Herbal Usage for Hormone Replacement Therapy-_Part IX
The FDA has unveiled a Web site at www.fda.gov/womens/menopause that contains information for women who choose to continue to use hormone replacement therapy (HRT). Women who choose to use the therapy to treat symptoms of menopause should use the lowest dose for the shortest period of time.
(7/4/13)- Going against the recommendation of its advisory panel, the Food and Drug Administration approved the first non-hormonal drug designed to treat hot flashes for women going through menopause.
The drug, which will be sold under the brand name Brisdelle, is a low-dose form of the antidepressant paroxentine, commonly known as Paxil. It will be marketed by Noven Pharmaceuticals Inc., a U.S. unit of Hisamitsu Pharmaceutical Co.Inc.
The advisory panel had voted 10-to-4 against the drug's benefit-risk profile. That same panel had voted 7-7 on whether clinical data submitted in support of the drug showed it was effective at reducing hot flashes.
The black box warning label for the drug will state it can increase the risk of suicide in children and young adults.
(3/16/13)- An advisory panel for reproductive health drugs of the Food and Drug Administration overwhelmingly rejected approval of two drugs to be the first non-hormones medications okayed for the treatment of hot flashes in women.
The panel voted 12 to 2 against approving Depomed's extended-release gabapentin, and voted 10 to 4 against a low-dose formulation of the antidepressant paraxetine developed by Noven Pharmaceuticals.
Panelists felt that the drugs offered only minimal benefits as opposed to the placebos used in the clinical trials. The FDA does not have to follow the advice of the panel, but that is not the usual procedure that ensues.
Since both drugs have been approved for other purposes, doctors may prescribe them for their patients if they feel the drugs really have a substantial benefit.
(10/27/12)- The Women's Health Initiative-(WHI) study was halted in July 2002, three years earlier than expected, when researchers noticed a high rate of breast cancer and heart disease among women taking estrogen and progestin hormones. About 70% of women in the study were over age 60, an average 12 years past menopause.
The U.S. Preventive Services Task Force issued draft guidelines recommending against women taking hormone therapy to prevent chronic diseases. Many medical experts still believe that hormone therapy does aid in the fight against osteoporosis.
(6/6/12)- In the June 5th edition of the New York Times an article, "Hormone Use Benefits May Trump Risks: Age Matters" by Melinda Beck states: "Women who are close to menopause face few dangers from hormone-replacement-therapy, and the benefits may outweigh the risks for those who are suffering from severe symptoms."
In that same vein, please see our item dated 4/11/11 below. That's the consensus of a spate of new analyses clarifying a decade of research since a big government study (The Women's Health Initiative-WHI) scared millions of women and their doctors away from using hormone therapy at menopause.
Analyses that have recently come out show that women over 50 to 59 who started hormone-replacement-therapy had fewer cardiovascular problems and fewer deaths from any cause than those who started later.
Another branch of the study showed that women who took estrogen only also had a lower risk of heart disease and breast cancer.
(4/11/11)- In a follow-up study of women who were part of the Women's Health Initiative, researchers found that the females who had taken only estrogen and have had hysterectomies, and were under 50 years of age when they started taken the hormone therapy, benefited as a result of taking the treatment. Included in the benefits were a sharply reduced risk of breast cancer and heart attack.
The results of the research were published in a recent edition of the Journal of the American Medical Association. Nationwide, about one-third of women in their 50s have had a hysterectomy. The estrogen-only group was not given progestin. The beneficial findings did not apply for women in their 70s.
The data indicates that for every 10,000 women in their 50s, those using estrogen only would experience 12 fewer heart attacks, 13 fewer deaths and 18 fewer adverse events like blood clots or stroke in a given year, compared with those in the placebo group.
For every women in their 70s, using estrogen only would cause 16 extra heart attacks, 19 extra deaths and 48 serious adverse events.
According to epidemiology Professor Andrea Z. LaCroix of the Fred Hutchinson Cancer Research Center in Seattle, one of the lead researhers in the study, " No new safety concerns emerged and some risk reductions became apparent" in the women who took estrogen beginning in their 50s.
Among women in their 70s, "risks of colorectal cancer, death and chronic diseases were elevated. In those women, estrogen use was linked to a 15% increase in occurrences of a range of diseases tracked in the study.
(10/28/10)- The Women's Health Initiative was a major federally funded study of 10,739 females that compared women taking hormone therapy with a group taking a placebo. The study was halted in 2002, three years ahead of schedule, because researchers found that the combined hormone therapy group (progestin and estrogen) had a small but significant increase in the risk of breast cancer, heart disease, strokes and blood clots in the lung.
In a follow-up study of the women that covered a period of 11 years from the original 5.6 years, it was determined for the first time, that women taking the hormones would develop more advanced and deadly cancer of the breast, than did the women who were taking the placebo.
Even though it was only a slight increase, women who took the hormone therapy were more likely to have cancerous lymph nodes, a sign of a more advanced disease than the women taking the placebo.
The treatment studied was the most commonly prescribed hormone replacement pill, Prempro, which contains estrogens from horse urine and a synthetic relative of the hormone progesterone.
Dr. Rowan T. Chiebowski, an oncologist who treats breast cancer patients at the Harbour-U.C.L.A Medical Center in Torrance, Calif., and a lead researcher of the new study went on to say that it may be harmful to take the treatment even for a short period of time. The results of the study were published in a recent edition of The Journal of the American Medical Association.
Among women with breast cancer, those who took hormones were more likely to have cancerous lymph nodes 23.7% versus 16.2% in the placebo group. There were 2.6 deaths per 10,000 per year among those taking hormones, versus 1.3 deaths per 10,000 per year in the placebo group.
