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The present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with PCOS.A total of 100 subjects will be enrolled into this study and will be randomized into two groups.
Auricular acupressure or sham auricular acupressure will be treated for three months. The primary outcome is the whole body insulin action assessed with HOMA-IR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular acupoints acupressure | Experimental |
| |
| Sham auricular acupoints acupressure | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupoints acupressure | Other | The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear. |
| Measure | Description | Time Frame |
|---|---|---|
| Homeostasis model assessment-insulin resistance (HOMA-IR) | HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5. | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone(T) | 3 month | |
| Androstadienedione (AND) | 3 month | |
| Sex hormone-binding globulin (SHBG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Heilongjiang University of Chinese Medicine | Harbin | Heilongjiang | 150040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31142530 | Derived | Li Y, Hou L, Wang Y, Xie L, Zhang M, Pan Z, Li Y, Ding Y, Sun M, Qu Y, Liu S. Auricular points acupressure for insulin resistance in overweight/obese women with polycystic ovary syndrome: protocol for a randomised controlled pilot trial. BMJ Open. 2019 May 28;9(5):e027498. doi: 10.1136/bmjopen-2018-027498. |
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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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|
| Sham auricular acupoints acupressure | Other | The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear. |
|
| 3 month |
| Dehydroepiandrosterone sulfate (DHEAS) | 3 month |
| Follicle stimulating hormone (FSH) | 3 month |
| Luteinizing hormone (LH) | 3 month |
| Estradiol (E2) | 3 month |
| Weight | 3 month |
| Waist/hip circumference | 3 month |
| BMI | 3 month |
| FG score | 3 month |
| Acne | 3 month |
| Short-Form Health Survey (SF-36) | 3 month |
| The Chinese Quality of Life questionnaire (ChQoL) | 3 month |
| Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ) | 3 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 |