The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.
Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities. Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Disposable, single-use, sterilized stainless-steel needles (Yunlong, Beijing, China; length 40/100 mm, diameter 0.30 mm) are inserted into waist, bilaterally. All of the six points are located in the Dai Meridian route corresponding to the ovaries. Four needles, 0.25mm in diameter and 25mm in length, are also placed in distal acupuncture points which are located in the feet and lower arms to enhance local points' effects. Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into GB26(Daimai) with a depth of 25-65mm by an angle of 15°, following the path of Dai Meridian (towards medial and downside). The other needles are inserted vertically into the acupoints with a depth of 10-30mm, depending on the thickness of muscles. Electro-acupuncture is applied to both sides of GB26 and ST25(Tianshu): cathode is connected to GB26; anode to ST25. Needles are stimulated electrically with low frequency (2 Hz) for 20 min.
The diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises.
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Dongfang Hospital Affiliated to Beijing University of Chinese
Beijing, Beijing Municipality, China
rate of recovered ovulation
the proportion of patients who have ovulation after treatment
Time frame: 12 weeks
evidence of clinically definite hyperandrogenism confirmed by mF-G score
Time frame: 12 weeks
evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System
Time frame: 12 weeks
frequency of menstruation
Time frame: 12 weeks
quantity of menstruation
pictorial blood loss assessment chart
Time frame: 12 weeks
Serum total testosterone (T)
Time frame: 12 weeks
FSH
follicle stimulating hormone (FSH)
Time frame: 12 weeks
LH
luteinizing hormone (LH)
Time frame: 12 weeks
ovarian volume measured by ultrasound
Time frame: 12 weeks
follicle number pre ovary measured by ultrasound
Time frame: 12 weeks
ovarian stromal blood flow measured by ultrasound
Time frame: 12 weeks
body weight in kilograms
Time frame: 4, 8 and 12 weeks
waist circumference in centimeter
Time frame: 4, 8 and 12 weeks
BMI in kg/m^2
Time frame: 4, 8 and 12 weeks
waist-to-height ratio
waist-to-height ratio=waist circumference in centimeter/height in centimeter
Time frame: 4, 8 and 12 weeks
Fasting serum PAI-1 level
Time frame: 12 weeks
International physical activity scale (IPAQ) short version
Time frame: 4, 8 and 12 weeks
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