(7/3/10)- The U.S. Supreme Court denied a bid by Pfizer Inc.'s Wyeth unit to obtain a full new trial on an Arkansas woman's suit that taking a combination of hormone-therapy drugs caused her breast cancer.
The court left in place a 2009 appeals-court decision that said that Wyeth was entitled to a partial new-trial proceedings to determine how much money it owed in punitive damages but was not entitled to another re-trial as to the issues in the case.
A federal jury in 2008 awarded Donna Scroggin $2.7 million in compensatory damaged from Wyeth, and another Pfizer unit, Pharmacia & Upjohn Co., the makers of hormone drugs that can be taken to treat symptoms of menopause.
The jury also awarded Ms. Scroggin another $19 million from Wyeth and almost $8 million from Upjohn in punitive damages. Ms. Scroggins had taken hormone drugs for 11 years before being diagnosed with breast cancer in 2000. She alleged that the drug manufacturers had failed to give her adequate warnings that the hormone-therapy drugs created an elevated risk of breast cancer.
The drugs she had taken were Premarin from Wyeth, the progestin drug Provera from Upjohn, and later, Wyeth's Prempro. The drugs remain on the market with a "black box" warning
(7/23/09)- In a study of more than 900,000 Danish women ages 50 to 79, researchers found 140 extra cases of ovarian cancer linked to hormone replacement therapy over eight years. That meant that there was a 38% greater risk of contracting the disease, compared with women who did not receive the therapy.
Lina Steinrud Morch of Copenhagen University led the study group, the results of which were published in a recent edition of the Journal of the American Medical Association.
The findings were similar to those in the 2002 Women's Health Initiative study, which was stopped because it found an increased risk of ovarian cancer, breast cancer, strokes and other health problems from the therapy.
Both studies found that the risk diminished about two years after therapy stopped.
Ovarian cancer is diagnosed in about 18 of 100,000 women in the United States each year, and it killed almost 15,000 American women in 2007, according to governmental statistics.
(4/1/09)- The Women's Health Study also found that there were no significant effect on total cancer incidence, or cancers of the breast, lung or colon, nor any effect on cancer deaths on the women in the study who took extra doses of vitamin E on a daily basis.
(3/18/08)- Follow-up studies are still being conducted on about 15,700 women who were part of the original Women's Health Initiative (WHI) study that was halted in 2002. The purpose of the follow-up study is to assess the health risks and benefits since the hormone treatments were stopped.
Researchers, led by Gerardo Heiss at the University of North Carolina, Chapel Hill, concluded that, after an average of 2.4 years of follow-up, the women in the hormone treatment group had about the same number of heart attacks, strokes and blood clots as compared with the women in the placebo group. One of the reasons why the original study was stopped was because there was a slight increase in the risk for coronary events among the women under the treatment as opposed to the placbo group.
The follow-up study did show however, that there was a slight increase in cancer rates in the group getting the treatment as opposed to the placebo group, which was not true when the study was first stopped. This increased risk was ever so slight, but was greatest in the number of breast cancer illnesses in the treatment group versus the placebo group.
Specifically, cancer occurred at a rate of 1.56% per year among women in the treatment group compared with 1.26% per year among women in the placebo group.
The results of this study appeared in a recent edition of the Journal of the American Medical Association.
(7/20/07)- A research study presented at the American Academy of Neurology's annual meeting in Boston by Victor W. Henderson, MD of Stanford University in California found that women who used estrogen hormone therapy before they were 65 years of age had about a 50% less chance of developing Alzheimer's disease or dementia than those who did not use estrogen replacement therapy (ERT) before age 65.
The study involved more than 7000 women aged 65 to 79 for an average of five years. Dr. Henderson is quoted as saying "It didn't matter how old the woman was when she started hormone therapy, how long or recently she took it, or what kind of prior therapy she had" as long as they started before age 65.
Obviously, this study does not apply to men, nor does it take into account potential adverse effects of ERT. This should not rule out a clinically relevant effect of ERT in certain women to reduce the chances of developing some form of dementia
(9/30/07)- Researchers at the University of Texas Southwestern Medical Center in Dallas believe that they have discovered a compound related to cholesterol that can block the hormone estrogen from performing functions in blood vessels that keep then healthy and free of disease that can lead to heart attacks. This may help to explain why some women are at heightened risk for heart attacks.
The Texas researchers call the molecule 27-hydroycholesterol, or 27HC, a byproduct created as the body processes cholesterol. The researchers found in experiments in mice that 27HC and estrogen target the same receptors in blood vessels. When estrogen is present in normal amounts and 27HC levels are low, as is typically the case in women before they enter menopause, the hormone successfully latches onto the receptors, triggering actions that protect the heart.
But when estrogen falls, as it does during menopause, 27HC is able to beat the hormone to the targeted receptors and block its beneficial effects. A report on the findings will be published in the October issue of Nature Medicine, which posted the study on its Web site. David J. Mangelsdorf, a Howard Hughes Medical Institute investigator at UT Southwest lab made the discovery.
(9/12/07)- One of the most popular herbal supplements that has been used to replace hormone therapy is black snakeroot, which is also known as black cohosh. The herb extract is sold in tablets, sometimes mixed in with vitamins or other plant products. They generally cost $10 to $40 for a bottle that lasts a month or two, depending on the dosage and are not covered by insurance.
Two recent large studies reached opposite conclusions in regards to the effectiveness of the product. One of the studies was funded by a German manufacturer of Remifemin, a brand that is marketed in the U.S by Enzymatic Therapy Inc. of Green Bay, Wis. The results of this study were published recently in the journal Obstetrics & Gynecology.
The results of this study of 304 women found that the herbal extract significantly beat a placebo. A NIH-funded study of 351 women last year found that there was no difference between black cohosh and a placebo. It concluded that cohosh has "little potential" in menopause treatment.
Black cohosh sometimes carries a warning that it could cause liver damage, based on very rare case reports.
(6/28/07)- Women in their 50s, who have had a hysterectomy, who use estrogen have healthier arteries than women who don't take the drugs according to a new study that was led by JoAnn E. Manson, a WHI investigator and Harvard professor. The results of the research were published in a recent edition of the New England Journal of Medicine.
The research team used high-tech artery scans to look at calcium buildup in the arteries of 1,064 women who took part in the WHIl study of menopause hormones. Women in the 50-to 59-year old category, who were taking estrogen, and had had hysterectomies were 30% to 40% less likely to have severe coronary-artery calcium than women of similar ages who received a placebo.
Coronary artery calcium is an important predictor of heart-attack risk. The study looked only at women who had undergone hysterectomies and used only estrogen. It is not clear why estrogen appears to protect a women's heart. Prior studies have shown that hormone usage lowers bad cholesterol and raise good cholesterol. The hormone also appears to increase the elasticity and dilation of blood vessels, as well as lowering diabetes risk.
The women were either on estrogen or dummy pills for an average of 7 1/2 years. They then had cardiac scans in 2005 to check for buildup of calcium in the arteries. The women were 64 years old, on average at the time of the scans. There were no baseline scans of the women when the study started. .
(4/7/07)- The results of a new analysis of the Women's Health Initiative (WHI) that were published in a recent edition of the Journal of the American Medical Association show that younger women are not at increased risk for heart attacks if they are undergoing hormone replacement therapy. This large study was halted in July 2002 because the data suggested that the women in the study group were subject to increased risk of heart attack or breast cancer.
There were actually two studies of 27,347 in the WHI study. The average age of the women in the study was 63 of whom only 3,425 were under the age of 55. Jo Ann Manson, a WHI investigator, Harvard professor of epidemiology and co-author of the new analysis, said t gives "the most reassuring evidence to date" that women who use hormones to treat menopausal symptoms are not putting their hearts at risk.
The combined analysis showed that for every 10,000 women aged 50 to 59 who use hormones there would be 10 fewer deaths among hormone users, compared with non-users. On the other hand, among women 70 to 79 who use hormones, there would be 16 additional deaths per 10,000 women.
The Journal of the American Medical Association and other WHI investigators played down the findings, saying that the age-of-use difference was not statistically significant, and could be due to chance.
Dr. Jacques Rossouw, a researcher for the National Heart, Lung and Blood Institute who directed the WHI study said, "This says that if you are older than 60, you should not take it (HRT)".
The original premise of the WHI study was that HRT could prevent heart attacks, and some even felt that it would be a sort of fountain of youth for women.
(2/24/07)- This week's issue of the medical journal Circulation reports on the results of a study that was conducted on 881 women who used a medical patch instead of taking pills for hormonal replacement therapy. The study found that the risk for blood clots was sharply reduced among a group of women who used a patch or a gel rather than using pills.
The study, which was conducted by French researchers, found that women who used hormone patches or gels were at no higher risk for blood clots than women who did not take hormones at all. Women who used the pills were at four times greater risk for developing blood clots as were women who did not use them.
The research, collected from a continuing study called ESTHER (Estrogen and Thromboembolism Risk), was funded primarily by French governmental health agencies, but also received some financing from drug companies that make patch treatments. The women who were studied were taking either estrogen only or an estrogen-and-progestin combination.
The most popular brands of the patch are Climara, made by Berlex of Wayne, NJ and Vivelle-Dot from Novogyne, a joint venture of Novartis and Noven Pharmaceuticals.
Some medical professionals explain the difference that may be resulting in the safer results for the patch is because the hormones delivered by the patch, or by usage of gel, do not having to pass through the liver. The hormones from the patch enter the blood stream directly, unlike a pill that has to be metabolized by the liver before it enters the blood stream.
More research is being conducted on this difference from a Kronos Early Estrogen Prevention Study, or KEEPS, which is now recruiting women who are within three years of menopause. Women in the KEEPS study, (www.keepstudy.org ) will be given different forms and types of estrogen and progestin, including patches and pills.
A nonprofit institute in Phoenix funds the study, at eight major medical centers.
(2/14/07)- The North American Menopause Society (NAMS) is a leading medical organization that advises women on midlife issues. The Society recently noted that the risk of diabetes is lowered for women who use hormones.
The organization said that there is not enough evidence as yet to suggest that women start taking the hormones to prevent diabetes, but the matter is presently under study. According to the World Health Organization more than 3.2 million deaths each year are attributable to diabetes Wulf Utian, executive director of the NAMS stated, "But there are now a number of studies suggesting that estrogens are having a beneficial effect on sugar metabolism."
Diabetes is the leading cause of blindness, kidney failure, impotence and amputations. It shortens life expectancy by 5 to 7 years. The leading cause of death among people with diabetes is heart attack and stroke.
In 2004 the incidence of diabetes increased by 34% among people between the ages of 45 and 64, jumping to 11.4 cases per 1,000 people form 8.5 cases in 1997. According to the Women's' Health Initiative, women who used estrogen and progestin were 21% less likely to develop diabetes, and women who used estrogen alone were 12% less likely to develop the disease.
(1/16/07)- The controversy in the medical community over the interpretation of the stoppage of the Women's Health Initiative study in 2002 still rages on today. That governmental-funded study of more than 27,000 women set out to determine whether menopause hormones helped prevent heart disease, a benefit widely ascribed to hormone use.
Many have questioned the methodology involved in the study since it involved older women who took menopause hormones long after they completed menopause. The average women in the study was 63, and most women in the study started taking hormones at least 10 years past menopause.
