The Truth About 'Bio-identical' Hormone Therapy

(HealthDay News) -- They're marketed as "bio-identical" hormones or "bio-identical hormone replacement therapy," and they claim to do everything from helping menopausal women lose weight to preventing senility.

They're touted as safer and sometimes even more effective than conventional hormone-replacement therapy.

But the U.S. Food and Drug Administration warns that these claims are "unproven" and that the products are "potentially dangerous." What's more, bio-identical hormone replacement therapy -- or "BHRT" -- is a "marketing term not recognized by FDA," the agency said.

Experts also are expressing some concerns about the products.

"We don't know anything [about these products]," said Dr. Suzanne Steinbaum, director of Women and Heart Disease at Lenox Hill Hospital in New York City. "This isn't FDA-approved. It's the same thing as a hormone. What concerns me is that people believe if it's not from a drug company, it's safe."

Added Dr. James Liu, chairman of the department of obstetrics and gynecology at MacDonald Women's Hospital at Case Medical Center, University Hospitals in Cleveland: "Over-the-counter products that are not listed as drugs can make some claims, and they have to be careful about it. Usually these are considered supplements. Suffice it to say, there is science behind some of what they say and a little bit of lack-of-science in other things."

And the Endocrine Society issued this position statement back in October 2006, expressing concerns about these products: " 'Bioidentical hormones,' particularly estrogen and progesterone, have been promoted as safer and more effective alternatives to more traditional hormone therapies, often by people outside of the medical community. In fact, little or no scientific and medical evidence exists to support such claims... Additionally, many 'bioidentical hormone' formulations are not subject to FDA oversight and can be inconsistent in dose and purity."

Since the release in 2002 of a Women's Health Initiative report, hormone replacement therapy (HRT) -- used to relieve symptoms of menopause -- has generated worrisome, and sometimes conflicting, headlines. While linked to a reduced risk of colon cancer and fractures, the therapy has also been associated with an increased risk of breast cancer, stroke, blood clots and heart attack. And -- so far, at least -- there are no indications that HRT has any effect on the development of dementia.

The not-inconsiderable list of potential risks of hormone-replacement therapy has left an opening for manufacturers of "natural products" to step up with supposedly better and safer versions of hormone therapy, according to the FDA.

Marketers of bio-identical hormones often say the products are identical to hormones produced by the body, and these "all-natural" pills, creams, lotions, and gels don't carry the risks of menopausal hormone therapies approved by the FDA. Agency-approved HRT drugs are typically prescribed to treat symptoms of menopause, such as hot flashes and vaginal dryness.

But the FDA said it hasn't approved compounded "BHRT" drugs and can't assure their safety or effectiveness.

Liu said that " 'bio-identical' really means that the structure of the compound you're claiming to be identical is biologically identical. It [the term] is applied primarily to female hormones that are used in hormone therapy."

But, Liu added, "the main problem is how a woman would obtain [bio-identicals]. If it's pharmaceutical grade, FDA-grade, it's prescribed. It's just how it's made."

Some of the bio-identical hormones are "compounded," meaning they are mixed specially to meet an individual's needs. For example, some dyes or preservatives may be eliminated if a person is allergic to them, according to the FDA.

"The pharmacist assumes that responsibility and the physician should specify that on the prescription," Liu said. So the bio-identical product may not have exactly the same ingredients as a standard product, he said.

But be leery if a pharmacy claims that such compounded mixtures are safer or more effective than other hormone formulations, the FDA warned. They may not be mixed according to a licensed health-care professional's instructions, the agency said.

"Women should be cognizant that both products have similar potencies, similar biological action and similar side effects," Liu said. "There's no reason to think bio-identicals are superior. There are either anecdotal or testimonial claims that one is better than the other. We're swayed by that as human beings."

Here are some points the FDA says to keep in mind:

• Approved hormone therapies are available by prescription only.
• Bio-identicals will have the same risks as the products they're identical to -- namely a heightened risk of breast cancer and serious heart problems. There may be other, as-yet-unknown risks, as well.
• Beware of claims that bio-identical products can be made based on hormone levels measured from a woman's saliva sample. Hormone levels fluctuate constantly. Saliva tests, which are FDA-approved, aren't specific enough to determine drug dosages.
• No drug containing the hormone estriol (the weakest of the three estrogens produced by the body) has been approved by the FDA. Only prescribers who have an investigational new drug (IND) application can compound drugs with estriol.
• In general, when using approved hormone-replacement therapies, the FDA and health-care professionals recommend using the lowest dose possible for the shortest period needed.

