Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran.
Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
BMC Complement Altern Med. 2019 Nov 21;19(1):324. doi: 10.1186/s12906-019-2715-1.
The present study was designed to investigate the effects of Berberis vulgaris (BV) juice consumption on plasma levels of insulin-like growth factor (IGF-1), IGF-binding proteins (IGFBPs), and the expression of PPAR-γ, VEGF and HIF in women with benign breast disease.
This parallel design randomized, double-blind controlled clinical trial was conducted on 85 eligible patients diagnosed with benign breast disease. They were assigned randomly into either BV juice group (n = 44, BV juice: 480 ml/day) or placebo group (n = 41, BV placebo juice: 480 ml/day) for 8 weeks intervention. Participants, caregivers and those who assessed laboratory analyses were blinded to the assignments. Plasma levels of biomarkers were measured at baseline and after 8 weeks by ELISA. Quantitative real-time PCR was used to measure the fold change in the expression of each interested gene.
The compliance of participants was 95.2% and 40 available subjects analyzed in each group at last. Relative treatment (RT) effects for BV juice caused 16% fall in IGF-1 concentration and 37% reduction in the ratio of IGF-1/1GFBP1. Absolute treatment effect expressed 111 ng/ml increased mean differences of IGFBP-3 between BV group and placebo. Plasma level of PPAR-γ increased in both groups but it was not significant. Fold changes in the expressions of PPAR-γ, VEGF and HIF showed down-regulation in the intervention group compared to placebos (P < 0.05).
The BV juice intervention over 8 weeks was accompanied by acceptable efficacy and decreased plasma IGF-1, and IGF-1/IGFBP-1 ratio partly could be assigned to enhanced IGFBP-1 level in women with BBD. The intervention caused reductions in the expression levels of PPAR, VEGF, and HIF which are remarkable genomic changes to potentially prevent breast tumorigenesis.
IRCT2012110511335N2. Registered 10 July 2013 (retrospectively registered).
本研究旨在探讨小檗碱（BV）汁对良性乳腺疾病患者血浆胰岛素样生长因子（IGF-1）、胰岛素样生长因子结合蛋白（IGFBPs）水平以及过氧化物酶体增殖物激活受体γ（PPAR-γ）、血管内皮生长因子（VEGF）和缺氧诱导因子（HIF）表达的影响。
这是一项平行设计、随机、双盲对照临床试验，共纳入 85 例符合条件的良性乳腺疾病患者。他们被随机分为 BV 汁组（n=44，BV 汁：480ml/天）或安慰剂组（n=41，BV 安慰剂汁：480ml/天），干预 8 周。参与者、护理人员和评估实验室分析的人员对分组情况均不知情。采用 ELISA 法在基线和 8 周后测量生物标志物的血浆水平。采用实时定量 PCR 法测量每个感兴趣基因表达的倍数变化。
参与者的依从性为 95.2%，最后每组有 40 名可分析的受试者。BV 汁的相对治疗（RT）效应导致 IGF-1 浓度下降 16%，IGF-1/IGFBP1 比值下降 37%。BV 组和安慰剂组之间 IGFBP-3 的平均差异增加了 111ng/ml，这是绝对治疗效应的表达。两组中 PPAR-γ 的血浆水平均升高，但无统计学意义。与安慰剂组相比，干预组 PPAR-γ、VEGF 和 HIF 的表达倍数均下调（P<0.05）。
BV 汁干预 8 周后具有可接受的疗效，并降低了血浆 IGF-1，IGF-1/IGFBP-1 比值的降低部分可能归因于 BBD 患者 IGFBP-1 水平的升高。干预降低了 PPAR、VEGF 和 HIF 的表达水平，这是潜在的预防乳腺癌发生的显著基因组变化。
IRCT2012110511335N2。2013 年 7 月 10 日注册（回溯注册）。