An American College of Obstetricians and Gynecologists (ACOG) task force concluded that menopause hormones are the most effective treatment, reducing hot flashes by up to 90%. The task force also recommended avoiding spicy foods, caffeine and alcohol.
If you are a healthy woman, and your flashes are severe or disruptive to your life, hormones are likely to be a good option. This is especially true if you have a good family history in regards to breast cancer or cardiovascular problems. The ACOG recommendation is to use the lowest effective dose for the shortest period of time possible, and to review the hormone therapy every year.
Women with a history of cardiovascular problems should refrain from using hormone therapy. Many in the medical community are convinced that hormones aren't risky to women who are still close to menopause, and may be actually benefit the heart.
Menopause hormones appear to increase the risk of blood clots and strokes, but since the average menopausal woman is younger than 55, her overall risk of stroke remains low. Women who are at high risk of having strokes should refrain from taking the hormones.
If you are a woman who has had a hysterectomy most medical experts feel you can take estrogen therapy without statistically increasing the risk of breast cancer for up to 20 years. After 20 years the risk does increase slightly.
Women in the WHI study who had never used menopause hormones but started taking them for the study were 9% more likely to be diagnosed with breast cancer than women who never took hormones at all.
(1/2/07)- The results of a study that was conducted on 351 women suffering from hot flashes and night sweats found that those given black cohosh got about the same amount of relief as those who took a placebo. The study was conducted at Seattle based Group Health, a health plan, and the results were published in the Annals of Internal Medicine.
The result was disappointing news for women seeking alternative treatment's to estrogen-progestin hormone supplements.
Dr. Rebecca Jackson, lead author of the Women's Health Initiative study recommends, for women older than 65 years, regular resistance or weight-bearing exercise 3 times/week for 30-60 minutes, calcium intake of 1200-1500 mg/day, with vitamin D intake of 600-800 IU/day.
(7/2/06)- Only about one-half of the women who take herbal supplements tell their physicians that they are taking these supplements according to a study, the results of which were published in the May/June issue of Menopause: The Journal of the North American Menopause Society. The study was carried out in June 2004, and included 781 women ages 40 to 60.
GalxoSmithKline financed the study, but the company played no role in the study's methodology, data collection or analysis. Dr. Jun Ma, a research associate at the Stanford Prevention Research Center at Stanford University was the lead author of the study.
The most frequently used products were ginko biloboa, ginseng, St. John's wort, black cohosh and combination herbal remedies. Even though about two-thirds of the current users thought that they were effective in relieving symptoms, 70% of the former users thought they did not help.
Many of the women in the survey felt that their physicians did not have enough knowledge about herbal supplements to give them knowledgeable answers to any questions that they might have about the supplements.
It was also determined that more than one-half the women in the study take soy supplements or herbs as part or all of their hormone therapy.
(5/10/06)- Because of the health risks associated with traditional hormone replacement therapy became known 4 years ago as part of the WHI study, sales of these drugs have fallen off sharply. According to the latest numbers from IMS Health, a research study firm, sales of these drugs have fallen about in half from 2002 to about $2 billion.
The maker of the biggest seller among these drugs, Wyeth has petitioned the FDA to take action against makers of pharmacy mixed, or "compounded" hormones which the drug company claims aren't being adequately regulated. The agency has not responded to Wyeth's position, but emails have been flooding into the FDA in support of the compounders.
Compounding involves custom making of a drug because of a particular need of the patient. Drugs manufactured by the drug industry are geared towards the average patient, while oftentimes, some patients have individual traits that require some deviation from the average. Many patients are convinced that custom-made drugs are safer that mass marketed drugs.
Pharmacies are regulated by the state's pharmaceutical boards, while it is the function of the FDA to oversee the drug industry as a whole. The compounded medications use custom doses of plant-based hormones, and they are often called bio-identical hormones because they are chemically similar to a woman's natural hormones.
(4/28/06)- As more and more of the data from the Women's Health Initiative becomes available, the degree of uncertainty about the results continues to increase. According to the latest report that appeared in the Journal of the American Medical Association, some investigators now feel that using estrogen alone, without progestin doesn't increase the risk of breast cancer. It was determined that estrogen users were 20% less likely to develop breast cancer after an average of seven years taking the drug than women taking a placebo.
This 20% figure isn't statistically significant and by itself does not support the use of estrogen to prevent breast cancer. The result of the study do however raise question marks about the use of progestin,, which many women had taken in combination with the estrogen.
On the other hand it was found that estrogen does raise the risk of blood clots in older women who were taking the drug, but not as much as supplements that also contained progestin. This study involved over 10,000 women. The results of this study appeared in the Archives of Internal Medicine.
Women who previously suffered from blood clots faced the highest risk of developing new clots during the estrogen-only study.
(4/4/06)- A recent article by Jane Brody in her Personal Health column of the N Y Times discussed how she accidentally found out that the epilepsy drug gabapentin, which had been sold under the brand name of Neurontin helped alleviate her own hot flashes. The article entitled "A Chance Find, and Voila! Goodbye, Hot Flashes, Hello, Sleep" discussed how she has been helped by taking gabapentin.
The writer of this article discussed in one of my other article how I also feel that both Neurontin, since I was taking that drug before it came off patent in 2004, and gabapentin helped me in my ongoing battle with spinal stenosis: "Spinal Stenosis- A Personal Chronicle-Gabapentin, the Generic Version of Neurontin is on the Market".
Please keep in mind that Neurontin was approved by the FDA for usage in connection with epilepsy in 1994. The FDA also approved it in 2002 to treat postherpetic neurolgia, which is an ailment wherein extreme nerve pain is involved. In both my own case and in Ms. Brody's case we were using the drug for off-label purposes.
