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. 2006 Dec;2(4):375-94.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study

H O Meissner  1 , A Mscisz, H Reich-Bilinska, P Mrozikiewicz, T Bobkiewicz-Kozlowska, B Kedzia, A Lowicka, I Barchia
Affiliations

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study

H O Meissner et al. Int J Biomed Sci. 2006 Dec.

Abstract

This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E2<40 pg/ml) and Follicle Stimulating Hormone (FSH>30 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups of 11 participants each). Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day). At admission and follow-up monthly intervals, body mass index (BMI), blood pressure, levels of gonadal, pituitary, thyroid and adrenal hormones, lipids and key minerals were measured. Bone markers were determined after four months M and P use in 12 participants. 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 and canonical variate technique was applied to GMS and KMI matrices. Two months application of Maca-GO stimulated (P<0.05) production of E2, suppressed (P<0.05) blood FSH, Thyroid (T3) and Adrenocorticotropic hormones, Cortisol, and BMI, increased (P<0.05) low density lipoproteins, blood Iron and alleviated (P<0.001) menopausal symptoms. Maca-GO noticeably increased bone density markers. In conclusion, Maca-GO applied to early-postmenopausal women (i) acted as a toner of hormonal processes along the Hypothalamus-Pituitary-Ovarian axis, (ii) balanced hormone levels and (iii) relieved symptoms of menopausal discomfort, (hot flushes and night sweating in particular), thus, (iv) exhibited a distinctive function peculiar to adaptogens, providing an alternative non-hormonal plant option to reduce dependence on hormone therapy programs (HRT).

Keywords: HRT; blood biochemistry; early-postmenopause; hormones; maca; menopausal symptoms.

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Figures

Figure 1
Figure 1
Canonical scores of 1st and 2nd variate transformed from Kupperman’s defined individual postmenopausal symptoms (KMI) for Months 0 = Admission Point and after monthly (1 to 4) intake of Maca-GO capsules according to treatment sequence applied intermittently with Placebo and computed using the data from the previous part (1) and the present part of the study. (Data for treatment sequences within each of the computed encircled clusters displayed as the vectors of combined 11 KMI symptoms, when separated from each other, shows significant difference at the P<0.05 level).
Figure 2
Figure 2
Canonical scores of 1st and 2nd variate transformed from Greene’s defined individual menopausal symptoms (GMS) for months 0 = Admission Point and after monthly (1 to 4) intake of Maca-GO capsules according to treatment sequence applied intermittently with Placebo and computed using the data from the previous part (1) and the present part of the study. (Data for treatment sequences within each of the computed encircled clusters displayed as the vectors of combined 21 GMS symptoms, when separated from each other, shows significant difference at the P<0.05 level).
Figure 3
Figure 3
Comparison of Placebo-corrected values for hormones: FSH (IU/ml), E2 (pg/ml), PRG (ng/ml) and LH (mU/ml), TSH (μIU/ml), T3 (pg/ml), T4 (pg/ml), Cortisol (μg/100ml) and ACTH (pg/ml), lipids: CHOL (mg/ml), Triglycerides (mg/100ml), HDL (mg/ml) and LDL (mg/ml), Iron (mcg/100ml)and BMI, after two months Maca-GO treatment (relative to Placebo) demonstrating the effect of two month Placebo when introduced prior to, or after Maca-GO capsules were administered to early-postmenopausal women according to APPMM or AMMPP treatment sequence.
Figure 4
Figure 4
Forearm bone density results expressed as Total Bone Density Score (“T-Score”) and corresponding hormone concentrations (FSH and E2) in early-postmenopausal women, measured at the Admission Point (A) and after four months administration of two treatment sequences: either Placebo (A-P-P-P-P) or Maca-GO (A-M-M-M-M).
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References

    1. Meissner HO, Mscisz A, Reich-Bilinska H, et al. Hormone-balancing effect of pre-gelatinised organic Maca (Lepidium peruvianum Chacon): (II) Physiological and symptomatic responses of early-post-menopausal women to standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study. IJBS. 2006;2:360. - PMC - PubMed
    1. Meissner HO, Kapczyński W, Mścisz A, et al. Use of Gelatinised Maca (Lepidium peruvianum) in Early-Postmenopausal Women - a Pilot Study. IJBS. 2005;1:33. - PMC - PubMed
    1. Meissner HO, Mrozikiewicz PM, Bobkiewicz-Kozlowska T, et al. Hormone-balancing effect of pre-gelatinised organic Maca (Lepidium peruvianum Chacon): (I) Biochemical and pharmacodynamic study on Maca using clinical laboratory model on ovariectomised rats. IJBS. 2006;2:260. - PMC - PubMed
    1. Meissner HO, Kedzia B, Mrozikiewicz PM, et al. Short- and Long-Term Physiological responses of Male and Female Rats to Two Dietary Levels of Pre-Gelatinised Maca (Lepidium peruvianum Chacon) IJBS. 2006;2:15. - PMC - PubMed
    1. Chacon G. 1st. Lima: Universidad Nacional Mayor de San Marcos; 2001. “Maca” Millenarian Peruvian Food Plant with Highly Nutritional and Medicinal Properties; pp. 1–337.

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