Affuso Flora, Mercurio Valentina, Ruvolo Antonio, Pirozzi Concetta, Micillo Filomena, Carlomagno Guido, Grieco Fabrizia, Fazio Serafino
Flora Affuso, Valentina Mercurio, Antonio Ruvolo, Concetta Pirozzi, Filomena Micillo, Guido Carlomagno, Fabrizia Grieco, Serafino Fazio, Department of Clinical Medicine, Cardiovascular and Immunological Sciences, Federico II University, 80131 Naples, Italy.
World J Cardiol. 2012 Mar 26;4(3):77-83. doi: 10.4330/wjc.v4.i3.77.
To test the efficacy of a proprietary nutraceutical combination in reducing insulin resistance associated with the metabolic syndrome (MetS).
Sixty-four patients with MetS followed at a tertiary outpatient clinic were randomly assigned to receive either placebo or a proprietary nutraceutical combination (AP) consisting of berberine, policosanol and red yeast rice, in a prospective, double-blind, placebo-controlled study. Evaluations were performed at baseline and after 18 wk of treatment. The homeostasis model assessment of insulin resistance (HOMA-IR) index was the primary outcome measure. Secondary endpoints included lipid panel, blood glucose and insulin fasting, after a standard mixed meal and after an oral glucose tolerance test (OGTT), flow-mediated dilation (FMD), and waist circumference.
Fifty nine patients completed the study, 2 withdrew because of adverse effects. After 18 wk there was a significant reduction in the HOMA-IR index in the AP group compared with placebo (ΔHOMA respectively -0.6 ± 1.2 vs 0.4 ± 1.9; P < 0.05). Total and low density lipoprotein cholesterol also significantly decreased in the treatment arm compared with placebo (Δlow density lipoprotein cholesterol -0.82 ± 0.68 vs -0.13 ± 0.55 mmol/L; P < 0.001), while triglycerides, high density lipoprotein cholesterol, and the OGTT were not affected. In addition, there were significant reductions in blood glucose and insulin after the standard mixed meal, as well as an increase in FMD (ΔFMD 1.9 ± 4.2 vs 0 ± 1.9 %; P < 0.05) and a significant reduction in arterial systolic blood pressure in the AP arm.
This short-term study shows that AP has relevant beneficial effects on insulin resistance and many other components of MetS.
测试一种专利营养补充剂组合在降低与代谢综合征（MetS）相关的胰岛素抵抗方面的疗效。
在一项前瞻性、双盲、安慰剂对照研究中，将一家三级门诊诊所随访的64例MetS患者随机分配接受安慰剂或由黄连素、多廿烷醇和红曲米组成的专利营养补充剂组合（AP）。在基线和治疗18周后进行评估。胰岛素抵抗稳态模型评估（HOMA-IR）指数是主要结局指标。次要终点包括血脂、空腹血糖和胰岛素、标准混合餐后及口服葡萄糖耐量试验（OGTT）后、血流介导的血管舒张（FMD）和腰围。
59例患者完成研究，2例因不良反应退出。18周后，与安慰剂相比，AP组的HOMA-IR指数显著降低（HOMA变化分别为-0.6±1.2 vs 0.4±1.9；P<0.05）。与安慰剂相比，治疗组的总胆固醇和低密度脂蛋白胆固醇也显著降低（低密度脂蛋白胆固醇变化为-0.82±0.68 vs -0.13±0.55 mmol/L；P<0.001），而甘油三酯、高密度脂蛋白胆固醇和OGTT未受影响。此外，标准混合餐后血糖和胰岛素显著降低，FMD增加（FMD变化为1.9±4.2 vs 0±1.9%；P<0.05），AP组动脉收缩压显著降低。
这项短期研究表明，AP对胰岛素抵抗和MetS的许多其他组分具有相关有益作用。
