| Authors |
이기호, 이득주, 김상안, 제상현, 김은기, 한혜승, 한인권 |
| Abstract |
Objectives: This research was designed to investigate the effects of natural herbal product, Estromon®, which is the newly developed phytoestrogen for perimenopausal women.
Methods: A prospective randomized clinical trial was performed. A total 48 perimenopausal women were included into this study and devided either into Estromon® group(n=24) or placebo group(n=24). The treatment group was treated for 12 months with oral administration of two capsules of Estromon® twice a day. Bone mass density, serum bone markers, weight, BMI, serum lipid profile, human growth hormone, FSH and E2 were measured at baseline and 3, 6, 9, 12 months. Final analysis was conducted for 42 subjects who were medicated continuously for 12 months.
Results: The oral administration of two capsules of Estromon® twice a day for 3months significantly improved climactieric symptoms about 5times more than placebo group. (OR=5.04, 95% C.l.1.40-18.14). In the group of 19 patients having taken Estromon®, alkaline phosphatase, as the bone marker, decreased from 73.35±21.02 (IU/L) to 66.21±4.87 (IU/L) after 12 months with statistical significance (paired t-test, p<0.05). Since osteocalcin also decreased (from 6.02±2.74ng/ml to 5.66±3.01ng/ml) in Estromon® group but increased (from 6.24±3.04ng/ml to 6.47±2.58ng/ml) in placebo group (Mann-Whitney Test p<0.05), bone density is expected to be improved in long-term treatment. As for BMD of femur neck, it increased (2.24%: from 0.746±0.10g/cm2 to 0.763±0.13g/cm2) during 12 months of treatment in Estromon® group, but decreased (1.14%: from 0.743±0.10g/cm2 to 0.733±0.14g/cm2) in placebo group. And this difference had statistical significance(p<0.05, Mann-Whitney test). Mean serum human growth hormone level was increased more in Estromon® group (268% ; from 0.25±0.21ng/ml to 0.92±0.97ng/ml) than placebo group (42% from 0.57±0.71ng/ml to 0.81±0.83ng/ml) after l-yr treatment(p<0.05, Mann-Whitney test). Among the subjects in Estromon® group, we found the reduction in serum triglyceride(119.10±54.72mg/dl to 92.16±49.94mg/dl) significantly(p<0.05, paired t-test), but there were no changes in placebo group. Serum E2, FSH, Blood pressure, LDL, HDL, Total cholesterol and BMD for spines were not changed significantly in both groups after 12 months.
Conclusions: Therefore, perimenopausal women may have benefit from Estromon® as a phytoestrogen supplement especially for climacteric symptoms, femur neck BMD, serum triglyceride and human growth hormone without weight gain or any serious side effects. |
