Clinical trial NCT01102075: The Effect of Electroacupuncture on Obesity
Official title: The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Electroacupuncture
Sham electroacupuncture
Waist circumference
Thickness of subcutaneous fat
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: waist circumference
timeFrame: At 5 weeks (post treatment)
Secondary outcomes:
measure: Thickness of abdominal subcutaneous fat
timeFrame: Study Day 1 (Baseline)
measure: Thickness of abdominal subcutaneous fat
timeFrame: At 3weeks
measure: Thickness of abdominal subcutaneous fat
timeFrame: At 5weeks (post treatment)
measure: Thickness of abdominal subcutaneous fat
timeFrame: At 8weeks after first treatment (follow up)
measure: Waist hip ratio
timeFrame: Study Day 1 (Baseline)
measure: Waist hip ratio
timeFrame: At 3weeks
measure: Waist hip ratio
timeFrame: At 5weeks (post treatment)
measure: Waist hip ratio
timeFrame: At 8weeks after first treatment (follow up)
measure: Body Mass Index
timeFrame: Study Day 1 (Baseline)
measure: Body Mass Index
timeFrame: At 3weeks
measure: Body Mass Index
timeFrame: At 5weeks (post treatment)
measure: Body Mass Index
timeFrame: At 8weeks after first treatment (follow up)
measure: Body fat ratio
timeFrame: Study Day 1 (Baseline)
measure: Body fat ratio
timeFrame: At 3weeks
measure: Body fat ratio
timeFrame: At 5weeks (post treatment)
measure: Body fat ratio
timeFrame: At 8weeks after first treatment (follow up)
measure: Visceral Fat Area
timeFrame: Study Day 1 (Baseline)
measure: Visceral Fat Area
timeFrame: At 3weeks
measure: Visceral Fat Area
timeFrame: At 5weeks (post treatment)
measure: Visceral Fat Area
timeFrame: At 8weeks after first treatment (follow up)
measure: Body weight
timeFrame: Study Day 1 (Baseline)
measure: Body weight
timeFrame: At 3weeks
measure: Body weight
timeFrame: At 5weeks (post treatment)
measure: Body weight
timeFrame: At 8weeks after first treatment (follow up)
measure: Obesity degree
timeFrame: Study Day 1 (Baseline)
measure: Obesity degree
timeFrame: At 3weeks
measure: Obesity degree
timeFrame: At 5weeks (post treatment)
measure: Obesity degree
timeFrame: At 8weeks after first treatment (follow up)
measure: Bulimia Test Revised
timeFrame: Study Day 1 (Baseline)
measure: Bulimia Test Revised
timeFrame: At 5weeks (post treatment)
measure: Korean version of Obesity-related QOL scale
timeFrame: Study Day 1 (Baseline)
measure: Korean version of Obesity-related QOL scale
timeFrame: At 5weeks (post treatment)
measure: Body Shape Questionnaire
timeFrame: Study Day 1 (Baseline)
measure: Body Shape Questionnaire
timeFrame: At 5weeks (post treatment)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
state: Hoegi-dong, Dongdaemun-gu
Study officials:
affiliation: Kyunghee University Medical Center Oriental Hospital
name: Sung Keel Kang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.