| Original Article |
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Short title - page header: Maca in Postmenopausal Women
The mailing address of principal 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
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ABSTRACT |
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INTRODUCTION |
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MATERIALS AND METHODS |
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RESULTS |
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DISCUSSIONS |
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CONCLUSION |
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ACKNOWLEGEDMENTS |
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DECLAIMER |
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REFERENCES |
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ABSTRACT
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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 (<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.
KEY WORDS
Maca (Lepidium peruvianum) - post menopause - hormones - plant alternative to
HRT
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INTRODUCTION
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Maca (Lepidium peruvianum Chacon) is an annual cruciferous root vegetable
(same botanical Brassicaceae family as the turnip and broccoli) which grows at
4.000-4,500 m above sea level in the high Andean plateaus of Peru.
Traditionally, Maca has been used by native Peruvians as both a food and
medicine. People living in the Andes mountains used Maca, since before the time
of the Incas for energy,hormone balancing, healthy thyroid functioning, sexual
functioning, PMS, menopause, help to maintain healthy bones, tonic for elderly
and convalescence. Properties of Maca as food and dietary supplement have been
previously reported by Lutomski (1) and therapeutic and
medicinal properties were summarized in publication by Chacon (2),
Zurowska (3) and number of other technical publications
originated mainly in the USA and Peru (4, 5,6,
7,8, 9, 10, and
11). Traditional use of Maca root, for nutritional and
putative medicinal purposes, mainly for its adaptogenic and fertility enhancing
properties in humans and animals have been in recent years experimentally proven
(7, 8 and 9).
In July 2002 reports were issued by the National Institutes of Health (NIH) in
the USA, indicating that the use of combination drugs in hormone replacement
therapy (HRT) in healthy menopausal women, increases the risk of invasive breast
cancer, heart disease, stroke, and blood clots, outweighing the drugs' possible
health benefits.NIH stopped a large-scale clinical trial on the Prempro
(conjugated horse estrogen, made from horse urine) and a synthetic form of
progesterone called progestin. Because of the excessive danger to women posed by
this drug, NIH recommended the 16,000 participants stop taking the
estrogen/progestin drugs immediately. Therefore, the search for safer
alternatives to HRT intensified worldwide and in the USA in particular, where
estimated six million women, in the past, have selected an option to help
relieve menopausal symptoms using HRT.
One of the alternatives to HRT ｨC Maca which contains no plant hormones (unlike
soy/genistein and black cohosh), has been presented at the Anti-Aging Medical
Conference in 1997 (5). Since then, it has been seen a dramatic
increase in the use of this medicinal herb by doctors practicing CAM
(Complementary/Alternative Medicine) in the USA (5). For years,
Maca has been used successfully by native people of Peru for hormonal
imbalances, menstrual irregularities, fertility, and menopausal symptoms,
including hot flashes, vaginal dryness, and loss of energy, libido and
depression (6). There were indications (12)
that Maca can be helpful in reducing discomfort caused by menopausal symptoms
and limited case studies on laboratory animals have shown that Maca can be
effective for premenstrual syndrome (PMS) as well (13). Results
of studies conducted so far, may suggest that action of Maca relies on plant
sterols, which act as chemical triggers to help the body itself produce a higher
level of hormones appropriate to the age and gender of person taking it(13).
There are a growing number of health care practitioners in the USA who have
integrated various herbal therapies into their medical practice and are aware
about Maca functional properties as an available alternative to prescription
drugs for effective relief of menopausal symptoms (4). In this
respect, women may be advised to work with practitioners who can order tests to
establish base line hormone levels before starting the Maca therapy, and follow
up two months later with a second series of hormone tests to find out if the
dose the patient is taking is sufficient and most appropriate to the particular
physiological status.However, due to private nature of treatment involved in
clinical practice, relevant data have not been freely available in research
literature so far.
Therefore, in this pilot study, an attempt has been made to observe a short- and
along-term effect of Maca on changes in levels of four sex hormones and in
alleviating symptoms of menopausal discomfort on two selected groups of
early-postmenopausal women (EPMW) volunteers.
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MATERIALS
AND METHODS |
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Aim:The aim of this double blind, placebo-controlled study was to
determine the effect of the two (2) and eight (8) months of oral administration
of capsules containing pre-gelatinized dried and pulverized hypocotyls of Maca (Lepidium
peruvianum Chacon). In this and subsequent papers in this series, the name
Lepidium peruvianum Chacon is used as representing the only-known and
traditionally-cultivated Maca plant, with its origin linked to Junin plateau in
highlands of central Peruvian Andes, from where Dr Gloria Chacon sourced Maca
roots for her pioneering work published back in 1961 (2). Her
interest and research on this indigenous plant, resulted in its propagation by
Peruvian farmers, initially for local market and subsequently extended into
larger Maca plantations, which led to commercialization of this plant for
international distribution as Peruvian root vegetable with traditionally- and by
now, scientifically-acknowledged therapeutic properties. Currently, Maca has
been placed on the list of indigenous plants under Peruvian government
protection as the Peruvian natural treasure, the fact already acknowledged
internationally by the FAO and its traditional status as dietary supplement
being reflected in the relevant UE regulation. All the internationally published
research on Maca, which followed work of Chacon (2), was
conducted on the cultivated Peruvian Maca. However, due to earlier
deposition of a specimen labeled Maca, being apparently a wild-growing plant
collected in Bolivian Andes, where locally it is known under the common name
Maca and given botanical name Lepidium meyenii Walpers, many research
papers erroneously used scientific name Lepidium meyenii as a
representation of material - roots originating from cultivated Maca.
Therefore,instead of referring to Maca as L. peruvianum or synonym L.
meyenii, as in many articles Maca is scientifically referred to, after
inspecting depositions of both plants in Herbarium in Lima, followed by
collection and deposition of both specimens in Herbariums of Medicinal plants in
Australia and Poland, it has been resolved to adopt in our work the proper term
for cultivated Maca as Lepidium peruvianum Chacon, being the only plant
with historically valid reference and traditionally established grounds to be
referred to in scientific work as Peruvian Maca, representing dietary,
therapeutic and medicinal characteristics duly referenced in research literature
and reflecting experimental work conducted on this plant to date. The plant
species is described in details in monographs by Obregon (10)
and Chacon (13), as well as in the catalogue of the flowering
plants and gymnosperms of Peru (12).
Maca:Maca roots, harvested and dried on the plantation site in Junin area
(Central Andean Region of Peru between 4200 and 4500 m altitude) with an
attestation of organic status, were transported to a processing plant at the
National Institute of Agricultural Research, National Agricultural University La
Molina in Lima (Peru), where it was subjected to a gelatinization process. After
cleaning (washing under pressure) and cutting into pieces, dried hypocotyls of
Maca were re-hydrated prior to being exposed to short-term elevated pressure
under moist conditions (a proprietary extrusion process), followed by drying and
pulverizing. Such treatment of Maca, without any chemicals used in the process,
resulted in the final powdered product (Maca-GO) achieving increased density,
hence higher product weight load in a capsule and through pre-gelatinization of
a starch component in the product (not less than 98% according to BRI Laboratory
assay), expected to promote its easier digestion. Composition of the
pre-gelatinized Maca-GO powder as received directly from the manufacturer in
Lima, Peru and verified by the Analytical Laboratory of the Research Institute
of Medicinal Plants in Poznan is given in Table 1.
| View this table: |
Table 1. Composition of Pre-Gelatinized Maca-GO (Lepidium peruvianum Chacon) |
Subjects: Twenty early postmenopausal Caucasian women volunteers (Trial
I) and eight (Trial II) aged between 45-62 years were selected to this pilot
study. They represented healthy EPMW who had experienced their last menstruation
not less than 2 months and not more than 12 months prior to the start of the
Trial. Prior to the study they were not used any hormonal treatment and were not
taking any medications during the study period. A signed informed consent was
obtained from all subjects regarding their voluntary participation in the trial
conducted under specialist Gynecologist's supervision in a Private Clinic in
Poznan (Poland). All enrolled subjects were informed of the purpose, benefit and
possible risks of the study.
