STUDY: Formal inquiry of the estrogen/androgen combination it approved for hot flashes back in 1976

JOURNAL: FDA

AUTHORS:

ABSTRACT: U.S. health officials questioned the effectiveness of a combination hormone therapy for treating hot flashes in women and said unapproved uses, such as restoring sex drive, must also be proven.

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COMMENTARY: The U.S. Food and Drug Administration said it was launching a formal inquiry of the estrogen/androgen combination it approved for hot flashes back in 1976.

The FDA said it knew of at least two currently marketed products affected by its action but did not name them.Belgian drug maker Solvay markets two estrogen/androgen combinations under the name Estratest.

"FDA is acting because it does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products to treat hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone".

The agency said it was aware that these products were being prescribed for female sexual dysfunction, a use not covered by the 1976 approval.While there might be significant benefits of such unapproved uses of a drug, the FDA said, there were important benefits in demonstrating safety and effectiveness through well-planned clinical investigations.

Debate has raged for years over the use of post-menopausal hormone therapy beyond hot flashes and night sweats, amid conflicting reports over whether it prevents brittle bones and heart disease.

STUDY: High levels of CRP corresponded with a 60 to 70 percent increase in stroke risk.

JOURNAL: Circulation 2003;107

AUTHORS: Dr. J. David Curb

ABSTRACT: High levels of a protein linked to inflammation may be a sign of increased risk for stroke in healthy, middle-aged men.

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COMMENTARY: In the study, men with the highest blood levels of a protein called C-reactive protein (CRP) were nearly four times more likely than men with the lowest levels to have a stroke a decade or more later.

More research is needed, according to a team led by Dr. J. David Curb at the Pacific Health Research Institute in Honolulu, Hawaii, to see whether measuring CRP levels can identify otherwise healthy people who may have an increased risk of cardiovascular disease.

Other studies have suggested that CRP increases the risk of artery disease, heart attack and stroke. However, researchers have been unsure how the protein is related to the risk of stroke in different age groups and in people with high and low risks of cardiovascular disease.

To investigate, the team of researchers followed about 8,000 Japanese-American men aged 48 to 70 for thromboembolic stroke - a type of stroke that occurs when a clot blocks an artery supplying blood to the brain. All of the men had their CRP levels measured in the late 1960s as part of the Honolulu Heart Program.

After 20 years of follow-up, 259 men had a stroke. This group of men was compared to 1,348 men who participated in the study who did not have a history of heart disease or stroke. Men who had the highest blood levels of CRP at the start of the study were almost four times more likely to have a stroke 10 to 15 years after the study began than men with the lowest levels of the protein, Curb's team reports.

What's more, even among men without diabetes and high blood pressure -- conditions that increase the risk for stroke -- high levels of CRP corresponded with a 60 to 70 percent increase in stroke risk.

Men aged 55 and younger who had the highest levels of CRP had a three-fold increased risk for stroke, and nonsmokers had a nearly six times greater risk of stroke than men with the lowest levels of CRP.

However, CRP levels were not a good indicator of stroke risk in men older than 55, past or current smokers or in men who had high blood pressure or diabetes.

Still, the findings do not rule out that inflammation may play a role in the risk for stroke among individuals who have other risk factors for stroke.

STUDY: HRT may increase risk of blood clots, and gallbladder disease

JOURNAL: Journal of the American Medical Association

AUTHORS:

ABSTRACT: Long-term hormone use doesn’t reduce heart attack risks in postmenopausal women with heart disease and may increase their chances of developing blood clots and gallbladder disease, new research suggests.

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COMMENTARY: THE FINDINGS in Wednesday’s Journal of the American Medical Association add to mounting evidence questioning doctors’ long-standing belief that hormone supplements benefit the heart by mimicking the effects of natural estrogen, which helps keep cholesterol at healthy levels.

The new research provides follow-up data on a study that was among the first to challenge that belief. The original data showed that heart patients followed for an average of about four years had more heart attacks in the first year on hormone treatment, but fewer in subsequent years. The trend suggested that benefits might occur only after long-term use.

Wyeth Pharmaceuticals, which makes the estrogen-progestin supplement Prempro used in the research, paid for the follow-up study.

The researchers found no such benefit after tracking many of the same 2,763 women for nearly three more years. During the follow-up, there were 111 heart events, including fatal and nonfatal heart attacks, in women on hormones than in those taking dummy supplements.

However, the blood clot rate was twice as high in the hormone group over the entire 6.8 years of study, with most of the risk occurring in the first few years. The rate of gallbladder disease requiring surgery was nearly 50 percent higher, bolstering evidence linking these conditions to hormone use.

The results suggest that women with heart disease should not take hormone supplements, said co-researcher Dr. Deborah Grady of the University of California at San Francisco. Grady said evidence that risks outweigh the benefits is strong enough to suggest that even women without heart disease should avoid supplement use except on a short-term basis to relieve hot flashes and other menopause symptoms.

