Tag Archives: menopause

Soy tablets NOT effective treating menopausal symptoms

Taking soy supplements will NOT ease the symptoms of menopause or protect against bone loss in women, researchers have reported. In fact, among women in the first five years of menopause, taking soy supplements was associated with a higher risk of bone loss compared with placebo, but significantly more women taking soy supplements had hot flashes. Continue reading

ConsumerLab.com announces test results of supplements for menopause

Women looking for relief from hot flashes and other menopausal symptoms often turn to supplements containing estrogen-like isoflavones (from soy or red clover), the herbal remedy black cohosh, or creams containing progesterone. A new report from ConsumerLab.com provides quality ratings for over 20 such products and identifies those providing amounts of compounds shown to be effective in clinical studies.  Continue reading

Flaxseed does not help reduce hot flashes

A new study is showing that flaxseed is NOT associated with a significant reduction in hot flashes for women with menopausal symptoms or breast cancer survivors taking anti-estrogen drugs. Continue reading

Isoflavones reduce postmenopausal insomnia, hot flashes

In a past blog, Natural Medications (Herbs, Vitamins, and Supplements) for Menopausal Symptoms, I discussed the data supporting a trial of isoflavones in women with menopausal symptoms. However, there was not a lot of data. Now, Medscape is reporting, “Isoflavones may reduce insomnia symptoms” in postmenopausal women, according to a small study in the journal Menopause. Continue reading

Antidepressant eases menopausal hot flashes

For menopausal women suffering from hot flashes, nothing has proven more effective than hormone replacement. However, many women are reluctant to utilize this therapy, so they often look to both natural medicine options (herbs, vitamins, and supplements) as well as other prescription medication options. Now there’s a new option for menopausal women to consider.

Bloomberg News reports that the antidepressant Lexapro (escitalopram) “eased hot flashes” in menopausal women, thus proving itself a “potential alternative to hormone treatments,” according to a study published in the Journal of the American Medical Association and sponsored by the National Institutes of Health as “part of a $22-million program to research potential treatments for menopause.”

According to the Los Angeles Times “Booster Shots” blog, the researchers randomized 205 “women who were experiencing hot flashes to take a daily dose” of escitalopram or a placebo. They found that for the women taking the antidepressant, “hot flashes decreased from 9.8 per day to 5.26.”

Moreover, women taking escitalopram said their hot flashes were not as severe. Women taking the placebo “experienced a decline in hot flashes, as well, but not as great: from 9.8 to 6.43 per day.”

The Washington Post “The Checkup” blog reported, “Although the benefit was modest, it appeared to be significant enough that women might consider trying it, the researchers said.”

According to the Time “Healthland” blog, “Many women currently have no effective long-term treatment for hot flashes.”

Physicians had long prescribed “hormone therapy as the go-to treatment for menopausal symptoms, but largely stopped doing so in 2002, when the results of the large, federally funded Women’s Health Initiative showed that the risks of hormone treatment — including heart disease and breast cancer risk — outstripped its benefits.”

CNN /Health.com points out, “Currently, hormone therapy is the only prescription treatment for hot flashes approved by the Food and Drug Administration, and the effectiveness of herbal remedies such as black cohosh and evening primrose oil is disputed.”

Still, noted HealthDay although selective serotonin reuptake inhibitors are approved by the FDA “for the treatment of depression,” some physicians “prescribe them for ‘off-label'” uses.

WebMD notes that the mechanism by which escitalopram relieves hot flashes remains unknown. The study authors theorized that “the antidepressant works by providing more of the hormone serotonin to the brain.”

So, this gives us physicians another tool to offer our menopausal patients suffering from hot flashes.

Hormone therapy helpful for younger women?

Hormone therapy (formerly called HRT or hormone replacement therapy) may pose little risk to younger women, and could even help some aspects of their health – but any benefit appears to disappear as women age, according to a new study.

