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.
____________________
Dr. Gorski practices obstetrics and gynecology in Arlington, Texas, and is president of the Greater Dallas-Fort Worth Council Against Health Fraud.