Phytoestrogens/insoluble fibers and colonic estrogen receptor β: randomized, double-blind, placebo-controlled study

AIM: To assess the safety and effect of the supplementation of a patented blend of dietary phytoestrogens and insoluble fibers on estrogen receptor (ER)-beta and biological parameters in sporadic colonic adenomas. METHODS: A randomized, double-blind placebo-controlled trial was performed. Patients scheduled to undergo surveillance colonoscopy for previous sporadic colonic adenomas were identified, and 60 eligible patients were randomized to placebo or active dietary intervention (ADI) twice a day, for 60 d before surveillance colonoscopy. ADI was a mixture of 175 mg milk thistle extract, 20 mg secoisolariciresinol and 750 mg oat fiber extract. ER-beta and ER-alpha expression, apoptosis and proliferation (Ki-67 LI) were assessed in colon samples. RESULTS: No adverse event related to ADI was recorded. ADI administration showed a significant increases in ER-beta protein (0.822 +/- 0.08 vs 0.768 +/- 0.10, P = 0.04) and a general trend to an increase in ER-beta LI (39.222 +/- 2.69 vs 37.708 +/- 5.31, P = 0.06), ER-beta/ER-alpha LI ratio (6.564 +/- 10.04 vs 2.437 +/- 1.53, P = 0.06), terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (35.592 +/- 14.97 vs 31.541 +/- 11.54, P = 0.07) and Ki-67 (53.923 +/- 20.91 vs 44.833 +/- 10.38, P = 0.07) approximating statistical significance. A significant increase of ER-beta protein (0.805 +/- 0.13 vs 0.773 +/- 0.13, P = 0.04), mRNA (2.278 +/- 1.19 vs 1.105 +/- 1.07, P < 0.02) and LI (47.533 +/- 15.47 vs 34.875 +/- 16.67, P < 0.05) and a decrease of ER-alpha protein (0.423 +/- 0.06 vs 0.532 +/- 0.11, P < 0.02) as well as a trend to increase of ER-beta/ER-alpha protein in ADI vs placebo group were observed in patients without polyps (1.734 +/- 0.20 vs 1.571 +/- 0.42, P = 0.07). CONCLUSION: The role of ER-beta on the control of apoptosis, and its amenability to dietary intervention, are supported in our study. (c) 2013 Baishideng. All rights reserved.