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www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 375
InternatIonal journal of BIomedIcal scIence
ABSTRACT
This is the second, conclusive part of the clinical study on responses of early-postmenopausal women to
standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers
-
-
nal hormones, lipids and key minerals were measured. Bone markers were determined after four months
conclusion, Maca-GO applied to early-postmenopausal women (i) acted as a toner of hormonal processes
function peculiar to adaptogens, providing an alternative non-hormonal plant option to reduce dependence
on hormone therapy programs (HRT).
Blood biochemistry; early-postmenopause; hormones; HRT; Maca; menopausal symptoms
Corresponding author: Dr Henry Meissner, GPO Box 4792, Sydney
2001, Australia. Tel: +(61) 414 836 159; Tel/Fax: +(61 2) 9906 1580; E-Mail:
hmeissner@ttdintnl.com.au.
Hormone-Balancing Eect of Pre-Gelatinized Organic Maca
(
Lepidium peruvianum
Chacon): (III) Clinical responses of
early-postmenopausal women to Maca in double blind,
randomized, Placebo-controlled, crossover conguration,
outpatient study
H O Meissner1, A Mscisz2, H Reich-Bilinska3, P Mrozikiewicz2, T Bobkiewicz-Kozlowska4,
B Kedzia2, A Lowicka2, I Barchia5
1Faculty of Health Studies, Charles Sturt University & Therapeutic Research International, GPO Box 4792, Sydney 2001,
Australia; 2Research Institute of Medicinal Plants, 27 Libelta St., 61-707 Poznan, Poland; 3Specialist Gynecology Private
Clinic, Glogow, Poland; 4Department of Pharmacology, Medical University, Poznan, Poland; 5Department of Primary
Industry, E. Macarthur Institute, Menangle, Australia
TT
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
376
In the previous paper from this series (1), the clinical
effects of administering a preparation of the non-hor-
monal root of the Andean plant Lepidium peruvianum
Chacon – pre-Gelatinized Organic Maca (Maca-GO)
were studied on 124 early-postmenopausal women. It has
been concluded that the non-hormonal Maca-GO prepa-
ration exhibits a hormone-balancing effect on the female
organism and thus reduces menopausal discomfort.
Those results conrmed earlier short- and long pilot clini-
cal studies (2). However, discrepancies existed between
results obtained in both the previous (1) and pilot study on
women (2) and in laboratory models on ovariectomised
rats (3), mainly in responses of estrogen (E2), follicle
stimulating hormone (FSH), progesterone (PRG) lutein-
izing hormone (LH), lipid metabolism indicators (triglyc-
erides –TRGL; cholesterol –CHOL; high- and low den-
sity lipoproteins - HDL and LDL) and minerals (Calcium
– Ca; Phosphorus – P; and Iron - Fe) to Maca-GO treat-
ment. Also, there were inconsistencies in the responses of
rats to short- and long-term administration of Maca-GO
in concentration of minerals in bone and muscle tissues
relative to mineral metabolism indicators based on blood
mineral proles (4). Therefore, in this, second and con-
cluding part of the clinical study which is a continuation
of the previously-reported research (1), physiological and
symptomatic responses of early-postmenopausal women
to standardized doses of Maca-GO were investigated in
relation to changes which may exist along a pituitary, thy-
roid, adrenal and gonadal axis, as measured by concentra-
tions of relevant hormones. Simultaneously, serum lipids
and key minerals were also analysed.
In this double blind, randomized, outpatient, four
months crossover design clinical Trial (2 × 2 months),
the effect of two months Maca-GO, parallel to Placebo
treatment on early-postmenopausal women, was studied.
In addition to analysis of four previously studied (1) hor-
mones (FSH, E2, PRG and LH), blood was analyzed for
Cortisol (CT), Adrenocorticotropic hormone (ACTH),
Thyroid hormones (thyroid stimulating hormone - TSH,
thyroxine - T3 and T4) and lipids (TRGL, CHOL, FSH
and LDL), parallel to observations of bone density mark-
ers. Using canonical variate analysis, statistical ranking
of individual menopausal symptoms contributing to sever-
ity of overall discomfort felt by menopausal women was
made as subjectively assessed by responses of participants
to menopausal tests according to Greene’s score (MGS)
and Kupperman’s index (MKI).
Maca
The Detailed description of Maca root (Lepidium
peruvianum Chacon), its botanical characteristics, tradi-
tional and current applications were described in details
by Chacon (5) and Obregon (6) and Maca-GO preparation
used in this Trial was obtained from the same batch of the
product described in detail previously (1, 3).
Subjects
All subjects considered for inclusion in the study were
early-postmenopausal women in good overall health and
fullling menopausal criteria set at the levels: for follicle-
stimulating hormone (FSH) of 30 IU/mL level or more
and E2 of 40 pg/mL levels or less. Subjects had experi-
enced absence of menses for at least 6 months, were not on
HRT, or had discontinued HRT at least 12 months before
admission to the study. Subjects were excluded if they
had a history of breast cancer, hyperplasia, endometrial
carcinoma, or cervical neoplasia; undiagnosed abnormal
vaginal bleeding; a bilateral hysterectomy; history of car-
diovascular disease; liver disease; history of chronic alco-
holism, medication hypersensitivity, or allergy to dietary
supplement ingredients; uncontrolled addiction or severe
depression; acute systemic infection or abnormal labora-
tory values.
The study was conducted on early-postmenopausal
women selected from patients regularly visiting a gyneco-
logic clinic CG-1 in Glogow municipality, the demograph-
ics of which were given previously (1).
As a result of screening procedures, a total of 34 par-
ticipants representing Caucasian, early-postmenopausal
women volunteers aged 49 to 58 years were selected. They
represented healthy subjects willing to participate in the
study of four months duration. The protocol in the cross-
over Trial required ve visits to the clinic: screening as a
baseline at an admission visit (A) and four, monthly, fol-
low-up visits. In the pilot bone density observation, two
visits were required: at admission and after four months of
either Placebo (P) or Maca-GO (M) treatment.
Two groups of 11 subjects each were used in a Trial
according to a crossover design and the following ran-
domized treatment sequence allocation: A-P-P-M-M and
A-M-M-P-P. Two groups of 6 women (M and P) were
involved in a forearm bone density observation, together
with levels of blood FSH and E2 recorded at the admis-
sion point and at the time of bone density scanning four
months later.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 377
The protocol and amendments to the entire study (1)
were approved by the Bioethics Committee of Medical
Review Board in Poznan (No. 11/2004). Written informed
consent was obtained from each enrolled subject regard-
ing voluntary participation in the trial conducted under
specialist Gynecologist’s supervision and after explana-
tion of the purpose, benets and possible risks of the study,
its requirements and procedures.
The Gynecologist - investigator enrolled all patients
and randomly allocated subjects to experimental groups,
after previous clinical conrmation of blood FSH and E2
eligibility criteria. The patients as well as the research
team were kept blind throughout the study.
At the admission and during further consultation visits
to the gynecologist, each eligible subject was given a com-
plete physical and pelvic examination, blood was sampled
for clinical tests and an assessment of specic symptoms
describing menopausal status was made during an inter-
view by the doctor using the questionnaires according to
GMS and KMI. Subjects were instructed to return any
unused portion of the monthly volume of capsules, so as to
determine compliance.
The protocol was identical to the one applied in the pre-
vious part of the study (1). At the start and then on comple-
tion of each monthly interval of the study, all women were
interviewed by the gynecologist and requested to answer
a set of standard questions according to questionnaires
designed by Greene (menopausal score) and Kupperman
(menopausal index). At the same time, body weight and
blood pressure were checked and blood was sampled for
hormones and other biochemical analyses.
The study was carried out by specialist Gynecologist
and researchers of the Research Institute of Medicinal
Plants and Medical University in Poznan under the strict
supervision of the Study Coordinator between January
2004 and June 2005.
Assays
Blood serum levels of hormones were measured on a
monthly basis: 17β-estradiol (E2), FSH, LH and PRG as
well as, CT, ACTH, and TSH, T3, T4). Blood pressure,
body weight, serum mineral contents (Ca, P, Fe) and lipid
proles (CHOL, TRGL, HDL, LDL) were also deter-
mined at monthly intervals together with indices of meno-
pausal discomfort determined in personal interviews by
doctor with the use of questionnaires of Greene (2) and
Kupperman accordingly (7).
Blood analyses were conducted by “Prodok” Medical
Laboratory, Przylep, Poland, using the ofcially accepted
standard clinical procedures on Immulite – DPC equipment.
Precision of analytical techniques in both Laboratories is
monitored by National Center of Quality of Diagnostic
Medical Laboratories in Poland and both Laboratories are
participants in the International Quality Control RIQAS
maintained by Randox Company.
Bone density was measured by applying standard
diagnostic system (equipment and technique) adopted
in public hospital (Diagnostic & Screening Department,
Copper Industry Health Centre, Lubin, Poland) for routine
bone density assessment according to National Screening
Program principles. Bone density of forearm was con-
ducted on STRATEC XCT-960 PQCT equipment.
Statistical analysis
Data were expressed as means with a linear mixed
model tted to data, allowing the comparison between
groups of individuals within each month and taking into
account the effects of individuals on each response vari-
able (combined xed and random effect). The errors were
assumed to follow a Gaussian (normal) distribution. All
parameters were estimated using the Restricted Maximum
Likelihood (REML) estimation (8). The comparisons
between groups within months were made using least sig-
nicant difference (LSD) test with the differences consid-
ered signicant at P<0.05 and highly signicant at P<0.01
and P<0.001 level.
