I’m happy to report that a new menopause treatment will most likely not be approved by the FDA. A panel of advisers to the Food and Drug Administration overwhelmingly voted against a Depomed drug called Gabapentin to treat hot flashes and other symptoms of menopause. Apparently, the benefits were heavily outweighed by the risks involved with this would be prescription menopause treatment.
Drug makers have been experimenting with non-hormonal treatments for menopause ever since they lost considerable market share with HRT drugs once they were proven to increase the risk for breast cancer and heart disease.
The FDA panelists overwhelmingly recommended the FDA reject the use of generically known Gabapentin pointing out that three company studies failed to show a significant reduction in hot flashes over 12 weeks. Patients also experienced side effects including dizziness, fatigue and balance problems. Gabapentin already carries a warning label that it can increase the frequency of suicidal thoughts. The FDA often follows the advice of panelists although it is not required to do so.
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How many women do you know that have been diagnosed, are being treated for, have survived, or even lost the battle against breast cancer? The current statistic is that 1 in 8 women will get breast cancer!
Breast cancer is occurring in alarming numbers of American women and nobody, not even the top doctors on the subject i.e. Dr. Susan Love, (who I recently heard at a conference), have definitive answers regarding the causes.
During menopause, many women turn to HRT for relief. Evidence linking breast cancer with HRT (Hormone Replacement Therapy) was recently released. This study, the largest ever done, was called the Women’s Health Initiative (WHI). It was first released in 2002 and now, more evidence from researchers following these women have found that HRT significantly increases a woman’s risk of being diagnosed with invasive type of breast cancer and cause death.
The new evidence suggests:
- high dose HRT increased a woman’s risk more than low-dose HRT, and
- combination HRT, both estrogen and progesterone carries an increase risk over estrogen only HRT.
After the initial WHI report was released in 2002, HRT use declined and a drop in breast cancer diagnoses was also evident.
“What’s important about this study is that it really provides tremendous clarity regarding the risks of hormone replacement therapy,” says Dr. Freya Schnabel, of New York University’s Langone Medical Center.
“I think from this point onward any woman who’s considering taking hormone replacement therapy will need to genuinely consider these risks,” says Schnabel.
What I believe is most important for women suffering from menopause symptoms such as hot flashes, night sweats, irritability etc, is to realize there are other options beyond HRT. Natural herbal remedies for menopause have been proven effective and have been used for generations of women. Women who chose to see health providers such as Acupuncturists, Homeopaths, Naturepaths and other Complementary Medicine practitioners know there are many other options for natural menopause relief.
Women really don’t need to suffer with hot flashes, poor sleep and low libido. Natural Menopause Relief does exist and it does work. If you are suffering with menopause symptoms, learn about other safer options than HRT.
Hot flashes and night sweats for 3 years, Oh MY! I friend of a friend just confided in me she’s been suffering with menopause symptoms in silence for years. When I inquire as to why, she said, “I just didn’t know what to do and I didn’t want the artificial hormones”.
Not all women need a menopause treatment plan. Menopause is a time of change and all women over 50 will experience an ending to their menstruation sooner or later.
But, not all women will need a treatment plan during their menopause years. According to Dr. Elaine Jolly, director of Ottawa’s Shirley E. Greenberg Women’s Health Centre, “Menopause is seen as not very sexy,” says Jolly. “And the menopause curriculum in medical schools is horrible. And that’s a pity, because mature women benefit from preventive care.” she says.
Jolly suspects she knows why the (menopause treatment) field is not a popular choice for medical students contemplating a specialty. It takes a full hour to have a proper consultation with a menopausal patient — and the pay is lower than other medical specialties. “You don’t get kudos for health prevention,” says Jolly. “In France, if you spend time counseling and talking about these things, you get paid.” Many frustrated women are turning to complementary and alternative medicine, she says. “They are not getting satisfaction through conventional medicine.”
I agree with you Dr. Elaine Jolly, women are turning to alternative medicine especially Chinese herbs for menopause treatment. The herbs used in Menopause Relief Herb Pack are the same ones used for centuries to help women balance their hormones and give them relief from hot flashes and night sweats.
