A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

Peking University

Status: Completed

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Other: lifestyle intervention; Device: Sham acupuncture; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06306417

PKUTH TCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Experimental group

Experimental group

Description:

acupuncture

Treatment:

Device: acupuncture

Other: lifestyle intervention

control group

Sham Comparator group

Description:

sham acupuncture

Treatment:

Device: Sham acupuncture

Other: lifestyle intervention