The Effect of Electroacupuncture on Obesity

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

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

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: Electroacupuncture; Device: Sham electroacupuncture procedure

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hoegi-dong, Dongdaemun-gu
    • Seoul, Hoegi-dong, Dongdaemun-gu, Korea, Republic of, 130-702
      • Kyunghee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electroacupuncture; 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; 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); Other Names: EA group
SHAM_COMPARATOR: Sham electroacupuncture procedure; 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; 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); Other Names: Sham EA group
NO_INTERVENTION: Waiting list; 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?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Investigators: Principal Investigator: Sung Keel Kang, Doctor, Kyunghee University Medical Center Oriental Hospital

Publications and helpful links

General Publications

• Lee SH, Lee BC. Electroacupuncture relieves pain in men with chronic prostatitis/chronic pelvic pain syndrome: three-arm randomized trial. Urology. 2009 May;73(5):1036-41. doi: 10.1016/j.urology.2008.10.047.
• Wang F, Tian DR, Han JS. Electroacupuncture in the treatment of obesity. Neurochem Res. 2008 Oct;33(10):2023-7. doi: 10.1007/s11064-008-9822-6. Epub 2008 Aug 22.
• Pittler MH, Ernst E. Complementary therapies for reducing body weight: a systematic review. Int J Obes (Lond). 2005 Sep;29(9):1030-8. doi: 10.1038/sj.ijo.0803008.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): May 1, 2010
• Study Completion (ANTICIPATED): May 1, 2010

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (ESTIMATE): April 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 12, 2010
• Last Update Submitted That Met QC Criteria: April 9, 2010
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Obesity; Electroacupuncture; Waist circumference; Sham electroacupuncture; Thickness of subcutaneous fat
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: KOMC MIRB 2009-6