Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (I) Biochemical and Pharmacodynamic Study on Maca using Clinical Laboratory Model on Ovariectomized Rats.

Ovariectomized rats were used in a model laboratory study to examine biochemical and pharmacodynamic effects of pre-gelatinized organic preparation of Lepidium peruvianum Chacon (Maca-GO). Biochemical and Pharmacodynamic effects of Maca-GO (250 mg Maca-GO per kg body weight (bw) administered by intubation twice daily) were assessed in a 28 day model laboratory study on ovariectomized (by laparoscopy) Wistar rats with pharmacodynamic tests performed at the conclusion of the trial followed by blood collection for morphology and biochemical tests. Toxicity of Maca-GO used in the study was determined in bioassay on mice and rats. Anti-depressive function (Porsolt's test) and anxiolytic sedative and cognitive effects (using elevated-plus maze, locomotor activity and passive avoidance tests) were assessed against control (laparotomized female rats with intact ovaries). In addition to blood morphology, the following blood serum constituents were analyzed: Estrogen (E2), Progesterone (PGS), Cortisol (CT), Adrenocorticotropic Hormone (ACTH), Thyroid Hormones (TSH, T3, and T4), Iron (Fe) and lipid profile (Triglycerides, Total Cholesterol, LDL, HDL). Analytically-determined non-toxic status of Maca-GO was confirmed in bioassays when applied to mice and rats at levels of 0.5 and up to 15mg/kg bw which shows it safe use in humans with the LD50>15 mg/kg bw. Maca-GO showed a distinctive, (P<0.05) antidepressant-like and sedative effect in ovariectomized rats only, while there was no anxiolytic activity nor disturbance of cognitive function observed in both, test and control animals. Observed in this study balancing effect of Maca-GO on sex hormone levels show its potential as a safe preparation for use in correcting physiological symptoms characteristic in postmenopausal stage with an indication of potentially even more value for its use in pre-menopausal women.

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.

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) <40 pg/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 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/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) - hence, reducing dependence on hormone therapy programs.

Use of gelatinized maca (lepidium peruvianum) in early postmenopausal women.

OBJECTIVE: This double-blind, placebo-corrected clinical pilot study was aimed at assessing the use of hypocotyls of cruciferous Andean plant Maca (Lepidium peruvianum Chacon), in alleviating symptoms of menopausal discomfort experienced by women in early post menopause as measured by profiles of serum hormones: Luteinizing Hormone (LH), Follicle-stimulating Hormone (FSH), Estrogen (E2) and Progesterone (PG) and as assessed by Greene's Menopausal Index. DESIGN: Study was conducted on 20 Caucasian healthy early-postmenopausal women volunteers during the three months period (Trial I) and on eight women during nine months period (Trial II). Hormone levels were determined in blood with a simultaneous assessment of menopausal index at the start of study, after one month use of placebo, and after two and eight months administration of 2g gelatinized Maca root powder (Maca-GO) in the form of two 500mg hard gel capsules, twice daily. RESULTS: In comparison to placebo, after both, two and eight months administration of Maca-GO capsules to EPMW, level of FSH significantly (P<0.05) decreased with a simultaneous significant (P<0.05) increase in the LH level, resulting in significant (P<0.05) increase in both E2 and PG, after eight months of Maca-GO treatment only. There was a significant (P<0.05) placebo effect resulting in an elevated PG level after one month administration of placebo capsules. Changes in hormone levels was accompanied by substantially-reduced feeling of discomfort associated with menopause, although, there was a distinctive, positive placebo effect as judged by responses to Greene's questionnaire. CONCLUSIONS: It is reasonable to suggest that Maca-GO when used in EPMW, depending on the length of use, was acting as a toner of hormonal processes as reflected by decrease in FSH and increased LH secretion, which stimulated production of both ovarian hormones, E2 and PG and resulted in a substantial reduction of menopausal discomfort felt by women participating in the study, with a distinctive placebo effect, thus, fully justifying further, more complex study on effectiveness of Maca-GO as a reliable alternative to HRT program.

[Vaginal delivery after previous cesarean section]. / Poród po przebytym cieciu cesarskim.

Data concerning frequency of cesarean section as well as frequency of vaginal delivery after cesarean section in Poznan region in years 1990-1991 were presented. During last years we observed significant increase of spontaneous deliveries after cesarean section. The indications for the previous cesarean section and the outcome of the present pregnancy are discussed.