Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

• Glucose Disposal Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  measured by hyperinsulinemic euglycemic clamp
• Measurement of sex steroids [ Time Frame: 3 months ] [ Designated as safety issue: No ]

• Oral glucose tolerance test (OGTT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Ovarian androgen biosynthesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Hormonal profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Fasting lipid metabolic profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Renal and liver function tests [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. [ Time Frame: Three months ] [ Designated as safety issue: No ]

• glucose levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Fasting glucose levels and OGTT 2h glucose levels
• Serum Triglycerides [ Time Frame: 3 month ] [ Designated as safety issue: No ]
• HDL-c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• ovulation rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.

• Polycystic Ovary Syndrome
• Obesity

• Drug: Berberine
  1.5g daily for 3 month
• Drug: Placebo
  placebo daily

• Experimental: Berberine
  Intervention: Drug: Berberine
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria

1. Age of women between 18 and 35 years.
2. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
3. Body mass index (BMI) equal to or greater than 23 kg/m2.
4. With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5.

Exclusion criteria are

1. Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
2. Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
3. Patients with known sever organ dysfunction or mental illness.