Comparing acupuncture and metformin for insulin resistance in women with PCOS

Acupuncture or Metformin for Insulin Resistance in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial

This study is testing whether acupuncture or the diabetes drug metformin can help women with PCOS improve their insulin sensitivity and overall health when combined with lifestyle changes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 303 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Karolinska Institutet (other)
• Locations: 2 sites (Beijing and 1 other locations)
• Trial ID: NCT02647827 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of acupuncture versus metformin, both combined with lifestyle management, in improving insulin sensitivity in women diagnosed with polycystic ovary syndrome (PCOS). The study aims to determine if these treatments can enhance glucose homeostasis and restore hormonal balance, potentially preventing the onset of type 2 diabetes. Participants will be randomly assigned to receive either acupuncture, metformin, or lifestyle management alone, with various metabolic and hormonal parameters being measured throughout the trial. The study also explores the impact of these interventions on quality of life and psychological well-being.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 40 with a BMI between 25 and 40 who have been diagnosed with PCOS according to the Rotterdam criteria.

Not a fit: Patients who do not meet the inclusion criteria, such as those with a BMI outside the specified range or without a PCOS diagnosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for women with PCOS, improving their insulin sensitivity and overall health outcomes.

How similar studies have performed: Previous studies have shown promising results for both acupuncture and metformin in managing insulin resistance, suggesting that this approach may be effective.

Eligibility criteria

Inclusion criteria - women with PCOS:

1. Age 18 to 40 years
2. Body mass index (BMI) ≥25 to ≤40 given that 95% of all women with PCOS with a BMI ≥25 are insulin resistant (71,72).
3. PCOS diagnosis according to Rotterdam criteria 2003 (73), with at least two of the following three symptoms: Clinical signs of hyperandrogenism (hirsutism or acne); oligo/amenorrhea; and/or polycystic ovaries (PCOS). Hirsutism is defined as a self-reported Ferriman-Gallwey (FG) score ≥8 (≥5 Asian) (74,75). Acne is defined by a positive response to the question Do you have acne? Oligomenorrhea is defined as an intermenstrual interval \>35 days and \<8 menstrual bleedings in the past year. Amenorrhea as \<3 cycles per year. PCO is defined by transvaginal ultrasound with ≥12 follicles 2-9 mm and/or ovarian volume ≥10 ml in one or both ovaries.
4. Willing to sign the consent form.

Inclusion criteria - controls:

Controls should have BMI \>25 to \<40, regular cycles with 28 days ± 2 days, and no signs of hyperandrogenism. They are excluded if they have menstrual irregularities, signs of hyperandrogenism (FG \>4), or evidence of PCO morphology on ultrasound.

Exclusion criteria for all women

1. Age \>40
2. Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L), androgen secreting tumors or suspected Cushing's syndrome.
3. Having known renal disease (creatinine clearance \< 60 mL/min), hepatic insufficiency, autoimmune disorders or cancer.
4. Any acute condition with potential to alter renal function or cause tissue hypoxia.
5. Type I diabetes.
6. Pharmacological treatment (cortizon, 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.
7. Hypersensitivity to metformin hydrochloride or to any of the excipients.
8. Blood pressure \>160 / 100 mmHg
9. Pregnancy or breastfeeding the last 6 months
10. Acupuncture the last 2 months
11. Daily smoking and alcoholic intake
12. Language barrier or disabled person with reduced ability to understand the information given.

In total 50 controls will be matched at baseline (age, weight and BMI) to women with PCOS. Controls will undergo screening and baseline visit, but will not be randomized to any treatment.

Where this trial is running

Beijing and 1 other locations

• Peking University — Beijing, China (RECRUITING)
• Karolinska University Hospital — Stockholm, Sweden (RECRUITING)

Study contacts

• Principal investigator: Elisabet Stener-Victorin, PhD — Karolinska Institutet
• Study coordinator: Elisabet Stener-Victorin, PhD

Conditions: Polycystic Ovary Syndrome, Insulin Resistance, Hyperandrogenism, Acupuncture, Metformin, Glucose metabolism, Hba1c