that of the acupuncture group (P=0.001,P= 0.029), but no difference in the thickness of the right umbilicus subcutaneous fat was observed between the medical cupping and acupuncture groups(Table 3).

Comparison of the MetS prevalence among the three groups after treatment

The MetS prevalence in the medical cupping and acupuncture groups was 38.1% and 39.1%, respectively,which was lower than that in the waiting group (85.0%)(χ2 = 12.86,P= 0.002) (see Table 4).

Discussion

MetS is a disorder that aggregates various metabolic risk factors, and its clinical consequences are mainly diabetes and cardiovascular and cerebrovascular diseases. In the recent years, the MetS incidence has increased sharply,and MetS has received more and more attention from both domestic and foreign scholars. With the advancement of research, abdominal obesity gradually emerged as an important role in the progression of MetS.

Table 1 Comparison of the general characteristics

Table 2 Comparison of metabolic indicators before and after treatment ()

Table 2 Comparison of metabolic indicators before and after treatment ()

Note: *Compared with the waiting group; #Medical cupping group compared with the acupuncture group. WC, Waist circumference; FBG, Fasting blood glucose; 2hBG, 2-h blood glucose; TG, Triglycerides; HDL-C, High-density lipoprotein cholesterol; SBP, Systolic pressure; DBP, Diastolic pressure.

Table 3 Comparison of subcutaneous fat thickness between pre-treatment and post-treatment groups ()

Table 3 Comparison of subcutaneous fat thickness between pre-treatment and post-treatment groups ()

Note: *Compared with the waiting group; #Medical cupping group compared with the acupuncture group.

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Table 4 Comparison of prevalence of MetS among three groups (n)

Currently, the only internationally recognized diagnostic criterion for MetS is proposed by the International Diabetes Federation (IDF) in 2005, which lists abdominal obesity as the primary and independent risk factor for MetS [3], suggesting that it is a triggering factor for MetS and its complications. According to the Chinese people’s characteristics, Chinese scholars established the first MetS standard in China in 2004 by the Chinese Diabetes Society (CDS). In 2007, the Joint Committee for the Development of Guidelines for the Prevention and Treatment of Adults with Experimental Dyslipidemia revised and improved the MetS-CDS2004 standard. In 2013, CDS updated the Chinese MetS standard based on the cohort study of large sample populations in China [18]. This standard uses abdominal obesity instead of body mass index to determine obesity factors and proposes the best WC cut-off point in China[16]. Abdominal obesity has been observed to play an important role in the occurrence and development of MetS and the importance of preventing and controlling of abdominal obesity in the field of metabolic diseases.

Comparing the components of MetS diagnostic criteria by IDF in 2005 and CDS in 2013, the major difference lies in the cut-off point of WC in women with abdominal obesity, which was modified from 80 cm by IDF to 85 cm by CDS. At present, the gold standard in diagnosing abdominal obesity is to define and measure the area of visceral fat tissue and subcutaneous fat tissue using computed tomography or magnetic resonance imaging(MRI) technology to calculate the visceral fat/subcutaneous fat value. However, this method is expensive, and the instrument itself has restrictions on the patient’s body weight and WC. Therefore, few studies were conducted on the detection of abdominal obesity using this method. In a cross-sectional study in China, the abdominal fat area of 1,140 adults aged 35-75 years was collected using the MRI technique. When the visceral fat area was cut-off at 80 cm2, the accumulation of risk factors was predicted to be the lowest [19]. Therefore, the corresponding male and female WCs are 90 and 85 cm respectively, and subsequently “China Hypertension Prevention Guide 2010” [20], CDS2010 and CDS2013 have used WC (male/female) of ≥ 90/85 cm as cut-off points for MetS and abdominal obesity. In previous clinical studies, subjects were recruited using the IDF2005 standard. The results showed that fewer women had a WC of 80-85 cm, and to avoid measurement errors,the study set the female WC cut-off point to 85 cm, which is more in line with the Chinese clinical practice.

We propose a “regulating Dai meridian method” for the treatment of abdominal obesity. Previous studies [10-14]have confirmed the efficacy of this method in the prevention and treatment of MetS; however, certain deficiencies were found: some patients have fear of acupuncture and the continuous effect of acupuncture is short. These shortcomings limit the clinical application of“regulating Dai meridian method.” Therefore, the TCM and cupping method were combined to manage patients with MetS abdominal obesity to regulate the Daimai function, thereby reducing abdominal fat accumulation and alleviating metabolic disorders. Traditional medical cupping therapy is a combination of cupping method and TCM therapy, which promotes local absorption of TCM through the warm stimulation and mechanical stimulation during cupping and facilitates the pharmacological action of TCM, thereby improving its therapeutic effect. Based on traditional medical cupping therapy, an Chinese medicine ointment was made. In clinical use, the ointment was applied to the waist and abdomen, and then cupping was applied to the waist and abdomen, which not only expands the scope of the drug but also strengthens the mechanical stimulation of the cupping to achieve the purpose of improving the clinical efficacy.

The results of this study show that medical cupping therapy can significantly reduce WC and abdominal fat thickness, improve glucose and lipid metabolism, and reduce the occurrence of MetS. Previous studies have suggested that the best treatment frequency for acupuncture treatment of obesity is three times a week[21]. In this study, the therapeutic effect of medical cupping therapy twice a week was similar to that of the acupuncture group. The subcutaneous fat thickness of the area above umbilicus and lateral waist for the medical cupping group was lower than that of the acupuncture group. It suggests that the combination of TCM and cupping can prolong the therapeutic effect and reduce the frequency of treatment. In addition, medical cupping therapy circumvents the fear of acupuncture in some patients, which makes it worthy of clinical application.

本文计算采用美国肯塔基州大学开发的KYPipe2010水锤分析软件。该软件水锤波特征方程基于弹性水柱理论的两个基本方程，数值求解方法采取的是拉格朗日波特性法，而非特征线法。

Conclusion

Medical cupping therapy can effectively alleviate the metabolic indices of abdominal fat obesity, reduce the thickness of abdominal subcutaneous fat and reduce the occurrence of MetS. The therapeutic effect is better than that of waiting group and is similar to that of acupuncture.The frequency of medical cupping therapy is lower than that of the acupuncture treatment, and at the same time,the fear of acupuncture is circumvented in some patients,which makes medical cupping therapy worthy of clinical application.

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