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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
| Beijing Municipal Science & Technology Commission | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture & lifestyle modification | Experimental | 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. |
|
| lifestyle modification | Active Comparator | diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of recovered ovulation | the proportion of patients who have ovulation after treatment | 12 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui HU, Doctor | Dongfang Hospital Beijing University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine | Beijing | Beijing Municipality | 100078 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25878993 | Background | Abazar E, Taghian F, Mardanian F, Forozandeh D. Effects of aerobic exercise on plasma lipoproteins in overweight and obese women with polycystic ovary syndrome. Adv Biomed Res. 2015 Mar 25;4:68. doi: 10.4103/2277-9175.153892. eCollection 2015. | |
| 10955058 | Background | Case problem: dietary recommendations to combat obesity, insulin resistance, and other concerns related to polycystic ovary syndrome. J Am Diet Assoc. 2000 Aug;100(8):955-7; discussion 957-60. doi: 10.1016/S0002-8223(00)00275-3. No abstract available. |
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| lifestyle modification | Behavioral | 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. |
|
| 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 |
| Dongfang Hospital Affiliated to Beijing University of Chinese | Beijing | Beijing Municipality | 100078 | China |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D056128 | Obesity, Abdominal |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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