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Jun 30, 2008 7:04 pm US/Central
21 Medical Myths You Need To Know
(Alan Johns, M.D.)
1. Myth:
Bio-identical hormones are safer and more effective than FDA-approved hormone therapy drugs
Fact:
"The FDA is not aware of credible scientific evidence to support claims made regarding the safety and effectiveness of "BHRT" products. No "BHRT" product has met federal standards for approval. "They are not safer just because they are 'natural,'" says Kathleen Uhl, M.D., Director of FDA's Office of Women's Health.
2. Myth
: Bio-identical hormone products can prevent or cure heart disease, Alzheimer's disease, and breast cancer.
Fact
: "BHRT" drug products have not been shown to prevent or cure any of these diseases. In fact, like FDA-approved hormone therapy drugs, they may increase the risk of heart disease, breast cancer, and dementia in some women.
3. Myth
: Bio-identical hormone products that contain estriol, a weak form of estrogen, are safer than FDA-approved estrogen products.
Fact
: "The FDA has not approved any drug containing estriol. The safety and effectiveness of estriol are unknown. "No data have been submitted to the FDA that demonstrate that estriol is safe and effective," according to Daniel Shames, M.D., a senior official in the FDA office that oversees reproductive products."
4. Myth
: If bio-identical products were unsafe, there would be a lot of reports of bad side effects.
Fact
: "Unlike commercial drug manufacturers, pharmacies aren't required to report adverse events associated with compounded drugs," says Steve Silverman, Assistant Director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "Also, while some health risks associated with "BHRT" drug products may arise after a relatively short period of use, others may not occur for many years. One of the big problems is that we just don't know what risks are associated with these so-called bio-identicals."
5. Myth
: A pharmacy can make "BHRT" drug products just for you based on hormone levels in a saliva sample.
Fact
: "Advertisements that a drug can be created 'just for you' are appealing," says Uhl, "but unrealistic." There is no scientific basis for using saliva testing to adjust hormone levels. Hormone levels in saliva do not accurately reflect the amount of hormones present in a woman's body for the purpose of adjusting those levels. A woman's hormone levels change throughout the day, and from day to day. FDA-approved tests can tell a woman's hormone level in a specific body fluid, such as saliva, blood, or urine, at that particular point in time. "These tests are useful to tell if a woman is menopausal or not," says Uhl, "but they have not been shown to be useful for adjusting hormone therapy dosages."
6. Myth
: The FDA wants all compounded hormone therapies off the market.
Fact:
"We are not trying to pull all compounded hormone therapies off the market," says Silverman. "We believe that, like all traditionally compounded drugs, a woman should have access to a compounded hormone therapy drug when her physician decides that it will best serve her specific medical needs. That said, we want women to know that they should be careful about choosing products that have not been proven safe and effective. And pharmacies cannot promote compounded drugs with false or misleading claims." In addition, as noted above, FDA has not approved any drug containing estriol, and consistent with FDA policy, pharmacies should not compound drugs containing estriol.
7. Myth
: Saliva testing for hormones is helpful in determining what dose you need.
Fact
: According to a committee opinion by the American College of Obstetricians and Gynecologists (ACOG, 2005), there is no scientific evidence to support claims of increased safety or effectiveness for individualized estrogen or progesterone regimens prepared by compounding pharmacies. Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing. The opinion by ACOG also pointed out that salivary hormone level testing used by proponents to 'tailor' this therapy isn't meaningful because salivary hormone levels vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables.
An assessment by the Institute for Clinical Systems Improvement (2006) concluded: "Currently, there is insufficient evidence in the published scientific literature to permit conclusions concerning the use of salivary hormone testing for the diagnosis, treatment or monitoring of menopause and aging."
The North American Menopause Society (2005) has concluded: "Salivary testing is not considered to be a reliable measure of testosterone levels."
There is no evidence that hormonal levels in saliva are biologically meaningful. Reference: ACOG Committee Opinion: Compounded Bioidentical Hormones, 2005
8. Myth
: Hormone replacement therapy should be individualized for every patient based on their hormone blood levels.
