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Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve insulin sensitivity. Whether these findings can be translated into women with PCOS has not been investigated. Therefore, this study aims to evaluate whether acupuncture improves insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles improves insulin resistance, induces ovulation and improves quality of life.
This is a prospective observational study. A total of 112 women with PCOS and insulin resistance will be recruited and randomized into two groups according to their body mass index (BMI), i.e. normal weight (BMI=18.5-23Kg/m2) group and overweight or obese (BMI > 23Kg/m2) group1. The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. The primary outcome is changes in insulin sensitivity from baseline to after 6 months of acupuncture treatment measured by OGTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | "Normal weight" group,the PCOS women with insulin resistance who are normal weight( BMI=18.5-23Kg/m2).The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. |
|
| acupuncture 2 | Experimental | "Over weight or obese" group ,the PCOS women with insulin resistance who are overweight or obese: BMI >23 Kg/m2.The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR | baseline,treat for 3 and 6 month ,3 or 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| FSH | Determine FSH by electrogenerated chemiluminescence. | baseline,up to 6 month,the follow-up of 3 or 6 month |
| LH | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition(weight,height,waist circumference,hip circumference) | baseline,every month in treatment,the follow-up of 3 or 6 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongxia HX Ma, Dorctor | Study sponsor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23676106 | Result | Zheng YH, Wang XH, Lai MH, Yao H, Liu H, Ma HX. Effectiveness of abdominal acupuncture for patients with obesity-type polycystic ovary syndrome: a randomized controlled trial. J Altern Complement Med. 2013 Sep;19(9):740-5. doi: 10.1089/acm.2012.0429. Epub 2013 May 15. | |
| 25941189 | Derived | Zheng Y, Stener-Victorin E, Ng EH, Li J, Wu X, Ma H. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study. BMJ Open. 2015 May 3;5(4):e007757. doi: 10.1136/bmjopen-2015-007757. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Androgen | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Progesterone | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Prolactin | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Estradiol | baseline,up to 6 month,the follow-up of 3 or 6 month |
| dehydroepiandrosterone(sodium)sulfate | baseline,up to 6 month,the follow-up of 3 or 6 month |
| sex hormone binding globulin | baseline,up to 6 month,the follow-up of 3 or 6 month |
| c-peptide | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Apoa1 | baseline,up to 6 month,the follow-up of 3 or 6 month |
| ApoB | baseline,up to 6 month,the follow-up of 3 or 6 month |
| TC | baseline,up to 6 month,the follow-up of 3 or 6 month |
| TG | baseline,up to 6 month,the follow-up of 3 or 6 month |
| glycosylated hemoglobin | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Questionnaire investigation | Health related quality of life, affective symptoms and personality: Will be determined by short form-36 (SF36), polycystic ovary syndrome questionnaire (PCOSQ),(generic and diagnosis-specific HRQL questionnaire),and the Chinese Quality of Life (ChQOL) ,and symptoms of anxiety and depression assessed by the Zung Self-Rating Anxiety Scale (Zung SAS) and Zung Self-Rating Depression Scale (Zung SDS). | baseline,up to 6 month,the follow-up of 3 or 6 month |
| Transvaginal ultrasound | baseline,up to 6 month,the follow-up of 3 or 6 month |
| 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 |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |