Wild Yam Cream
While the diosgenin found in wild yam
created quite a stir in the 1990s as a cure
for menopausal disorders and other symptoms
of aging in women, the plant itself has no
proven hormonal action, nor have any studies
shown it to be effective in treating hormone
related disorders. It is true that diosgenin
can be converted into steroidal compounds,
which are then used in the chemical
synthesis of progesterone, but this is in
the laboratory—not in the human body. There
is essentially no scientific evidence of
wild yam's effectiveness in treating
menopausal symptoms or osteoporosis.
Although many individuals claim relief of
symptoms such as vaginal dryness with the
use of progesterone creams, some of which
contain an extract of Dioscorea villosa,
no well-designed studies have evaluated
these creams. Moreover, many products that
claim to contain natural progesterone
actually contain synthetic
medroxyprogesterone acetate (MPA).
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"Wild Yam Cream" Threatens Women's Health
Timothy N. Gorski, M.D.
Many women are being encouraged to purchase and use
"Wild Yam Cream" said to offer relief from premenstrual
and menopausal symptoms. The preparation is made by a
company called "NATURAL efx" and is promoted with
materials that include testimonials, the recommendation
of a "Dr. Betty Kamen," and citations of medical
literature purported to support the claims being made.
According to this promotional literature, "Hormonal
Imbalance!!!" and "Estrogen Dominance" cause "Cramps,
Migraines, Bloat, Breast Tenderness, Hot Flashes, Can't
Lose Weight, Lack of Energy, Depression -- Mood Swings,
Fibroid Tumors, Endometriosis -- Infertility, Family
History Female -- Related Cancer, Foggy Thinking,
Perimenopause, [and] Losing Height." These conditions
are said to be effectively treated by the application of
the product twice daily. Also claimed is that the cream
"Enhances libido, Improves energy, stamina and
endurance, Stimulates the body's own production of
estrogen, progesterone, testosterone, [and] other
hormones," and that "Women report [an] overall feeling
of well being and euphoria." It is also asserted that
"synthetic progestins have serious side effects" whereas
"natural progesterone has none" and that the only reason
the former is used is that it can be patented. Finally,
even men are claimed to benefit from the product, which
is said "to help balance testosterone with no feminizing
effects."
There is, of course, reason to suppose that hormones
play a part in several of the conditions mentioned. For
some of these conditions, though, this role remains
uncertain or unlikely. It is certainly unwarranted to
say that "Estrogen Dominance" is the cause of all the
disorders mentioned and that a progesterone product can
prevent, alleviate, or cure them. In t premenstrual
syndrome, for example, double-blind controlled trials
have demonstrated that progesterone supplementation is
no better than a placebo. Also blatantly false is the
claim that synthetic progestins are dangerous whereas
natural progesterone is harmless. Progesterone in any
form may cause side effects. In addition, the major
synthetic progestin now in use (medroxyprogesteron) has
been off patent for some time. It is generally preferred
over progesterone -- which is also produced
synthetically -- because it is much better absorbed when
taken orally.
The more blatantly erroneous claim is that the
Mexican yam, Dioscorea villosa, from which the
cream is supposedly made is a source of progesterone. It
is not. In fact, the main hormonally active substances
present in the plant would probably be estrogenic.
Extracts of D. villosa do have significant
amounts of the substance diosgenin. The plant is
therefore very useful because in the lab -- not in the
human body -- diosgenin can be used to synthesize
steroid hormones including progesterone. Indeed, it was
this discovery that led to the first commercially
available oral contraceptives. The progesterone listed
among the ingredients in Wild Yam Cream may very well
have been derived in this way via the test tube from
naturally occurring diosgenin. But that, of course,
isn't mentioned in the product literature.
Also left unmentioned is the fact that, once
introduced into the body by any effective means
(including through the skin), the progesterone molecule
can be metabolized to a wide variety of other compounds
including estrogens, androgens, and even
corticosteroids. Indeed, all of these vital hormones are
the products of the continuous production of
progesterone and its physiologic conversion of in the
ovaries, testes, and adrenal glands. Part of the
usefulness of synthetic progestins, on the other hand,
is that they are not subject to these biochemical
pathways but are able to exert their desired effects
until metabolized and excreted.
Thus, not only is there little reason to suppose that
Wild Yam Cream would be helpful for the medical
conditions for which it is being promoted, but it
doubtful that it ever could be as useful as synthetic
progesterone.
The greatest danger posed by this product and its
deceptive promotion is that it will lead many menopausal
women to forego or even discontinue appropriate
hormone-replacement therapy (HRT).
Although HRT is not for everyone (and few prescription
medications are), hormone replacement has proven value
in alleviating hot flushes, vaginal atrophy, and other
symptoms as well as reducing bone loss and bone
fractures. In fact, research suggests that the risks of
combined HRT may attach more to the progestin component
than to estrogen. Fear and confusion created by
promoters of wild yam creams and other unproven products
is especially tragic since so many women already have
trouble maintaining a consistent HRT regimen. The last
thing American women need is another unproven "natural
alternative" promoted by a campaign of deceit at the
expense of their life, health, and well-being.
Besides all these concerns, Wild Yam Cream costs
more. A month's supply costs about $27. A month's supply
of the prescription drugs Premarin and Estrace cost $12
and $18 respectively.
Enforcement Actions
The most outrageous promotion I have encountered is a
"Medical Recall Notice" mailing from "Health
Notification Service" of Henderson, Nevada. The
official-looking contents purported to be a recall of
all "Prescription Estrogens and Progestins" because of
"Severe and Prolonged Life-Threatening Side Effects."
According to this mailing, the "Indicated Treatment" to
be substituted was a "Natural Progesterone Cream" with
"No Harmful Side Effects," with the order form
conveniently enclosed. FDA-approved progesterone
medications, incidentally, do not make the false claim
of "no side effects."
In September 2000, the
FDA warned the company owners
(Roger J. and Debra L. Peeples) that it was illegal to
suggest that their "Miracle Wild Yam Cream" was useful
in treating or preventing osteoporosis, symptoms of
menopause, depression, premenstrual
syndrome, breast cancer, postpartum depression, ovarian
cysts, fibrocystic mastitis, infertility, or other
diseases and conditions. In February 2002, the Illinois
Attorney General charged the company and owners with
violating the Consumer Fraud and Deceptive Business
Practices Act and the Illinois Food, Drug and Cosmetic
Act. |