The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- waist circumference
研究概览
简要总结
The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waist circumference: Male>= 90 cm, Female >= 85 cm
- •BMI over than 25kg/m2
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Electroacupuncture (Device)
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.
干预措施: Sham electroacupuncture procedure (Device)
Waiting list
No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.
结局指标
主要结局
waist circumference
时间窗: At 5 weeks (post treatment)
次要结局
- Visceral Fat Area(At 8weeks after first treatment (follow up))
- Thickness of abdominal subcutaneous fat(At 8weeks after first treatment (follow up))
- Waist hip ratio(At 8weeks after first treatment (follow up))
- Body Mass Index(At 8weeks after first treatment (follow up))
- Body fat ratio(At 8weeks after first treatment (follow up))
- Body weight(At 8weeks after first treatment (follow up))
- Obesity degree(At 8weeks after first treatment (follow up))
- Bulimia Test Revised(At 5weeks (post treatment))
- Korean version of Obesity-related QOL scale(At 5weeks (post treatment))
- Body Shape Questionnaire(At 5weeks (post treatment))
- Waist hip ratio(Study Day 1 (Baseline))
- Waist hip ratio(At 3weeks)
- Waist hip ratio(At 5weeks (post treatment))
- Thickness of abdominal subcutaneous fat(Study Day 1 (Baseline))
- Body Mass Index(At 3weeks)
- Thickness of abdominal subcutaneous fat(At 5weeks (post treatment))
- Thickness of abdominal subcutaneous fat(At 3weeks)
- Body Mass Index(Study Day 1 (Baseline))
- Body Mass Index(At 5weeks (post treatment))
- Body fat ratio(Study Day 1 (Baseline))
- Body fat ratio(At 3weeks)
- Body fat ratio(At 5weeks (post treatment))
- Visceral Fat Area(Study Day 1 (Baseline))
- Visceral Fat Area(At 3weeks)
- Visceral Fat Area(At 5weeks (post treatment))
- Body weight(Study Day 1 (Baseline))
- Body weight(At 3weeks)
- Body weight(At 5weeks (post treatment))
- Obesity degree(Study Day 1 (Baseline))
- Obesity degree(At 3weeks)
- Obesity degree(At 5weeks (post treatment))
- Bulimia Test Revised(Study Day 1 (Baseline))
- Korean version of Obesity-related QOL scale(Study Day 1 (Baseline))
- Body Shape Questionnaire(Study Day 1 (Baseline))