Abstract
A combination of soy isoflavones and Liu Wei Di Huang Wan (LWDHW) is potentially effective for postmenopausal women with intolerable vasomotor episodes who are not suitable candidates for hormonal therapy. The objective of this open-label, three-phase, crossover study was to determine the influence of both single and multiple oral doses of LWDHW on isoflavone pharmacokinetics in healthy postmenopausal women. Eleven subjects were assigned to receive the following regimens in a fixed sequence with washout periods of at least one week: Phase A, a single oral dose of soy milk; Phase B, a single oral dose of soy milk coadministered with LWDHW; and Phase C, multiple oral doses of LWDHW for 14 days followed by a single oral dose of soy milk. Blood samples were collected and mixed with β-glucuronidase/sulfatase to hydrolyze isoflavone conjugates to their respective aglycones (i.e., daidzein and genistein) and were determined using high performance liquid chromatography. The pharmacokinetic parameters analyzed were maximal plasma concentration (C max), time to reach peak concentration (T max), area under the plasma concentration-time curve (AUC), and half-life (t 1/2). The results found no statistically significant differences in pharmacokinetic parameters of daidzein and genistein among the three regimens.
Highlights
Menopause is a period of time in a woman’s life defined as the cessation of menstruation for more than 12 months and involves permanent failure of ovarian function secondary to depletion of the follicular pool
The mean plasma concentration-time curves of daidzein and genistein from the 11 participants receiving the three regimens during the respective study phases are shown in Figures 2 and 3, respectively
The earlier peaks of both isoflavones occurred at approximately 2 hours, whereas the later peaks occurred at approximately 6–8 hours
Summary
Menopause is a period of time in a woman’s life defined as the cessation of menstruation for more than 12 months and involves permanent failure of ovarian function secondary to depletion of the follicular pool. This commonly occurs in Asian women who are in their mid-to-late 40s [1, 2]. Vasomotor episodes are the most characteristic manifestation of the menopause These episodes are described as hot flushes (the sensations of warmth, usually felt on the chest, neck, and face), hot flashes (episodes with sweating, sometimes followed by a chill), and night sweats. Concern over the potential adverse effects of HT leads many women to look for natural alternatives that would provide benefits comparable to those of estrogen but without serious complications
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