Menopause

Plano OB Gyn Associates J. Kyle Mathews, MD

Welcome to the Virtual Office for Plano OB Gyn Associates. Founded by J. Kyle Mathews, MD, Plano OB Gyn Associates is dedicated to providing state of the art care for women. Our staff offers timely, compassionate and personalized care. We strive to provide you with answers and options, as quickly as possible, and to assist you in understanding the personal solutions best suited to meeting your individual needs. Through this site you access to the latest medical information on Women’s Health and the ability to establish a personal medical home in order to receive guidance regarding you healthcare concerns.

Menopause

Menopause is the permanent end of menstruation and fertility, defined as occurring 12 months after your last menstrual period. It is a natural process in a woman’s life marking the end of her reproductive years. This process causes the ovaries to produce fewer hormones that cause menstrual periods, which leads to irregular and eventually the end of menstruation altogether. The average age of the menopause is 51 but symptoms may begin well before this.

Menopause is broken down into three categories, perimenopause, or “pre” menopause, menopause, and postmenopause. Perimenopause is the time in which your body begins to move toward menopause and can range anywhere from two to eight years. During this time the levels of your reproductive hormones (estrogen and progesterone) can become imbalanced. Your menstrual cycles may lengthen or shorten, and you will begin to have menstrual cycles in which you don’t ovulate. Menopause is reached once you have not had a menstrual period for 12 consecutive months. This period is often associated with symptoms most often associated with menopause such as vasomotor symptoms (hot flashes or flushes), vaginal dryness, interruption of sleep, and mood swings. This period may last for several months or several years but eventually most symptoms resolve. The Postmenopausal period is generally a period where most symptoms have resolved.

Worldwide, the life expectancy for women has increased and in the United States women can expect to live 80 years or more. It is estimate 30 million women in the US are now menopausal and that an additional 6 million women will reach this stage during this decade.

Most important, even though menopause is not an illness, you shouldn’t hesitate to get treatment if you’re having severe symptoms. Many treatments are available, from lifestyle adjustments to hormone therapy.

Symptoms of Menopause

Even though Technically, you don’t actually “hit” menopause until it’s been one year since your final menstrual period, the signs and symptoms of menopause, often appear long before the one-year anniversary of your final period.

They may include:

Irregular periods
Vaginal dryness
Hot flashes or flushes, Vasomotor Symptoms
Sleep disturbances
Mood swings
Increased abdominal fat
Thinning hair
Male Pattern Hair Growth
Loss of sexual desire, Libido
And others

Testing and Diagnosis of Menopause

Menopause is diagnosed by history and physical. Laboratory test to check your level of follicle-stimulating hormone (FSH) and estrogen (estradiol) may be done. As menopause occurs, FSH levels increase and estradiol levels decrease. These test help confirm menopause and rule out other possible causes of symptoms.

Treatment of Perimenopause, Menopause, and Postmenopause

The treatment of Perimenopause, Menopause, and Postmenopause has become extremely confusing for women. Many traditional therapies using estrogen were called into question by the WHI study in 2001. This has allowed a vast proliferation of misinformation, misinterpretation of scientific data, and the development of treatment “potions” by unethical providers.

Dr. Mathews is committed to providing patients with factual information regarding treatment options and management to allow women to make an informed decision regarding their care.

Most treatments focus on relieving your signs and symptoms you may experience.

Treatments may include:

Hormone therapy. Estrogen therapy remains, by far, the most effective treatment option for relieving menopausal hot flashes. Depending on your personal and family medical history, replacement estrogen in the lowest dose needed to provide symptom relief for you may be indicated. Women who still have their uterus will require the addition of progesterone to prevent the uterus from developing possible problems.
Low-dose antidepressants. Venlafaxine (Effexor), an antidepressant related to the class of drugs called selective serotonin reuptake inhibitors (SSRIs), has been shown to decrease menopausal hot flashes. Other SSRIs can be helpful, including fluoxetine (Prozac, Sarafem), paroxetine (Paxil, others), citalopram (Celexa) and sertraline (Zoloft).
Gabapentin (Neurontin). This drug is approved to treat seizures, but it also has been shown to significantly reduce hot flashes.
Clonidine (Catapres, others). Clonidine, a pill or patch typically used to treat high blood pressure, may significantly reduce the frequency of hot flashes, but unpleasant side effects are common.
Bisphosphonates. Doctors may recommend these nonhormonal medications, which include alendronate (Fosamax), risedronate (Actonel) and ibandronate (Boniva), to prevent or treat osteoporosis. These medications effectively reduce both bone loss and your risk of fractures and have replaced estrogen as the main treatment for osteoporosis in women.
Selective estrogen receptor modulators (SERMs). SERMs are a group of drugs that includes raloxifene (Evista). Raloxifene mimics estrogen’s beneficial effects on bone density in postmenopausal women, without some of the risks associated with estrogen.
Vaginal estrogen. To relieve vaginal dryness, estrogen can be administered locally using a vaginal tablet, ring or cream. This treatment releases just a small amount of estrogen, which is absorbed by the vaginal tissue. It can help relieve vaginal dryness, discomfort with intercourse and some urinary symptoms.