Among more than 70,000 postmenopausal women, some of whom had elected to take hormone therapy (HT), younger HT-users were less likely to die from all causes over a nearly 10-year period than women of the same age who had never taken HT. However, as women aged, taking HRT was no longer associated with a lower risk of death. Here are the details in a report from Reuters Health:

“Whatever benefits there are for younger women, they don’t really persist for older women,” study author Dr. Daniel Stram of the Keck School of Medicine in California told Reuters Health.

HRT has remained controversial since 2002, when the Women’s Health Initiative, a massive government-sponsored clinical trial investigating HRT’s benefits, was abruptly halted. Researchers stopped the study when they found that women on HRT were not only not enjoying any protection from heart disease, they were showing higher rates of heart attack, stroke, breast cancer and blood clots than placebo users.

This week, investigators revealed in still another study that women who took HRT had more advanced breast cancers and were more likely to die from them than women who took a placebo. You can read my blog on this study here.

As a result, experts now advise that while HRT is effective at relieving menopausal symptoms — like hot flashes and vaginal dryness — women should take it at the lowest dose and for the shortest time possible.

In the meantime, researchers are still analyzing data to tease out the health effects, both positive and negative, associated with hormone replacement.

In the current report, published in the journal Menopause, Stram and his team reviewed data collected from 71,237 postmenopausal women, some of whom had elected to take HRT. They found that, among women younger than 65, those who took HRT were at least 45 percent less likely to die during an 8- or 9-year period than those who never took hormones. Even women up to age 74 experienced a slightly lower death rate when taking HRT.

By age 75, however, death rates became equal among HRT-users and never-users.

Given the mix of evidence about HRT, however, it’s too soon to say that hormones are good for younger women, cautioned Dr. Graham A. Colditz at Washington University School of Medicine in Missouri, where he is associate director of the Siteman Cancer Center. Instead, this and other studies suggest that any benefit, if it exists, disappears as women age. “The older they get, the longer they take (hormones), the less benefit they seem to get from taking them,” Colditz told Reuters Health.

One reason studies show different effects of HRT may stem from differences in how the studies are designed, he added. In the current study, women chose whether or not they wanted to take HRT, while in others – such as the halted government clinical trial – investigators randomly assigned women to receive either HRT or placebo.

It’s possible that women who choose to take HRT are healthier overall than other women their age, suggested Colditz, who was not involved in the current study.

It’s also not clear why, biologically, HRT might have different effects on younger and older women, he added. “I hope some of the ongoing studies will give us a bit of insight into this.”

Hormone therapy after menopause may worsen breast cancer

The CBS Evening News recently reported, “For women going through menopause, the decision about whether to take hormone replacement therapy has been controversial and confusing.” In 2009, “40 million prescriptions for hormones were filled here in the US, but there’s new evidence tonight that this treatment may be even riskier than previously thought.”

ABC World News also covered the story, reporting, “The Women’s Health Initiative reports today that among post-menopausal women, the use of estrogen and progestin is not only linked to an increased risk of breast cancer, but the kind that kind of cancers that have higher fatality rates. The safety of more hormone replacement therapy was first questioned in 2002.”

NBC Nightly News, not to be outdone, reported, “Our lead story tonight has to do with an emotional and perplexing topic for millions of American women — hormone replacement therapy; specifically, its relationship to breast cancer.” Chief science reporter Robert Bazell explained that a new study published in the Journal of the American Medical Association “suggests that hormone replacement therapy, estrogen plus progestin, once the most commonly prescribed medication for women 50 and older, not only increases the risk of aggressive breast cancer, but increases the risk that cancers will be more advanced and deadly.”

In a follow-on piece, NBC Nightly News reported, “Some big questions come out of this. What does this all mean?” Dr. Beth Dupree, medical director of the Breast Health Program at Holy Redeemer Health System in Pennsylvania, explained to viewers that women who are using or considering taking hormone replacement therapy to manage the symptoms of menopause need to “weigh the risks and benefits” in the light of severity of symptoms and discuss them with their physicians. Dr. Dupree also added that the “study shows women are dying at a higher frequency and those hormones probably played a role in that.”