-
Analysis of total scores dened by
both Greene (GMS) and Kupperman (KMI) were analyzed
using the conventional analysis of variance to compare the
individual groups (Menopausal status by Maca treatment
combinations). Weighted total scores of 21 in GMS and
indexed 11 symptoms based on KMI formula were ana-
lyzed in a similar way to the hormone data. Signicant
differences were tested using the least signicant differ-
ence (LSD) at 5% level.
A multivariate analysis via the canonical variate tech-
nique (9) was used to relate 21 (GMS) or 11 (KMI) response
variates to groups of menopausal women treated in vari-
ous sequence combination of Maca & Placebo treatment.
Canonical variate coefcients (Vector loadings) were cal-
culated from the sums of squares and product matrix of
the 21 GMS or 11 KMI response variates and correspond-
ing canonical variate scores were calculated from the rst
two largest eigen-values. Monthly data were analyzed sep-
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
378
arately. All analyses were performed using SAS statistical
software (10).
The study commenced with total of 34 subjects regis-
tered at the admission point: 22 in a crossover congura-
tion Trial and 12 in a Pilot Bone Density Observation.
All 22 women participating in the crossover Trial
completed four months of the study. In the Pilot Bone
Density Observation, two participants from Placebo group
and one from Maca-GO group have not completed the four
months study as they failed to take their daily doses of
capsules and therefore, they were excluded from the analy-
sis of data.
Table 1 summarizes data on BMI, systolic and diastolic
blood pressure of participants during this 4-month cross-
over Trial. Maca-GO treatment signicantly (P<0.05)
reduced BMI in the sequence group in which Placebo was
introduced for two months prior to two months of Maca-
GO treatment (APPMM). No signicant (P>0.05) effect
was recorded in either systolic or diastolic blood pressure
in relation to admission point nor to Placebo treatment,
although, Maca-GO showed a slight tendency (P>0.05) to
lower systolic blood pressure.
Results from hormone assays summarized in Table 2
demonstrate that after two months of Placebo or Maca-GO
treatment (prior to crossover), there were no signicant
differences existing between the two treatment sequences
in FSH and PRG (P>0.05). However, Maca-GO signi-
cantly (P<0.05) increased overall E2 level with simultane-
ous signicant (P<0.05) reduction of the overall LH levels
as compared to Placebo treatment. The changes induced
by Placebo treatment on E2 and LH prior to crossover
into Maca-GO were more pronounced than the effect of
Average Admission (A) and monthly values for Body Mass Index (BMI), Systolic (SBP) and Diastolic (DBP) Blood Pressure at
ve sampling points (Month Model)1 and Placebo (P) versus Maca-GO (M) contrast (Treatment Model) for two application sequences
in a crossover design: A[PP × MM] and A[MM × PP] (n=11 in both groups) during four months long study
Measure-
ment TreatmentAdmission
(A)
Month 3
Month 4 SED 3Maca SED P
BMI APPMM 27.78 28.04A27.62A27.71A26.99B0.21* 27.83A27.47B0.16 <0.05
AMMPP 27.38 27.59 27.33 27.11 27.48 0.21 27.29 27.46 0.16 ns
SED 2.42 2.42 2.42 2.42 2.41 2.41
P ns ns ns Ns ns ns
SBP APPMM 118.5 125.7 118 120.5 110 5.1 121.8 117 4.2 ns
AMMPP 120 123.5 113.5 111.5 114.4 5.1 112.9 118.5 4.2 ns
SED 8.1 8.1 8.1 8.1 7.3 7.3
P ns ns ns ns ns ns
DBP APPMM 74.5 80.9 71 76 74 4.08 75.95 75.3 3.28 ns
AMMPP 74 77 71 70 71.11 4.08 70.53 74.0 3.28 ns
SED 5.94 5.94 5.94 5.94 5.25 5.25
P ns ns ns ns ns ns
In this and subsequent Tables:
1 A linear mixed model was tted to data, allowing the comparisons between treatment groups: treatment by month differences in one model
and Maca versus Placebo contrast in another model. The random effects included both individual variation and residuals. Two models may
be written as follows: Month Model, Fixed (Treatment + Month + Interaction) + Random (Individuals + error); Treatment Model, Fixed
(Treatment + Maca + Interaction) + Random (Individuals + er ror). The errors are assumed to follow a Gaussian (normal) distribution. All
parameters were estimated using the Restricted Maximum Likelihood (REML) estimation. The differences between treatments within each
month and between Maca and Placebo were tested using least signicant difference (LSD) test at 5% and 1% signicance levels. 2 Average
age of women in treatment sequence APPMM = 51.6±1.29 and in AMMPP = 53.1±0.75; Average time since the last period for treatment
sequence APPMM = 12.6 and for AMMPP = 14.0 months. 3 Capital letters attached to the means indicate signicant difference between val-
ues in columns. Small letters indicate signicant differences between values in rows. * existence of signicant differences between monthly
measurements within the same treatment sequence group. Values marked with unlike capital letters are considered statistically signicant
at P<0.05.
SED, Standard error of differences; P, Probabilities of signicance. ns, not signicant at P>0.05; <0.05, signicance at 5%
probability level; <0.01, signicance at 1% probability level; <0.001, signicance at 0.1% probability level.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 379
Placebo introduced to participants after the Maca-GO
treatment. This reduced effect of Placebo after previous
Maca-GO application may indicate a residual effect of
Maca-GO on women.
From the results of other hormone levels summarized
in Table 3, it appears that there were no statistical differ-
ences (P>0.05) observed in concentrations of the TSH and
T4 in blood of early-postmenopausal women while T3 and
adrenal hormones (Cortisol and ACTH) showed statisti-
cally signicant (P<0.05) reduction in recorded values
as compared to overall Placebo effect in postmenopausal
women. After the rst month of Maca-GO application, in
both sequence groups, T3 was noticeably increased but the
second month of Maca-GO treatment resulted in substan-
tial lowering of T3, below the admission and both months
of Placebo treatment levels.
Table 4 which summarizes lipid and mineral metabo-
lism data, shows that the overall effect of Maca-GO on
Cholesterol, Triglycerides and HDL in relation to overall
Placebo effect was statistically not signicant (P>0.05).
However, in relation to Placebo, Maca-GO treatment sig-
nicantly increased (P<0.05) LDL with a simultaneous
slight, but statistically not signicant (P>0.05) increase
in HDL contents as compared to sampling at the admis-
sion point.
After two months of Maca-GO treatment in AMMPP
sequence group, there was signicant (P<0.05) increase
in serum Iron content in relation to both admission
point and the second month of Placebo introduced after
the Maca-GO treatment. Similarly to Iron, in AMMPP
group, plasma Calcium level was signicantly higher
(P<0.05) after the second month of Maca-GO treatment
as compared to Placebo after the crossover point and at
the start of the Trial. In sequence group APPMM, after
second month of Placebo treatment, there was a difcult
to explain increase in Calcium level, however difference
between Placebo and Maca block of data was not statisti-
cally conrmed (P>0.05).
Results of bone density markers presented in Table 5
demonstrate that after four-month intake of Placebo cap-
sules, there was a reduction in individual and combined
bone density values and computed score, while during the
same period, participants who self-administered Maca-
GO capsules during four months observation, recorded
Average Admission (A) and monthly values for FSH, E2, Progesterone (PRG) and E2 levels at ve sampling points (Month
Model)1 and Placebo (P) versus Maca-GO (M) contrast (Treatment Model) for two application sequences in a crossover design:
A[PP × MM] and A[MM × PP] (n=11 in each group) during four months long study
Hormone Treatment Admission
(A)
Month 3
Month 4 SED Maca SED P
APPMM 64.62 70.54 71.28 65.6 60.66 8.08 70.91 63.56 5.6 ns
AMMPP 69.03 62.01 57.27 53.63 59.22 7.465 56.42 59.64 5.29 ns
SED 17.301 17.348 17.371 19.208 16.565 15.618
P ns ns ns ns
APPMM 19.11 8.33 15.14 45.72 58.43 22.195 11.73B50.95A15.36 <0.05
AMMPP 8.62 12.08 25.3 25.61 17.14 21.602 21.13 18.69 15.05 ns
SED 31.661 28.375 29.016 35.96 18.992 19.124
P ns ns ns Ns ns ns
APPMM 0.201 0.203 0.213 0.277 0.286 0.232 0.208 0.282 0.176 ns
AMMPP 0.224 0.233 0.373 0.281 0.252 0.281 0.266 0.303 0.125 ns
SED 0.429 0.425 0.224 0.261 0.172 0.148
P ns ns ns ns ns ns
APPMM 43.79 38.92 38.91 34.05 32.41 3.985 38.91A33.38B2.74 <0.05
AMMPP 36.66 32.69 32.58 30.03 32.5 3.678 31.27 32.64 2.59 ns
SED 8.6 8.566 8.622 8.805 6.203 6.035
P ns ns ns Ns ns ns
1 For explanation see Table 1.
SED, Standard error of differences; P, Probabilities of signicance. ns, not signicant at P>0.05; <0.05, signicance at 5%
probability level; <0.01, signicance at 1% probability level; <0.001, signicance at 0.1% probability level.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
380
noticeable increase in their bone density measures in rela-
tion to the admission point and to Placebo treatment.
Due to low number of women participating in the bone
density observation test, results were expressed as groups’
means and standard deviation only, since calculation of
statistically-signicant differences would lack credibil-
ity. Observed increase in bone density markers due to
Maca-GO administration was accompanied by a substan-
tial decrease in FSH (55%) and an increase in E2 values
(135%), while in Placebo group, during the same length
of the Trial, there was much reduced change observed in
the same hormone values (11% decrease for FSH and 83%
increase in E2).
