The primary objective of this multicenter randomized controlled trial is to evaluate treatment effectiveness of intervening simple obesity people with catgut implantation at preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate safety and superiority of treating simple obesity with catgut implantation at acupoints to provide high-level evidence for it clinically.
This randomized, double-blind sham-controlled clinical trial will be conducted at Hubei Provincial Hospital of TCM, Dongzhimen Hospital Beijing University of Chinese Medicine and the First Hospital of Hunan University of Chinese Medicine. This study includes the following time points: a treatment period of 16 weeks after screening and a follow-up period of 24 weeks. The total study period will be 40 weeks. All patients will be randomized into the real catgut implantation at acupoints group or the sham catgut implantation at acupoints group.The primary outcome measurement of this study is the rate of waistline reduction compared with baseline. The secondary outcome measurements are the rate of reduction of weight, BMI, hipline, WHR and PBF, and changes in the IWQOL-Lite compared with baseline. These parameters will be evaluated at week 0, week 4, week 8, week 12, week 16, week 28 and week 40. Changes in SF-36, HAD and SES compared with baseline will be evaluated at week 0, week 16 and week 40. SF-36 and IWQOL-Lite will be used to evaluate obese patient quality of life. HAD and SES will be used to evaluate psychological status. In addition, hepatorenal function, blood fat, liver bladder spleen colour ultrasound, FBG and insulin concentration will be used to evaluate whether catgut implantation at acupoints can improve the physiological function of obese patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
216
1. Absorbable surgical suture will be embedded in acupoints as below. Group A :Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B :Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks. 2. lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week .
Empty needles without catgut will be pushed into the chosen position as below :Group A :1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B :1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks. lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group.
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
the rate of waistline reduction compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of weight compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of body mass index compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of hipline compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of waist-hip ratio compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of percentage of body fat compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
changes in IWQOL - Lite scale score compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
changes in SF - 36 life quality scale score compared with baseline
Time frame: week4 ,week16,week40.
changes in HAD scale score compared with baseline
Time frame: week4 ,week16,week40.
changes in self-esteem scale score compared with baseline
Time frame: week4 ,week16,week40.
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changes in serum total cholesterol compared with baseline
Time frame: week16.
changes in serum triglyceride compared with baseline
Time frame: week16.
changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline
Time frame: week16.
changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline
Time frame: week16.
changes in fasting blood-glucose (FBG)compared with baseline
Time frame: week16.
changes in fasting insulin ( FINS) compared with baseline
Time frame: week16.
The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events.
The adverse effects of catgut implantation at acupoints include local swelling, pruritus, fever, festering and unbearable pain. In the event of an adverse effect during the trial, the patient should immediately contact the physician. All adverse effects should be promptly recorded.
Time frame: from week 2 to week 16.