In her article, Ms. Brody goes on to quote from Dr. Thomas J, Guttuso, Jr. a neurologist at the University of Rochester Medical Center. According to Dr. Guttso, gabapentin: "does not interact with any other medications, which is very unique, so doctors don't have to worry about other drugs a patient might be taking. Also, gabapentin is not metabolized, so it has no effect on the liver. It's fully excreted in the urine."
Two companies are currently conducting studies involving gabapentin. Pharma-Nova, has patented a sustained-release formulation of gabapentin to see if it can reduce hot flashes, as occurred for example with Ms. Brody. Pfizer, which was the patent holding company for Neurontin, has introduced and sold Lyrica, which has been approved for treating nerve pain caused by shingles and diabetes.
Both Ms. Brody, and I coincidentally, initially took 300-mg dosages of the drug 3 times a day. I was able to reduce the dosage to two times a day, then to one, and then to none. Ms. Brody does continue to take the drug. In updating my article recently, I discussed the fact that the pain is beginning to reappear, with my last spinal cortisone shot having been administered in July 2004. I received my first spinal shot in July of 2002, and attribute the relief that it brought me more to the shot than I do to the gabapentin.
When my physician administered the spinal cortisone shots to me, he did explain to me, that if they do work, it is good for about a two-year period. You can only have 3 cortisone shots administered within a 6-month period of time. I did require two of the shots to help alleviate my pain in 2002, but needed only one of them in 2004
(3/3/06)- A large clinical study of the effectiveness of calcium and vitamin D supplements in preventing broken bones found that they were of little use in preventing broken bones in postmenopausal women. This seven year, $18 million study was part of the Women's Health Initiative (WHI) study, that concluded in 2002 that hormone replacement therapy that was stopped early because it was found that HRT did increase the risk of stroke and heart attacks in post-menopausal women.
In this study, the investigators will continue to monitor the subjects for another 5 years. The investigators also concluded that calcium and vitamin D supplements were not meaningfully useful in preventing colon cancer.
Last week, the WHI study concluded that low fat diets do not protect against breast or colorectal cancer, or heart disease. The trial looked only at postmenopausal women, and did not study whether calcium and vitamin D supplements were helpful in warding off osteoporosis before the onset of menopause.
Rebecca D. Jackson, an endocrinologist at the Ohio State University Medical Center in Columbus, Ohio, and the study's lead author said, that calcium and vitamin D still remains a "foundation' of good bone health. Women involved in the study were randomly assigned to take 1,000 mgs of calcium and 400 international units of vitamin D a day, or to take placebos for seven years. There were 36,282 subjects involved in the study who were normal, healthy women between the ages of 50 to 79.
Researchers looked for effects on bone density, fractures and colorectal cancer. One of the subgroups data did indicate that there was an increase in hip bone density. There was no significant difference in the rates of fractures among the calcium takers and the control group for spinal fractures, arm and wrist fractures, or "total" fractures, a group that includes most other bone breaks.
(2/13/06)- The Women's Health Initiative trials were carried out under the auspices of the National Heart, Lung and Blood Institute and other centers at the National Health Institutes of Health. One section included 16,608 postmenopausal women from 50 to 79 who were taking a popular combination of estrogen and progestin, which is a synthetic form of progesterone, or a placebo pill. This trial was halted in 2002 when the researchers concluded that after five years women who were taking the hormones were at increased risk for breast cancer, stroke and blood clots, and were not protected from heart disease. They were at a significantly higher risk from heart attacks during the first year of treatment.
The other section included 10,739 women who had had hysterectomies and who were taking estrogen alone or a placebo. It was stopped prematurely in February 2004, when researchers concluded that after almost seven years the therapy increased the risk of strokes and clots in the leg, and did not curb heart disease.
The average age of the participants in the study was 64, while the average age of menopause is 51.4. Many health experts are now questioning the fact that hormone replacement therapy is harmful, when in fact, the age of the women involved in the tests were far above the age for the onset of menopause. They are recommending that younger women continue to take HRT therapy to help alleviate the symptoms of menopause.
The Kronos Early Estrogen Prevention Study, or KEEPS is presently recruiting women for a randomized clinical trial that hopes to better answer the question of whether timing of hormone use makes a difference in terms of risks and benefits particularly to the heart. To find out more about this study please go to www.kronosinstitute.org/keeps.html . It will track markers of early atherosclerosis in 720 women initiating hormone therapy within three years of menopause.
Another trial sponsored by the National Institute of Aging, the Early vs. Late Intervention Trial With Estradiol, or Elite, will follow 504 postmenopausal women for an average of three years. Investigators for the Women's Health Initiative have been tracking 1,000 women who were in their 50's when they enrolled in the estrogen only study. The research will measure their rates of coronary artery calcification.
(2/2/06)- Recent evaluations of hormone replacement therapy indicates that younger women may lower the risk of heart attacks by using this treatment. The results of the findings were recently published in the Journal of Women's Health. In 2002 all women were warned that hormone usage increases the risk for heart attacks and strokes in addition to the risk of breast cancer.
The article in the Journal was co-written by JoAnn Manson, the chief of preventive medicine at Brigham and Women's Hospital in Boston and the principal investigator for the Women's Health Initiative report that linked hormones with higher heart-attack risks.
In this new article researchers found that risk of heart problems among hormones users increased the more time that had elapsed since the woman experienced menopause. Women who started hormones between the ages of 50 and 59 had a 44% lower risk of heart problems. Women who started hormones between the ages of 70 and 79 had a 4% higher risk of heart attacks.
Women who began hormone therapy near menopause had about a 30% lower risk for heart disease than women who did not use hormones.
Those women who used estrogen and progestin within 10 years of menopause showed an 11% lower risk of heart problems than nonusers. Women who started hormones 10 to 19 years past menopause had a 22% higher risk of heart attack. In general, women who took estrogen or a combination of estrogen and progestin did not make a marked difference in risk.