Experimental protocol:Hard gel capsules (size "0") both placebo and
Maca-GO (500mg net per capsule), used in this study were custom-made at the
Institute of Medicinal Plants in Poznan.During the 1st month period (Placebo
phase), all EPMW received 4 x 500mg capsules daily of placebo (2,000 mg sorbitol
& cellulose daily), followed by the identical dosage of capsules containing
Maca-GO (Maca-GO phase). Although Chacon (2 and 13)
recommends approximately 5g of Maca powder daily when used as a source of
functional food supplementing daily diet, the choice of 2g/day dose of Maca-GO
adopted in this study was based on clinical and practical experience reported by
Muller (5 and 6), who recommended for women in
the USA, to administer 2g of Maca powder per day for alleviation of menopausal
discomfort. Capsules were self-administered according to the following schedule:
2 capsules some 30 minutes before the morning and 2 capsules before the evening
meal for the period of either one month Placebo followed by two months (Trial I)
or eight months (Trial II) of Maca-GO.With the start and at the end of each
phase of the trial, all women were interviewed by the gynecologist and requested
to answer a set of standard questions according to Greene's questionnaire. This
in order to determine a Menopausal Index at the time when blood was taken for
hormone analyses (FSH, LH, E2 and PG).
The study was carried out by specialist Gynecologist and researchers of the
Research Institute of Medicinal Plants in Poznan under international supervision
between May 2002 and March 2003.
Assays: Serum LH, FSH, E2 and PG were measured before the Trial (Sampling
A), after 1 month placebo treatment (Sampling B) and then, two months (Trial I)
or two and eight months (Trial II) after administration of Maca. Hormone assays
were conducted by a Clinical Diagnostic Laboratory LABO-MED in Poznan using
officially accepted standard chemiluminescence procedure on Immulite ｨC DPC
equipment. Precision of this technique is monitored by National Center of
Quality of Diagnostic Medical Laboratories in Poland and the Laboratory is a
participant of the International Quality Control RIQAS maintained by Randox
Company.
Statistical analysis:Data were expressed as mean (±SEM) where
applicable. Statistical analysis was performed by the Student｡ｯs t-test with the
difference considered significant at P<0.05.
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RESULTS
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| View this table: |
Table 2.Hormone levels in postmenopausal women (n=13) at start of the trial, after one month use of placebo and after two months of Maca-GO treatment (2,000mg/day) by 12 EPMW. |
In personal interviews conducted by a gynecologist during the Trial I, as many as 42% participating women have reported reduction in feeling of menopausal discomfort already after one month administration of Placebo capsules. According to subjective assessment by participants, after two months of Maca-Go treatment, majority of women (9 of 12 which concluded the three month trial) observed noticeable reduction in feeling discomfort, typical to menopause, which they experienced at the start of the Trial. However, according to responses given by participants in Greene's questionnaire (Table 3), after one month of Placebo application, they already reported improvement in such characteristics as: reduced nervousness, less difficulties in falling asleep, better concentration improved ability to concentrate, feeling of being more energetic, less frequent feeling of numbness and headaches as well as a reduction in night sweating. After further two months of Maca-GO application, correcting responses for Placebo effect, there was a positive reaction of EPMW to the following symptoms: an increase in feeling of being more energetic, lesser nervous tension, reduction in hot flushes and return of interest in sex life, as assessed according to the Greene's menopausal index. In symptoms covered by other questions, and in particular incidence in night sweating, feeling of anxiety, state of depression, excessive crying, irritability, and the responses were inconclusive.
| View this table: |
Table 3. Summary of Greene's Menopausal Test Score1 after 30 days placebo (B) and after two months of use of encapsulated Maca-GO (2,000mg/day) by 12 EPMW |
Trial II: Eight women, who volunteered to nine months participation in
the study, in which after one month Placebo phase, they were given Maca-GO
capsules for eight months period, following the same experimental protocol as in
Trial I, all of them concluded the eight month study period.
