Berberine and Polycystic Ovary Syndrome

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Polycystic Ovary Syndrome; Berberine

Treatments: Dietary Supplement: Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT04932070

1206/14122018

Details and patient eligibility

About

Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.

Enrollment: 12 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
• newly detected Polycystic Ovary Syndrome

Exclusion criteria

• any concomitant medication
• presence of liver, renal and thyroid disease
• smoking
• drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Berberine

Experimental group

Description:

2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

Treatment:

Dietary Supplement: Berberine