Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity

Conditions
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Polycystic Ovarian Syndrome, Obesity, Abdominal

Intervention / Treatment
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* Device: electroacupuncture
* Behavioral: lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Polycystic Ovarian Syndrome. Clinical diagnosis of abdominal obesity. Agree to participate in clinical trials. Exclusion Criteria: Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia. Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness). Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results. Pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture & lifestyle modification<br>Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks. | Device: electroacupuncture<br>* 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.<br>Behavioral: lifestyle modification<br>* 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.<br>|
| Active Comparator: lifestyle modification<br>diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks | Behavioral: lifestyle modification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of recovered ovulation | the proportion of patients who have ovulation after treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of clinically definite hyperandrogenism confirmed by mF-G score |  | 12 weeks | 
| evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System |  | 12 weeks | 
| frequency of menstruation |  | 12 weeks | 
| quantity of menstruation | pictorial blood loss assessment chart | 12 weeks | 
| Serum total testosterone (T) |  | 12 weeks | 
| FSH | follicle stimulating hormone (FSH) | 12 weeks | 
| LH | luteinizing hormone (LH) | 12 weeks | 
| ovarian volume measured by ultrasound |  | 12 weeks | 
| follicle number pre ovary measured by ultrasound |  | 12 weeks | 
| ovarian stromal blood flow measured by ultrasound |  | 12 weeks | 
| body weight in kilograms |  | 4, 8 and 12 weeks | 
| waist circumference in centimeter |  | 4, 8 and 12 weeks | 
| BMI in kg/m^2 |  | 4, 8 and 12 weeks | 
| waist-to-height ratio | waist-to-height ratio=waist circumference in centimeter/height in centimeter | 4, 8 and 12 weeks | 
| Fasting serum PAI-1 level |  | 12 weeks | 
| International physical activity scale (IPAQ) short version |  | 4, 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroacupuncture, lifestyle modification, diet, exercise, Dai Meridian