Carotid Atherosclerosis Progression in Postmenopausal Women Receiving a Mixed Phytoestrogen Regimen: Plausible Parallels with Kronos Early Estrogen Replacement Study.
Tatiana V KirichenkoVeronika A MyasoedovaAlessio L RavaniIgor A SobeninVarvara A OrekhovaElena B RomanenkoPaolo PoggioWei-Kai WuAlexander N OrekhovPublished in: Biology (2020)
This randomized double-blinded, placebo-controlled clinical trial evaluated the progression of intima-media thickness of common carotid artery (cIMT) and the effect of phytoestrogen therapy on atherosclerosis development in early and late postmenopausal women. The 2-year cIMT progression was evaluated in 315 early postmenopausal women aged 40-55 years and in 231 late postmenopausal women aged 60-69 years free of cardiovascular disease. B-mode ultrasound was done at baseline and after 12 and 24 months of follow-up. The study revealed no significant changes in the rate of cIMT progression in 315 early postmenopausal women. By contrast, a statistically significant difference in the rate of atherosclerosis development was observed in late postmenopausal women treated with phytoestrogens compared to placebo (p = 0.008). The rate of cIMT progression in the placebo group was 0.019 mm/year led to a significant increase of cIMT during the observation period (p = 0.012), while the rate of cIMT progression in phytoestrogen late postmenopausal recipients was 0.011 mm/year, and total change did not reach statistical significance during the follow-up period (p = 0.101). These results suggest that late postmenopausal women can be a suitable cohort for trials assessing the anti-atherosclerosis effects of phytoestrogen preparations. In particular, the beneficial effect of phytoestrogens on cIMT progression was demonstrated in late postmenopausal women.
Keyphrases
- postmenopausal women
- bone mineral density
- cardiovascular disease
- double blind
- placebo controlled
- clinical trial
- phase iii
- type diabetes
- open label
- magnetic resonance imaging
- stem cells
- randomized controlled trial
- phase ii
- coronary artery disease
- metabolic syndrome
- mesenchymal stem cells
- computed tomography
- radiation therapy
- cell therapy
- single cell
- ultrasound guided
- study protocol
- rectal cancer
- phase ii study