Menopausal Score (GMS)
The objective in analysis of menopausal symptoms
was to examine the effect of Maca-GO treatment admin-
istered over variable time frames (one or two months)
intermittently with Placebo (at pre and post Maca-GO
administration), on the alleviation of menopausal symp-
toms as subjectively assessed by early-postmenopausal
women during personal interviews with gynecologists.
In analysis of the answers provided by participants to
the questionnaires according to Kupperman and Greene,
the emphasis was put on those symptoms which had
been indicated by women at admission as having the
most pronounced effects on their life as they entered
menopause Listed in descending order of priority, the
following symptoms reflect the degree of discomfort
attributed to their early-postmenopausal stages: hot
flushes, nervousness, excessive sweating (profuse per-
spiration), interrupted sleep pattern, depression, gen-
eral weakness, headache, joint pain, heart palpitations,
loss of body balance and numbness in hands and/or
legs-feet.
Table 3. Average Admission (A) and monthly values for TSH, T4, T3, Cortisol and ACTH levels at ve sampling points (Month Model)1
and Placebo (P) versus Maca-GO (M) contrast (Treatment Model) for two application sequences in a crossover design:
A[PP x MM] and A[MM x PP] (n=11 in each group) during four months long study
Hormone Treatment Admission
(A)
Month 3
Month 4 SED Maca SED P
TSH
APPMM 2.072 2.094 1.857 1.793 1.495 0.391 1.975 1.67 0.27 ns
AMMPP 2.692 2.478 2.573 2.424 2.978 0.367 2.701 2.525 0.256 ns
SED 0.817 0.817 0.817 0.84 0.774 0.779
P ns ns ns ns ns ns
T4
APPMM 1.177 1.183 1.081 1.159 1.194 0.037 1.177 1.132 0.029 ns
AMMPP 1.21 1.169 1.1 1.216 1.09 0.039 1.135 1.164 0.031 ns
SED 0.058 0.058 0.058 0.061 0.053 0.054
P ns ns ns ns ns ns
T3
APPMM 3.168 3.316 3.204 3.642 2.997 0.116 3.26 3.376 0.126 ns
AMMPP 3.277 3.593 2.925 3.793 3.269 0.108 3.531A3.259B0.12 <0.05
SED 0.218 0.218 0.218 0.225 0.216 0.22
P ns ns ns ns ns ns
Cortisol
APPMM 177.8 185.1 199.3 150.8 166.6 20.75 192.2A157.3B14.6 <0.05
AMMPP 159.7 159.9 199.8 182.3 181 19.5 181.6 179.9 13.9 ns
SED 26.3 26.3 26.3 28.1 22.4 22.8
P ns ns ns ns ns ns
ACTH
0PPMM 18.92 18.33 25.45 15.4 17.39 3.305 21.89A16.22B2.44 <0.05
AMMPP 20 20.8 28.25 24.43 22.68 3.22 23.55 24.11 2.39 ns
SED 5.56 5.56 5.56 5.79 5.14 5.24
P ns ns ns ns ns ns
1 For explanation see Table 1
SED, Standard error of differences; P, Probabilities of signicance. ns, not signicant at P>0.05; <0.05, signicance at 5%
probability level; <0.01, signicance at 1% probability level; <0.001, signicance at 0.1% probability level.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 381
-
After one month of treatment with either Maca-GO or
Placebo, both sequence groups responded in similar, sta-
tistically signicant (P<0.001) manner showing reduction
in total values of KMI and GMS, with Maca-GO having
much more pronounced effect on sum of the individual
symptoms than the same length of Placebo treatment (Table
6). The second month of Maca-GO treatment magnied
the positive effect on alleviation of individual menopausal
symptoms as measured by KMI only. Extending Placebo
treatment into the second month resulted in reversing the
positive effects observed in total KMI values after the rst
month of Placebo use. This was particularly distinctive in
Table 4. Average Admission (A) and monthly values for Lipids: Cholesterol (CHOL), Triglycerides (TRGL), High Density Lipoproteins
(HDL) and Low Density Lipoproteins (LDL) and Minerals: Calcium (Ca), Phosphorus (P) and Iron (Fe) levels at ve sampling points
(Month Model)1 and Placebo (P) versus Maca-GO (M) contrast (Treatment Model) for two application sequences in a
crossover design: A[PP × MM] and A[MM × PP] (n=11 in each group) during four months study
Measure-
ment Treatment Admission
(A)
Month 3
Month 4 SED Maca SED P
CHOL
(mg/100ml)
APPMM 215.1 222.9 233.7 232.3 230.6 9.2 228.3 231.6 6.6 ns
AMMPP 221.3 220.4 226.6 235 222.4 8.47 228.7 223.5 6.2 ns
SED 21.1 21.1 21.2 21.7 20.2 20.2
P ns ns ns ns ns ns
TRGL
(mg/100ml)
APPMM 147.2 134.7 166.1 160.1 176.7 24.4 150.4 166.9 17.1 ns
AMMPP 167 160.4 134.3 140.6 161.3 22.52 151 147.3 16.1 ns
SED 40.7 40.7 41.1 42.9 37.8 37.9
P ns ns ns ns ns ns
HDL
(mg/100ml)
APPMM 59.41 66.73 67.72 67.82 70.07 3.19 67.23 68.75 2.27 ns
AMMPP 64.66 64.77 66.2 68.29 61.25 2.94 64.77 65.49 2.15 ns
SED 7.75 7.75 7.79 7.95 7.49 7.5
P ns ns ns ns ns ns
LDL
(mg/100ml)
APPMM 138 150.1 142.8 168 169.3 10 146.8B168.6A6.8 <0.01
AMMPP 148.6 152.8 148 163.9 154.5 8.37 159.2 150.4 5.9 ns
SED 20.7 21 21.2 21.6 20 20.1
P ns ns ns ns ns ns
Minerals
Ca
(mEq/L)
APPMM 4.46 4.73 5.03 4.8 4.714 0.085 4.88 4.765 0.075 ns
AMMPP 4.49 4.69 B 4.95 A 4.73 B 4.63 B 0.085 * 4.68 4.82 0.071 ns
SED 0.119 0.119 0.119 0.119 0.104 0.104
P ns ns ns ns ns ns
P
(mg/100ml)
APPMM 3.22 3 3.16 3.14 3.143 0.203 3.08 3.141 0.157 ns
AMMPP 3.27 3.66 3.19 3.62 3.28 0.203 3.45 3.425 0.157 ns
SED 0.258 0.258 0.258 0.258 0.217 0.217
P <0.05 ns ns ns ns ns
Fe
(mcg/100ml)
APPMM 69.27 82.08 80.78 81.39 82.23 10.51 81.43 81.74 8.02 ns
AMMPP 85.45 120.1 101.97 97.49 75.38 10.51 86.43B111.04A8.02 <0.01
SED 11.32 11.32 11.32 11.32 8.63 8.63
P <0.01 ns ns ns ns <0.01
1 For explanation see Table 1. * existence of signicant differences between monthly measurements within the same treatment sequence
group. Values marked with unlike capital letters are considered statistically signicant at P<0.05.
SED, Standard error of differences; P, Probabilities of signicance. ns, not signicant at P>0.05; <0.05, signicance at 5%
probability level; <0.01, signicance at 1% probability level; <0.001, signicance at 0.1% probability level.
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DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
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the APPMM sequence group and when the KMI was used.
Differences between Placebo and Maca-GO treatments
were more pronounced in the KMI as compared to GMS
with the GMS values showing signicant (P<0.01) effect
of Placebo in one sequence group only (APPMM) while
KMI recorded values in both sequence groups showed
highly signicant (P<0.001) difference between Placebo
and Maca-GO treatment.
When Placebo was introduced after previous Maca-GO
period, then there was a statistically signicant increase
(P<0.001) in KMI values (Table 6) indicating an increase
in severity of menopausal symptoms contributing to the
computed KMI values after Maca-GO was withdrawn.
Since GMS was less sensitive to changes induced by
both Maca-GO and Placebo, the severity of individual
symptoms in relation to Maca-GO and Placebo were fur-
ther assessed using KMI test only. Analyzing KMI results
for individual 11 symptoms as recorded in the APPMM
sequence treatment (Table 7), one month Placebo admin-
istration resulted in highly signicant (P<0.001) reduction
in severity of most of the menopausal symptoms with,
excessive sweating, interrupted sleep pattern, nervous-
Table 6. Dynamics of overall monthly changes in total values from individual symptoms determined according to Kupperman’s
Menopausal Index (KMI) and Greene’s Menopausal Score (GMS) recorded between Admission point (A), at four monthly
sampling points (Month Model)1 and Placebo (P) versus Maca-GO (M) contrast (Treatment Model) according to two
sequences of Maca-GO application (pre- and post Placebo) during four month of crossover Trial (n=22)
Treatment Admission
A
After
After
After
Month 3
M
After
Month 4
M
SED Maca SED P
Kupperman’s Menopausal Index (KMI)
OPPMM 30.40 15.20 24.00 10.80 6.99 1.69 19.60 9.65 1.31 <0.001
OMMPP 29.64 13.09 9.45 14.88 19.58 1.52 17.21 11.27 1.30 <0.001
SED 3.52 3.52 3.53 3.59 3.47 3.47
Greene’s Menopausal Score (GMS)
OPPMM 25.80 10.90 8.60 8.90 3.30 1.55 9.75 6.10 1.44 <0.01
OMMPP 30.91 12.45 10.91 13.00 7.18 1.48 10.09 11.68 1.37 ns
SED 4.28 4.28 4.28 4.28 4.35 4.04
1 For explanation see Table 1.
SED, Standard error of differences; P, Probabilities of signicance. ns, not signicant at P>0.05; <0.05, signicance at 5%
probability level; <0.01, signicance at 1% probability level; <0.001, signicance at 0.1% probability level.
