The Effect of Electroacupuncture on Obesity

Phase 2

• Conditions: Obesity
• Interventions: Device: Sham electroacupuncture procedure; Device: Electroacupuncture

• Registration Number: NCT01102075
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2009-09
• Study Start: 2010-01
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-09
• Last Update Submitted: 2010-04-09
• Study First Posted: 2010-04-12
• Last Update Posted: 2010-04-12
• Primary Completion: 2010-05
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham electroacupuncture procedure	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.
Electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
waist circumference	At 5 weeks (post treatment)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyunghee University Medical Center; 🇰🇷 Seoul, Hoegi-dong, Dongdaemun-gu, Korea, Republic of