%0 Journal Article %T Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and symptomatic responses of early-postmenopausal women to standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study %A H O Meissner %A A Mscisz %A H Reich-Bilinska %A W Kapczynski %J International Journal of Biomedical Science %D 2006 %I %X This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene¡¯s Score (GMS) and Kupperman¡¯s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) ¨C hence, reducing dependence on hormone therapy programs. %K blood biochemistry %K early-postmenopause %K hormones %K HRT %K Maca (Lepidium peruvianum) %U http://ijbs.org/User/ContentFullTextFrame.aspx?VolumeNo=2&StartPage=360