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  Hormone Replacement Therapy (HRT)  
         
 

In July 2002, the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), announced that it was terminating a major clinical trial in of the risks and benefits of combined estrogen and progestin (Prempro) treatment. Since that time, Health Ministries has received calls and questions from Presbyterian women who were concerned about the risks of hormone replacement therapy (HRT), particularly in light of the terminated clinical trial. In order to address the questions, we are providing a brief overview of the study with Web addresses for those who want to read more on this topic, information about alternative therapies, benefits and risks of HRT, and concluding with resources.

[We are not recommending any particular course or treatment, merely providing what seems to be reliable resources which can help women—along with their own health care provider make informed and educated decisions.]

Prempro Study
On July 9, 2002, NHLBI stopped one of the clinical studies, within the Women's Health Initiative (WHI) Hormone Program, involving 16,608 women with a uterus who took estrogen plus progestin therapy or a placebo. NIH halted this trial after 5.2 years, concluding that the risks for the study group on combined HRT outweighed the benefits.

Risks included small but significant increased risks of breast cancer, coronary heart disease, stroke, and blood clots for the group of women on HRT. Benefits of HRT use included lower risks for hip fractures and colon cancer.

The goal of this eight year trial was to study the relationship between HRT and its possible benefits for heart disease and hip fracture, as well as its possible risks for breast cancer, endometrial cancer, and blood clots. The trial was not intended to study the effect of HRT on menopausal symptoms or on other conditions such as Alzheimer's disease.

Another goal was to see if those possible benefits were greater than the possible risks for breast cancer, endometrial cancer, and blood clots. The results of this study only apply to women who have not had hysterectomies and are receiving Prempro. The study did not address the short-term risks and benefits of hormones for the treatment of menopausal symptoms. The NIH is continuing to study the long-term effects to women who have had a hysterectomy and use only estrogen therapy.

The data with respect to women taking estrogen alone is still inconclusive.

 
         
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Definitions—Perimenopause and Menopause

Perimenopause is the gradual period of change leading into menopause. During perimenopause, the ovaries produce increasingly less estrogen and ovulation can become infrequent. Hormones fluctuate, causing irregular periods and physical and emotional changes similar to those of puberty, though they are often more intense. For most women, perimenopause lasts only a few years, although for some women, it can last up to 12 years.

Menopause—clinically defined as a point at which a woman has not experienced a menstrual period for one year—is commonly referred to as "midlife." It happens when the ovaries stop releasing eggs. The average age for natural menopause is 51 years, and the process can be gradual or sudden.

What about HRT?
Choosing whether or not to use hormone replacement therapy has typically been frustrating and confusing for women and sometimes uncomfortable to discuss with physicians. Yet, it is one of the most important health decisions women face during this time of their life. Due to recent events—like the Prempro study termination—this decision is even more perplexing. The best suggestion is to study the options and then in conjunction with your health care provider, choose what is best for you.

Benefits and Risks of Hormone Replacement Therapy

  • Benefits—HRT has been used to relieve the short-term symptoms of menopause, such as hot flashes, sweats, and disturbed sleep. It is also believed to be useful in preventing or alleviating an increased rate of bone loss that leads to osteoporosis. Additionally, it can bring relief from vaginal atrophy (dryness and thinness of the vaginal lining).
  • Risks—There are short-term and long-term side effects from HRT. Medical research findings for long-term use are still unknown.Short- term effects—Some women report side effects from taking HRT, including unusual vaginal discharge and bleeding, headaches, nausea, fluid retention and swollen breasts. Long-term effects are still unknown.
 
         
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Menopause Treatment Options
There are three primary treatment options for menopause: lifestyle management (exercise, especially weight bearing, proper diet, stopping smoking, and routine checkups), hormone replacement therapies (prescription treatments of estrogen or estrogen plus progestin) and alternative therapies.

Since the cancellation of the NIH study, more women want to know about alternative therapies. Many women are currently using some form of alternative therapy. According to a 1997 study conducted by the North American Menopause Society, more than 30 percent of women use acupuncture, natural estrogen(s), herbal supplements, or so-called plant estrogens (phytoestrogens). Botanical products containing or acting like estrogens may provide some of the benefits of estrogen in relieving menopausal symptoms.

"Natural" Alternatives to HRT
Women wishing to consider alternative treatments to HRT to alleviate the symptoms often experienced concurrent with menopause frequently find themselves searching through volumes of sometimes confusing and contradictory information. Often it is difficult to identify health care professionals who are willing to explore treatment options. The following information is provided as a beginning resource for women who wish to familiarize themselves with natural alternatives. The resources provided here should be used for education only and are not in any way intended to be complete. Any decisions regarding medical treatment, including supplements and herbal extractions should be made in consultation with a qualified health professional.

Nutritional Supplementation
Calcium—Calcium is a number-one consideration for women before, during, and after menopause. Calcium's importance for maintaining strong, healthy bones and slowing bone loss cannot be overstated.

Magnesium—While calcium gets the most attention when it comes to mineral nutrition for bones, magnesium is also vitally important. Magnesium is required for calcium to work properly: magnesium helps bone absorb calcium.

Gamma Oryzanol—Gamma oryzanol is a natural substance found in the bran of grains such as rice. The body converts gamma oryzanol into a compound called "ferulic acid," which acts as an antioxidant and as a hormone regulator.

Soy Isoflavones—In Asia and other cultures where soy products are consumed in abundance, women's health problems, certain cancers, and cardiovascular disease are reported to be less prevalent. Soy isoflavones (genistein and daidzein) are rich in phytoestrogens and are thought to reduce the symptoms of menopause, decrease the loss of bone, and decrease the risk of certain cancers.