Results from hormone assays summarized in Table 4 demonstrate that in comparison
to placebo, after 2 months of using Maca-GO capsules, level of FSH significantly
decreased (P<0.05) with further reduction after 8 month of Maca-GO
administration. On the other hand, there was a statistically significant
(P>0.05) increase in LH level after 2 months of Maca-GO intake with a further
slight increase after 8 months of administration. Levels of Progesterone
increased with progression of the Trial II, but only the value recorded after 8
months of Maca-GO administration was statistically significant (P<0.05) as
compared to the previous samplings (at the start of the Trial, after placebo and
after two months Maca-GO treatment). While there were no significant (P>0.05)
changes in the E2 levels recorded between the start of the Trial and one month
Placebo treatment, the levels recorded after two and eight months of Maca-GO
administration were significantly higher (P<0.05) as compared to the start of
the trial and one month placebo treatment.
| View this table: |
Table 4.Hormone levels in postmenopausal women (n=8) at start of the trial, after one month placebo, after 2 month Maca-GO and after 8 month Maca-GO treatment (2,000mg/day) by eight EPMW. |
Subjective assessment by participants of their condition of “wellbeing” during
and after completion of the Trial II, as expressed during interviews with the
doctor, indicated that all participating women reported overall improvement in
reduction of feeling menopausal discomfort experienced at the start of the
Trial, with an improvement observed already after one month of placebo
treatment.
Responses given by participants to Greene's questionnaire and expressed as a
score of points assigned to each individual question according to severity of
symptoms experienced during one week prior to the interviews with the
gynecologist (who has recorded all the answers during the trial), confirmed
distinctive placebo effect on Greene's score index (Table 5). All reported
responses to individual questions in Table 5 and relevant scores recorded with
the end of the two and eight months of Maca-GO application have been corrected
for placebo effect (expressed as a percentage of a Placebo score). After two
months of Maca-GO application, a noticeable improvement was observed in such
characteristics as: feeling of being more energetic and lesser muscle and joints
aces less frequent feeling of numbness and headaches as well as a reduction in
night sweating.
| View this table: |
Table 5 Summary of Greene's Menopausal Test Score1 after 30 days placebo and after 2 and 8 month of use of encapsulated Maca-GO (2,000mg/day) by eight EPMW. |
Eight months of self-administration of Maca-GO capsules by early postmenopausal
women, resulted in a distinctive beneficial effect on majority of menopausal
symptoms listed in the Greene's menopausal index with the most pronounced
reduction recorded in frequency of sudden feeling of anxiety. Also such
characteristics as less incidences of excessive alertness, abnormally-fast heart
beat rate, lesser nervous tension, nervousness, irritability and excessive
crying, less frequent headaches, unhappiness and being depressed, lesser
incidence in muscle and joints aces were distinctively noticed by the
participants. This was associated with reduction in a frequency of hot flushes
and excessive night sweating with a simultaneous noticeable improvement in
falling asleep, feeling to be less tired and more energetic with return of
interest in sex life.
