EstroG-100 Manages Menopausal Symptoms
March 3, 2010
ORANGE COUNTY, Calif.SunBio released results of its U.S.-based human clinical study on EstroG-100, an herbal extract utilized for the management of menopausal symptoms. The unpublished, three-month study on 61 non-Asian women was based on randomized, double blind, placebo-controlled protocols to confirm its previous human study results on Asian women. The Kupperman Menopause Index analysis showed impressive alleviation of all the major symptoms, while weight, biochemical safety markers and serum hormone levels all failed to show any statistically significant changes.
The U.S.-based human study observed how the oral administration of EstroG-100changes the menopausal symptoms on pre-, peri- and post-menopausal women, including hot flash, paresthesia, insomnia, nervousness, melancholia, vertigo, fatigue, rheumatic pain, headache, palpitation, formication and vaginal dryness. A previous unpublished study conducted in South Korea demonstrated the significant efficacy of EstroG-100 on menopause symptoms; however, the study participants were limited to Korean women. Since menopausal symptoms experienced by women are similar regardless of ethnicity, the efficacy of EstroG-100 on different ethnicities was expected to be positive. The current study examined the effect of EstroG-100on menopausal symptoms in non-Asian women.
Recruited participants showed no significant differencesbetween the study group and the placebo groupin their physical profiles, serum hormone concentrations (E2, FSH) and serum metabolic profiles. Through the test period of 12 weeks, the mean Kupperman Menopause Index score was significantly reduced in EstroG-100 group (29.5±7.4 at baseline to 13.6±7.6 at week six after and to 11.3±5.8 at week 12) compared to the placebo group (29.2±6.6 at baseline to 23.3±9.0 at week six after and to 23.7±7.7 at week 12). The improvements at week six and 12 were statistically significant between the two groups (P<0.01), as well as from the baseline (P<0.01) for EstroG-100 group.
In terms of the absolute and comparative changes in several anthropometric and laboratory measurements between baseline and week 12,there were no statistically significant differences between the two groups on blood pressure, serum E2, triglyceride, total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Even though the mean concentration of serum FSH differed significantly between both groups, there were no significant changes between the baseline and week 12 in the EstroG-100 group. In this study, the mean serum estradiol level in the EstroG-100 group did not increase, which implies EstroG-100 is not an active estrogen hormone. Mean serum FSH level also remained unchanged, indicating EstroG-100 does not appear to exert its effect at the hormone receptor levels. This is consistent with previous receptor binding affinity test, which showed EstroG-100 does not bind to both estrogen receptor-alpha and beta. EstroG-100 appears to significantly improve the symptoms of menopause without affecting the female hormone levels in the body.
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