Plain language summary
Individuals diagnosed with benign breast disease (BBD) are at an increased risk of developing breast cancer. A hormone known as insulin-like growth factor-1 (IGF-1) has been reported to correlate with the development of BBD into breast cancer. Berberis vulgaris (BV) is a herbal plant, which may have anti-cancer properties. Previous studies have reported alterations in proteins involved in tumour growth upon regular consumption, but none have looked at IGF-1 in individuals with BBD. This randomised double-blind trial aimed to study the effects of BV on IGF-1 and other proteins involved in tumour growth in 85 women recently diagnosed with BBD over an 8-week period. The results showed that compliance to BV treatment was high. IGF-1 significantly decreased within both groups. When compared to each other, there was a 16% drop in IGF-1 in the BV group compared to the placebo group. Several proteins and growth factors were also altered by BV treatment in favour of reducing breast cancer risk. The authors concluded that BV juice may reduce the risk of BBD turning into breast cancer. Clinicians could use this study to recommend regular consumption of BV to individuals with BBD as part of a wellness regime to reduce their risk of developing breast cancer.
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSIONS 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. TRIAL REGISTRATION IRCT2012110511335N2. Registered 10 July 2013 (retrospectively registered).
Methodological quality
Jadad score
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5
Allocation concealment
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Yes