It is important that you are evaluated during the years leading up to menopause (perimenopause) and the years after menopause (postmenopause) for preventive health care as well as care of medical conditions that may occur with aging.

A Word About “Bio-Identical Hormones

Bioidentical hormones are sometimes called “natural” hormones—even though they are synthesized in a laboratory— because they are identical to the hormones that women make in their bodies. (Conventional hormone therapy uses estrogens or progestins that differ slightly from the hormones made in the body. Likewise, hormones purified from natural sources are not necessarily bioidentical.)

There are two types of bioidentical hormone products:

• Pharmaceutical products. These are compounds that have been approved by the U.S. Food and Drug Admini- stration (FDA). Their quality and safety is regulated so it is the same product every time. These products (particularly estradiol) are available as pills, patches, gels, and vaginal inserts.

• Custom-made products. When many people think of bioidentical hormones, they think of custom- made products. These are made in a compounding pharmacy (a pharmacy that mixes medications according to a doctor’s specifications). Often these contain varying amounts of two or three types of estrogen. Although some ingredients are approved by the FDA, the compounds (the final product that is created after all the individual ingredients are combined) are not. And because these compounds are not regulated by the FDA, they can be of low quality and the dosage can change with each batch.

Both types can be taken by mouth (pills), through the vagina (creams, rings) or through the skin (patch, gel, injection). Because the quality of custom- made products can vary, it is probably safer to use pharmaceutical products. This way you’ll know exactly what you’re getting and how much.

How do you know what is best for you?

Are bioidentical hormones safer to use than other forms of hormone therapy?

To date there is no scientific proof to show that bioidentical hormones, whether prepared by a compounding pharmacy or pharmaceutical company, are safer to use than other forms of hor- mone replacement. All forms of HT may have potential risks, whether compound- ed or pharmaceutical, bioidentical or not.

The lack of FDA oversight of compounded hormones means that the dose you get may not be the same from refill to refill. For consistent safety and dose, it is best to take FDA-approved hormone preparations, whether they are bioidentical or synthetic.

Bio-Identicals: Sorting Myths from Facts

“A natural, safer alternative to dangerous prescription drugs”

“Can slim you down by reducing hormonal imbalances”

“Prevents Alzheimer’s disease and senility”

All of these claims have been made by marketers of compounded “bio-identical” hormones, also known as “bio-identical hormone replacement therapy” (BHRT). But these claims are unproven. FDA is concerned that claims like these mislead women and health care professionals, giving them a false sense of assurance about using potentially dangerous hormone products.

FDA is providing the facts about “BHRT” drugs and the uncertainties surrounding their safety and effectiveness so that women and their doctors can make informed decisions about their use.

“BHRT” is a marketing term not recognized by FDA. Sellers of compounded “bio-identical” hormones often claim that their products are identical to hormones made by the body and that these “all-natural” pills, creams, lotions, and gels are without the risks of drugs approved by FDA for menopausal hormone therapy (MHT). FDA-approved MHT drugs provide effective relief of the symptoms of menopause such as hot flashes and vaginal dryness. They also can prevent thinning of bones. FDA has not approved compounded “BHRT” drugs and cannot assure their safety or effectiveness.

During menopause, a woman’s body produces less of the hormone estrogen, which may lead to hot flashes, vaginal dryness, and thin bones. MHT drugs contain estrogen or a combination of estrogen and another hormone, a progestin. FDA-approved MHT drugs are sold by prescription only, and FDA advises women who choose to use hormones to use them at the lowest dose that helps, for the shortest time needed.

Some “BHRT” drugs are compounded in pharmacies. Traditional compounding involves combining, mixing, or altering ingredients by a pharmacist, according to a prescription from a licensed health care professional, to produce a drug that meets an individual’s special medical needs. FDA considers traditional compounding to be a valuable service when used appropriately, such as customizing a drug for someone who is allergic to a dye or preservative in an FDA-approved medicine. But some pharmacies that compound “BHRT” drugs make unsupported claims that these drugs are more effective and safer than FDA-approved MHT drugs.

FDA is taking action against pharmacies that make false and misleading claims about “BHRT” drugs and is encouraging consumers to become informed about these products and their risks. Here is some information to help sort the myths from the facts:

Myth: “Bio-identical” hormones are safer and more effective than FDA-approved MHT drugs.

Fact: FDA is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded “BHRT” drugs. “They are not safer just because they are ‘natural,’” says Kathleen Uhl, M.D., Director of FDA’s Office of Women’s Health.

Drugs that are approved by FDA must undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug to ensure its safety and effectiveness—from early testing, to the design and results of large clinical trials, to the severity of side effects, to the conditions under which the drug is manufactured. FDA-approved MHT drugs have undergone this process and met all federal standards for approval. No compounded “BHRT” drug has met these standards.