Most of the 27,000 women in the WHI clinical trial were older women who started hormones 10 or more years after menopause. Hormones still have been found to carry the risk of blood clots and increased breast cancer risk. The FDA recommendation that if women used the hormones, it should be done in lower doses only still stands.
The Kronos Early Estrogen Prevention Study, or KEEPS is presently recruiting women for a randomized clinical trial that hopes to better answer the question of whether timing of hormone use makes a difference in terms of risks and benefits particularly to the heart. To find out more about this study please go to www.kronosinstitute.org/keeps.html .
(11/19/05)- Many medical experts contend that the now-famous Women's Health Initiative study overstated many of the risks for the majority of women who use hormones replacement therapy. Prescriptions for both estrogen and estrogen/progestin combinations dropped by 10% during the first eight months of the year compared with the same period last year, according to IMS Health, a pharmaceutical consulting company.
In the non-pill area growth continues to take place. Patches, vaginal creams and lower-dose hormone treatments continue to be extensively used by women. Many health experts continue to believe that two to three year usage of the higher dose hormone treatment has not proven to be dangerous to woment.
The WHI was initially designed to determine whether giving hormones to older women might protect them from heart disease so most of the study participants were in their 60s and 70s. The women who were in that study who were in their 50s showed that there was no increased risk for heart attacks or breast cancer in their age group.
Older women who start hormones long past menopause clearly are at higher risk. It has also been determined from a second aspect of the WHI study that women who took estrogen alone, instead of the estrogen/progestin combination had a lower risk for heart problems and breast cancer. The usage of low-dose hormone treatments, such as low-dose Prempro has surged 54% in the past eight months. Prescriptions for the estrogen patch Vivelle-Dot have also jumped sharply this year. The use of vaginal Premarin has also shown a sharp rise this year.
(1/27/05)- The FDA has granted approval to Warner Chilcott to begin marketing its low-dose version of Femhrt, a hormone therapy treatment prescribed for symptoms of menopause. The company said it would begin selling the product sometime in the 2nd quarter of 2005. The product combines two hormones, an estrogen called ethinyl estradiol and a progestin, norethindrone acetate. The new version is half the dose already being sold. Warner Chilcott is a closely held maker of women's health care products, and is based in Craigavon, Northern Ireland and Rockaway, N.J.
(10/14/04)-In addition to the increased risk for stroke and breast cancer that women have in connection with hormone replacement therapy, researchers have now added the hazard of blood clotting to the list of risks. The researchers found that there is about double the risk of venous blood clots, which can travel to the lungs and result in fatality. This study was also based on an analysis of the Women's Health Initiative (WHI). The WHI involved the taking of estrogen plus progestin. The drug involved Prempro has since been removed as a recommended treatment therapy.
According to a group of researchers and doctors at the MedStar Research Institute in Washington hormone replacement therapy may be especially dangerous for older women with diabetes. The group under the leadership of Barbara Howard studied 423 women past menopause who had atherosclerosis and also abnormal glucose tolerance meaning that they had diabetes or a precursor. The researchers found that if these women took hormone replacement therapy, they had a much higher risk of developing heart disease.
The study was based on an analysis of the Women's Health Initiative. In another report that was published in the June issue of Fertility and Sterility, doctors said that younger women just entering menopause might be at risk of heart disease from the treatment.
It has long been known that half of the women who are over 50 will experience some sort of bone fracture related to osteoporosis. About 25% of those who suffer a hip fracture require long-term care, and the risk for dying within a year jumps by as much as 20%. "Women who are 50 should be far more concerned about their bone health," says Steven Goldstein, co-Director of Bone Densitometry at the NYU School of Medicine.
The FDA has approved The Menostar,a new low-dose estrogen patch for use in osteoporosis prevention. The patch is manufactured by Berlex of Montvale, N.J.. The patch delivers a dose of 14 micrograms of estrogen a day. In a 2-year study of the patch even the tiny estrogen dose was shown to increase bone density by 2% to 3% in women's spines. Women in the study did not take progestin and did not show a higher risk for endometrial cancers. The patch is only for osteoporosis prevention, and it is not clear whether it would have any impact on menopause symptoms.
It is generally recommended that a woman get a bone-density scan at the age of 65, but many doctors recommend the scans as early as 50. Once you get a bone-density scan you learn your "T-score", a number used to indicate your level of bone health. For post-menopausal women, a score up to minus 1.0 is normal. A score between minus 1.0 and minus 2.5 is classified as osteopenia or low bone density. Anything below minus 2.5 is considered osteoporosis.
The National Institutes of Health has announced that it has halted the second part of the Women Health Initiative because of the "increased risk of stroke" for women on estrogen therapy a year ahead of schedule. In addition to the finding of the increased risk for stroke the institute also found that the treatment offered no protection against heart disease. An earlier part of the study was halted in 2002 because researchers found an increased risk of breast cancer in women taking the combined hormones estrogen and progestin.
The FDA said it would assess the findings to determine whether the labelling on estrogen and directions to patients should change. The estrogen study included 11,000 women ages 50 to 79 who were assigned either estrogen tablets or a placebo and followed them for an average of seven years. The women in the second part all had hysterectomies.
In a study it was also determined that postmenopausal women who developed colorectal cancer while on the combined hormone treatment of estrogen and progestin were diagnosed later with the disease than women who were not on the treatment. The study was done under the leadership of Rowan Chlebowski, who is the medical director and an oncologist of a WHI center in Torrance, California.
Doctors halted a major international study on hormone-replacement-therapy after preliminary results suggested that even short-term use significantly increased the risk of tumor recurrence in breast-cancer survivors. An international study was originally planned to follow at least 1,300 women (for a period of 5 years) who have had breast cancer. The trial was stopped after about two years. In the study the 345 women who were enrolled in the test were divided into two groups.