In general, accumulated score of responses to Greene's questionnaire confirmed
the fact that after one month placebo, the EPMW reported a 59% reduction in
severity of menopausal discomfort, from “occasional” and “often” to “symptoms not experienced” category (Table 6). While further two months of Maca GO treatment
has only slightly higher incidence of increasing number of questions assessed in
“symptoms not experienced category” then after 8 month of use of Maca-GO, there
were twice as much symptoms recorded by women in this category as compared to
the score as recorded at the start of the trial. This may be the closest to a
single objective numeric representation of a positive effect, which Maca-GO had
in this study on participating EPMW in terms of reduction in severity of their
menopausal discomfort along the period of the eight months study.
| DISCUSSIONS
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In the pioneering work on Maca by Chacon (2), she established
that there were four alkaloids in the Maca root, and not its plant hormones,
that produced fertility effects on the ovaries and testes of the rats. These
effects were measurable within 72 hours of dosing the animals. She deduced that
the alkaloids were acting on the hypothalamus-pituitary gland, which explains
why both male and female rats were afflicted in a gender-appropriate manner.
This may also explain why the effects of Maca in humans are not limited to
ovaries and testes, but through acting on the adrenals, gives a feeling of
greater energy and vitality and through this possibly affecting the pancreas and
thyroid as well.
Medicinal properties and energizing functionality of Maca for men and women are
linked to a peculiar composition of this plant, cultivated and grown in the
central Andes of Peru in the puna, where only alpine grasses and native high
frost tolerant plants can survive and produce crops of any economic
significance. Maca roots, grown and then dried under such a harsh environmental
conditions, exposed to full spectrum of solar radiation, low humidity and
extreme temperatures between day and night as experienced at such a high
elevation, exhibit specific ?yet unresolved to the present days - endocrine
effect, which, as demonstrated in this paper, helped to alleviate menopausal
symptoms in women ?as a natural, non-hormonal alternative to the currently used
HRT treatment. A superior nutritional quality of Maca (22) and
doses as dietary component for use at the level 5g/day as recommended by Chacon
(2 and 13), may not explain the effects of 2g/day doses administered to EPMW in
the Trial I and II. It is most likely that the complexity of components present
in Maca root powder such as sterols (campesterol, stigmasterol and
beta-sitosterol), polyunsaturated acids and their amides, called “macaenes” and “macamides”(9), aromatic glucosinolates (23) and
several alkaloids ?yet to be characterized, through their complex synergistic
and/or interactive action amongst them, will eventually provide an answer to
physiological action of specific doses of Maca recommended for prophylactic
and/or specific therapeutic effect for men and women. Dini (22)
suggests that observed aphrodisiac powers of Maca for men and women may be
ascribed to presence of prostaglandins and sterols in the hypocotyls of Maca and
overall fertility enhancing properties may be attributed to the presence of
biologically-active aromatic isothiocyanates derived by hydrolysis of the
glucosinolates and specifically due to benzyl isothiocyanate and p-methoxybenzyl
isothiocyanates (23). On the other hand, benzyl isothiocyanate
present in Maca root has been reported to be a potent cancer inhibitor of
mammary gland and stomach (24).
Since introduction of Maca to medical practice in the USA, it has been
increasingly used to treat menopausal patients at various clinics, where, as
reported by Muller (6), some 50 percent of patients were
satisfied from using Maca preparations instead of genistein supplements made
from soy, which have been shown as having stimulating effect on breast cancer
cells (6). Various personalized programs with the use of Maca
were developed for patients, some of them using Maca in conjunction with
nutritional supplements, to wean women off of hormone replacement therapy. For
those women who still had some symptoms, a combination protocols have been
developed, with involvement of Maca extract and a minute amounts of natural
estrogen together with natural progesterone, which, unlike progestin, is
considered not carcinogenic (6).
Maca, which has been confirmed, since the first report of Chacon (2),
to not contain plant estrogens or any other hormones, through plant sterols,
stimulate endocrine system helping to maintain hormonal balance in a way that is
not yet well understood (13, 6). These sterols
are used by the body with the help of the pituitary to improve adrenal function,
ovarian and testicular function, as well as the functioning of the thyroid and
the pancreas, and the pineal gland (which makes melatonin). Multi-functional
effect of Maca on endocrine relationships may also explain reported in the
literature, its positive influence on stimulation of endocrine glands in
regulation of hormonal balances in the body in distinctively different way than
those reported when women treat menopausal complaints with cimicifuga (16,
17) or preparations based on red clover (18,19) or soy (20)
phyto-estrogens.