The American Menopause Society recently published the results of a study on the use of Chinese herbs as a menopause treatment. It's always nice to see a clinical trial like this published in English (many are in Mandarin only) and this study was completed in a manner consistent with top notch clinical protocol. The study was double-blind, randomized and controlled…..ahhhh the gold standard for clinical research.
Chinese Herbal Formulas Can Reduce Menopausal Hot Flashes Safely and Effectively
Even three months after the study ended, the participants said their hot flashes did not increase after the study ended and they stopped using the menopause herbal remedy. This study shows, compared with Hormone Replacement therapy, Chinese herbs are a safe and viable alternative for menopause symptoms.
Although previous studies have found that Chinese herbs can help reduce hot flashes, those studies were not of the same quality methodology as this study, according to the researchers at Menopause: The Journal of The North American Menopause Society.
SOURCE: Menopause: The Journal of The North American Menopause Society, online February 25, 2013.
The question many women suffering with menopausal hot flashes and night sweats are asking is whether bio-identical hormones such as progesterone cream and phytoestrogen (plant sourced estrogen) are safe and effective AS the chemical hormones found in hormone replacement therapy (HRT) drugs?
Many women today are being told "bio-identical" hormones are identical to those your body makes. Even though progesterone and estrogen bio-identical creams may be closer to what your body produces there are certainly risks in using any hormone therapy. Some doctors believe the risks are just as great as taking an hormone replacement therapy drug (HRT) others believe the jury is still out because we have no long term data since these products are still very new to the market. Risks may be tied to the dosage which varies greatly from women to women.
Bio-identical hormones made from plant sources may be perfectly safe in low doses, which is the way we would ingest these chemicals found in yams, soy beans and a handful of herbs but at higher doses may be harmful. Nearly every substance found in nature can be safe in minute doses yet toxic at a higher dose. Even water can kill us when taken in to large a dose over a very short time period. Knowing what dose is right for your body can be tricky depending on blood, urine and saliva testing which may not give an accurate reading of circulating hormones in your blood which changes daily and even hourly.
Bio-identical hormones, make no mistake can be just as powerful and dangerous as taking a prescription hormone replacement drug. Phytoestrogen used in minute doses the way we find in nature may be completely safe and effective. Asian women have a long history of eating soy beans nearly everyday of their life from childhood through adulthood and experience very few menopausal symptoms. The isoflavones in soy are known to act as a hormone balancing chemicals.
So, which should you choose, bio-identical hormones or synthetic hormone replacement therapy for your menopausal symptoms? How about neither! There is a third option that women in Asia have used for centuries and the Western world is just beginning to see on store shelves. Traditional Chinese herbs are another option for menopause symptom relief. You can learn more about it here.
Breast cancer has climbed to 1 in every 8 women and now the finger is beginning to point to drug manufacturers. Wyeth and Pfizer have made combination hormone drugs for over 30 years and these HRT drugs (hormone replacement therapy) are commonly used for menopause treatments. About 10,000 cases against these pharmaceutical giants have already been filed and Pfizer has spent nearly $900 million to resolve about half of them.
Some go to trial, others settle more quietly out of court. Just last week, a Utah jury found Wyeth responsible for one woman’s breast cancer and awarded her $5 million in compensation. Utah does not allow for punitive damages.
Studies, such as the Women’s Health Initiative (WHI) study, released this statement with it’s results: “Women using Hormone Replacement Therapy (“HRT”) are more likely to develop breast cancer than those who are not using HRT.”
The National Institute of Health completed the Million Women Study in Britain a few years ago. Based on the results, the NIH concluded that the “Current use of HRT is associated with an increased risk of incident and fatal breast cancer; the effect is substantially greater for oestrogen-progestagen combinations than for other types of HRT.”
One expert testified that his research showed as many as 15,000 cases of breast cancer per year occurred in women taking the combination hormone drug. Yet the “defense witnesses told you the same thing, the same story line, that Wyeth wanted them to tell you over and over — that no one knows what causes breast cancer,” said Russell T. Abney, another attorney representing Okuda. “We are not arguing that Ms. Okuda didn’t have an abnormal cell in her body. What we are arguing is that [estrogen plus progesterone] promoted that abnormal cell to grow.”
Women don’t have to choose between drugs and cancer for debilitating symptoms of menopause. There are other choices of menopause treatment.