More information
Visit the FDA for more on menopause and hormones.

CDC Scientists ID New Killer Germ, but What Should They Call It?

By Theresa Tamkins

Getty Images
I just returned from the sprawling campus of the Centers for Disease Control and Prevention (CDC) in Atlanta. This huge federal agency is on the front line of fighting just about every kind of health threat, from biological weapons to dengue fever to obesity—both in the United States and abroad. (They have 14,000 employees in countries around the world).
But more importantly (for glamour-seeking sci-fi fans), the CDC has played a starring role in just about every apocalyptic movie or book ever made, from Stephen King’s The Stand to Richard Preston’s Hot Zone. Will Smith researched his role in I Am Legend by chatting with CDC scientists. (Yes, he is as nice as he seems, CDC insiders say.)
So is working at the CDC as exciting as the movies make it out to be? Well, yes. On the day I was there for a tour, I met Pierre Rollin, MD, of the Special Pathogens Branch, who had just come from a meeting to discuss a name for a new killer virus. Read More

Health Tip: Taking ADHD Medications

(HealthDay News) -- Medications prescribed to treat Attention-deficit hyperactivity disorder (ADHD) may effectively manage symptoms, but they can also cause a number of side effects.

The American Academy of Family Physicians offers these suggestions to minimize side effects caused by ADHD drugs:

• Take only the minimal dose necessary to control your symptoms. Speak with your doctor about determining the right dose for you.
• If you have stomach upset, take your ADHD meds with food.
• As long as your doctor says it's OK, consider the weekend "drug-free days" when you can skip your medication.
• If ADHD meds cause undesired weight loss, add healthy snacks to the day's menu.

Defining Cancer

Defining Cancer - Cancer is a term used for diseases in which abnormal cells divide without control and are able to invade other tissues. Cancer cells can spread to other parts of the body th...... Read more

Are Detox Diets Good for You?

You know when it’s time to clear out clutter and streamline your closets. But do your liver and lymph nodes need a good purging, too? It’s true that some detox regimens—like herbal supplements, spa treatments, and special diets that are designed to mop up pollutants, chemicals, dietary waste, and even unwanted pounds—can actually do you some good. But how to know whether you should be trying any of them? Health checked with traditional and alternative medicine experts to find out which regimens might be worthwhile—and which ones just aren’t. Read more

Health Tip: Prevent Carbon Monoxide Poisoning

(HealthDay News) -- Carbon monoxide is an odorless, colorless gas that can lead to serious illness or death if inhaled in significant amounts.

Potential sources include: unvented kerosene and gas space heaters, furnaces, wood stoves, gas stoves, fireplaces and water heaters, and automobile exhaust.

Symptoms of carbon monoxide poisoning could include tiredness, headache, confusion, nausea and dizziness.

The National Safety Council offers these suggestions to help protect you and your loved ones from carbon monoxide poisoning:

• Make sure that every appliance in your home is installed properly and is working correctly.
• Have your furnace, chimneys and flues inspected and cleaned each year.
• If using a fireplace, make sure the flue is open.
• Never heat your home with a gas range or oven.
• Be sure that your stove and furnace vent outdoors and there are no leaks in the exhaust systems. Also make sure that your furnace takes in enough fresh air.
• Never burn charcoal indoors or in any enclosed space, such as in a camper or R.V.
  Never leave a gas-fueled tool or vehicle running inside a garage or tool shed, or anywhere indoors.
• Never use kerosene or gas heaters indoors.

Benefits of Cleansing

Your body is a perfectly designed self-cleaning organism. It efficiently eliminates toxins through exhaling, coughing, sneezing, sweating, urinating and moving the bowels. Theoretically, your body should have the ability to eliminate all normal metabolic waste matter as well as accumulated toxic matter from breathing, eating and other environmental contacts. Read more

Why Would Anyone Go on a Gluten-Free Diet if He Didn’t Have To?