Pharmacies that compound these “BHRT” drugs may not follow good drug manufacturing requirements that apply to commercial drug manufacturers. Compounding pharmacies custom-mix these products according to a health care professional’s order. The mix contains not only the active hormone, but other inactive ingredients that help hold a pill together or give a cream, lotion, or gel its form and thickness so that it can be applied to the body. It is unknown whether these mixtures, which are not FDA-approved, are properly absorbed or provide the appropriate levels of hormones needed in the body. It is also unknown whether the amount of drug delivered is consistent from pill to pill or each time a cream or gel is applied.

Myth: “Bio-identical” hormone products can prevent or cure heart disease, Alzheimer’s disease, and breast cancer.

Fact: Compounded “BHRT” drugs have not been shown to prevent or cure any of these diseases. In fact, like FDA-approved MHT drugs, they may increase the risk of heart disease, breast cancer, and dementia in some women. (See www.nhlbi.nih.gov/whi/index.html for information on the Women’s Health Initiative, a large, long-term study that tested the effects of FDA-approved MHT drugs.) No large, long-term study has been done to determine the adverse effects of “bio-identical” hormones.

Myth: “Bio-identical” hormone products that contain estriol, a weak form of estrogen, are safer than FDA-approved estrogen products.

Fact: FDA has not approved any drug containing estriol. The safety and effectiveness of estriol are unknown. “No data have been submitted to FDA that demonstrate that estriol is safe and effective,” according to Daniel Shames, M.D., a senior official in the FDA office that oversees reproductive products.

Myth: If “bio-identical” products were unsafe, there would be a lot of reports of bad side effects.

Fact: “Bio-identical” products are typically compounded in pharmacies. “Unlike commercial drug manufacturers, pharmacies aren’t required to report adverse events associated with compounded drugs,” says Steve Silverman, Assistant Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “Also, while some health risks associated with ‘BHRT’ drugs may arise after a relatively short eriod of use, others may not occur for many years. One of the big problems is that we just don’t know what risks are associated with these so-called ‘bio-identicals.’”

Myth: A pharmacy can make a “BHRT” drug just for you based on hormone levels in a saliva sample.

Fact: “Advertisements that a drug can be created ‘just for you’ based on saliva testing are appealing,” says Uhl, “but unrealistic.” Hormone levels in saliva do not accurately reflect the amount of hormones a woman has in her body for the purpose of adjusting hormone therapy dose levels. A woman’s hormone levels change throughout the day, and from day to day. FDA-approved tests can tell a woman’s hormone level in a specific body fluid, such as saliva, blood, or urine, at that particular point in time. “These tests are useful to tell if a woman is menopausal or not,” says Uhl, “but they have not been shown to be useful for adjusting hormone therapy dosages.”

Myth: FDA wants all compounded hormone therapies off the market.

Fact: “We are not trying to pull all compounded hormone therapies off the market,” says Silverman. “We believe that, like all traditionally compounded drugs, a woman should be able to get a compounded hormone therapy drug when her physician decides that it will best serve her specific medical needs. But we also want women to be informed and careful about choosing products that have not been proven safe and effective. And pharmacies cannot promote compounded drugs with false or misleading claims.”

In addition, FDA has not approved any drug containing the hormone estriol. Pharmacies should not compound drugs containing estriol unless the prescriber has a valid investigational new drug (IND) application. INDs provide benefits that include allowing physicians to treat individual patients with drugs that are not FDA-approved, while also providing additional safeguards for patients.

Myth: All women who take FDA-approved MHT drugs are going to get blood clots, heart attacks, strokes, breast cancer, or gall bladder disease.

Fact: Like all medicines, hormone therapy has risks and benefits. For some women, hormone therapy may increase their chances of getting these conditions. However, there are no convincing data that there is less risk of developing a blood clot, heart attack, stroke, breast cancer, or gall bladder disease with a “BHRT” product. Women should talk to their health care professional about taking hormones. If you decide to use MHT drugs for menopause

use at the lowest dose that helps
use for the shortest time needed

If you are taking a compounded “BHRT” drug now, talk to your health care professional about treatment options to determine if compounded drugs are the best option for your particular medical needs.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm

ACOG American College of Obstetrics & Gynecology’s Stance on Bioidentical Hormones

Despite celebrity testimonials touting scientifically unfounded benefits of compounded bioidentical hormones, the bottom line is that most have not undergone rigorous clinical testing for safety or efficacy, nor are they approved by the FDA. ACOG also stresses that salivary testing of a woman’s hormone levels is not useful because they vary within each woman depending on her diet, time of day, the specific hormone being tested, and other variables. Although monitoring salivary hormone levels is promoted by some as a means of ‘tailoring’ a hormone treatment to an individual, hormone therapy does not require customized dosing.

http://www.acog.org/from_home/publications/press_releases/nr02-03-09.cfm

This site offers you access to the latest medical information on Women’s Health.

BMD Testing Click Here

Chest Pain Click Here

Cholesterol Click Here

Colorectal Cancer Screening Click Here

Dementia Click Here

Herbal Therapies Click Here

Menopause & Sexual Desire Click Here

Osteo Calcium Click Here

Transdermal Hormone Therapy Click Here

Vaginal Atrophy Click Here