Abstract
This randomized controlled study aimed to assess the efficacy and safety of an extract mixture of kudzu flower and mandarin peel (KM) on hot flashes (HFs) and markers of bone turnover in women during the menopausal transition. Healthy women aged 45–60 years with the menopausal HFs were randomly assigned in a 1:1 ratio to either KM (1150 mg/day) or placebo arms for 12 weeks (n = 84). The intent-to-treat analysis found that compared with the placebo, the KM significantly attenuated HF scores (p = 0.041) and HF severities (p < 0.001), with a mean difference from baseline to week 12. The KM also improved bone turnover markers, showing a significant reduction in bone resorption CTx (p = 0.027) and a tendency of increasing bone formation OC relative to the placebo. No serious adverse events and hormonal changes were observed in both groups. These findings suggest that KM consumption may improve the quality of life in ways that are important to symptomatic menopausal women.
Highlights
Menopause is a natural process of women aging that increases vulnerability to physical [1]and emotional [2] stresses, leading to a reduced quality of life and increased burden for health care needs [3,4]
Menopause is characterized by increased follicle-stimulating hormone (FSH) levels and a fluctuating/eventual decline in estrogen [5]
Because circulating estrogen plays a vital role in preventing bone loss and promoting bone formation, menopausal estrogen deficiency may contribute to diminished bone mineral density (BMD) [8]
Summary
Menopause is a natural process of women aging that increases vulnerability to physical [1]. Two recent animal studies focused on the HFs and BMD [17,18], respectively, in OVX mice treated with an extract mixture of kudzu flower and mandarin peel (KM) at the ratio of 6.5:5. It triggered us to study the potentials of KM in human subjects Based on these findings, we hypothesized that KM might potentially modify HFs and BMDs in menopausal women. We hypothesized that KM might potentially modify HFs and BMDs in menopausal women To test this hypothesis, we conducted a double-blind placebo-controlled human trial to determine the safety and effectiveness of KM on modulating HFs and bone turnover markers in peri- and post-menopausal women
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