On its front page, the New York Times reports, “Hormone treatment after menopause, already known to increase the risk of breast cancer, also makes it more likely that the cancer will be advanced and deadly,” the study found.

Specifically, “women who took hormones and developed breast cancer were more likely to have cancerous lymph nodes, a sign of more advanced disease, and were more likely to die from the disease than were breast cancer patients who had never taken hormones.” Notably, “the treatment studied was the most commonly prescribed hormone replacement pill, Prempro [conjugated estrogens and medroxyprogesterone], which contains estrogens from horse urine and a synthetic relative of the hormone progesterone.”

According to the coverage by the Washington Post, “The study of more than 12,000 women who were followed for about 11 years produced powerful evidence that deaths from breast cancer were more common among hormone-users, apparently because their cancers had already started to spread.”

The Post notes that “for years, doctors recommended that women take hormones to alleviate hot flashes and other symptoms of menopause to protect their hearts and generally remain more youthful. But eight years ago, the federally funded Women’s Health Initiative revealed that hormones’ benefits were outweighed by risks, including heart disease and breast cancer.”

Bloomberg News reports that the present study’s “findings conflict with previous studies showing breast cancers in women taking hormone therapy had a lower risk of death, said Christopher Loder, a spokesman for New York-based Pfizer, in a statement yesterday.” Pfizer is the manufacturer of Prempro. Loder stated, “We stand behind the current, science-based guidance in Prempro’s label, which advises doctors to prescribe the medicine at the lowest effective dose and for the shortest duration.” He suggested that “women should talk to their doctors about how long they should be on the therapy.”

The Los Angeles Times “Booster Shots” blog noted, “As of now, doctors recommend hormone therapy only for women who have severe menopausal symptoms — such as hot flashes — and only for a year or two.”

However, “a study on whether even one or two years of hormone therapy increases the risk of breast cancer is needed, Dr. Peter B. Bach, of Memorial Sloan-Kettering Cancer Center, in New York, said in an editorial accompanying the study.” Bach wrote, “Clinicians who prescribe brief courses of hormone therapy for relief of menopausal symptoms should be aware that this approach has not been proven in rigorous clinical trials and that the downstream negative consequences for their patients are of uncertain magnitude.”

The Wall Street Journal and HealthDay also covered the story for consumers, while healthcare professionals may want to review the coverage by MedPage Today and Medscape.

8 Tips for Eating Healthy During Menopause

Good news! Aging does not have to equal weight gain. Women do tend to put on a pound a year in their 40s and 50s, but it’s more likely due to a drop in activity rather than hormones. However, hormonal changes can shift your body composition, so any pounds you do gain tend to land in your middle. Here are some tips from Rachel Meltzer Warren, MS, RD, that were first published on Health.com:

Here are some ways to stay slim, reduce menopausal symptoms, and cut the health risks that can rise after menopause.

1) Go fish

Heart disease risk is likely to rise after menopause, so you should try to eat at least two servings of fish per week (preferably those with healthy fats like salmon or trout).

“Women may want to give [fish oil] supplements a try if having two servings of fish a week is problematic,” says JoAnn Manson, MD, chief of preventive medicine at Brigham and Women’s Hospital, in Boston.

Preliminary research suggests that fish oil may also help prevent breast cancer.

Aim for two servings of fish a week—and talk to your doctor about whether or not you should try a supplement.

2) Slim down

If you’re overweight you can minimize menopausal symptoms and reduce the long-term risks of declining hormones by losing weight, says Mary Jane Minkin, MD, clinical professor of obstetrics, gynecology, and reproductive sciences at Yale University School of Medicine, in New Haven, Conn.

Slimming down not only reduces the risks of heart disease and breast cancer, both of which go up after menopause, says Dr. Minkin, but new research shows that it may also help obese or overweight women cut down on hot flashes.