Forearm bone density results (Trubecular, Cortical + Subcor tical, Total Density (mg/103mm) and Total Density Score “T-Score”)
and related concentrations of two blood hor mones (FSH and E2) in early-postmenopausal women at the Admission and
after four months ad ministration of either Placebo (A-P-P-P-P; n = 4) or Maca-GO (A-M-M-M-M; n=5)
At Admission After 4 months At Admission After 4 months
Measurement & Group (mg/103mm) Cortical + Subcortical (mg/103mm)
Mean SE1Mean SE Mean SE Mean SE
A-P-P-P-P 12.1 12.6 13.5 23.9
A-M-M-M-M 11.9 13.4 34.7 44.4
(mg/103mm)
Mean SE Mean SE Mean SE Mean SE
A-P-P-P-P 15.3 17.4 0.15 0.19
A-M-M-M-M 21.5 25.5 0.32 0.38
Hormone (mIU/ml) (pg/ml)
A-P-P-P-P 3.86 4.11 0.45 0.96
A-M-M-M-M 3.27 3.07 0.94 4.17
1 SE(±), standard error of mean.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 383
ness, depression, loss of body balance, heart palpitations
and numbness in hands & legs being most pronounced
(P<0.001), with KMI values in remaining symptoms also
signicantly lowered, but to a lesser degree (P<0.05).
With the second month of Placebo application, values of
most KMI symptoms were increased, as compared to the
rst month values, with the exception of loss of body bal-
ance, joint pain and heart palpitations. On the other hand,
KMI values for hot ushes and excessive sweating after
the second month of Placebo treatment increased to a
higher level than those recorded at the Admission point.
Introducing Maca-GO after the second month of Placebo
treatment signicantly (P<0.001) reduced KMI values for
the following symptoms: hot ushes, excessive sweating,
interrupted sleep pattern and nervousness, while values
for other symptoms were less (P<0.05) or not signicantly
(P>0.05) affected.
Canonical variate analysis of results derived from
Vector loadings (Table 8) of the rst canonical vari-
ate for all the treatment groups in this and previous part of
the study (1) shows that at the Admission point, general
weakness was the symptom with the largest coefcient
value (coefcient loading) of the rst canonical variate
equation. This indicates that this symptom was the most
important indicator of post-menopause separating treat-
ment groups. This was followed by nervousness, exces-
sive sweating and interrupted sleep pattern. Hot ushes
were the symptom with the largest coefcient loading for
the 2nd canonical variate equation, followed by interrupted
sleep pattern and depression. It is important to notice that
hot ushes were statistically highly correlated (r=0.315;
P<0.01) with the excessive sweating, which may be one
of the reasons that the symptom excessive sweating was
not so important in the equation, because hot ushes have
been a dominating symptom as per outcome of the analy-
sis for the 2nd canonical equation.
After 2 months administration of Maca-GO or Placebo
treatment, hot ushes showed the highest coefcient (in
absolute value) in the rst canonical variate equation
(Table 8), which indicated statistically signicant sepa-
ration of the treatment groups (Placebo from Maca-GO),
followed by such symptoms as interrupted sleep pattern,
nervousness and loss of body balance. In the 2nd canoni-
cal equation such symptoms as depression, general weak-
ness and joint pain were the top 3 factors separating the
treatment groups. The correlation between hot ushes and
excessive sweating increased after 2 months of treatment.
Monthly changes in values of individual symptoms determined according to Kupperman’s Menopausal Index (KMI) recorded
for APPMM treatment sequence (n = 11) between Admission (A), and four sampling points at monthly intervals (Month Model)1 with two
months Placebo (P) followed by two months Maca-GO (M)
Admission
A
After
After
After
M
After
M
SE(±) P Maca SED P
Hot ushes 2.20 1.70 2.60 1.00 0.83 0.251 <0.001 2.15 0.92 0.17 <0.001
Excessive sweating 2.10 0.70 2.20 1.10 0.71 0.396 <0.001 1.45 0.91 0.29 0.066
Interrupted sleep 2.30 1.20 1.80 0.60 0.57 0.399 <0.001 1.50 0.59 0.29 0.004
Nervousness 2.50 1.00 1.90 0.30 0.14 0.262 <0.001 1.45 0.22 0.18 <0.001
Depression 1.30 0.40 0.20 0.50 0.43 0.354 0.034 0.30 0.46 0.20 0.407
Balance 0.90 0.10 0.10 0.20 0.00 0.199 <0.001 0.10 0.10 0.10 1.000
General weakness 1.90 1.10 0.60 1.00 0.14 0.397 0.001 0.85 0.57 0.28 0.318
Joint pain 1.20 0.40 0.40 0.60 0.25 0.375 0.115 0.40 0.43 0.23 0.912
Headaches 1.00 0.40 0.10 0.20 0.14 0.237 0.002 0.25 0.17 0.13 0.563
Heart palpitations 1.10 0.20 0.20 0.20 0.14 0.263 0.003 0.20 0.17 0.13 0.832
Numbness hands & legs 0.40 0.00 0.20 0.10 0.14 0.166 0.189 0.10 0.12 0.10 0.836
Total value
16.9 7.20 10.30 5.80 3.51 0.185 <0.001 19.60 9.40 1.31 <0.001
SED, Standard error of differences; P, Probabilities of signicance. ns, not signicant at P>0.05; <0.05, signicance at 5%
probability level; <0.01, signicance at 1% probability level; <0.001, signicance at 0.1% probability level. Scoring index: 0,
symptom not experienced; 1, occasionally; 2, often; 3, very often; Kupperman’s Indexing Factors: for K-1, ×4; K-2 to K-5 , ×2; the remain-
ing, ×1).
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DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
384
After the second month, hot ushes were also signicantly
correlated with interrupted sleep pattern (P<0.01) and ner-
vousness (P<0.05).
After the fourth month of the study, hot ushes remained
the highest coefcient of the 1st canonical equation, fol-
lowed by heart palpitation (Table 8). In the 2nd canonical
equation symptoms of joint pain, interrupted sleep pat-
tern and general weakness, were mostly inuencing the
treatment group separation. At this stage hot ushes were
no longer related to excessive sweating, interrupted sleep
pattern or nervousness, which may support observations
that Maca-GO signicantly reduced hot ashes as a prime
symptom affecting early-postmenopausal women at the
time of admission to the study.
Figure 1 shows separation of the individual treat-
ment groups by canonical variate analysis of KMI prior
to (Month 0) and after the 1st, 2nd, 3rd and 4th months of
application of the individual sequences of treatments in
the whole study (for all the sequence groups used in previ-
ous part (1) and this trial. Group sequence APPMM was
segregated from the rest of groups by the rst canonical
variate. Group APMM was separated from AMMPM and
APPMM by the rst canonical variate after one month of
study, while Group AMMPM was separated from APPMM
by the second canonical variate. Two months application
of all treatment sequences to women resulted in a sepa-
ration of Group sequence APPMM and APMM from the
remaining treatments. After four months of applying treat-
ment sequences, all the four Groups: AMMPP, APPMM,
AMMPM and APMMP were discriminated by the canoni-
cal variates. Figure 1 also shows that the participants from
the three groups (APMM, AMMP and APPM) were clus-
tered separately by the canonical variate analysis even
before the treatments were administered.
Using scores recorded for individual symptoms
of the GMS for all the sequence groups used in this Trial
and the previous part of the study (1) and relevant vector
loadings for the rst and second canonical variate equa-
tions as determined and summarized in Table 9, the fol-
lowing individual GMS symptoms used as variables, were
the most important indicators of postmenopausal condi-
tions at the Admission to the study: nervousness, exces-
sive crying, excessive alertness, sudden feeling of anxi-
ety, excessive night sweating, headaches and irritability,
nervousness and depression being of the highest impor-
tance at 1st canonical variate and irritability, nervousness,
unhappiness and depression were important symptoms at
2nd canonical variate, which separated results collected in
four sequence groups at Admission point. In order to com-
pare separation of clusters during four months of study, in
Figure 2 the overall degree of separation was demonstrated
using clusters of GMS data for all the sequence groups as
observed at Admission point (Month 0) and during four
months of the relevant treatment sequences as used in the
entire study. Similar pattern of separation was observed as
the one obtained in analysis of KMI data shown in Figure
1, indicating separation of computed clusters of canoni-
Coefcients (vector loadings) of the rst and second canonical variate equations for Kupperman’s Menopausal Index as calcu-
lated for the Admission point and after one, two, three and four months of Maca-GO treatment sequences applied inter mittently with
Placebo using the data f rom the previous par t (1) and the present part of the study (Total n = 146 women)
Symptom
st
nd
A Month 3 Month 4
A Month 3 Month 4
Hot ushes 0.040 -0.001 -1.101 0.728 -2.561 1.016 1.035 -0.297 -1.448 0.114
Excessive sweating 0.359 -0.303 -0.055 0.531 0.227 -0.318 -0.549 0.202 0.193 0.137
Interrupted sleep pattern 0.353 -0.253 -0.658 0.033 -0.341 0.438 0.443 0.049 0.254 1.131
Nervousness 0.614 -0.834 -0.432 0.198 -0.271 -0.377 -0.050 0.181 0.309 -0.174
Depression -0.419 -0.066 -0.114 0.104 - 0.169 0.388 0.467 0.679 -0.161 0.350
Losing body balance -0.332 0.056 0.505 0.562 -0.187 -0.534 -0.847 -0.348 0.362 0.229
General weakness 0.945 -0.536 0.025 0.518 0.423 -0.168 0.414 0.578 0.728 -0.848
Joint pain 0.147 -0.453 -0.072 0.315 0.234 -0.098 -0.651 0.564 0.107 1.729
Headaches -0.240 0.089 0.282 -0.457 -0.420 - 0.016 -0.331 0.066 -0.267 -0.115
Heart palpitations -0.153 0.088 -0.033 -0.370 1.117 -0.306 -0.502 0.016 0.633 -0.120
Parestesy/Numbness -0.003 0.115 -0.038 -0.540 -0.165 -0.418 -0.013 0.181 -0.905 -0.339
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 385
cal scores for matrices of 21 menopausal symptoms and
demonstrating that Maca-GO affected position of clusters
represented by individual groups and signicantly inu-
enced reduction in severity of symptoms associated with
early-postmenopause.
