In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.
This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.
Linda Zhong
Kowloon Tong, Kowloon, Hong Kong
Changes in waist circumference
Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).
Time frame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks
Changes in hip circumference
hip circumference measured at the level of maximum posterior extension of the buttocks
Time frame: 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks
Adverse events after treatment and follow up
Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.
Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in waist-to-hip circumference ratio
waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).
Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in Body Mass Index
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in body fat percentage
The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.
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Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)
Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.
Time frame: 0, 8 weeks