Fact
: There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens. Reference: ACOG Committee Opinion: Compounded Bioidentical Hormones, 2005
9. Myth
: Hormones that are compounded (made) by a pharmacist or doctor are better and safer than those produced by pharmaceutical companies.
Fact
: Compounded products are not approved by the FDA and have no official labeling (ie, a package insert), they are exempt from including the contraindications and warnings required by the FDA in class labeling for hormone therapy. Given the lack of well-designed and well conducted clinical trials of these alternative therapies, compounded hormone products should be considered to have the same safety issues as those associated with hormone therapy agents that are approved by the FDA. They also may have additional risks intrinsic to compounding. Reference: ACOG Committee Opinion: Compounded Bioidentical Hormones, 2005
10. Myth:
All hormones are bad.
Fact:
Hot flashes and night sweats can be worse. Believe it or not, I know.
11. Myth
: Alternative medicine is safer.
Fact
: I suppose not treating at all would be even safer. It depends on how you define "safe." To my mind, a treatment is not very "safe" if it causes no side effects but lets you die. Most of us don't just want "safe:" we want "effective." What we really want to know is the risk/benefit ratio of any treatment. Science provides the best answer to that question.
12. Myth
: CAM (Complimentary and Alternative Medicine) has a lot of evidence supporting its safety and effectiveness in the prevention and treatment of disease.
Fact:
If any CAM method was backed by sufficient evidence to conclude that it was safe and effective - it would already be part of mainstream scientific medicine. It would no longer be "complimentary" or "alternative", it would just be medicine.
13. Myth
: Homeopathy is safer and more effective than conventional medical therapy.
Fact:
Systematic reviews have not found homeopathy to be a definitively proven treatment for any medical condition. Reference the National Center for Complementary and Alternative Medicine.
14. Myth
: Herbs are always good, they are natural.
Fact
: Check out information about your favorite herb, you might be surprised. NCCAM herb information.
15. Myth:
Acupuncture is a proven treatment for many serious medical conditions.
Fact
: Acupuncture alone has not been shown in rigorous, duplicated studies to benefit any defined medical condition.
16. Myth
: Ca 125 is a good screening test for ovarian cancer in premenopausal women
Fact:
The CA-125 test is not recommended for use alone as an early detection method. The rate of false positives is very high, and there has been no data concerning change in mortality. Johns Hopkins Pathology CA-125 Questions and Answers.
17. Myth
: Vasectomy is the safest, easiest, and most effective method of permanent birth control for couples.
Fact:
Hysteroscopic sterilization (which can be done in an office setting in about 3 minutes) involves no incisions, no recovery, and very minimal anesthesia. It also has the lowest pregnancy rate and lowest complication rate. In the vast majority of women, there is no longer any reason to have a laparoscopic tubal ligation. Reference: vol. 111, no. 1, January 2008, Peterson , Sterilization (Clinical Expert Series – Obstetrics & Gynecology)
18. Myth:
Most hysterectomies for benign conditions must be done with large abdominal incisions.
Fact:
Unfortunately, in the U.S. most are still done this way, but it is unnecessary in the great majority of cases. If the surgeon is sufficiently skilled and experienced with laparoscopic and vaginal techniques, over 90% of hysterectomies for benign disease can be done without large abdominal incisions. Reverence: Clinical Expert Series, Obstetrics & Gynecology, VOL. 111, NO. 3, MARCH 2008 Falcone and Walters, Hysterectomy for Benign Disease
19. Myth:
If you are having a hysterectomy for benign disease, you should have your ovaries removed to avoid problems later.
Fact:
In the majority of cases, normal ovaries should not be removed unless you are 65 years of age or older. Reference: Parker WH, Ovarian conservation at the time of hysterectomy for benign disease. Obstet Gynecol 2005;106:219–26
20. Myth:
If you are diagnosed with breast cancer, you should have surgery as quickly as possible.
Fact:
At the time the diagnosis is made, the cancer has been there for quite a few years. The surgeon you choose and the treatment they recommend is absolutely critical to you. You must take enough time to make the correct choices.
21. Myth
: Men don't get breast cancer
Fact
: Yes they do, ask me.
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