Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
J Biol Regul Homeost Agents. 2013 Jul-Sep;27(3):717-28.
Nutraceuticals and functional foods have attracted considerable interest as potential alternative therapies for treatment of different cardiovascular disorders and insulin resistance. We evaluated the efficacy of a combination of Berberis Aristata/Silybum Marianum extract (Berberol®) in a sample of overweight, dyslipidemic patients at low cardiovascular risk. We enrolled 105 Caucasian, euglycemic, overweight, dyslipidemic patients, of either sex. At baseline all patients underwent a 6 months run-in period during which they followed an adequate diet and practiced physical activity. At the end of the run-in period, patients were randomised to take placebo or a combination of Berberis aristata/Silybum marianum, 1 tablet during the lunch and 1 tablet during the dinner, for three months, in a double-blind, placebo-controlled design. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (wash-out period), and all patients continued with only diet and physical activity. At the end of the wash-out period, patients re-started Berberis aristata/Silybum marianum or placebo twice a day for further 3 months. We evaluated during the run-in period, at randomisation, before and after the wash-out period these parameters: body weight and BMI, fasting plasma glucose, lipid profile, insulin resistance, retinol binding protein-4 (RBP-4), adiponectin (ADN), resistin. Total cholesterol, LDL-C, and Tg decreased, and HDL-C increase after 3 months of Berberis aristata/Silybum marianum, both compared to baseline and placebo. Berberis aristata/Silybum marianum decreased fasting plasma insulin, and HOMA-IR, both compared to baseline and to placebo. Moreover, there was a decrease of RBP-4, and resistin, and an increase of ADN after 3 months of Berberis aristata/Silybum marianum. All these positive effects disappeared after the wash-out period, and re-appeared after the re-introduction of the drug. We observed a significant correlation between HOMA-index decrease and resistin, and RBP-4 decrease, and between HOMA-index decrease and ADN increase in Berberis aristata/Silybum marianum group, but not in placebo group. Berberis aristata/Silybum marianum fixed combination seems to be safe and effective in improving lipid profile, but also in improving insulin resistance and adipocytokines levels.
天然药物和功能性食品因其作为治疗不同心血管疾病和胰岛素抵抗的潜在替代疗法的潜力而受到广泛关注。我们评估了含有小檗碱/水飞蓟素的复方制剂（Berberol®）在低心血管风险的超重、血脂异常患者中的疗效。我们招募了 105 名白种人、血糖正常、超重、血脂异常的患者，无论性别如何。所有患者在基线时均进行了 6 个月的洗脱期，在此期间他们遵循适当的饮食并进行体育锻炼。在洗脱期结束时，患者被随机分配至安慰剂组或 Berberis aristata/Silybum marianum 联合治疗组，午餐和晚餐时各服用 1 片，共 3 个月，采用双盲、安慰剂对照设计。Berberis aristata/Silybum marianum 和安慰剂随后中断 2 个月（洗脱期），所有患者仅继续饮食和体育锻炼。在洗脱期结束时，患者重新开始每天服用 Berberis aristata/Silybum marianum 或安慰剂，共 3 个月。我们在洗脱期内、随机分组时、洗脱期前后评估了以下参数：体重和 BMI、空腹血糖、血脂谱、胰岛素抵抗、视黄醇结合蛋白 4（RBP-4）、脂联素（ADN）、抵抗素。Berberis aristata/Silybum marianum 治疗 3 个月后，与基线和安慰剂相比，总胆固醇、LDL-C 和三酰甘油降低，HDL-C 升高。Berberis aristata/Silybum marianum 还降低了空腹胰岛素和 HOMA-IR，与基线和安慰剂相比均有显著差异。此外，Berberis aristata/Silybum marianum 治疗 3 个月后，RBP-4 和抵抗素降低，ADN 升高。洗脱期后，所有这些积极影响均消失，重新开始使用药物后又再次出现。我们观察到 Berberis aristata/Silybum marianum 组的 HOMA 指数降低与抵抗素和 RBP-4 降低之间，以及 HOMA 指数降低与 ADN 升高之间存在显著相关性，但在安慰剂组中未观察到这种相关性。Berberis aristata/Silybum marianum 固定复方制剂似乎安全有效，可改善血脂谱，还可改善胰岛素抵抗和脂肪细胞因子水平。
