Berberine and Polycystic Ovary Syndrome

Berberine is an Effective Insulin Sensitizer and Improves Homeostasis of Metabolic and Hormonal Disorders in Women With Polycystic Ovary Syndrome: a Novel Treatment Strategy for PCOS

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Berberine
• Intervention / Treatment: Dietary supplement: Berberine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Azienda di Servizi alla Persona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Berberine; 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets	Dietary supplement: Berberine; 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on insulin resistance	Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2.4	Changes from baseline insulin resistance at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on inflammation	C-Reactive Protein (mg/dl)	Changes from baseline inflammation at 8 weeks
Changes on inflammation	Tumor Necrosis Factor alpha (pg/ml)	Changes from baseline inflammation at 8 weeks
Changes on lipid profile	Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Very Low Density Lipoprotein (mg/dl),Triglycerides (mg/dl)	Changes from baseline lipid profile at 8 weeks
Changes on Carbohydrate profile	Glycemia (mg/dl)	Changes from baseline Carbohydrate profile at 8 weeks
Changes on Carbohydrate profile	Insulin (mcU/ml)	Changes from baseline Carbohydrate profile at 8 weeks
Changes on Hormonal profile	Sex Hormone Binding Globulin (nmol/l)	Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile	Testosterone (ng/ml)	Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile	Free Androgen Index (ratio)	Changes from baseline Hormonal profile at 8 weeks
Changes on safety	Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)	Changes from baseline safety at 8 weeks
Changes on safety	Total bilirubin (mg/dl)	Changes from baseline safety at 8 weeks
Changes on safety	Gamma Glutamyl Transferase (U/I), Creatine Phosphokinase (U/I)	Changes from baseline safety at 8 weeks
Changes on anthropometry	waist circumference (cm), hip circumference (cm)	Changes from baseline anthropometry at 8 weeks
Changes on anthropometry	Weight (kg)	Changes from baseline anthropometry at 8 weeks
Changes on anthropometry	Body Mass Index (Kg/m2)	Changes from baseline anthropometry at 8 weeks
Changes on body composition	Fat mass (g), lean mass (g), visceral adipose tissue (g)	Changes from baseline body composition at 8 weeks
Changes on acne assessment	Global Acne Grading System (scale): each type of acne lesion is given a value depending on severity: no lesions = 0, comedones = 1, papules = 2, pustules = 3, and nodules = 4. Each of the location was graded separately on 0-4 scale, with the most severe lesion within that location determining the local score. The severity was then graded according to the global score which is the summation of all local scores. A score of 1-6 was considered mild; 7-18, moderate; 19- 26, severe; and 27-32, very severe. The maximum score was 32	Changes from baseline acne assessment at 8 weeks
Changes on acne assessment	Cardiff Acne Disability Index (scale): the Cardiff Acne Disability Index consists of five questions with a Likert scale, four response categories (0-3). The five questions relate to feeling of aggression, frustration, interference with social life, avoidance of public changing facilities and appearance of the skin-all over the last month-and an indication of how bad the acne was now. The CADI score was calculated by summing the score of each question resulting in a possible maximum of 15 and minimum of 0. CADI scores were graded as low (0-4), medium (5-9), and high (10-15)	Changes from baseline acne assessment at 8 weeks

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2020
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; berberine
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 1206/14122018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No