小檗碱磷脂对空腹血糖受损（IFG）超重受试者的血糖谱有积极影响：一项随机、双盲、安慰剂对照的临床试验。

Berberine phospholipid exerts a positive effect on the glycemic profile of overweight subjects with impaired fasting blood glucose (IFG): a randomized double-blind placebo-controlled clinical trial.

机构信息

Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2023 Jul;27(14):6718-6727. doi: 10.26355/eurrev_202307_33142.

DOI:10.26355/eurrev_202307_33142

PMID:37522683

Abstract

OBJECTIVE

Berberine is a plant alkaloid known to exert positive metabolic effects. Human studies have confirmed its ability to improve the lipid and glycemic profile. This study aimed to evaluate the potential benefit of oral supplementation of Berberine PhytosomeTM (2 tablets/day, 550 mg/tablet) on the metabolic profile of subjects with impaired fasting blood glucose (IFG).

PATIENTS AND METHODS

A total of 49 overweight subjects, 28 females and 21 males, were randomly assigned to either the supplemented group (n=24) or placebo (n=25). We considered glycemia as the primary endpoint and total cholesterol, high-density lipoprotein (HDL), total cholesterol/HLD, low-density lipoprotein (LDL), LDL/HDL, triglycerides, insulin, glycated hemoglobin, Homeostasis Model Assessment (HOMA), ApoA, ApoB, ApoB/ApoA, androgen suppression treatment (AST), alternative lengthening of telomeres (ALT), gamma-glutamyl transferase (GGT), creatinine, and body composition by dual-energy X-ray absorptiometry (DXA) as secondary endpoints. These parameters have been assessed at baseline, after 30 days, and after 60 days.

RESULTS

After two months of treatment, through the use of linear mixed effect models, a statistically significant difference between supplemented and placebo groups was observed for glycemia [β=-0.2495% C.I. (-0.47; -0.06), p=0.004], total cholesterol [β=-0.25, 95% C.I. (-0.45; -0.04), p=0.05], total cholesterol/HDL [β=-0.25, 95% C.I. (-0.43; -0.06), p=0.04], triglycerides [β=-0.14, 95% C.I. (-0.25; -0.02), p=0.05], insulin [β=-1.78, 95% C.I. (-2.87; -0.66), p=0.009], ApoB/ApoA [β=-0.08, 95% C.I. (-0.13; -03), p=0.004], Visceral adipose tissue (VAT) [β=-91.50, 95% C.I. (-132.60; -48.19), p<0.0001] and fat mass [β=-945.56, 95% C.I. (-1,424.42; -441.57), p=0.004].

CONCLUSIONS

The use of berberine had no adverse events, supporting its use as a natural alternative to pharmacological therapies in the case of IFG.

摘要

目的

小檗碱是一种植物生物碱，已知其具有积极的代谢作用。人体研究证实了它改善血脂和血糖谱的能力。本研究旨在评估口服补充黄连素 PhytosomeTM（每天 2 片，每片 550 毫克）对空腹血糖受损（IFG）患者代谢状况的潜在益处。

患者和方法

共有 49 名超重受试者，28 名女性和 21 名男性，随机分为补充组（n=24）或安慰剂组（n=25）。我们将血糖作为主要终点，总胆固醇、高密度脂蛋白（HDL）、总胆固醇/HDL、低密度脂蛋白（LDL）、LDL/HDL、甘油三酯、胰岛素、糖化血红蛋白、稳态模型评估（HOMA）、载脂蛋白 A（ApoA）、载脂蛋白 B（ApoB）、载脂蛋白 B/ApoA、雄激素抑制治疗（AST）、端粒的替代延长（ALT）、γ-谷氨酰转移酶（GGT）、肌酐和通过双能 X 射线吸收法（DXA）评估的身体成分作为次要终点。这些参数在基线、30 天和 60 天时进行了评估。

结果

经过两个月的治疗，通过使用线性混合效应模型，补充组和安慰剂组在血糖[β=-0.2495%置信区间（-0.47；-0.06），p=0.004]、总胆固醇[β=-0.25，95%置信区间（-0.45；-0.04），p=0.05]、总胆固醇/HDL[β=-0.25，95%置信区间（-0.43；-0.06），p=0.04]、甘油三酯[β=-0.14，95%置信区间（-0.25；-0.02），p=0.05]、胰岛素[β=-1.78，95%置信区间（-2.87；-0.66），p=0.009]、载脂蛋白 B/ApoA[β=-0.08，95%置信区间（-0.13；-03），p=0.004]、内脏脂肪组织（VAT）[β=-91.50，95%置信区间（-132.60；-48.19），p<0.0001]和脂肪质量[β=-945.56，95%置信区间（-1,424.42；-441.57），p=0.004]方面存在统计学显著差异。