It was reasonable to assume, that, as an adaptogenic herb, after two months use
of Maca-GO by EPMW, may help to correct symptoms of FSH dominance and may slow
down or counteract a decline in E2 level helping in relief from various symptoms
and associated manifestations of menopausal discomfort. Extending period of
Maca-GO administration to 8 months (Trial II), it was expected to observe
differences, if any, in short- and longer-term responses of EPMW to Maca
administration in hormone levels and Greene's Menopausal Index.
Results reported in this pilot study supported both above assumptions, since, in
addition to overall relief from most of the menopausal symptoms as subjectively
assessed in both Trials and confirmed in answers by participating EPMW to
Greene's questionnaire, the levels of FSH were reduced significantly (P<0.05)
after both, short (2 months) and longer period (8 months) of Maca-GO
administration, although, in Trial I, reduction was substantial but not
significant (P>0.05). On the other hand, in Trial II, Maca-GO treatment resulted
in significant (P<0.05) increase in the E2 level after long-term (8 months) of
Maca-GO use only, in relation to level recorded after placebo treatment, while
there was no significant effect of two months Maca-GO administration..
Observed in this study positive effect of Maca-GO in lowering FSH level after
both short- and longer-term use was associated with a parallel significant
(P<0.05) increase in LH concentration. The ratio between the two hormones (FSH
and LH) were maintained in both Trials at the level close to 1.6 after two month
of Maca-GO intake and reduced to 1.2 after 8 months of Maca-GO administration,
which is typical to commonly observed in early menopausal stage (>1.1).
While in Trial I, two months administration of Maca-GO had no significant
(P>0.05) effect on PG blood concentration, there was a significant (P<0.05)
increase in PG after one month placebo intake only, indicating that two months
Maca-GO treatment has no effect on changes in PG levels ?the fact confirmed by
results obtained in Trial II. However, there was a significant (P<0.05) increase
in progesterone blood concentration after a long-term administration of Maca-GO
to EPMW.
Implications of the pituitary stimulating effects of Maca-GO as may be deducted
by reduction of FSH and an increase in LH blood concentration are important in
this respect, that opens a new avenue to interpretation of the effect of Maca on
a complex of physiological processes which may lead to further investigation of
possible use of Maca-GO as a “Non-Hormonal Replacement Therapy” – which appears to
be a safer and less controversial treatment to currently disputed conventional
HRT with the use of pharmaceutical hormone preparations.
The E2 levels observed in women participating in this study were below 30pg/ml
in Trial I and between 30 and 35pg/ml levels, which may confirm postmenopausal
status of participants and/or dysfunction or atrophy of ovaries. Observations
made by Malespina (11), indicated levels of 30pg/ml and above
as the absolute minimum that a woman needs to avoid symptoms of discomfort
characteristic to post menopause and 60-75pg/ml are considered as adequate
levels.
On the basis of results obtained in this study on EPMW, it is reasonable to
assume that Maca-GO significantly influenced the organs of internal secretion.
By stimulating the pituitary to significant increase in FSH and LH secretion,
Maca-GO seemed to contributed to regulatory mechanism responsible for the
remaining ovarian functions, which resulted in an increased secretion of the
minimum quantity of Estrogen, known to be necessary to avoid or substantially
reduce problems of mental, physiological and physical discomfort associated with
menopause as manifested by symptoms listed in Greene's Menopausal Index.
Suggestion of Chacon (3, 13), that Maca,
through stimulation of pituitary gland, may have indirect effect on pineal
gland, which secretes melatonin could be supported by observations made in this
study, explaining a sedative and calming effect of Maca-GO on menopausal women,
according to symptoms listed in Greene's Menopausal Index.