By Sean Kelley

123rf/Health

For the last few years, the number of Americans going on gluten-free diets has increased. It make sense: Doctors are diagnosing more people with celiac disease or gluten intolerance.
But a strange thing is happening: People who don’t have either condition are cutting gluten out of their diet in an effort to lose weight and cleanse their system. And that could lead to health problems—and even weight gain. Read More

The Seed That Staves Off Heart Disease

Can something the size of a pinhead help your heart? Sure, if it's asimple . . . Read more

To Protect Yourself, Wash Those Germs Away

(HealthDay News) -- Of all the advice your mother gave you, there's one tidbit that doctors stand by as the best way to keep yourself healthy:

Wash your hands.

Keeping hands free of germs is one of the simplest and most effective ways to keep from catching the flu, a cold or some other infectious disease, experts say.

"Disease transmission is hand-to-hand combat, at least for infectious diseases," said Dr. Thomas Weida, professor of family and community medicine at Penn State University's Hershey Medical Center in Hershey, Pa. "By washing your hands regularly, you decrease the spread of disease."

The U.S. Centers for Disease Control and Prevention lists hand-washing as one of the top recommended ways to avoid catching the flu.

Hand-washing also can keep you from becoming infected with bacteria such as salmonella or E. coli, said Marcia Patrick, director of infection prevention and control for MultiCare, a health system in Tacoma, Wash. That's critical because the CDC says an estimated 76 million Americans are stricken with a food-borne illness each year, and 5,000 die from their illness.

"All the different things we touch in the regular course of our day can contain germs: grocery cart handles, elevator buttons, keyboards, telephones," added Patrick, who's also a spokeswoman for the Association for Professionals in Infection Control and Epidemiology.




Those germs transfer to your hands, and from your hands get into the body through the eyes, nose or mouth.

"A lot of upper respiratory infections are caused by hands that got contaminated by someone else's upper respiratory discharges," Patrick said.

Basic hand-washing involving soap and water is a relatively simple affair, but the order in which you do things is important. Start with warm water and wet your hands. After that, dispense the soap into your hands.

"What that does is [help] disperse the soap over the hands' surface," Patrick said. "If you put the soap in your hands and then wet them, you lose a lot of the soap to the running water."

Then rub your hands together vigorously for at least 15 to 30 seconds, scrubbing all surfaces of the hands and fingers, Weida said. That friction is key because it dislodges all the germs -- bacteria and viruses -- from the skin surface.

"To do a thorough job, when you're standing in front of a sink, it can seem interminable," Patrick said. "Singing through at a reasonable pace either 'Happy Birthday' or 'Row, Row, Row Your Boat' twice will help you get through it."

Afterward, rinse your hands briskly in running water to remove the suds -- and with them, the germs. "Make sure you rinse thoroughly to get all the soap off because soaps can be drying to your skin," Patrick said.

Blot your hands dry with a couple of paper towels to finish the job. "Ideally, use the damp towels to then turn the faucet off," Weida said.

You might also consider using the paper towels to open the door on your way out of the restroom, too, Patrick said.

"How many times have you been in a stall and there's a toilet flush and the next sound you hear is the person leaving, with no stop at the bathroom sink?" she said.

Weida and Patrick differ on whether your soap should be antibacterial or not.

Although regular soap will do the job, Weida prefers antibacterial soap. "I don't have any studies showing one way or the other," he said, "but I tend to lean toward antibacterial."

But Patrick is concerned that antibacterial soaps can be harsh on the skin, particularly if people wash their hands as often as they should. "If you are washing your hands thoroughly, regular soap is great," she said.

Both agree that if your hands are visibly clean, and you just want to make sure that you're not transmitting germs, then an alcohol-based disinfectant gel will work just as well as soap and water.

"The alcohol gel works very well," Patrick said. "It will kill upwards of 99 percent of the bacteria on your skin, and does it quickly and cleanly."

Just apply a dab to your hands and rub until it evaporates, Weida said. The friction assists the alcohol in killing the germs on your hands.

In general, you should clean your hands before you eat or after you go to the bathroom, Weida said.

The CDC also recommends washing your hands after changing diapers, before and after tending to someone who is sick, after handling an animal or animal waste, after handling garbage, before and after treating a cut or wound, and after blowing your nose, coughing or sneezing.

"For me, here in the office, our policy is to use an alcohol-based hand-washing gel both before and after we examine a patient," Weida said. "Before so I don't give something to the patient, and after so the patient doesn't give something to me."

"People ask me, 'Gosh, what special shot do you get to keep yourself healthy, seeing all these sick people?' And I say it's hand-washing that protects me," Weida said.

More information
To learn more about hand hygiene, visit the Minnesota Department of Health.