Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
insulin resistance
Brief summary
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.
Detailed description
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. 1. To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS; 2. To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.
Interventions
OTHERlifestyle intervention
lifestyle intervention
DEVICEacupuncture
acupuncture
DEVICESham acupuncture
Sham acupuncture
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
Exclusion criteria
1. Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L) thyroid dysfunction and hyperprolactinemia. 2. Type I diabetes or not well controlled type II diabetes 3. Stage 2 hypertension (resting blood pressure ≥160/100mmHg) 4. Psychiatric diagnoses or using psychiatric medications including antidepressants 5. Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | baseline and after 4 months | calculation of HOMA-IR: \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5) \[Time Frame: Baseline\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| high density lipoprotein (HDL) | baseline and after 4 months | Examined with the blood sample |
| low density lipoprotein (LDL) | baseline and after 4 months | Examined with the blood sample |
| Bile acidomics | baseline and after 4 months | Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry). |
| Hirsutism(FG score >4）, acne and early alopecia | baseline and after 4 months | general condition |
| AUC insulin | baseline and after 4 months | during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve |
| Follicle stimulating hormone (FSH) | baseline and after 4 months | Examined with the blood sample |
| luteinizing hormone (LH) | baseline and after 4 months | Examined with the blood sample |
| Progestin (P) | baseline and after 4 months | Examined with the blood sample |
| Estrogen (E2) | baseline and after 4 months | Examined with the blood sample |
| Prolactin (PRL) | baseline and after 4 months | Examined with the blood sample |
| Androgen(T) | baseline and after 4 months | Examined with the blood sample |
| Anti-mullerian hormone (AMH) | baseline and after 4 months | Examined with the blood sample |
| Sex hormone-binding globulin (SHBG) | baseline and after 4 months | Examined with the blood sample |
| Free testosterone index (FAI) | baseline and after treatment | testosterone (nmol/ml) ×100 / SHBG (nmol/ml). |
| triglycerides | baseline and after 4 months | Examined with the blood sample |
| Metagenomics and 16S rDNA sequencing analysis | baseline and after 4 months | gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000. |
| short form-36 (SF36) | baseline and after 4 months | determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better |
| Self-Rating Anxiety Scale (SAS) | baseline and after 4 months | determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse. |
| Self-Rating Depress Scale (SDS) | baseline and after 4 months | determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse |
| polycystic ovary syndrome questionnaire, PCOSQ | baseline and after 4 months | Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS |
| BMI | baseline and after 4 months | calculation:BMI=weight(kg)/height(m)\^2 |
| Fat% | baseline and after 4 months | examined by body composition analyzer |
| waist to hip ratio(WHR) | baseline and after 4 months | calculation of WHR: waist circumference(cm)/ hip circumference(cm) |
| glycosylated hemoglobin level | baseline and after 4 months | Examined with the blood sample |
| ovarian size | baseline and after 4 months | baseline and after 4 months, explained by 3 diameters: length(cm) \* width(cm) \* height(cm) |
| number of follicles | baseline and after 4 months | observed by B-ultrasound |
| uterine size | baseline and after 4 months | observed by B-ultrasound |
| endometrial thickness | baseline and after 4 months | observed by B-ultrasound |
| total cholesterol | baseline and after 4 months | Examined with the blood sample |
Countries
China
Outcome results
None listed