3) Bone up on calcium

Your calcium needs go up after age 50, from 1,000 milligrams per day to 1,200 mg. “With less estrogen on board, your bones don’t absorb calcium as well,” says Dr. Minkin.

If you have a cup of low-fat milk, one latte, and one 8-ounce yogurt, you’re getting around 1,100 mg calcium. This means you need to take only an additional 100 mg of supplements a day—less than one caplet’s worth—to make up the difference.

If you’re eating dairy, choose low-fat products. These have roughly the same amount of calcium as their full-fat counterparts, but with fewer calories.

4) Ease bloating

“About 100% of my patients going through menopause complain of bloating,” says Dr. Minkin. Although the reasons aren’t clear, fluctuating hormones during perimenopause may play a role.

Dr. Minkin recommends cutting the amount of salt and processed carbohydrates in your diet, as they can make you retain water. But don’t skimp on whole grains, which are rich in heart-healthy fiber, as well as fruits and vegetables.

If healthy food, such as apples and broccoli, make you feel bloated, Dr. Minkin suggests taking Mylanta or Gas-X to combat gas buildup.

5) Rethink that drink

Red wine gets a lot of press for its impact on heart health, but for menopausal women the drawbacks of alcohol might outweigh the benefits.

“One drink a day has been linked to an increased risk of breast cancer,” says Dr. Manson. “So while it has been linked to a reduced risk of heart disease, it really is a trade-off for women.”

If you enjoy a glass of Pinot, try watering it down with seltzer to make a spritzer (you’ll cut calories too). Also keep in mind that red wine and other drinks may bring on hot flashes as a result of the increase in blood-vessel dilation caused by alcohol.

6) Say yes to soy

Soy contains plant estrogens, so many women think it can increase their breast cancer risk, says Dr. Minkin. However, there is little data to support this. The misconception likely comes from studies of high-dose soy supplements, which may stimulate the growth of estrogen-sensitive tumors.

Soy foods like tofu, soy nuts, and soy milk may offer relief from mild hot flashes and are not thought to increase breast cancer risk. “Women in Japan have the highest soy intake and the lowest risk of breast cancer, but Japanese women who move to the U.S. and eat less soy have a higher risk,” adds Dr. Minkin.

7) Try iced herbal tea

A warm cup of joe might be as much a part of your a.m. routine as brushing your teeth. Still, starting your day with a piping-hot drink may not be the best idea during menopause.

“In general, warm beverages seem to trigger hot flashes,” says Dr. Manson. “And the caffeine in coffee and tea could also be having an effect.”

Cover your bases by swapping your morning cup with something cool and decaffeinated—like a Tazo Shaken Iced Passion Tea at Starbucks or a decaf iced coffee.

8) Find a diet that fits

If you need to shed pounds, weight loss is no different during menopause than before it. “If you take in less calories than you burn for a long period of time, you’re going to lose weight,” says Dr. Minkin.

Any balanced diet that cuts calories—and that you can stick with in the long run—will do the job.

However, one study found that postmenopausal women who were on a diet that was low in fat and high in carbohydrates from vegetables, fruits, and grain were less likely to gain weight than women who ate more fat. Consider the new CarbLovers Diet which is rich in whole grains and other figure-friendly foods.

Weight loss may help reduce menopausal hot flashes in overweight or obese women

CNN reports, “Overweight women who experience hot flashes — the uncomfortable flushing and sweating spells that accompany menopause — may be able to cool those symptoms by losing weight,” according to a study published in the the Archives of Internal Medicine.

HealthDay explained that study participants “were encouraged to exercise at least 200 minutes a week and reduce caloric intake to 1,200-1,500 calories per day.” Meanwhile, matched controls “received monthly group education classes for the first four months.”

WebMD pointed out that participants all “had a BMI of 25 or higher” at the study’s start.

