Keywords
Berberine
Insulin resistance
Phytotherapy
How to Cite
Copyright © | All rights reserved.
The journal holds the exclusive copyright for the publication of this article under the terms of Brazilian law 9610/98.
Partial reproduction
The use of parts of the texts, figures and questionnaire of the article is free, being mandatory the citation of the authors and journal.
Total reproduction
It is expressly prohibited and must be authorized by the journal.
Abstract
Objective: To analyze the metabolic, hormonal, and reproductive effects of berberine and its novel formulations in the treatment of Polycystic Ovary Syndrome (PCOS). Methods: An integrative literature review was conducted in April 2026 using PubMed, SciELO, Scopus, Web of Science, Embase, and LILACS, following PRISMA guidelines. The research question was structured according to the PICO strategy. Primary human studies published between 2016 and 2025 in English, Portuguese, or Spanish were included. Results: Four interventional studies met the eligibility criteria. Berberine consistently improved insulin resistance, lipid profile, and body composition. It also reduced free testosterone levels, increased sex hormone-binding globulin (SHBG), and alleviated manifestations of hyperandrogenism. Menstrual cycle regularization was observed in up to 70% of patients. Berberine Phytosome demonstrated comparable efficacy at lower doses and showed better gastrointestinal tolerability. Overall, berberine exhibited efficacy similar to metformin, with a more favorable safety profile. Final considerations: Berberine is a promising complementary strategy for PCOS management, particularly in its phytosome formulation. However, larger, multicenter randomized clinical trials are needed to confirm its clinical effectiveness.
References
ARODA VR, et al. Long-term metformin use and vitamin B12 deficiency in the diabetes prevention program outcomes study. The Journal of Clinical Endocrinology & Metabolism, 2016; 101(4): 1754-1761.
ASGHARI P, et al. Berberine's impact on health: Comprehensive biological, pharmacological, and nutritional perspectives. Metabolism Open, 2025; 28: e100399.
AZZIZ R. Polycystic ovary syndrome. Obstetrics & Gynecology, 2018; 132(2): 321-336.
COSTELLO M,et al. A review of first line infertility treatments and supporting evidence in women with polycystic ovary syndrome. Medical Sciences, 2019; 7(9): e95.
DI PIERRO F, et al. Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial. Frontiers in Pharmacology, 2023; 14: e1269605.
GREFF D, et al. Inositol is an effective and safe treatment in polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials. Reproductive biology and endocrinology, 2023; 21(1): e10.
INFANTE M, et al. Long-term metformin therapy and vitamin B12 deficiency: an association to bear in mind. World journal of diabetes, 2021; 12(7): e916.
JOHAM AE, et al. Polycystic ovary syndrome. The lancet Diabetes & endocrinology, 2022; 10(9): 668-680.
LEGRO RS, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. New England Journal of Medicine, 2014; 371(2): 119-129.
LI MF, et al. The effect of berberine on polycystic ovary syndrome patients with insulin resistance (PCOS‐IR): a meta‐analysis and systematic review. Evidence‐Based Complementary and Alternative Medicine, 2018; 2018(1): e2532935.
LIU Q, et al. Vitamin B12 status in metformin treated patients: systematic review. PloS one, 2014; 9(6): e100379.
MCCARTNEY CR, MARSHALL JC. Polycystic ovary syndrome. New England Journal of Medicine, 2016; 375(1): 54-64.
MISHRA N, et al. Study on the effect of berberine, myoinositol, and metformin in women with polycystic ovary syndrome: a prospective randomised study. Cureus, 2022; 14(1): e21781
NAZARI A, et al. The effect of berberine supplementation on glycemic control and inflammatory biomarkers in metabolic disorders: an umbrella meta-analysis of randomized controlled trials. Clinical Therapeutics, 2024; 46(2): e64-e72.
OUZZANI M, et al. Rayyan—a web and mobile app for systematic reviews. Systematic reviews, 2016; 5(1): e210.
PAGE MJ, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Revista Panamericana de Salud Pública, 2022; 46: e112.
RASHID, R, et al. Polycystic ovarian syndrome-current pharmacotherapy and clinical implications. Taiwanese Journal of Obstetrics and Gynecology, 2022; 61(1): 40-50.
REN G, et al. Berberine stimulates lysosomal AMPK independent of PEN2 and maintains cellular AMPK activity through inhibiting the dephosphorylation regulator UHRF1. Frontiers in pharmacology, 2023; 14: e1148611.
RONDANELLI M, et al. Berberine phospholipid is an effective insulin sensitizer and improves metabolic and hormonal disorders in women with polycystic ovary syndrome: A one-group pretest–post-test explanatory study. Nutrients, 2021; 13(10): e3665.
SANTOS CMC, et al. A estratégia PICO para a construção da pergunta de pesquisa e busca de evidências. Revista latino-americana de enfermagem, 2007; 15(3): 508-511.
TEEDE HJ, et al. Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome. European journal of endocrinology, 2023; 189(2): G43-G64.
TEEDE HJ, et al. Polyendocrine metabolic ovarian syndrome, the new name for polycystic ovary syndrome: a multistep global consensus process. The Lancet, 2026; No prelo.
UTAMI AR, et al. Berberine and its study as an antidiabetic compound. Biology, 2023; 12(7): e973.
WHITTEMORE R, KNAFL K. The integrative review: updated methodology. Journal of advanced nursing, 2005; 52(5): 546-553.
WU XK, et al. Randomized controlled trial of letrozole, berberine, or a combination for infertility in the polycystic ovary syndrome. Fertility and Sterility, 2016; 106(3): 757-765.
XIE L, et al. The effect of berberine on reproduction and metabolism in women with polycystic ovary syndrome: A systematic review and meta‐analysis of randomized control trials. Evidence‐based Complementary and Alternative Medicine, 2019; 2019(1): e7918631.
ZHANG S, et al. Effect and mechanism of berberine against polycystic ovary syndrome. Biomedicine & Pharmacotherapy, 2021; 138: e111468.
ZHANG Y, et al. Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). Nature communications, 2020; 11(1): e5015.
ZHAO H, et al. Comparative efficacy of oral insulin sensitizers metformin, thiazolidinediones, inositol, and berberine in improving endocrine and metabolic profiles in women with PCOS: a network meta-analysis. Reproductive health, 2021; 18(1): 171.