Hormonal balance after Maca-GO treatment in early-
postmenopausal women
In the present study, applying Maca-GO treatment to
early-postmenopausal women, in addition to a signicant
increase in E2, lowered LH, T3, CT, ACTH and steady
FSH and PRG levels, there was a highly signicantly
reduction in BMI and both frequency and intensity of
menopausal symptoms such as hot ushes, profound
perspiration (night sweating), as well as reduced depres-
sion, irritability, difculty in falling asleep and other as
demonstrated by the KMI and GMS, which may indicate
similar effect as the one induced by the HRT treatment.
In addition, unlike the reported negative consequences
of the HRT programs (11), Maca-GO has not contrib-
uted to an increase in blood pressure, nor triggered an
increase in body weight, depression and mood swings,
which all are considered as negative side-effects of HRT
(11, 12, 13, 14). Demonstrated in this study was the posi-
tive effect of Maca-GO on lowering E2, and a signi-
cant reduction in the range of menopausal symptoms not
restricted to hot ushes and night sweating, with a simul-
taneous lowering in BMI without affecting blood pres-
sure, together showing that Maca-GO has all the pre-
requisites to become a natural non-hormonal treatment
superior to HRT in terms of all the additional benets
not delivered by HRT programs.
A similar pattern in responses of women observed
in FSH and LH results after application of Maca-GO in
various sequence groups in the previous part of the study
(1) with simultaneous reverse effects recorded in E2 val-
Table 9. Coefcients (vector loadings) of 1st and 2nd canonical variate equations dened by symptoms according to Green’s Menopausal
Score (GMS) on early-postmenopausal women computed for Maca-GO treatment sequences applied intermittently with Placebo
using the GMS data from the previous part (1) and the present part of the study (Total n = 146 women)
Symptom
st canonical variate
nd canonical variate
Month 3 Month 4 Month 3 Month 4
Abnormally-fast heart rate -0.320 -1.612 -1.526 0.810 -0.649 0.031 0.274 -0.152 0.216 0.719
Nervousness -1.214 0.019 0.411 0.978 -0.706 0.589 0.441 0.178 0.646 0.072
Difculty falling asleep 0.180 0.285 -0.150 0.016 0.648 0.361 0.265 -0.136 -0.150 -0.395
Excessive alert ness 0.903 0.376 0.475 -0.608 0.293 -0.252 -0.239 0.041 -0.037 0.269
Sudden feeling of anxiety 0.767 0.444 -0.028 -0.658 -3.456 -0.248 1.263 -0.377 0.575 1.353
Difculty concentrating -0.026 0.338 0.406 0.381 -0.054 0.135 0.246 -0.677 -0.128 1.004
Feeling of tiredness/lack of energy -0.110 -0.106 0.250 -0.023 -0.154 -0.277 0.177 0.159 0.009 0.725
Lack of interest -0.248 0.223 0.016 -0.456 -0.825 -0.052 0.040 -0.024 0.451 1.661
Unhappy/depressed -0.027 0.033 -0.109 0.272 0.483 0.549 0.083 -0.895 -0.455 -0.314
Excessive crying -0.926 -0.346 0.010 0.572 2.124 0.159 -1.050 0.773 0.432 0.842
Irritability -0.375 0.119 0.331 -0.460 1.476 -0.819 0.145 -0.802 - 0.161 -1.578
Loss of consciousness -0.198 0.552 0.252 0.698 0.466 -0.497 -0.609 0.514 0.668 -1.237
Nervous tension 0.274 0.480 0.477 0.323 1.112 -0.227 -0.332 0.786 0.249 2.038
Numbness / “pins & needles” -0.202 -0.180 -0.027 -0.720 0.434 -0.162 0.122 0.499 0.271 -1.574
Headaches 0.357 -0.078 0.312 -0.056 -0.506 -0.339 -0.327 -0.038 0.542 1.443
Muscle and joint aches and pains 0.146 0.158 -0.095 0.376 -0.554 -0.042 0.243 -0.326 -0.107 -1.117
Loss of feeling in feet & hands -0.043 -0.170 -0.037 -0.040 0.379 0.283 0.037 0.007 0.135 2.164
Difculty breathing 0.283 0.363 0.534 -1.112 6.352 0.397 0.243 0.592 1.414 -1.839
Hot ushes 0.165 0.500 0.049 0.104 -1.696 0.249 0.540 -0.716 -0.287 -1.244
Excessive night sweating -0.612 -0.144 -0.316 -0.049 0.912 -0.204 -0.283 -0.188 -0.324 0.156
Loss of interest in sex life -0.086 0.175 -0.383 0.466 -0.340 -0.308 -0.287 0.579 -0.995 1.365
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DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
386
ues being signicant in APMMP and APPMM sequence
groups only (P<0.01 and P<0.05 respectively).The above
results conrmed the trend observed in the previous part
of the study (1) in which Maca-GO increased E2 and low-
ered FSH levels, while in the present Trial, E2 level only
was increased without signicant effect on FSH.
The existence of a positive relationship between Maca-
GO treatment and its hormone balancing function in
early-postmenopausal women observed in this study may
be supported also by previous pilot observations on early-
postmenopausal women (2) and in-depth biochemical and
physiological observations made in bioassays using sexu-
ally-experienced (4) and ovariectomised laboratory ani-
mals (3).
Canonical scores of 1st and 2nd variate transformed
from Kupperman’s dened individual postmenopausal symp-
toms (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 signicant
difference at the P<0.05 level).
OPPMM
OMMMP
OPMMP
OPMMOMMPP
OMMPM
OMMP
Canonical variate 2
0
-3
-3
-1
1
3
3
21
-2
2
0
-1-2
Canonical variate 1
Month 0
OPPMMOMMMP
OPMMP
OPMM
OMMPP
OMMPM
OMMP
Canonical variate 2
-1
3
-2
0
2
21
-3
0
1
3
-1-2-3
Canonical variate 1
Month 1
OPPMM
OMMMP
OPMMP
OPMM
OMMPP
OMMPM
OMMP
2
-4
0
Month 2
-2
Canonical variate 1
-4 -2 20
Canonical variate 2
OPPMM
OMMMP
OPMMP OPMM
OMMPP
OMMPM
OMMP
Month 3
3
Canonical variate 1
2
1
0
-1
-2
-3
-4
-4 -3 -2 -1 0 1 2 3
Canonical variate 2
OPPMM
OMMMP
OPMMP
OMMPP
OMMPM
-2
-4
1
2
2
4
3
4
-4
1
0
Month 4
-2 -1-3
-1
3
0
-3
Canonical variate 1
Canonical variate 2
Canonical scores of 1st and 2nd variate transformed
from Greene’s dened 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 signicant
difference at the P<0.05 level).
OPPM
OPMM
OMMP
-2
-3
1
2
2
3
1
0
-3
3
-1
0-1-2
Canonical variate 2
Canonical variate 1
Month 0
-4
-5
-1
0
0
2
1
2
3
-1
-2
3
-5
1
-3
-2-3-4
OPPM
OPMM
OMMP
Canonical variate 2
Canonical variate 1
Month 1
-4
-6
2
2
0
-6
-2
0-2-4
OPPM
OPMM
OMMP
Canonical variate 2
Canonical variate 1
Month 2
-2
-3
1
2
2
3
1
0
-3
3
-1
0-1-2
OPPM
OPMM
OMMP
Canonical variate 2
Canonical variate 1
Month 3
-2
-4
2
3
3
4
-3
-1
1
1 2 40
-4
0
-1-2-3
OPPMM
OMMMP
OPMMP
OMMPP
OMMPM
Canonical variate 2
Canonical variate 1
Month 4
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 387
Maca-GO and thyroid function
Accord ing to Lucille (15), on the basis of his clinical
exper ience, the balance between progesterone, estra-
diol a nd thyroid fu nction is one of the key factors i n
the female, responsible for maintaining hormonal bal-
ance du ring the reproductive years and at menopause.
It is a key fu nction of progesterone to control estra-
diol and prevent the negative ef fects of its dominance
during the pre-menopausal years as well as to support
thy roid f unction i n mai nt aining growth, healthy bone
metabolism and to mai nt ain psychological equilibrium
in females during and after their reproductive stage
of life. Such a relat ionship has been confi rmed in t his
study, since Maca-GO treatment resulted in lowering
T3 and elevation of E2, with positive effect on bone
density markers and alleviation of psychological type
menopausal sy mptoms in postmenopausal women
enrolled in the study.
There was a signicant response of early-postmeno-
pausal women in hormonal proles and menopausal
symptoms after one month Placebo treatment, introduced
immediately after the admission to the Trial. This effect
was eliminated or substantially reduced after the second
month of Placebo treatment, which indicates an existence
of a distinctive Placebo effect, which should be taken into
account in observation of results from treatments on post-
menopausal women. This observation is consistent with
previous reports (1) on use of the Maca-GO where there
was a strong indication of the existence of Placebo effect
linked to emotional response of participant, in expecta-
tion of a positive effect of “the treatment” to which they
were exposed.