Melatonin—Melatonin levels decrease as we age with a distinct difference noted between premenopausal women and postmenopausal women. Some medical literature suggests a beneficial role of melatonin in menopausal women experiencing insomnia.

Vitamin C and Vitamin D—Bone loss and decreases in bone mineral density is inevitable as we age. It is important to slow this process, maintain strong healthy bones and thus decrease the risk of bone fractures. According to the National Osteoporosis Foundation, over half of Americans older than 50 have low bone mineral density and 80 percent of them are women. Especially when used with other therapies, numerous studies have supported the use of vitamin C to help support bone mineral density. Vitamin D is one of the primary regulators of calcium absorption. Deficiencies are frequently found in postmenopausal women with or at risk for osteoporosis. Considering this relationship, vitamin D insufficiency may have an effect on bone strength.

Flaxseed Oil—Flaxseed oil is one of the greatest sources of essential fatty acids. These fatty acids have several important functions and may potentially have a valuable role in protecting against cardiovascular risks in postmenopausal women.

Herbal Supplementation
Black Cohosh—A tall perennial plant, Black Cohosh was valued by Native Americans as an herbal remedy. The herb became known in colonial days for relieving menstrual cramps. Its usage then spread to Europe, where it still remains popular today as an alternative to Hormone Replacement Therapy in European phytotherapy.

Chasteberry—The chasteberry tree originated in the Mediterranean. Harvested and dried for its medicinal value, chasteberry fruit has a long folk history of use for women's health issues. Chasteberry has been recommended for mild to moderate conditions, especially in endometriosis, menopausal discomforts, and PMS.

Red Clover—Red clover has been used traditionally as a medicinal herb in the Orient, in Europe, and among Native American tribes. Red clover's isoflavones bind to estrogen receptors on cells surfaces

The American College of Obstetricians and Gynecologists
Physicians are beginning to educate themselves on non-medical treatments. A recent Practice Bulletin, Botanicals for Management of Menopausal Symptoms, developed by the ACOG Committee on Practice Bulletins was published June 2001 (NUMBER 28). It was designed to aid practitioners who are members of the the American College of Obstetricians and Gynecologists in making decisions about appropriate obstetric and gynecologic use of botanicals.

Their cautious recommendations based primarily on consensus and expert opinion follow:

Soy and isoflavones may be helpful in the short-term (<=2 years) treatment of vasomotor, sleep disturbance, "hot flashes", vaginal dryness and dyspareunia, although sources of isoflavones and beneficial amounts are not standardized. Given the possibility that these compounds may interact with estrogen, these agents should not be considered free of potential harm in women with estrogen-dependent cancers.

St. John's wort may be helpful in the short-term (<=2 years) treatment of mild to moderate depression in women.

Black cohosh may be helpful in the short-term (<=6 months) treatment of women with vasomotor symptoms.

Soy and isoflavone intake over prolonged periods may improve lipoprotein profiles and protect against osteoporosis. Soy in foodstuffs may differ in biological activity from soy and isoflavones in supplements.

More Study Needed
Additional studies are needed to define the possible benefits of these botanical products in promoting bone, heart, and brain health, as well as the potential risks of increasing breast, endometrial, or other cancers in diverse populations of postmenopausal women. Much current verification of benefit is based on anecdotal information or small study groups. Long-term studies, conducted under strictly controlled conditions are needed to provide reliable and consistent conclusions.

Regulation
An additional complication encountered with use of non-prescription treatment is the lack of regulation commonly depended upon to assure purity, consistency and uniformity. Natural supplements and herbal extractions are not regulated as medication, therefore may be measured in differing units and may be of inconsistent quality.

To make an educated decision about whether to use or not use HRT and/or alternative therapies, do extensive reading and talk with your health care provider to develop an individualized plan. Together you and your health care provider discuss options, discuss individual risks and benefits, and watch for side effects and monitor outcomes.

 
         
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Additional Information
The following Web sites provide additional information on the topics covered in this text.

For more information on the NIH study go to www.nhlbi.nih.gov/whi/hrtupd/index.htm.

The American College of Obstetricians and Gynecologists (ACOG) provides questions and answers about hormone replacement therapy (HRT)
www.acog.com/from_home/publications/press_releases/nr08-30-02.cfm. You may download this important news release in printable Adobe Acrobat format. This file requires the free Adobe Acrobat Reader.
For best results, right-click the link (or click and hold for Macintosh), select "save target as" and save the document to your desktop for viewing and printing.
Graphic: Get Adobe Acrobat Reader

For more information on perimenopause and menopause go to

For more information on the risks and benefits of HRT go to http://www.4woman.gov/faq/hormone.htm?src=ng

For more information about treatment options:

For basic information on supplements and herbal remedies, a very helpful site is hosted by The Dietary Supplement Education Alliance, a partnership created to promote the responsible use of vitamins, minerals, herbs and specialty supplements. On this site you can search for individual supplements and by specific medical conditions. www.supplementinfo.org/

Resources:

National Heart, Lung, and Blood Institute Information Center
(301) 592-8573
www.nhlbi.nih.gov/health/infoctr/index.htm

National Institute on Aging
(800) 222-2225
www.nih.gov/nia/

North American Menopause Society
(440) 442-7550
www.menopause.org/

American College of Obstetricians and Gynecologists
(202) 863-2518
www.acog.org/

The Hormone Foundation
(800) 467-6663
www.hormone.org/

Women's Health Initiative
1-800-54-WOMEN,
(301) 402-2900
www.nhlbi.nih.gov/whi/index.html

If you have further questions, please feel free to email the Office of National Health Ministries.

 
         
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