VOLUME 27 - 6 Hormone Replacement

Health Tips

Hormone Replacement Therapy

What is Menopause?

Menopause, or climacteric, is the time in a woman's life when menstruation ends and the ovaries produce lower levels of the sex hormones-estrogen and progesterone. Progesterone becomes nearly absent, and estrogen levels are reduced to approximately one-tenth of pre-menopause levels. Menopause usually occurs between the ages of 45 and 55, although it varies between individuals. "Surgical menopause," or oophorectomy, occurs when a woman's ovaries are surgically removed.

During menopause, many women experience problems such as hot flashes, night sweats, sleeplessness, mood swings, and vaginal dryness. Bone loss (osteoporosis), angina, and heart attack (coronary artery disease) are also more common in women after menopause.

What Is Hormone Replacement Therapy? To counter some of the problems often associated with menopause or to prevent some long-term conditions that are more common in postmenopausal women, such as osteoporosis, medical doctors may recommend using hormone replacement therapy (HRT)-for a period from one month to five or more years.1

HRT usually involves treatment with either estrogen alone or estrogen in combination with progesterone. Progestin, a synthetic hormone with effects similar to those of progesterone, may be used as a substitute. The use of these substances can effectively double hormone levels in post-menopause women, but this therapy does not produce the natural hormone levels seen before menopause.

Do the Benefits of HRT Outweigh the Risks? The best evidence to date for the risks and benefits of HRT comes from the Women's Health Initiative (WHI) study, in which 16,000 healthy women, ages 50 through 79, took either hormones or a placebo-a pill that does not contain the drug under study. The trial was discontinued early in 2002, when investigators reported that the overall risks of estrogen plus progestin outweighed the benefits.2

According to recent studies, HRT with estrogen plus progestin may increase the risk of: · Dementia, i.e. deterioration of mental abilities resulting in an inability to function, by 50 percent-in women age 65 and older.6

• Blood clots by 50 percent.2
• Stroke by 41 percent.2
• Heart disease by 29 percent.2
• Breast cancer by 26 percent.2 The breast cancers were also slightly larger and more advanced.3 The risk increased with prolonged duration of hormone use and returned to normal five or more years after hormone use was discontinued.4
• Death from ovarian cancer-in women who used estrogens for 10 or more years.7 Benefits of the use of estrogen plus progestin:
• Relief for menopausal symptoms2
• Fewer cases of hip and spine factures2
• Reduction in the risk of developing colon cancer by 37 percent was reported among women using estrogen plus progestin.2 Studies do suggest, however, that to maintain bone density, women must continue taking the hormone.

To date, HRT has not been proven beneficial in older women with pre-existing heart disease.5 Additionally, the use of estrogen plus progestin hasn't been shown to affect post-menopausal women's general health, vitality, mental health, depressive symptoms, or sexual satisfaction.8

The risks and benefits of estrogen-only therapy, the use of different forms of hormones, including experimentation with lower doses, utilization of different hormones-or different routes of administration are currently being researched. Safer and more effective therapies may become available in the future.

Are There Alternative Therapies to HRT? While hormone therapy can have short-term benefits, many short-term menopause-related symptoms will eventually disappear, and many frequently require no treatment. However, although there are substantial concerns about the use of HRT, it has not been proven beneficial for long-term menopausal problems. If you feel that HRT is not a good choice for you, you may want to consider an alternative approach.

Exercising regularly, eating healthy foods, and not smoking is always good. A healthy lifestyle helps to decrease the risk of bone loss. Health professionals also recommend taking calcium and vitamin D supplements to prevent osteoporosis.9 The effect of calcium and vitamin D supplements on hip, spine, and wrist fractures, as well as its effect on colon cancer is being tested.

Some foods and nutritional supplements can be helpful in reducing the symptoms of menopause:

• Estrogen-containing foods: soy-based products, whole-grain cereals, fruits, and vegetables
• Evening primrose
• Black cohosh
• Dong quai
• Vitamin E
• Vitamin B complex
• Hormone creams.

The benefits and risks of most of these agents are not definitively proven, but are being researched. Before taking any dietary supplement, consult with your health care provider.

Lawrence Wyatt, DC, DACBR, clinical sciences professor, Texas Chiropractic College, Writer

Carol Kline, MA, and Nataliya Schetchikova, PhD, Editors David Cundiff, MFA, Art Director

References

1. Brett KM, Madans JH. Use of menopausal hormone replacement therapy: estimates from a nationally representative cohort study. Am J Epidemiology 1997;145(6):536-45.

2. Writing Group for the Women's Health Initiative. Risks and benefits of combined estrogen and progestin in healthy menopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333.

3. Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, et al. Estrogen Plus Progestin Influence on Breast Cancer and Mammography in Healthy Postmenopausal Women in the Women's Health Initiative Randomized Trial. JAMA 2003;289:3243.