Although, positive effect of both, short- and longer-term administration of
Maca-GO in alleviating symptoms of menopausal discomfort experienced by EPMW
prior to involvement in the study can not be disputed after being confirmed by
figures summarized in the Greene's Menopausal Index, the
statistically-significant (P<0.05) different response of women in levels of sex
hormones recorded after short- and a longer-term use of Maca-GO, may indicate
different mechanisms of action of Maca constituents on endocrine system in EPMW
- the fact warranting further, more complex study.
The question remains however, whether Maca as adaptogenic herb has a
"stimulating" or a "balancing" effect? According to Muller (6)
depending on the dosage involved, Maca can have balancing or stimulating effect
under wide range of circumstances. In the USA, women with menopausal symptoms
are advised to take 3 ?4 Maca capsules daily for balancing effect, but very
sensitive menopausal woman may only need 2 capsules daily. Such a dosage may
reduce or completely eliminate hot flashes in as little time as 4 days to a week
(6). On the other hand, with too high dosage, in women highly
sensitive to Maca, there may be a stimulating and not balancing effect, which
actually may increase the amount of hot flashes.
Various commercial Maca preparations are available on the therapeutic market in
the USA and Europe and are recommended by practitioners, who, based on their
personal clinical experience and limited research conducted so far, recommend
Maca to be used by women for number of reasons such as hormone balance, for
energy, for PMS, for menopausal symptoms, including hot flashes, vaginal
dryness, the "blues", for thyroid health, immune balance, and nutritional
support for postmenopausal women to maintain healthy bones (5,
6, 11). As far as nutritional support to Maca-Go preventive
and/or therapeutic treatment of menopausal symptoms or menopausal irregularities
concerns, dietary routine in this period of time should be based on the “new food pyramid” based on U.S. Department of Agriculture dietary recommendations released
in January 2005, with the prime direction to adopt into daily dietary routine
being a strong emphasis on grains, fruits, and vegetables with limited amounts
of meats, oils, and fat. The main thrust of the retooled pyramid is "first and
foremost, moderation?with necessity to pay attention to what it is eaten,
maintaining moderation, and then, being involved in some sort of physical
activity ?exercise, with the recommendation that even a little practically
possible exercise “will make a difference". There was no requirement for
participants to follow up or report on their dietary habits - which may have a
distinctive influence on responses of EPMW to the Maca-GO. Therefore, slight
discrepancies and variation in hormonal profiles and related subjective
assessment of improvement reported by the participating women after two months
of Maca treatment in the Trial I and II, may also be attributed to the
un-accounted in this study, dietary factor.
Results from the study presented here shows that Maca-GO has a potential to be
used in early post-menopausal women and under dosage conditions as described in
this paper, through stimulation of secretion of pituitary hormones (FSH and LH)
may act on ovaries in a specific manner which induce hormonal balance in this
period of woman life, which provides a certain degree of alleviation in
menopausal discomfort as expressed in symptoms listed in the Greene's Menopausal
Index. As demonstrated in this study, it is important however, to take into
account a strong placebo effect on EPMW involved in assessment of effectiveness
of Maca-GO used for treatment of menopausal symptoms.