Information on the effects of hormones in healthy postmenopausal women is expected to come in 2005 from the Women’s Health Initiative, a large national study comparing results from women taking hormones for 12 years with those on placebo pills.

If you are considering HRT talk it over with your doctor. A wise choice would be to try natural alternatives first and only resort to the stronger hormones if all else fails.

Here at the clinic the majority of women are able to go through menopause using natural HRT and take care of their bodies by doing aerobic and weight bearing exercises.

STUDY: Certain people are better than others at detecting a certain component of body odor

JOURNAL: American Psychological Society's

AUTHORS: Pierce

ABSTRACT: Certain people are better than others at detecting a certain component of body odor called androstenone, and those who can sniff out that ingredient are also more likely than others to like or dislike another person based on how they smell, according to new research.

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COMMENTARY: The people who are sensitive to androstenone are also more likely to use odors as a way of evaluating people.

Androstenone is an often-touted human pheromone, or chemical attractant, found in certain body secretions, such as human sweat. Men release the most androstenone, but women also secrete the chemical in small amounts.

About half of people cannot smell androstenone at all. In those that do catch a whiff, around half enjoy the odor, rating it as musky or similar to sandalwood. However, for the rest, the smell can resemble the foul scent of urine or sweat.



Since androstenone is only a small component of body odor, even those whose noses are blind to the particular chemical can pick up on a person's overall scent. When people do smell androstenone, it may put a certain note on a body that wouldn't be there otherwise.

In the experiment, Pierce and his team tested the androstenone-smelling abilities of 258 undergraduate students, average age 19. The investigators asked the students to smell samples of concentrated androstenone and amyl acetate, a clear liquid with a banana-like odor. They were then asked to rate how strongly another person's odor would affect their feelings about him or her.

Fifty-five participants could not detect an odor from androstenone, although all could smell the amyl acetate. Androstenone smelling ability tended to correlate with how much participants judged a person by his or her smell, with androstenone-smellers saying they were much more likely to like or dislike people based on odor. Those who rated the androstenone as unpleasant had stronger feelings about people based on smell than those who enjoyed the odor, Pierce and his team noted.

The next step in this research is to test a person's ability to sniff out other odors, and whether that also relates to how much that person uses odor to rate others in a social context. Not surprisingly, one of the next odors they plan to look at is underarm odor.

STUDY: Risks of hormone replacement outweigh benefits

JOURNAL: Journal of the American Medical Association

AUTHORS: Dr. Jacques Rossouw

ABSTRACT: Not only did hormone replacement therapy not prevent heart disease, it actually increased the risk of heart disease, strokes and blood clots, say researchers.

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The large federal study designed to help settle the raging debate over whether hormone replacement therapy benefits postmenopausal women has been abruptly halted, researchers said Tuesday. The reason: The overall health risks of the hormones taken by some six million American women exceed their benefits, the study showed.

COMMENTARY: For Years, doctors and patients alike have struggled with the question of whether the benefits of the drugs, estrogen and progestin, outweigh their risks.

Given to replace the hormones that naturally decline after menopause, the drugs relieve hot flashes, mood swings and night sweats. And early research suggested the hormones also improve a woman’s overall health.

Instead, the large Women’s Health Initiative has found that combined hormone replacement therapy raises a woman’s risk of breast cancer, stroke and heart disease.

Doctors have been anxiously awaiting the results of the trial — the first and largest study to compare the effects of the drugs to placebo in healthy women.

Upon stopping the trial, the federal government immediately sent a letter to the 16,000 participants and their doctors, advising them to stop the drugs.

DO NOT PANIC

But women taking the medications should not panic, experts stressed, noting that the absolute risk of harm to any individual is extremely small.

And there are some benefits — chiefly a reduced risk of colorectal cancer and hip fractures, the study showed.

THE BOTTOM LINE

Women who are currently taking estrogen plus progestin should have a serious talk with their doctor to see if they should continue it,” said study author Dr. Jacques Rossouw of the National Heart, Lung, and Blood Institute.

Not only did this therapy not prevent heart disease, it actually increased the risk of heart disease, strokes and blood clots. Compared with placebo, HRT raised the risk of strokes by 41 percent, heart attacks by 29 percent and breast cancer cases by 26 percent, the study showed.

Women taking the hormones for the short-term for hot flashes and other symtoms of menopause may not have a higher risk of disease but taking the drugs for years is no longer advisable, experts said. For women who have had hysterectomies and who need HRT, estrogen alone may be safer.The study did not address the question of taking estrogen alone. Its benefits and risks are being evaluated in a second clinical trial of 11,000 women, also by the Women’s Health Initiative.

This is very important to all of you out there taking HRT. Please contact your doctor and talk it over. Here at the clinic we support many women with alternatives to HRT.

You do have Options!!!!!!!