One of the groups had been taking hormone therapy and the other a therapy other than hormones. It was found that 26 patients reported a new case of breast cancer in the hormone-therapy group while only seven women reported a new case of breast cancer in the group that received other than hormone therapy. Lars Holmberg of the University Hospital in Uppsala, Sweden was one of the authors of the paper that was published in the British medical journal Lancet.
One of the weaknesses of the trial was that the doses of hormone therapy varied, so it was impossible to ascertain which dose, or which combination of hormones poses the greatest risk for patients.
About one-quarter of the women who stop taking hormone-replacement therapy because of its risk have been found to resume taking the pills since they suffered such painful menopause symptoms according to a research study that examined the problem. Deborah Grady a researcher at the University of California, San Francisco, randomly surveyed 377 patients in the Kaiser Permanente health plan in Northern California who had given up on hormone-replacement therapy.
According to Dr. Grady's study about 1/4 of the women returned to taking the pills even if they had tapered off slowly from taking the pills. Dr. Grady said that if the women are otherwise low risk candidates for heart disease or cancer they shouldn't be scared away from taking the pills. Some women have switched from the hormone treatments to taking the anti-depressants such as Prozac and Effexor, which can offer some relief even if the users aren't depressed.
The most commonly used herbal remedy that has been recommended as an alternative to the estrogen pills is black cohosh, but research results are mixed in connection with its effectiveness. Clonidine, a blood-pressure medicine is another possible alternative but the negative to this alternative is that it may drive your blood pressure to extremely low levels. Trazodone, a sleeping pill has been shown to be somewhat effective for women who were experiencing hot flashes.
The Web site includes a pocket guide for women to bring to their doctor's office when discussing the various options that are available to them, including the alternatives to HRT. It explains how to weigh the risks and benefits of both the estrogen-progestin combination and estrogen alone, which is an option for women who have had a hysterectomy. The FDA is partnering with several women's health groups to distribute information on this topic.
"Even among women at high risk of fracture, there was no added benefit," said Dr. Jane Cauley, a professor of epidemiology at the University of Pittsburgh, and the leading author of a study of hormone replacement therapy. Even though hormones do prevent broken bones in postmenopausal women, the researchers say the benefit is not worth the risks. The risks include increased risk of heart disease, breast cancer, strokes and blood clots in the lungs.
The FDA does permit the usage of Prempro to prevent osteoporosis, but agency officials will meet with researchers to reevaluate this position. The study results were published in the October 7 edition of the Journal of the American Medical Association.
In an article in the August 12th edition of the N.Y. Times, written by Leslie Berger entitled "Herbs for Hot Flashes:New Attention, Mixed Results" mention is made of the fact that upon review, black cohosh seems to be the most promising herbal remedy so far in connection with the hot flashes associated with menopause.
The study was lead by Dr. Adriane J. Fugh-Berman, an expert in women's health at George Washington University, and Dr. Fredi Kronenberg, a professor of physiology at Columbia University in New York. "Their review, published in the Annals of Internal Medicine, found that in 10 clinical trials of five herbs and one herbal mixture tested for hot flashes, just black cohosh has shown a beneficial effect."
In another report of the results of the Women's Health Initiative it was found that hormone therapy nearly doubles a woman's risk of having a heart attack during her first year of treatment. It reinforces the thought that hormone replacement therapy should be restricted to healthy middle-aged women seeking temporary relief from the symptoms of menopause.
"There did not appear to be any group of women with clear evidence of heart protection from hormone therapy," stated Dr. Jo Ann Manson, one of the principal investigators of the Women's Health Initiative. Dr. Manson is chief of preventive medicine at Harvard's Brigham and Women's Hospital in Boston. The researchers found that a women's risk of heart attack rises by 81% in the first year of the therapy. It levels off, so that after 5.6 years the increased risk is 24%.
A new analysis of data from the Women's Health Initiative found that even short-term use of Wyeth's drug Prempro increases the risk of breast cancer and also causes abnormal mammograms. The latest report found that women taking Prempro after only three years had a 26% higher risk of invasive breast cancer than women taking the placebos. The study found that compared with women not on hormones, those who take estrogen and progestin tend to develop tumors that are discovered at a more advanced stage and are harder to cure. For some unknown reason the mammograms for women on hormone replacement treatment are harder to read since they are much murkier than those women who are not on the treatment.
The latest analysis of the WHI study found that even during the first year, the rate of abnormal mammograms increased in the treated group. In the Prempro group, 9.4%, or 716 women had abnormal mammograms, compared with 5.4%, or 398, in the placebo group. Since nearly two-thirds of the women in the WHI study were women aged 60 or over, results need to be kept in perspective for younger women. This is because HRT has been shown to be effective at relieving symptoms that many menopausal women find debilitating, including insomnia, hot flashes and mood changes.
Another study published in The Journal of the American Medical Association found that combined hormones doubled the risk of Alzheimer's disease and other types of dementia in women who began the treatment at age 65 or older. Prempro combines a form of estrogen derived from the urine of pregnant mares and synthetic progestin. Some of the newer forms of HRT use a different form of estrogen-estradiol-which is closer to what women actually lose in menopause, and a form of progesterone that is identical to that found in the body. These newer forms of HRT have not been shown to have the same links to breast cancer and heart disease as Prempro.
In January of 2003 the FDA called on all makers of estrogen and estrogen-plus progestin products to carry a warning label. Prempro carries the warning on its label highlighting the increased risk of heart disease and breast cancer.