Analyzing Placebo-corrected score on the list of symptoms in the Greene's
Menopausal Index, both in Trial I and II, it appears that in majority of
participating EPMW, after two months of Maca-GO treatment, there was a
distinctive reduction in severity of stress related symptoms contributing to
overall alleviation in menopausal discomfort. This trend was continued further
with an extension of Maca-GO administration into the eight month period (Table 6
and 7). In recently-published work by Lopez-Fando et al. (21),
it was demonstrated, that under laboratory conditions, where a methanolic
extract of Lepidium Peruvianum was used, it was possible to attenuate or even
eliminate variations in homeostasis produced by stress, with the most visible
manifestation being a reduction or even healing of stress-induced ulcers and
normalizing corticosterone and glucose levels as well as bringing to normal an
increased weight of adrenal glands induced by stress. The question remains
however, to what degree results from the use of Maca extract, representing
fractions of selected components eluted from the root by methanol or other
solvent(s), may be compared with those obtained using gelatinized Maca root
powder representing its unaltered therapeutic characteristics in its
traditionally-understood coherent complexity of the root preparation and
administered at the appropriate dose, specific to the purpose of its use as
dietary supplement and/or phyto-therapeutic for cure and/or prevention.
Obtained results and available literature evidence may suggests that Maca-GO,
when taken in a right dose is acting as a toner of hormonal processes which may
alleviate discomfort felt by women during early postmenopausal stage. However,
there is also an indication, that due to strong sedative effect of Maca and
strong anti-stress activity as observed in this study, when comparing scores
which assessed intensity of symptoms experienced by the EPMW and expressed by
their answering questions in the Greene's Menopausal Index, Maca may induce
calming effect which has different dynamics of action, compared to balancing or
stimulating effect as may be interpreted by assessing changes in hormonal levels
after Maca-GO administration. Muller (5and 6)
also commented that, while low doses of Maca result in balancing effect on
women, then, larger doses, 3g per day and above, may induce stimulation of
hormonal secretion. Observations made in this pilot study justify further
clinical research on use of Maca in postmenopausal women. This in order to
assess effectiveness of Maca-GO as a non-hormonal therapeutic supplement which
may help women to reduce discomfort associated with menopause as an alternative
to HRT programs.
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CONCLUSION
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1. 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. At the same time,
levels of both E2 and PG, significantly (P<0.05) increased, however after eight
months of Maca-GO treatment only, without significant effect after two month of
similar treatment. There was a significant (<0.05) placebo effect resulting in
an increased PG level after one month administration of placebo capsules.
2. According to responses given by EPMW in related to menopausal symptoms
specified in Green's questionnaire, both, short- and long-term Maca-GO
administration has substantially reduced feeling of discomfort associated with
menopause. There was however, a distinctive positive placebo effect as judged by
responses given in Greene's questionnaire.
3. Based on results obtained in this study, it is reasonable to suggest that
Maca-GO was acting as a toner of hormonal processes in EPMW as judged by
decrease in FSH and increased LH secretion by pituitary gland, which resulted in
stimulation of both ovarian hormones, E2 and PG, which in turn, induced a
substantial reduction in discomfort felt by women during early postmenopausal
stage.
4. Preliminary observations outlined in this paper, particularly different
responses of women to a short- and long-term administration of Maca-GO to EPMW,
justify further clinical study on effectiveness of Maca as a non-hormonal
therapeutic supplement, which may help women to reduce discomfort associated
with menopause as an alternative to HRT program.
| View this table: |
Table 6 Accumulated score in answers to questions reflecting Individual symptoms in Greene's Menopausal Index 1 |
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ACKNOWLEDGEMENTS
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This paper commemorates research of Professor Dr hab. (HC) Jerzy Lutomski,
deceased in 2003, whose vision of potential benefits derived from medicinal
properties and energizing functionality of Maca and other medicinal plants from
Australasia, Pacific and South America, for men and women in Poland, led to a
five year of R&D work, first part of which, has been presented in this paper. A
joint funding of the project by the Research Institute of Medicinal Plants in
Poznan and TTD International Pty Ltd Sydney is duly acknowledged. Participation
of NatureCorp Pty Ltd, Australia in costs related to securing commercial batch
of standardized Maca-GO used in this study, is also gratefully acknowledged.
Some results from the introductory 3 month period, in a preliminary form, were
published (in Polish) in Advances of Physiotherapy. 2003; 1: 19.
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DISCLAIMER
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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.
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REFERENCES
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