This study also conrmed the existence of a residual
effect of Maca-GO, clearly visible in the series of measure-
ments recorded and summarized in Figure 3. Analytically
determined results have full support in trends recorded
as subjective responses of women to GMS and KMI
determined at the time of blood sampling for analyses of
hormones and other blood constituents. The majority of
women, who after Placebo run-in period received Maca-
GO capsules, recorded highly signicant (P<0.001) reduc-
tion in feeling of menopausal discomfort as expressed by
the total point scores of the GMS and KMI (Table 6). On
the other hand women who changed from Maca-GO to
Placebo treatment observed gradual, but not signicant
(P>0.05) increase in feeling of menopausal discomfort,
with severity of symptoms increasing with the duration of
the Placebo treatment.
egaP 1.
80 90 100 110 120 130 140
E2
APPMM
AMMPP
MacaGO effect re lative to Placebo
434
P<0.05
80 85 90 95 100 105
LH
APPMM
AMMPP
MacaGO e ffect relative to Placebo
P<0.05
92 94 96 98 100 102 104
T3
APPMM
AMMPP
MacaGO effect re lative to Placebo
P<0.05
80 85 90 95 100 105
Cortisol
APPMM
AMMPP
MacaGO effect rela tive to Placebo
P<0.05
70 75 80 85 90 95 100 105
ACTH
APPMM
AMMPP
MacaGO effect rela tive to Placebo
P<0.05
H O R M O N E S L I P I D S
SEXUAL Thyroid +Adrenal&Pituitary + IRON & BMI
88 91 94 97 100 103 106
FSH
APPMM
AMMPP
MacaGO effect rela tive to Placebo
90 92 94 96 98 100 102
Progesterone
APPMM
AMMPP
MacaGO e ffect relative to Placebo
80 85 90 95 100 105
TSH
APPMM
AMMPP
MacaGO effe ct relative to Placebo
94 96 98 100 102 104
T4
APPMM
AMMPP
MacaGO effect rela tive to Placebo
AMMPP
TSH
APPMM
AMMPP *
T3
APPMM
AMMPP
T4
APPMM
AMMPP
Cortisol
APPMM *
AMMPP
ACTH
APPMM *
AMMPP
CHOL
APPMM
AMMPP
Tri-Glyc
APPMM
AMMPP
HDL
APPMM *
AMMPP
LDL
APPMM
AMMPP **
Fe
APPMM
AMMPP
BMI
APPMM *
AMMPP
FSH
APPMM
AMMPP
E2
APPMM *
AMMPP
PRG
APPMM
AMMPP
LH
APPMM *
95 100 105 110 115 120 125 130
Fe
APPMM
AMMPP
MacaGO effect relative to Placeb o
P<0.01
98.0 98.5 99.0 99.5 100.0 100 .5 101.0
BMI
APPMM
AMMPP
MacaGO effect relative to Placebo
P<0.05
95 96 97 98 99 100 101
MacaGO effect relative to Placebo
APMM
AMMP
Cholesterol
75 80 85 90 95 100 105
MacaGO effect relative to Pla cebo
APMM
AMMP
Tri-Glicerides
97 100 103 106 109 112
MacaGO effect relative to Pla cebo
APMM
AMMP
P<0.05
HDL
92 94 96 98 100 1 02
MacaGO effect relative to Placebo
APMM
AMMP
LDL
Comparison of Placebo-
corrected values for hormones: FSHFSH
(IU/ml), E2 (pg/ml), PRG (ng/ml) and
LH (mU/ml), TSH (�IU/ml), T3 ( pg/TSH (�IU/ml), T3 (pg/
ml), T4 (pg/ml), Cortisol (�g/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.
Asterisks indicate existing signicant
difference: *, signicance at P<0.05
level; **, signicance at P<0.01 level.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
388
It was also apparent from results in this study that
the length of Maca-GO treatment had an effect on most
of the measurements taken, as based on comparison of
results recorded after one or two month of Maca-GO
application, with two months of application magnifying
the therapeutic effects which are observed after the rst
month of Maca-GO use. Similar trends were observed in
GMS and KMI total values (Table 6), as well as in the
example of individual menopausal symptoms summa-
rized in Table 7, clearly demonstrating, that one month of
Maca-GO treatment was not sufciently long to exhibit
full therapeutic effects on individual menopausal symp-
toms experienced by early-postmenopausal women. The
above results are consistent with observations reported
in the previous part of this study (1), in a pilot study on
early-postmenopausal women (6) and in bio-assays on
adult female and male rats (4).
Depending on circumstances, which are almost always
dependent on the dosage involved, Maca may exhibit a
“stimulating” or a “balancing” effect on the organism.
Based on clinical experience, reported by Muller (14), most
women with menopausal symptoms, need a minimum of
three to four 500mg capsules with Maca powder daily,
therefore in this study, four 500mg capsules were used as
arbitrarily-chosen daily dose 2g per each participant. It is
however important to note, that the very sensitive meno-
pausal woman may need only two 500mg capsules per day
(14). Dosage can be increased on a weekly basis and, if
this amount is not sufcient, until the optimum (minimum
effective) dosage is found. Taken at the correct dosage,
which differs for each woman, Maca-GO may be able to
reduce or completely eliminate hot ashes in women, in
as little as 4 days to a week (14). It is also important to
mention that, if the dosage is too high - and some women
are very sensitive - the Maca will have a stimulating and
not balancing effect, and will actually increase the num-
ber of hot ashes. If this happens, Maca-GO users can cut
the dosage in half for a week, and then re-evaluate. If the
problem persists, cutting the dosage in half again may help
to identify the optimal daily dose (14).
It is therefore recommended for women using Maca-
GO on their own, without a health practitioner’s supervi-
sion, to start with a small dose of the product and gradu-
ally increase its intake, as needed. However, in order to
nd precisely, the optimal dose of Maca-GO, which is suf-
cient and most appropriate to the particular physiologi-
cal status of the woman, it is advisable to consult a health
practitioner. He can order laboratory tests to establish base
line hormone levels before starting the Maca-GO therapy,
with a follow up, second series of hormone tests some two
months later, after the initial daily dose of Maca-GO has
been introduced, so as to establish the dose most appro-
priate to individually-adjusted physiological optimum for
assisting in alleviation of menopausal symptoms.
Observations made in this and the previous study on
Maca-GO (2, 4) as well as results reported elsewhere (14),
shows that potential “stimulating” or “balancing” action
of Maca as an adaptogen, is dependent on the level and
the length of Maca intake resulting in a display of dif-
ferent therapeutic end-effects. Therefore, in the further
study, it will be essential to establish a range of quantita-
tive administrations of Maca-GO which would act within
acceptable degrees of certainty, either as a stimulating or
balancing dietary supplement, custom-designed for well-
dened groups of subjects in their specic physiological
state (gender, age, weight etc.) and again, for specic end-
result in terms of the purpose and expected functionality.
The positive effect of Maca-GO on Iron level in blood
of early-postmenopausal women as observed in this study,
is in accord with results obtained in a laboratory models
on rats (3, 4,) and reported in the literature (16), indicating
that Maca-GO may play an important role in stimulation of
absorption of dietary Iron from the digestive tract and pos-
sibly other minerals present in the diet. Although Maca-
GO has not visibly affected levels of serum Calcium and
Phosphorus in this study, the observed positive effect of
Maca-GO treatment on bone density measures may indi-
cate that Maca-GO may stimulate absorption of minerals
from the digestive tract and their retention in the body by
their deposition in bones, hence, their low levels in the cir-
culating blood. It appears that Maca-GO may have differ-
ent effects on the metabolic pathways relating to digestion
and absorption of Calcium and Phosphorus from the effect
observed in Iron, which was retained in blood circulation,
assuming its priority of use in hemoglobin synthesis and
red blood cells’ regeneration and formation.
Maca-GO and its effect on mineral metabolism and
bone density
An important observation was made that after only
four months of Maca-GO treatment, a distinctive increase
in bone density (T-Score) was recorded (Figure 4), which
conrmed earlier observations made in laboratory mod-
els, in which bones and muscles of test animals showed
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 389
noticeable increase in Calcium and Phosphorus content
(4). It may suggest that Maca-GO has a positive inuence
on absorption from the digestive tract of those two dietary
minerals responsible for calcication of bones (and pos-
sibly other minerals not analyzed in this study), since the
quantity of daily Calcium and Phosphorus intake present
in the total 2g Maca-GO in four capsules was only 6mg –
7mg, compared to approximately 1,000mg daily Calcium
supplementation needed to prevent bone density loss and
retard the progress of osteoporosis in postmenopausal
women (17). Increased bone density observed in this study
in women receiving Maca GO treatment, supports an
assumption that Maca-GO may stimulate absorption and/
or re-absorption of Calcium and other key minerals from
the diet, thus providing metabolic support in preventing
loss of bone mass in postmenopausal women.
This loss of bone mass in turn, may lead to progres-
sion of, or development of osteoporosis and all the symp-
toms associated with it, including an increased excretion
of Calcium in the urine which occurs with high intake of
protein and sugars. Such impairment in bone calcication
has been observed with high consumption of soft drinks,
which is a common cultural- and socio-economic-related
issue in the United States and other industrially-devel-
oped countries where osteoporosis and reduced calcium
level in adults and children is becoming a major medical
problem (18).
Irrespective of the dietary supplement(s) used, in
order to prevent or reduce loss of bone density by post-
menopausal women, an adoption of the following dietary
measures can help to achieve this goal: eating a medium
protein, low sugar, low sodium and ber-rich diet, reduc-
ing intake of high phosphate-containing soft drinks,
including Coca-Cola and Pepsi (18), introducing low or
medium intensity exercise into daily routine (aerobic,
weight-building, Pilates) and having sufcient Omega 3
fats (including ground ax seeds or oil and fatty sh in
the diet).
