IRCCS Mondino Foundation, 27100 Pavia, Italy.
Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy.
Nutrients. 2021 Oct 19;13(10):3665. doi: 10.3390/nu13103665.
Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in females of reproductive age and is characterized by multifactorial unhealthy conditions related to hormonal unbalance and also to dysmetabolism and inflammation. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. The aim of this one-group pretest-post-test explanatory study was to evaluate, in normal-overweight PCOS women with normal menses, the effectiveness of berberine on: Insulin resistance (IR) by Homeostasis Model Assessment (HOMA); Inflammation by C-Reactive Protein (CRP), Tumor Necrosis Factor α (TNF-α); 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 DXA. Finally, adverse effects were assessed by liver and kidney functions and creatine phosphokinase (CPK). All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Twelve females (aged 26.6 ± 4.9, BMI 25.3 ± 3.6) were supplied for 60 days with two tablets/day (550 mg/table) of the bioavailable berberine. Results showed a statistically significant decrease in HOMA, CRP, TNF-α, Triglycerides, testosterone, Body Mass Index (BMI), Visceral Adipose Tissue (VAT), fat mass, GAGS and CADI scores, and a statistically significant increase in sex hormone-binding globulin (SHBG). Liver and kidney functions and CPK are not statistically significantly different. Therefore, berberine can represent a safe novel dietary supplement, helpful in treatment strategy for PCOS.
多囊卵巢综合征（PCOS）是育龄女性最常见的内分泌疾病，其特征是与激素失衡以及代谢和炎症相关的多种不健康状况。最近，越来越多的证据表明，天然植物产品可能在 PCOS 的管理中发挥作用。本研究采用单组前后测试解释性研究设计，旨在评估正常超重的月经正常的 PCOS 女性中，小檗碱对以下方面的有效性：胰岛素抵抗（IR）通过稳态模型评估（HOMA）；C 反应蛋白（CRP）、肿瘤坏死因子 α（TNF-α）的炎症；脂代谢；性激素谱和与高雄激素相关的症状，如痤疮，通过全球痤疮分级系统（GAGS）和加的夫痤疮残疾指数（CADI）；通过 DXA 评估身体成分。最后，通过肝肾功能和肌酸磷酸激酶（CPK）评估不良反应。所有这些参数均在基线和补充新型生物利用度和安全性小檗碱制剂 60 天后收集。12 名女性（年龄 26.6 ± 4.9，BMI 25.3 ± 3.6）连续 60 天每天服用两片（550mg/片）新型生物利用度小檗碱。结果显示，HOMA、CRP、TNF-α、甘油三酯、睾酮、体重指数（BMI）、内脏脂肪组织（VAT）、脂肪量、GAGS 和 CADI 评分均显著降低，性激素结合球蛋白（SHBG）显著升高。肝肾功能和 CPK 无统计学差异。因此，小檗碱可以作为一种安全的新型膳食补充剂，有助于 PCOS 的治疗策略。