Six months later, “compared with those in the health education program, women who were in the weight loss program and were bothered by hot flashes had more than twice the odds of reporting a measurable improvement after six months.”

What’s more, those women also lost weight, had a smaller waist size, and a decreased BMI.

Of course, the weight

Hormone Therapy for Menopause Reviewed

According to a new review of the role of perimenopausal hormone therapy published in Obstetrics & Gynecology, women must be informed of the potential benefits and risks of all treatment options for menopausal symptoms and concerns and should receive individualized care. Here’s an update from MedPage. It’s long, but very helpful:

“With the first publication of the results of the Women’s Health Initiative (WHI) trial in 2002, the use of HT [hormone therapy] declined dramatically,” write Jan L. Shifren, MD, and Isaac Schiff, MD, from Harvard Medical School and Massachusetts General Hospital in Boston.

“Major health concerns of menopausal women include vasomotor symptoms, urogenital atrophy, osteoporosis, cardiovascular disease, cancer, cognition, and mood. … Given recent findings, specifically regarding the effect of the timing of HT initiation on coronary heart disease [CHD] risk, it seems appropriate to reassess the clinician’s approach to menopause in the wake of the recent reanalysis of the WHI.”

Many therapeutic options are currently available for management of quality of life and health concerns in menopausal women.

Treatment of vasomotor hot flushes and associated symptoms is the main indication for hormone therapy, which is still the most effective treatment of these symptoms and is currently the only US Food and Drug Administration–approved option.

For healthy women with troublesome vasomotor symptoms who begin hormone therapy at the time of menopause, the benefits of hormone therapy generally outweigh the risks.

However, hormone therapy is associated with a heightened risk for coronary heart disease. But, based on recent analyses, this higher risk is attributable primarily to older women and to those who reached menopause several years previously.

Hormone therapy should not be used to prevent heart disease, based on these analyses. However, this evidence does offer reassurance that hormone therapy can be used safely in otherwise healthy women at the menopausal transition to manage hot flushes and night sweats.

Although hormone therapy may help prevent and treat osteoporosis, it is seldom used solely for this indication alone, particularly if other effective options are well tolerated.

Short-term treatment with hormone therapy is preferred to long-term treatment, in part because of the increased risk for breast cancer associated with extended use. Also, the lowest effective estrogen dose should be given for the shortest duration required because risks for hormone therapy increase with advancing age, time since menopause, and duration of use.

Low-dose, local estrogen therapy is recommended vs systemic hormone therapy when only vaginal symptoms are present.

Alternatives to hormone therapy should be recommended for women with or at increased risk for disorders that are contraindications to hormone therapy use. These include breast or endometrial cancer, cardiovascular disease, thromboembolic disorders, and active hepatic or gallbladder disease.

In addition to estrogen therapy, progestin alone, and combination estrogen-progestin therapy, there are several nonhormonal options for the treatment of vasomotor symptoms:

  • Lifestyle interventions include reducing body temperature,
  • maintaining a healthy weight,
  • stopping smoking,
  • practicing relaxation response techniques, and
  • receiving acupuncture.

Although efficacy greater than placebo is unproven, nonprescription medications that are sometimes used for treatment of vasomotor symptoms include isoflavone supplements, soy products, black cohosh, and vitamin E. (You can read more about these in a previous post of mine.)

There are several nonhormonal prescription medications sometimes used off-label for treatment of vasomotor symptoms, but they are not approved by the Food and Drug Administration for this purpose. These drugs, and their accompanying potential adverse effects, include the following:

  • Clonidine, 0.1-mg weekly transdermal patch, with potential adverse effects including dry mouth, insomnia, and drowsiness.
  • Paroxetine (10 – 20 mg/day, controlled release 12.5 – 25 mg/day), which may cause headache, nausea, insomnia, drowsiness, or sexual dysfunction.
  • Venlafaxine (extended release 37.5 – 75 mg/day), which is associated with dry mouth, nausea, constipation, and sleeplessness.
  • Gabapentin (300 mg/day to 300 mg 3 times daily), with possible adverse effects of somnolence, fatigue, dizziness, rash, palpitations, and peripheral edema.

