madman
Super Moderator
Abstract
The present randomized, double-blinded, placebo-controlled study investigated the effect of a standardized fenugreek extract (FHE) on perimenopausal discomforts and its influence on hormonal balance and safety. Healthy women characterized with perimenopausal symptoms (n = 48), as assessed by MRS questionnaire, were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%). Further hormone analysis revealed an enhancement in serum estradiol (18.9%), free testosterone (38.2%), and progesterone (19.9%) concentrations and a significant decrease in FSH (38.2%) and SHBG (21.1%) concentrations toward establishing a hormonal balance among FHE-group; without significant changes in other clinical safety parameters. Thus, FHE supplementation offered a significant reduction in vasomotor effects and depression in perimenopausal women, without any adverse effects.
Practical applications
Fenugreek is a popular kitchen spice and Ayurvedic medicine for a variety of health conditions including diabetes, hypercholesterolemia, hepatotoxicity, gastritis, and also for a variety of hormone-related health conditions such as sexual functions, lactation, osteoporosis, PCOS, and post/perimenopausal discomforts. Fenugreek is rich in alkaloids, steroidal saponins, flavonoids, and 4-hydroxyisoleucine. The present randomized-controlled study investigated the plausible application of a standardized hydro-ethanolic extract of fenugreek seeds (FHE) having a unique 3:1 ratio for protodioscin to trigonelline in the management of perimenopausal discomforts. It was observed that FHE at a dosage of 250 mg × 2/day for 42 days significantly reduced the discomforts, especially vasomotor symptoms, and depression, and helped to attain a hormonal balance without any adverse effects or deviations in clinical safety parameters. Thus, FHE could be a potential natural agent for the management of post and perimenopausal discomforts and has to be explored in future studies.
The present contribution represents the first double-blinded randomized placebo-controlled clinical study to evaluate the efficacy of a fenugreek extract on perimenopausal discomforts, especially on hormonal imbalance and vasomotor symptoms. Fenugreek extract used in the present study is rich in protodioscin and trigonelline, the two important phytochemicals that are reported to have an estrogenic effect. Previously, supplementation of fenugreek seed powder (6 g/day for 8 weeks) was shown to relieve early menopausal symptoms especially hot flashes (Hakimi et al., 2006). Our earlier study with 500 mg × 2/day of FHE has also been shown a significant beneficial effect on postmenopausal women (Shamshad Begum et al., 2016). A recent study has also shown significant improvement among postmenopausal discomforts when supplemented with 250 mg × 2/day of FHE for 42 days (unpublished data, communicated). Another study states that fenugreek seed flavonoids exhibit an antidepressant-like effect by downregulating the KLF11/SIRT1-MAO-A pathway, inhibiting MAO-A expression and activity, as well as upregulating monoamine neurotransmitters levels (Wang et al., 2019).
5 | CONCLUSION
As in the case of postmenopausal women, somatic, psychological, and urogenital issues are prevalent among perimenopausal participants as well, though with varying degrees of severity. In the current study, the supplementation of a standardized extract of fenugreek having a unique 3:1 ratio of protodioscin to trigonelline concentrations (FHE) at 250 mg × 2/day for 42 days contributed significant improvement in somatic, psychological, and urogenital scores; particularly on vasomotor symptoms and depression. A significant reduction in the severity of symptoms was evident on day 28. Further, intra-group comparison of the hormone levels revealed significant variations in serum concentrations of estradiol, free testosterone, progesterone, FSH, and SHBG toward achieving a hormonal balance. The observed changes in hormone levels were within the safe reference range indicating the safety of FHE. The further hematological and biochemical analysis also demonstrated the absence of any toxic changes with FHE.
The present randomized, double-blinded, placebo-controlled study investigated the effect of a standardized fenugreek extract (FHE) on perimenopausal discomforts and its influence on hormonal balance and safety. Healthy women characterized with perimenopausal symptoms (n = 48), as assessed by MRS questionnaire, were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%). Further hormone analysis revealed an enhancement in serum estradiol (18.9%), free testosterone (38.2%), and progesterone (19.9%) concentrations and a significant decrease in FSH (38.2%) and SHBG (21.1%) concentrations toward establishing a hormonal balance among FHE-group; without significant changes in other clinical safety parameters. Thus, FHE supplementation offered a significant reduction in vasomotor effects and depression in perimenopausal women, without any adverse effects.
Practical applications
Fenugreek is a popular kitchen spice and Ayurvedic medicine for a variety of health conditions including diabetes, hypercholesterolemia, hepatotoxicity, gastritis, and also for a variety of hormone-related health conditions such as sexual functions, lactation, osteoporosis, PCOS, and post/perimenopausal discomforts. Fenugreek is rich in alkaloids, steroidal saponins, flavonoids, and 4-hydroxyisoleucine. The present randomized-controlled study investigated the plausible application of a standardized hydro-ethanolic extract of fenugreek seeds (FHE) having a unique 3:1 ratio for protodioscin to trigonelline in the management of perimenopausal discomforts. It was observed that FHE at a dosage of 250 mg × 2/day for 42 days significantly reduced the discomforts, especially vasomotor symptoms, and depression, and helped to attain a hormonal balance without any adverse effects or deviations in clinical safety parameters. Thus, FHE could be a potential natural agent for the management of post and perimenopausal discomforts and has to be explored in future studies.
The present contribution represents the first double-blinded randomized placebo-controlled clinical study to evaluate the efficacy of a fenugreek extract on perimenopausal discomforts, especially on hormonal imbalance and vasomotor symptoms. Fenugreek extract used in the present study is rich in protodioscin and trigonelline, the two important phytochemicals that are reported to have an estrogenic effect. Previously, supplementation of fenugreek seed powder (6 g/day for 8 weeks) was shown to relieve early menopausal symptoms especially hot flashes (Hakimi et al., 2006). Our earlier study with 500 mg × 2/day of FHE has also been shown a significant beneficial effect on postmenopausal women (Shamshad Begum et al., 2016). A recent study has also shown significant improvement among postmenopausal discomforts when supplemented with 250 mg × 2/day of FHE for 42 days (unpublished data, communicated). Another study states that fenugreek seed flavonoids exhibit an antidepressant-like effect by downregulating the KLF11/SIRT1-MAO-A pathway, inhibiting MAO-A expression and activity, as well as upregulating monoamine neurotransmitters levels (Wang et al., 2019).
5 | CONCLUSION
As in the case of postmenopausal women, somatic, psychological, and urogenital issues are prevalent among perimenopausal participants as well, though with varying degrees of severity. In the current study, the supplementation of a standardized extract of fenugreek having a unique 3:1 ratio of protodioscin to trigonelline concentrations (FHE) at 250 mg × 2/day for 42 days contributed significant improvement in somatic, psychological, and urogenital scores; particularly on vasomotor symptoms and depression. A significant reduction in the severity of symptoms was evident on day 28. Further, intra-group comparison of the hormone levels revealed significant variations in serum concentrations of estradiol, free testosterone, progesterone, FSH, and SHBG toward achieving a hormonal balance. The observed changes in hormone levels were within the safe reference range indicating the safety of FHE. The further hematological and biochemical analysis also demonstrated the absence of any toxic changes with FHE.
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