The effect of Maca-GO on individual menopausal
symptoms
It appears that in comparison to Placebo, women par-
ticipating in this study responded to two months Maca-
GO treatment by signicantly increasing E2 level which
was associated with alleviation of a number of individual
menopausal symptoms, most distinctive being a reduction
in frequency and severity of hot ushes, excessive sweat-
ing, interrupted sleep pattern, nervousness depression,
headaches and loss of libido - interest in sex life (Table
7). Studies reported by other authors (19) also indicate
that Maca can be helpful in reducing discomfort caused
by menopausal symptoms. Calculated combined effect of
Maca-GO on alleviation of individual menopausal symp-
toms in early-postmenopausal women expressed in the
format of canonical variate equations depicted in Figure 1
for 11 symptoms according to KMI and for 21 symptoms
according to GMS - Figure 2, conrm that irrespective of
the test used, both frequency and severity of symptoms
were signicantly reduced. Extending the length of Maca-
GO treatment from one to two months reduced this effect
further. This was demonstrated by increased separation
between clusters of values for menopausal symptoms
recorded with the progress of the study and an extension
of Maca-GO use from one to two months period.
Both menopausal tests demonstrated that Maca-GO
may also be considered as a non-hormonal energizing
supplement with signicant sedative, calming and anti-
depressive effects, helping to improve concentration and
alertness, these facts conrming results obtained in ear-
lier pilot study (2) and demonstrated in laboratory models
using bioassays on ovariectomised rats (3).
-0.8
-0.6
-0.4
-0.2
0.0
0.2
0.4
1 2
Bone Tot al Densit y (T s core)
(±0.2) (±0.3) (±0.4) (±0.3) (±SE)
0
20
40
60
80
100
21
FSH(m IU/ml)
A-P - P- P- P A- M- M - M- M
0
5
10
15
20
25
30
35
21
E2 (pg/ml)
A-P - P- P- P A- M- M - M- M
At Admission After 4 months At Admission After 4 months
At Admission After 4 months
Measurement Point
A
MMMM
A
PPPP
Total Bone Densit
y
(“T-Score”)
Forearm bone density results expressed as Total
Bone Density Score (“T-Score”) and corresponding hor mone
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).
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
390
activity test values. This led to the conclusion that the anti-
depressive action of Maca-GO is based on different modes
of action in non- and ovariectomised rats as compared to
the antidepressive effect of Fluoxetin, which can be trans-
lated to the expected different responses of pre- and post-
menopausal women to Maca-GO. The above results from
a model laboratory test (24) in conjunction with the results
recorded in this study on postmenopausal women, suggest
that active phyto-components present in Maca-GO act in
a specic way to trigger release of body’s own steroids
or by affecting the hypothalamus-pituitary-ovarian axis
in women which results in triggering similar, but other
than serotoninergic response mechanisms as induced by
Fluoxetine, which, in turn results in its anti-depressive
action demonstrated on rats (24). These anti-depressive
and stress-reducing actions of Maca-GO would need fur-
ther, more detailed study.
Comparing the degree of statistical signicance in inu-
ences of Maca-GO on KMI and GMI in terms of detected
reduction in frequency and severity of menopausal symp-
toms, it appears that KMI is more sensitive in displaying
the effect of both Placebo and Maca-GO treatments on the
recorded scores of menopausal tests as compared to GMS
(Table 6), the fact observed also in a previous part of the
study on postmenopausal women (1).
The model laboratory study with the use of Maca-
GO in rats (4) resulted in a signicant increase in blood
glucose level, which may explain the energizing effect of
Maca-GO on early-postmenopausal women as observed
in this study. This observation may also indicate that
Maca-GO may nd its use as an energizing dietary
supplement for sports people and those whose lifestyle
requires energy reserves for intensive physical-related
activity (12, 25, 26).
Maca-GO and its adaptogen-like function
The most distinctive effect of Maca-GO, which doesn’t
contain any phyto-hormones, was an increase in E2 at
slight PRG elevation, parallel to a reduction in FSH con-
centration in early-postmenopausal women. This pecu-
liar hormone balancing function displayed by Maca-GO
prepared from powdered hypocotyls of Lepidium peru-
vianum Chacon and applied in its natural entire cohesive
form to early-postmenopausal women, strongly supports
the conclusion that it closely resembles functions attrib-
Signicant reduction in symptoms of depression (KMI;
K-5) after two months of treatment with 2g daily dose of
Maca-GO was parallel with signicant reduction in CT
and ACTH in the AMMPP sequence group only, while in
APPMM group, reduction in symptom of depression was
apparent without reduction in CT and ACTH levels. In the
previous study on laboratory animals (4), at both high and
low levels of intake, Maca-GO signicantly lowered CT,
while ACTH was distinctively, although not signicantly,
increased at low dose and distinctively lowered at the
high Maca-GO dose. This observation indicated that anti-
depressive effect of Maca-GO treatment was a dose-related
response during short-term administration. However, dur-
ing an extended use of Maca-GO (90 days), both CT and
ACTH were substantially lowered, which could be an indi-
cation of the positive effect of longer-term use of Maca-GO
in reducing symptoms of depression frequently affecting
menopausal women. Results obtained in the present study
with Maca-GO reducing depressive symptoms, conrmed
reports in the literature (21, 22) of the close association
existing between depressive symptoms and elevated CT
and ACTH levels. The same relationship as reported in
the literature (21) was also observed in the earlier part of
this paper on ovariectomised rats (3), which after 28 days
Maca-GO administration showed antidepressive (Porsolt
test) and sedative effect (locomotor activity test), associ-
ated with signicant reduction in both CT and ACTH, -
the relationship conrmed by results reported in this paper
on postmenopausal women.
Responses of participants in alleviation of stress attrib-
uted to Maca-GO treatment, conrmed results of the pre-
viously conducted laboratory trials on rats (3, 4), where
Maca-GO reduced blood CT, indicating possible positive
effect of treatment on lowering susceptibility of rats to
stress factors and sedative effect on laboratory animals -
the existence of such relationship reported by Lopez Fondo
et al. (23). The study conducted on the same samples of
Maca-GO as used in this paper using laboratory model on
rats (24), when tested against Fluoxetine, a known anti-
depressant agent, conrmed the assumption that Maca-
GO possesses typical antidepressant–like characteristics.
After Maca-GO administration to ovariectomised rats,
both blood CT and ACTH as well as spontaneous activ-
ity and immobility time (Porsolt test) were signicantly
(P<0.05) reduced, while Fluoxetine induced an anti-
depressive effect in control, non-ovariectomised animals
only, without affecting ovariectomised rats. Fluoxetine
increased the blood CT in non-ovariectomised rats only,
without signicantly affecting ACTH and spontaneous
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 391
uted to an adaptogen. The full meaning of this currently
adopted term is as follows: (i) It must cause only mini-
mal disorders in the body’s physiological functions; (ii) It
must increase the body’s resistance to adverse inuences
not by a specic action but by a wide range of physical,
chemical, and biochemical factors; and (iii) It must have
an overall normalizing effect, improving all kinds of con-
ditions and aggravating none. Maca-GO conforms and is
characterized by all three characteristics, which consti-
tute the complex description of what is expected from an
adaptogen in classication terms as has been accepted in
relation to Panax ginseng (27). There may be several vari-
ations of those three characteristics but all have similar
meaning in physiological and biochemical interpretation
terms. In earlier years, terms “general tonic” (increasing
the overall tone of the whole body) – or more specically
“adrenal tonic” (increasing the tone and function of the
adrenal glands) were used but have been replaced by the
modern term “adaptogen”, as more precisely-dened by
the three characteristics as given above. There is a con-
sensus of opinion that Maca exhibits strong biologic action
characteristic to plant adaptogens, the opinion expressed
by Muller (14), supporting observations based on results
presented in this study.
Results obtained in this study, give reason to conclude
that Maca-GO acted as a toner of hormonal processes
along the axis Hypothalamus-Pituitary-Ovaries, signi-
cantly stimulating production of E2 without signicant
affect on PRG, with a simultaneous suppression of blood
FSH, LH, T3, Cortisol and ACTH levels, together with
an increase in blood Fe and bone density index, as well
as alleviation of menopausal symptoms as per KMI and
GMS and a decrease in BMI recorded after two months of
Maca-GO treatment. It appears that Maca-GO, by exhib-
iting functions and properties characterizing adaptogens,
offers an attractive addition to the choices available as
non-hormonal plant alternative to HRT for balancing lev-
els of gonadal, pituitary, thyroid and adrenal hormones
and relieving symptoms of menopausal discomfort with
hot ushes and night sweating in particular, thus provid-
ing early-postmenopausal women with an option to reduce
dependence on HRT programs.
Maca-GO as a non-hormonal plant preparation – pos-
sible mode of therapeutic action
From research conducted so far on composition of
Maca hypocotyls and various powdered root preparations,
it appears that it does not contain any analytically-deter-
mined plant estrogens, or hormones (28, 29, 30, 31). It has
been initially suggested (12), that action of Maca relies on
plant sterols, acting as chemicals which trigger chain of
biochemical reactions helping the body itself to produce or
modulate production of hormones and other compounds,
appropriate to the age and gender of the person taking it. In
this respect, sterols in Maca may be used by the body with
the help of the pituitary to improve adrenal and ovarian (or
testicular) functions, and therefore affect the thyroid, the
pancreas, and the pineal gland (which also makes mela-
tonin and which may have some connection to improved
quality of sleep as observed in this study). The above may
be one of the possible explanations why Maca-GO is so
much more effective than phyto-estrogens in regulating
hormonal balance and mobilizing action of the endocrine
glands to work better. The multi-functional effects of Maca
on endocrine relationships may also explain reports in the
literature, of its positive inuence on stimulation of endo-
crine glands in regulating hormonal balances in the body
(12) and particularly in women who have already entered
the postmenopausal stage of life.