“Women must be informed of the potential benefits and risks of all therapeutic options, and care should be individualized, based on a woman’s medical history, needs, and preferences,” the review authors write.

“For women experiencing an early menopause, especially before the age of 45 years, the benefits of using HT until the average age of natural menopause likely will significantly outweigh risks.

St. John’s wort may cool the hot flashes of menopause

Reuters Health has a nice report on the popular herbal remedy, St. John’s wort, and some news from a small study that says it may help ease menopausal hot flashes. St. John’s wort is probably best known as an herbal antidepressant, with some clinical trials suggesting that it can help relieve mild to moderate depression symptoms. A few studies have also investigated the herb’s effects on menopausal symptoms, but have focused on its impact on mood — and not the so-called vasomotor symptoms of menopause, which include hot flashes and night sweats. Here’s the Reuter’s report:

“(The) findings of our study suggest that this herbal medicine can be used to treat hot flashes due to menopause, and it is a new finding about the usage of St. John’s wort,” Marjan Khajehei, of Shiraz University of Medical Sciences in Iran, told Reuters Health in an email.

Khajehei and her colleagues found that among a group of women they randomly assigned to take either St. John’s wort or an inactive placebo for eight weeks, those using the herb saw a greater reduction in daily hot flashes.

Among women taking St. John’s wort, the average number of hot flashes declined from roughly four per day at the start of the study to fewer than two per day at week eight. In contrast, women in the placebo group were having an average of 2.6 hot flashes per day by the eighth week. The herb also appeared to lessen the duration and severity of the women’s hot flashes, Khajehei and her colleagues report in the journal Menopause.

The study included 100 women who were 50 years old, on average, and had been having moderate to severe hot flashes at least once per day. The women were randomly assigned to take either drops containing St. John’s wort extract or placebo drops three times a day for eight weeks. While women in both groups saw their hot flashes improve, those taking the herbal extract had a better response, on average.

St. John’s wort contains estrogen-like plant compounds called phytoestrogens, and it’s possible that these compounds explain the benefits seen in this study, according to Khajehei. However, she said, further research is needed to confirm that the herb eases hot flashes and that phytoestrogens are the reason.

St. John’s wort is generally considered safe when taken as directed, Khajehei noted. Still, she added, since phytoestrogens have mild estrogen-like effects in the body, women who have any contraindications to using estrogen — such as a history of breast or endometrial cancers — should talk with their doctors before starting St. John’s wort.

The herb has also been shown to interact with certain medications, including antidepressants, the heart medication digoxin, the birth control pill, and the blood thinner warfarin.

I join with many other experts who generally recommend that people on any medication talk with their doctors or pharmacists before starting an herbal remedy.

The study is published in the journal Menopause, March 2010. You can find the table of contents of this edition here. The abstract of the study is available for free toward the bottom of the page.

To learn more about alternative medicine, take a look at my best-selling book, Alternative Medicine: The Christian Handbook. You can also view the table of contents here and read the first chapter here.

You can read more on this topic at my blog entry, Natural Medications (Herbs, Vitamins, and Supplements) for Menopausal Symptomshere.

Amberen a new supplement for hot flashes. Does it work?

According to a new report by the Natural Medicines Comprehensive Database (NMCD), Amberen is a popular new dietary supplement used mainly for menopausal symptoms such as hot flashes. The manufacturer says the product is “Backed by published clinical, toxicology and safety studies, and over 30 years of research, Amberen is your best choice for a natural alternative to HRT.”

The NMCD say, of Amberen, “It contains unusual ingredients including ammonium succinate, calcium disuccinate, magnesium disuccinate hydrate, and others.” But, does it work? The Database relates, “Although patient testimonials suggest that the product might help, there is NO reliable clinical research.”