4. Schairer C, Lubin J, Troisi R, Sturgeon S, Brinton L, Hoover R. Menopausal estrogen and estrogen-progestin replacement therapy and breast cancer risk. JAMA 2000;283(4):485-491.

5. Grady D, Herrington D, Bittner V, Blumenthal R, Davidson M, Hlatky M, et al. Cardiovascular disease outcomes during 6.8 years of hormone therapy. JAMA 2002; 288:49-57.

6. Shumaker, SA, Legault C, Rapp SR, Thal L, Wallace RB, Ockene JK, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women. JAMA 2003;289:2651-2662.

7. Rodriguez C, Patel AV, Calle EE, Jacob EJ, Thun MJ. Estrogen replacement therapy and ovarian cancer mortality in a large prospective study of US women. JAMA 2001;285(11):1460-1465.

8. Hays J, Ockene JK, Brunner RL, Kotchen JM, Manson JE, Patterson RE, et al. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003;348: 1839-54.

9. Keller C, Fullerton J, Mobley C. Supplemental and complementary alternatives to hormone replacement therapy. Amer Acac Nurse Pract 1999;11(5):187-98.

Research

Study Contradicts FDA on Crestor Risks
By JAMIE STENGLE DALLAS (AP) -

New research seems to challenge a Food and Drug Administration decision not to pull the cholesterol-lowering drug Crestor off the market, with data showing it causes more kidney and muscle problems than rival medications.

The FDA in March contended Crestor's risks were no greater than its competitors, and it rejected consumer efforts to remove the drug, made by AstraZeneca PLC, from store shelves. Instead, the FDA ordered a warning on the label, saying Crestor could cause serious muscle problems and kidney damage, especially among Asians.

The new study, based on side effects reported to the FDA, said kidney problems and muscle weakness were two to eight times more frequent among Crestor users than those taking other cholesterol-lowering medications like Lipitor, Zocor and Pravachol.

Even so, results from the study published online Monday by the American Heart Association's journal Circulation said the cholesterol drugs - called statins and taken by millions of Americans - showed that most are very safe and that the risk of serious problems, even with Crestor, are very low.

FDA spokeswoman Laura Alvey said that the new analysis yielded no new information. ``We haven't found any convincing evidence that Crestor poses any more of a risk than the other statins,'' she said.

AstraZeneca said the higher reports of side effects may have been the result of heightened awareness of the problems with another cholesterol drug, Baycol, which was pulled from the market in 2001. Crestor went on the market two years later.

``We strongly disagree with the conclusions of this study,'' the company said in a statement.

An estimated 20 million Americans are believed to be taking statins, which researchers say are still the best drugs for lowering high cholesterol and reducing the risk of heart disease and stroke.

Many of the drugs cause muscle problems among some people, but experts advise patients to talk to their doctors about lowering their dosage, which can solve the problem. Doctors said patients should not stop taking statins but should discuss any problems with their doctors.

In a teleconference, doctors reiterated that the drugs are safe overall.

``Statins in general are very safe drugs and they can be life-saving to high-risk patients,'' said Dr. Scott Grundy, of the University of Texas Southwestern Medical Center in Dallas.

For the new study, researchers analyzed reports of side effects sent to the FDA for Crestor and compared them to the rates during the same time period for three other statins: Lipitor, Zocor and Pravachol.

``What we've shown is that amongst this family of drugs, Crestor has a poorer safety profile, but that the overall rate of adverse effects is still quite low,'' said study leader Dr. Richard Karas, director of the preventive cardiology at Tufts-New England Medical Center in Boston.

Karas, who has received research grants and speaker fees from several drug companies - including the maker of Crestor - said that, generally, the people who should consider taking Crestor are those who are unable to lower their cholesterol enough with other drugs or those who may be allergic to other drugs.

The year after Crestor came on the market in October 2003, more than 5 million prescriptions were filled for the drug.

The researchers also compared the rate of adverse event reports during the first year of marketing for the current statins and the earlier withdrawn drug, Baycol.

Complications were more common with Crestor than the other three statins available, but less than half the rate of those reported during the first year of Baycol's use. But even for Crestor, the absolute risk of a serious problem was very low - 1 in 35,862.

An expert and the study's authors agree that there were limitations to the study, including the possible underreporting of side effects. Also the removal of Baycol from the market likely heightened public awareness of drug safety concerns.

Dr. Benjamin Ansell, co-director of the cholesterol treatment program at UCLA medical center in Los Angeles, suggested there also is a tendency to overreport side effects, especially when a drug, like Crestor, has gotten a lot of media attention.

``I would say the study has to be interpreted with skepticism and recognizing its imitations,'' Ansell said. But one consumer advocate said the warning should be heeded.

``This will be further reason to take the drug off the market,'' said Dr. Sidney Wolfe of the group Public Citizen. He said his group would try again to get the drug off the market.

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