The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women.
We will recruit 90 females aged from 16 year-old to 65 year-old with body mass index(BMI) 27㎞/㎡ and waist circumference≧80cm. After inform consent, they will be randomly assigned into two groups. In group A, catgut embedding will be applied to six acupuncture points on the abdomen including Qihai (Ren-6), Shuifen (REN-9), bilateral shuidao (ST-28) and Siman (ST-26), which have been proved to be effective on obesity in our previous study, once each week for six times. In group B, sham catgut embedding will be applied on the same acupoints once each week for six weeks. This trial will go on for six weeks with six course of treatment. Our primary outcome measurements is complexion which included body mass index(BMI),waist circumstances, and waist-hip ratio. In our second outcome measurments, we will evaluate the life quality of these patients using 12-Item Short Form Health Survey (SF-12) which developed for the Medical Outcomes Study (MOS) and also using questionnaire of quality of life that was designated by World Health Organization. We will also classify the patients by questionnaire designed for TCM syndrome of obesity. We will check blood test included lipid profile (TG, Chol, HDL-C, LDL-C), inflammatory markers, and hormone peptide related to obesity such as insulin,leptin,ghrelin,adiponectin. Each enrolling patients will be evaluated at the baseline before treatment and after 6 times treatments completed by above parameters to find out the therapeutic effects and mechanism of catgut embedding in acupoints in obese women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
An extensive form of acupuncture that involves weekly infixing self-absorptive chromic catgut sutures into acupoints with a specialised needle under antiseptic precautions. The catgut then stimulate those points over a long period. The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger with chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26)
The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26)
Branch of Chinese Medicine, Taipei City Hospital
Taipei, Taiwan, Taiwan
body weight
Time frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
body mass index
Time frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
waist circumference
Time frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
hip circumference
Time frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
cholesterol
cholesterol (Chol),
Time frame: Assess at baseline and after 6 weeks of treatment
triglyceride (TG)
triglyceride (TG),
Time frame: Assess at baseline and after 6 weeks of treatment
low-density lipoprotein cholesterol (LDL-C)
low-density lipoprotein cholesterol (LDL-C)
Time frame: Assess at baseline and after 6 weeks of treatment
High-density lipoprotein cholesterol(HDL-C)
High-density lipoprotein cholesterol(HDL-C)
Time frame: Assess at baseline and after 6 weeks of treatment
Quality of life
short-form 12 items and WHOQOLBREF
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Time frame: Assess at baseline and after 6 weeks of treatment
Questionnaire on traditional Chinese medicine syndrome groups
Obesity subjects will be classified into six groups including stomach heat, yin deficiency, qi stagnation, qi deficiency, kidney deficiency and blood stasis With more than two "yes"in items, patient will be classified to that kind of syndrome
Time frame: Assess at baseline and after 6 weeks of treatment
sugar
AC sugar,
Time frame: Assess at baseline and after 6 weeks of treatment
glycohemoglobin
glycohemoglobin (HbA1c),
Time frame: Assess at baseline and after 6 weeks of treatment
liver function
ALT
Time frame: Assess at baseline and after 6 weeks of treatment
kidney function
Cr
Time frame: Assess at baseline and after 6 weeks of treatment
inflammatory markers
hsCRP
Time frame: Assess at baseline and after 6 weeks of treatment