The Effect of Electroacupuncture on Obesity

Study Overview
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Brief Summary
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The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.

Detailed Description
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Many studies have reported on the beneficial effects of acupuncture for obesity, although some negative reports also existed.(Wang F. et al. 2008)Recently conducted systematic review of Pittler and Ernst reported that there was insufficient, but not conclusive evidence to support the efficacy of acupuncture and acupressure for weight loss. However, most of these studies had methodological limitation, such as lack of adequate control group or unclear specific effect of electroacupuncture alone because auricular acupuncture was administered as well. In this sudy, we had three-arm randomized controlled trial(with sham control group) to investigate whether electroacupuncture is effective in the treatment of obesity.

Official Title
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The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study

Conditions
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Obesity

Intervention / Treatment
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* Device: Electroacupuncture
* Device: Sham electroacupuncture procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Waist circumference: Male>= 90 cm, Female >= 85 cm BMI over than 25kg/m2 Exclusion Criteria: Secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, Cushing's syndrome, hypothyroidism etc. Heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker Hypertension, hyperlipidemia or hypercholesterinemia patients on medication Stroke or otherwise unable to exercise Pregnant or lactating women Childbirth within 6 months Management for weight control within 3 months Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br>The Electroacupuncture therapy protocol included a total of 12 acupuncture points at the CV12,CV6, bilateral ST25, SP15, SP14,LI4, LI11, ST36, ST44. All acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Abdominal acupuncture points were inserted horizontally 6 6.5cm in depth and the others were inserted vertically 2 2.5cm in depth until patient can feel De-Qi. All acupuncture points were stimulated electrically with a frequency of 24 Hz an intensity of 0.27-1.3mA(tolerable strength) with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks by practitioner who had had 6 years of acupuncture training and 3 more years of clinical experience. | Device: Electroacupuncture<br>* We used Electrical stimulator(STN-111,Stratek)with a frequency of 24 Hz and intensity of 0.27-1.3mA(tolerable strength), asymmetric interactive pulse with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks(10 sessions) by practitioner.(n=13)<br>* Other names: EA group;|
| Sham Comparator: Sham electroacupuncture procedure<br>The Sham electroacupuncture therapy protocol(Non-acupoint, No electrical stimulation)included the same number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment, but superficially at non acupuncture points 15 mm to the lateral of each acupuncture point was treated. The points were not stimulated electrically, but the sound of the pulse generator was heard by the participants. (Lee SH, LeeBC 2009) Those receiving EA or SEA therapy were treated on alternate days to prevent crosstalk among groups, which could have compromised the blinded study design. | Device: Sham electroacupuncture procedure<br>* We used same electroacupuncture device, number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment. Specific details are as described in the arm description.(n=13)<br>* Other names: Sham EA group;|
| No Intervention: Waiting list<br>No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference |  | At 5 weeks (post treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of abdominal subcutaneous fat | Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack). | Study Day 1 (Baseline) | 
| Thickness of abdominal subcutaneous fat | Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack). | At 3weeks | 
| Thickness of abdominal subcutaneous fat | Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack). | At 5weeks (post treatment) | 
| Thickness of abdominal subcutaneous fat | Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack). | At 8weeks after first treatment (follow up) | 
| Waist hip ratio |  | Study Day 1 (Baseline) | 
| Waist hip ratio |  | At 3weeks | 
| Waist hip ratio |  | At 5weeks (post treatment) | 
| Waist hip ratio |  | At 8weeks after first treatment (follow up) | 
| Body Mass Index | Body Mass Index was measured by Inbody 720 | Study Day 1 (Baseline) | 
| Body Mass Index | Body Mass Index was measured by Inbody 720 | At 3weeks | 
| Body Mass Index | Body Mass Index was measured by Inbody 720 | At 5weeks (post treatment) | 
| Body Mass Index | Body Mass Index was measured by Inbody 720 | At 8weeks after first treatment (follow up) | 
| Body fat ratio | Body fat ratio was measured by Inbody 720 | Study Day 1 (Baseline) | 
| Body fat ratio | Body fat ratio was measured by Inbody 720 | At 3weeks | 
| Body fat ratio | Body fat ratio was measured by Inbody 720 | At 5weeks (post treatment) | 
| Body fat ratio | Body fat ratio was measured by Inbody 720 | At 8weeks after first treatment (follow up) | 
| Visceral Fat Area | Visceral Fat Area was measured by Inbody 720 | Study Day 1 (Baseline) | 
| Visceral Fat Area | Visceral Fat Area was measured by Inbody 720 | At 3weeks | 
| Visceral Fat Area | Visceral Fat Area was measured by Inbody 720 | At 5weeks (post treatment) | 
| Visceral Fat Area | Visceral Fat Area was measured by Inbody 720 | At 8weeks after first treatment (follow up) | 
| Body weight | Body weight was measured by Inbody 720 | Study Day 1 (Baseline) | 
| Body weight | Body weight was measured by Inbody 720 | At 3weeks | 
| Body weight | Body weight was measured by Inbody 720 | At 5weeks (post treatment) | 
| Body weight | Body weight was measured by Inbody 720 | At 8weeks after first treatment (follow up) | 
| Obesity degree | Obesity degree was measured by Inbody 720 | Study Day 1 (Baseline) | 
| Obesity degree | Obesity degree was measured by Inbody 720 | At 3weeks | 
| Obesity degree | Obesity degree was measured by Inbody 720 | At 5weeks (post treatment) | 
| Obesity degree | Obesity degree was measured by Inbody 720 | At 8weeks after first treatment (follow up) | 
| Bulimia Test Revised |  | Study Day 1 (Baseline) | 
| Bulimia Test Revised |  | At 5weeks (post treatment) | 
| Korean version of Obesity-related QOL scale |  | Study Day 1 (Baseline) | 
| Korean version of Obesity-related QOL scale |  | At 5weeks (post treatment) | 
| Body Shape Questionnaire |  | Study Day 1 (Baseline) | 
| Body Shape Questionnaire |  | At 5weeks (post treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Electroacupuncture, Sham electroacupuncture, Waist circumference, Thickness of subcutaneous fat