To doctors NMCD says, “Don’t recommend this product until there is reliable evidence of safety and effectiveness.” For menopausal women, this is one product I’d recommend you skip until there’s more reliable data.

You can read more on this topic at my blog entry, Natural Medications (Herbs, Vitamins, and Supplements) for Menopausal Symptoms, here.

No Science to Back Actress Somers’ Potentially Harmful Menopause Advice

Miserable in menopause, Elizabeth Alsgaard pondered an awful choice: Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed “bioidentical” hormones, just like ones the body makes.
“Anything I can put into my body that’s natural has to be better,” said Alsgaard, a California audiologist who admitted having “no knowledge base to go on other than fear” when she took Somers’ advice.
Millions of women have tried custom-compounded hormones or herbal supplements like black cohosh and red clover since 2002, when a big federal study found risks from traditional hormone replacement therapy, or HRT.
Alternative remedies are especially popular with upscale, educated women who like to research and find their own solutions to medical problems. They like the idea of personalized treatments versus off-the-shelf prescription drugs.
However, instead of a safer option, they are getting products of unknown risk that still contain the estrogen many of them fear, women’s health experts say.
“Misinformation is rampant” about bioidenticals, said Dr. JoAnn Manson, preventive medicine chief at Harvard-affiliated Brigham and Women’s Hospital in Boston. “It really is buyer beware.”
She and other experts explain:
—”Bioidentical” is a marketing term that has no accepted medical meaning. Its implied benefit is not unique to alternative remedies; many prescription drugs contain hormones that chemically match estrogens and progesterones made naturally by the body.
—Custom-compounded hormones are not approved by the federal Food and Drug Administration and have not been proved safe or effective. They may carry the same cancer and heart risks as traditional treatments and have had even less testing to find out.
—Hormone preparations do not need to be customized for each woman; a few standard doses work for almost everyone, medical experts say. The saliva tests that some women are given to tailor formulas are of dubious value because hormone levels fluctuate widely throughout the day.
—Compounding pharmacists use such different methods that a customized prescription can contain widely varying amounts of hormones depending on who fills it.
—Many compounders use estriol, a form of estrogen not approved for sale in the United States. The FDA is in a battle with compounding pharmacies over its use.
The bottom line?
“Women need to understand there’s no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there’s much less evidence for efficacy and very little research on long-term safety,” said Manson, who has no industry ties and was a key researcher in the big federal study that warned women in 2002 of the health risks from long-term hormone use.
For years, medical groups have warned against custom-compounded hormones. The American College of Obstetricians and Gynecologists has denounced claims about their safety. The American Medical Association has urged more FDA oversight. The Federal Trade Commission has filed complaints against online sellers who made health claims for natural progesterone creams without supporting evidence.
In 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Manson writes in her book, “Hot Flashes, Hormones and Your Health.”
That has not stopped their popularity, and Somers has promoted them in several best-selling books and on “The Oprah Winfrey Show” earlier this year.
“I laugh when they call me a quack,” said Somers, who rubs hormones on her arms, injects them vaginally and takes some 60 supplement pills each day. In a phone interview, Somers said she is not trying to play doctor but to share with women what worked for her.
The issue flared last year, when the FDA declared that custom-mixed hormones were no safer than traditional treatments and warned pharmacies to stop using estriol, which is not approved in the United States for any use. (Most traditional menopause therapies use a different form of estrogen with a similar name — estradiol.)
The industry claimed it was being persecuted and fought back. In full-page ads in major newspapers, several alternative medicine groups claimed that estriol is safe, criticized “synthetic, hyper-expensive” prescription drugs, and asked, “Why is the FDA so hostile to ‘natural’ medicine?”
There are several thousand compounding pharmacies in the United States and hormones are a significant part of their business, said L.D. King, executive director of the International Academy of Compounding Pharmacists in Missouri City, Texas. No one knows how many women use these products, but “we believe the FDA action on the estriol issue would have affected hundreds of thousands of women,” King said.
