The Effect of Electroacupuncture on Obesity

Kyung Hee University

Status and phase: Unknown; Phase 2

Conditions: Obesity

Treatments: Device: Electroacupuncture; Device: Sham electroacupuncture procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01102075

KOMC MIRB 2009-6

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Electroacupuncture

Experimental group

Description:

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.

Treatment:

Device: Electroacupuncture

Sham electroacupuncture procedure

Sham Comparator group

Description:

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.

Treatment:

Device: Sham electroacupuncture procedure

Waiting list

No Intervention group

Description:

No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.