Maca exhibits specic, yet not fully understood endo-
crine effects, ranging from being an energizing plant (12),
stimulating reproductive functions (2, 4, 3) and balancing
hormones (5, 6, 2) as well as alleviating physical, physi-
ological and psychological discomfort associated with
menopause in women (5, 13, 14). Since individual active
compound(s) which could be biochemically identied as
the key active Maca root component(s) responsible for spe-
cic therapeutic functionality of Maca root, have not been
yet clearly determined, the authors are referring to Maca-
GO root in its entirety and cohesive complexity consid-
ered as a therapeutic unaltered herb with its historically-
acknowledged and “traditionally-unquestioned” dietary
and medicinal properties (5, 6, 12). It is reasonable to sup-
pose that the complexity and uniqueness of components
present in Maca root such as sterols (campesterol, stig-
masterol and beta-sitosterol), polyunsaturated acids and
their amides, called “macaenes” and “macamides” (32),
aromatic glucosinolates (29, 30, 31, 33) and several alka-
loids and others constituents of Maca – yet to be character-
ized, through their complex synergistic and/or interactive
action, will eventually one day provide an answer to spe-
cic physiological action of standardized Maca prepara-
tions, applied at specic, individually-adjusted doses to be
recommended for prophylactic and/or specic therapeutic
effects for men and women.
According to Dini (28), reported in the literature, the
aphrodisiac powers of Maca for men and women, may be
ascribed to the presence of prostaglandins and sterols in
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
DECEMBER 2006 VOL. 2 NO. 4 I J B S w w w.i jbs .or g
392
the hypocotyls of Maca and overall fertility enhancing
properties may be attributed to the presence of biologi-
cally-active aromatic isothiocyanates derived by hydro-
lysis of the glucosinolates and specically due to benzyl
isothiocyanate and p-methoxybenzyl isothiocyanates (29,
30). In addition, benzyl isothiocyanate present in Maca
root has been reported to be a potent cancer inhibitor of
mammary gland and stomach (31).
Remembering that Maca-GO itself, does not con-
tain any hormones (2, 12, 13, 14, 28), the action of Maca
hypocotyls, traditionally is linked to its coherent and
unique complexity of integral active constituents such
as alkaloids, sterols, glucosinolates, amino acids, fatty
acids, minerals and others yet to be established (8, 29,
30). Selectively extracted groups of components such as
macamides and macaenes (32) may remove synergisti-
cally-essential constituents from Maca roots, eliminating
other biologically-active compounds from Maca, tradi-
tionally used by natives of Peru as a whole root. In such
a form Maca exerts its expected (and observed for cen-
turies), therapeutic action on the body by stimulating the
pituitary to produce and secrete the precursor hormones,
which in tern, elevate estrogen, and testosterone levels,
with simultaneous help in balancing the adrenal glands,
the thyroid and the pancreas. Therefore, it is reasonable
to suppose that Maca-GO may regulate ovarian function
rather than stimulating the ovaries as is the case when
other phytoestrogenic preparations, such as black cohosh,
soy, red clover and others are used.
metabolism
Observed in this study, the signicant increase (P<0.05)
in LDL concurrent with a stable level of HDL after two
months Maca-GO application in relation to Placebo, was
inconsistent with previously obtained results (1) show-
ing Maca-GO signicantly increasing HDL only, without
affecting LDL, CHOL, TRGL. While, the previous results
(1) showed a distinctive reduction in LDL/HDL ratio (from
2.7 to 2.3) after Maca-GO treatment, then, similar ratio
in this Trial was minimally increased (from 2.2 to 2.4),
but maintained at the levels similar in magnitude to the
one observed after Maca-GO application in the previous
part of the study (1). Lack of consistency in HDL and LDL
results obtained in this and the previous study (1) on early-
postmenopausal women, together with data in the previous
laboratory study on adult (4) and ovariectomised rats (3),
may suggest that the reports in the literature of hypo-lipid-
emic effect of Maca (33) may be dependent on a number of
factors such as genetics, dietary habits, lifestyle, exercise,
physiological constitution, ethnic predispositions (34),
anti-oxidative properties (35) and environmental circum-
stances, etc. This aspect of lipid metabolism in relation
to Maca-GO needs further consideration in view of the
observation in this study of signicant decrease in BMI
after two months Maca-GO treatment, which may indicate
its positive effect on reducing weight at the expense of fat
tissues – a very desirable outcome of treatment for women
in their pre- and postmenopausal stage, and specically
for those women opting for non-hormonal approach – as
an alternative to HRT at early stages of their hormonal
transition time.
Closing remarks
Only one level of Maca-GO (2g/day) was used in this
clinical study, without information recorded on the dietary
habits of participants, level of physical exercise, socio-eco-
nomic and environmental considerations etc., which may
appear, from the data reported in this and previous part
(1) of the study, to be important factors in personalizing
wellbeing of women during and shortly after menopausal
transition. The complex mode of action of Maca is still far
from fully understood. Therefore, in view of the demon-
strated multi-factorial metabolic action of Lepidium peru-
vianum Chacon as an important cultivated therapeutic
Andean plant used as dietary supplement (36, 37), it would
be of further practical and academic interest to investi-
gate gender-related Maca-GO issues in relation to dos-
age levels, therapeutic effect, availability of key dietary
and active compounds inuencing menopausal women,
dietary habits, body mass, exercise, geographical location,
socio-economic status, including habitual and environ-
mental considerations and other.
Results of the present study and previously reported
work (2, 3, 4, 7), demonstrate that Maca-GO exhibits all
the characteristics of a non-hormonal therapeutic prepara-
tion with functions ascribed to an adaptogen. This indi-
cates that through balancing effects on the body, Maca-GO
helps to produce its own optimal hormonal equilibrium,
thus, providing a natural alternative in preventing and/or
helping to treat hormonal dysfunctions or imbalances in
early-postmenopausal women. This hormone-balancing
function of Maca-GO appears to be a much more appropri-
ate proposition, as an alternative to the generally-practiced
routine of supplying women with synthetic, semi-syn-
thetic or “bio-identical hormones” from outside sources
or phyto-estrogenic preparations, as is the case in various
hormone therapy and HRT programs.
maca In PostmenoPausal Women: (III) clInIcal study - crossover desIgn
www.ij bs. or g I J B S VOL . 2 NO. 4 DECEMBER 2006 393
Maca-GO applied in parallel with Placebo during four
months cross-over Trial, signicantly increased E2, LDL
and Iron (P<0.05), reduced FSH, T3, Cortisol, ACTH,
LH, BMI (P<0.05) and noticeably improved bone density
markers.
Maca-GO treatment signicantly (P<0.001) lowered
total KMI and GMS, relieving symptoms responsible for
negative physiological and psychological manifestations,
frequency and severity of ushes and night sweating – in
particular, which are recognized under commonly-used
term of “menopausal discomfort”.
In addition to hot ashes and profuse sweating, Maca-
GO treatment signicantly (P<0.01) alleviated such
menopausal symptoms as, nervousness, mood swings,
interrupted sleep pattern, fatigue, stress, headaches
depression, and decreased libido observed in early-post-
menopausal women.
Computed canonical variate equations for 11 or 21
symptoms according to KMI and GMS respectively, con-
rmed signicant progressive reduction in both frequency
and severity of symptoms with the length of Maca-GO
treatment from one to two months.
After two month treatment, the 1st and the 2n d canoni-
cal vector loadings for 11 KMI symptoms showed signi-
cant (P<0.01) energizing effect of Maca-GO in early-post-
menopausal women, with a signicant improvement in
concentration accompanied by an antidepressant-like and
sedative inuence.
For Maca-GO to exhibit its signicant hormone-bal-
ancing and therapeutic effect, it was essential to use it con-
tinuously during two consecutive months.
After Maca-GO treatment was replaced for one month
by Placebo, there was a reduced degree of Placebo effect on
women as compared to Placebo introduced prior to Maca-
GO treatment which indicates an existence of “residual
effect” of the treatment.
Observed in this study were multi-functional actions
and multi-directional effects of non-hormonal Maca-GO
administration on endocrine relationships, which may
explain its positive inuence on endocrine glands to regu-
late the hormonal balance in women, who have just entered
menopause.
This study was conducted and jointly supported by a
long-term joint R&D program of the Research Institute of
Medicinal Plants (RIMP) in Poznan, Poland and School
of Health Study, Charles Sturt University & Therapeutic
Research International, Sydney, Australia on medici-
nal plants and therapeutic preparations originating in
Australasia, Oceania and South America. Thanks are
due to Ms. Dorota R. Meissner of Therapeutic Research
International, for assistance in collecting results from clin-
ics and diagnostic laboratories in Poland including help in
data compilation and formatting for computation and pro-
cessing, and Ms. Jan Roberts for assistance in editing of
the nal draft. A supply of a standardized Maca-GO pow-
der by NatureCorp Pty Ltd, Australia for encapsulation in
RIMP, is gratefully acknowledged.
Reference to a company and/or product named in this
paper is only for purpose of information and does not
imply approval or recommendation of the product to the
exclusion of others which may also be suitable. Some
results from Part III in a preliminary form were presented
at the 7th Congress of European Association of Clinical
Pharmacology and Toxicology in Poznan (Poland), 25-29
June 2005.
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