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To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.
A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | acupuncture |
|
| control group | Sham Comparator | sham acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle intervention | Other | lifestyle intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR | calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5) [Time Frame: Baseline] | baseline and after 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hirsutism(FG score >4）, acne and early alopecia | general condition | baseline and after 4 months |
| AUC insulin | during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haolin Zhang | Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University third hospital | Beijing | China |
We haven't decided whether to share the data
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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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| acupuncture |
| Device |
acupuncture |
|
| Sham acupuncture | Device | Sham acupuncture |
|
| baseline and after 4 months |
| Follicle stimulating hormone (FSH) | Examined with the blood sample | baseline and after 4 months |
| luteinizing hormone (LH) | Examined with the blood sample | baseline and after 4 months |
| Progestin (P) | Examined with the blood sample | baseline and after 4 months |
| Estrogen (E2) | Examined with the blood sample | baseline and after 4 months |
| Prolactin (PRL) | Examined with the blood sample | baseline and after 4 months |
| Androgen(T) | Examined with the blood sample | baseline and after 4 months |
| Anti-mullerian hormone (AMH) | Examined with the blood sample | baseline and after 4 months |
| Sex hormone-binding globulin (SHBG) | Examined with the blood sample | baseline and after 4 months |
| Free testosterone index (FAI) | testosterone (nmol/ml) ×100 / SHBG (nmol/ml). | baseline and after treatment |
| total cholesterol | Examined with the blood sample | baseline and after 4 months |
| triglycerides | Examined with the blood sample | baseline and after 4 months |
| high density lipoprotein (HDL) | Examined with the blood sample | baseline and after 4 months |
| low density lipoprotein (LDL) | Examined with the blood sample | baseline and after 4 months |
| Bile acidomics | Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry). | baseline and after 4 months |
| Metagenomics and 16S rDNA sequencing analysis | gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000. | baseline and after 4 months |
| short form-36 (SF36) | determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better | baseline and after 4 months |
| Self-Rating Anxiety Scale (SAS) | determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse. | baseline and after 4 months |
| Self-Rating Depress Scale (SDS) | determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse | baseline and after 4 months |
| polycystic ovary syndrome questionnaire, PCOSQ | Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS | baseline and after 4 months |
| BMI | calculation:BMI=weight(kg)/height(m)^2 | baseline and after 4 months |
| Fat% | examined by body composition analyzer | baseline and after 4 months |
| waist to hip ratio(WHR) | calculation of WHR: waist circumference(cm)/ hip circumference(cm) | baseline and after 4 months |
| glycosylated hemoglobin level | Examined with the blood sample | baseline and after 4 months |
| ovarian size | baseline and after 4 months, explained by 3 diameters: length(cm) * width(cm) * height(cm) | baseline and after 4 months |
| number of follicles | observed by B-ultrasound | baseline and after 4 months |
| uterine size | observed by B-ultrasound | baseline and after 4 months |
| endometrial thickness | observed by B-ultrasound | baseline and after 4 months |
| 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 |