Results of the Women's Health Initiative study showed that hormone therapy doubled the risk of Alzheimer's disease and other types of dementia in women who began the treatment at age 65 or older. In four years, there were 40 cases of dementia in the hormone group, and 21 in the placebo group. Translating this to larger numbers it would mean that for every 10,000 women 65 and older who took the hormone treatment, there will be 45 cases of dementia a year, with 23 of them being attributable to the hormones.
Wyeth, the company that makes Prempro, the hormone drug, said it would add a new warning about the increased risk of dementia to the drug's labeling. It is not known whether the results apply to women younger than 65 who were taking the treatment. About 2.7 million American women take combination hormone therapy, including 1.2 million who use Prempro. Prempro was never approved to prevent or treat Alzheimer's disease.
In a notice placed in the Federal Registry, the FDA has called into question a hormone-replacement therapy drug that has been on the market since 1964. The drug in question is Estratest, a combination of estrogen and methyltestosterone made by the Belgium drug company Solvay SA. The drug generated $178 million in sales last year, and doctors have written nearly 35 million prescriptions for it in the last 12 years.
The drug did not have FDA approval but fell within the cracks of the law since it has been around for so long. The drug was intended to help women through hot flashes, vaginal dryness and other symptoms of menopause. The FDA stated that it "no longer believes' there is evidence that the drug combination is effective for its intended use. The action by the FDA initiates the process for the drug maker to either prove the efficacy of the drug or else it will be removed from the market.
The FDA also announced that it was starting a formal inquiry of the estrogen-androgen combination it approved for hot flashes in 1976. It also stated that proof would be required for the claim that it restored sex drive.
The latest announcement from the Women's Health Initiative study was that hormone replacement therapy for menopause does not affect the quality of life for the women taking the treatment. Women taking the drug do not feel more energetic, or have more sexual pleasure or even more restful sleep. They were not less depressed, did not have clearer minds nor did their memories improve to any appreciable extent. Thus in addition to the prior finding of increased health risk we must now look at the fact that there is no great benefit to the quality-of-life for women taking the treatment. The results will be published in The New England Journal of Medicine on May 8, but the journal released the results early because of the significance of the finding. There were 16,608 women involved in the study
Medical experts cautioned that the study did not include the minority of women with symptoms so severe that they were ineligible to accept the possibility of taking a placebo as part of the study. According to Dr. Barbara Alving, the study's director, the study shows that when it comes to quality of life, "there really is no difference."
A panel that was created to advise the federal government in connection with health issues has joined the growing chorus of experts who have expressed doubts about the value of hormone replacement therapy in preventing many of the diseases associated with aging. The panel, known as the United States Preventive Services Task Force, consists of 14 independent experts in the health field, and it recommendations are generally adopted by Medicare, health plans and insurers. The panel did not advise for or against hormone therapy to treat menopausal symptoms, but instead said that women should consult their personal physicians on this matter.
Dr. Janet D. Allen, vice-chairwoman of the task force, and dean of the school of nursing at the University of Maryland, said that the federally financed study, the Woman's Health Initiative (WHI), was particularly important in the panel's decision on this matter. The WHI study did find a slight increase in heart attacks, stoke and blood clots, but did find decreases in broken hips and colorectal cancer.
Wyeth has changed the labels on its hormone-replacement products to advise doctors of studies that linked some of the treatments to health risks. The company changed the product label information for Prempro, Premarin and Premphase to reflect the higher risk involved for women who take the drug in connection with their menopause problems.
With the news that hormone replacement therapy carries a slightly higher risk for women to develop heart disease, breast cancer and strokes many women and their physicians are looking to herbal usage for safe products that at the same time can help with the problem. They certainly are being inundated with a plethora of ads on the subject. The organization that represents the manufacturers and retailers of herbal supplements, The Dietary Supplement Education Alliance has produced a video which informs women about alternative treatments that its members have available for treating menopause symptoms.
GlaxoSmithKline's herbal product that it is promoting for safe usage for women with the problem is Remifemin. Novogen claims that its herbal product Promensil relieves hot flashes and helps with bone growth and heart strength. Transitions for Health Inc.is advertising its Pro-Gest menopause cream to help women deal with the problem.
According to the North American Menopause Society, about 30% of menopausal women use some kind of alternative therapy from acupuncture to so-called phytoestrogens, estrogen-like substances found in plants. Black cohosh has been used in Europe for centuries to treat hot flashes. Even its proponents acknowledge however that it takes anywhere from four to six weeks before relief will be felt. Doctors who do recommend black cohosh do also recommend that it be used for only 6 months since the National Institute of Health's study of the effect on the bone, heart and mood has not been published yet. The NIH is still recruiting volunteers for the study at 212 342 0104.
Studies have shown that soy also reduces cholesterol levels, hot flashes and helps with bone growth. The down side of soy consumption is the fear the large consumption of soy may increase the risk of breast cancer.
The Chinese herb dong qua is widely used in Asia to reduce hot flashes and cardiovascular circulation. The down side of its usage is that it can cause bleeding and sensitivity to the sun. Other herbal supplements making claims as to being able to help with the menstrual problem are evening primrose, red clover and wild yam.
Please keep in mind that manufacturers of herbal supplements and vitamins aren't required to prove their products safety and efficacy by the FDA. The quality of their products is also an issue that has to be of concern to the consumer.
Please See: Herbs and Dietary
Supplements-St. John's Wort-Part I
St. Johns Wort -Herbs and Dietary Supplements-Part II-Ephedra
Phytomedicine or Herbalist-What is It?-Part III
Herbal Medicine and Botanical Supplements Caveat-Part IV
Treating Osteoarthritis with Dietary Supplements-Part V
St John's Wort: Does It Help Treat Depression-Part VI
Herbal Products:Use With Caution-Part VII
Kava: Safety Alert-Part VIII
Latest Research Questions the Effectiveness of Herbal Supplements-Part X
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
updated July 4, 2013
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