A group of nine compounding pharmacies sued the FDA. After a murky ruling by a federal court in Louisiana centering on federal versus states’ authority, neither side appealed, King said.
“It gets complicated and there’s not a win,” he said. “We continue to advocate that FDA’s action is wrong.”
Alsgaard was not aware of the flap. She was 52 and living in San Diego when she stopped taking birth control pills, and menopause symptoms “hit me like a brick wall.” Her doctor, a specialist in women’s health, urged traditional hormone replacement therapy.
“She was just so aggressive it really flipped me out,” said Alsgaard, who feared a cancer risk from the pills. After reading one of Somers’ books, Alsgaard went to a different doctor specializing in bioidentical hormones.
“She spoke at a physician’s level, talked about metabolic things I didn’t understand and sold me a couple hundred dollars of supplements I never took,” Alsgaard said. “I was so desperate it was like, ‘OK, OK, just give me whatever I need.”‘
Although Alsgaard did not use the supplements, she did spend about $1,000 for saliva tests, hormone creams and custom-compounded hormone pills the doctor prescribed. Six months later, she was still miserable.
Disgusted with the doctor and in the middle of moving to Los Angeles, she found a new doctor and asked again for a natural remedy, believing those are safer than traditional hormone pills.
“He did a lot more extensive workup on me and put me on a bioidentical implant, a pellet implanted into the hip,” she said.
Pellets containing estrogen, testosterone or both are the latest craze in this field. They are implanted just under the skin every few months under a local anesthetic, and are not FDA-approved for treating menopause. Problems that have been reported include difficulty removing the pellets if the therapy has to be discontinued, infection or pain at the injection site and fluctuating blood levels of estrogen, including a potentially high cumulative effect over several years.
Alsgaard did not know the pellets lack FDA approval. Her first, implanted in April, has done the trick, she said.
“I feel awesome. I have no night sweats, no hot flashes, no mood swings. After feeling so terrible, I’d forgotten how good it feels to feel normal,” she said.
Whether her estrogen pellet is any safer than traditional estrogen pills is unknown.
Her physician, Dr. Kevin Pimstone, an internist at UCLA, said hormone pellets are “a very small part of my practice” — a few patients a month.
“I’m a really conventional doctor who offers this to patients who ask for it,” he said. “I don’t think there’s any evidence that bioidentical hormones are any safer than conventional hormones.”
———
On the Net:
FDA on hormone compounds: http://tinyurl.com/kv7sqb
Federal alternative medicine center: http://nccam.nih.gov/health/menopause/menopausesymptoms.htm
The AP is carrying a story about a woman who was miserable in menopause, Elizabeth Alsgaard, who “pondered an awful choice:” Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed “bioidentical” hormones, just like ones the body makes. But, is there any science to support Somers’ claims? And, could her claims be potentially harmful to women? Continue reading

Hormones beat botanicals for hot flashes but memory may suffer

My patients suffering with perimenopausal or menopausal symptoms often wonder about the safety and effectiveness of hormone therapy or botanicals (such as black cohosh and red clover) to treat their symptoms. Two recent studies will help inform wise decision making for these problems.

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Hormone therapy for menopause symptoms increases ovarian cancer risk. Should you worry?

I’ve received questions from women who are taking hormone therapy for menopausal symptoms who are wondering about a flurry of news reports this last week like this one from Bloomberg News: “Women who had hormone therapy for menopause symptoms were more likely to develop ovarian cancer, regardless of the length, formulation, or type of treatment they received.” If you or someone you love is on hormone therapy, should you worry?

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New Guidelines on Postmenopausal Hormone Therapy

MedScape is reporting that the North American Menopause Society (NAMS) has updated its guidelines on postmenopausal hormone therapy (HT) and issued a position statement published in the July/August issue of Menopause. Recent data suggest that the benefit-risk ratio for HT is favorable near menopause but decreases with aging and time since menopause in previously untreated women.

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