Hormone Therapy Health Risks

A new study evaluated the health risks and benefits of estrogen and progestin therapy and found an increased risk of fatal and nonfatal illnesses (malignancies).

Researchers from the University of North Carolina, Chapel Hill, reported that the Women's Health Initiative (WHI) trial of estrogen plus progestin was stopped early, after a mean of 5.6 years of follow-up, because the overall health risks of hormone therapy exceeded its benefits.

The study analyzed health outcomes three years (mean 2.4 years of follow-up) after the intervention was stopped.

The intervention phase was a double-blind, placebo-controlled, randomized trial of estrogen plus progestin (conjugated equine estrogens 0.625 milligrams daily plus medroxyprogesterone acetate 2.5 milligrams daily) in 16,608 women aged 50-79 years. The post-intervention phase commenced July 8, 2002 and included 15,730 women.

The primary end points were coronary heart disease and invasive breast cancer. A global index summarizing the balance of risks and benefits included the two primary end points plus stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture and death due to other causes.

The study found that after the intervention, cardiovascular risk was comparable by initial randomized assignments: 1.97 percent (annualized rate) in the hormone therapy group (343 events) and 1.91 percent in the placebo group (323 events).

The researchers observed a greater risk of malignancies in the estrogen plus progestin group than in the placebo group (1.56 percent vs. 1.26 percent). More breast cancers were diagnosed in women who had been randomly assigned to receive hormone therapy vs. placebo (0.42 percent vs. 0.33 percent) with a modest trend toward a lower hazard ratio during the follow-up after the intervention.

All-cause mortality was somewhat higher in the estrogen plus progestin group than in the placebo group (1.20 percent vs. 1.06 percent).

The global index of risks and benefits was unchanged from randomization through March 31, 2005, indicating that the risks of estrogen plus progestin therapy exceed the benefits for chronic disease prevention, reported the researchers.

The increased cardiovascular risks in the women assigned to hormone therapy during the intervention period were not observed after the intervention.

The study authors concluded that a greater risk of fatal and nonfatal malignancies occurred after the intervention in the estrogen plus progestin group and the global risk index was 12 percent higher in women randomly assigned to receive conjugated equine estrogens plus medroxyprogesterone acetate compared with placebo.

Integrative therapies with good scientific evidence in the treatment of menopause include calcium, sage and soy.

Calcium is the nutrient consistently found to be the most important for attaining peak bone mass and preventing osteoporosis. Adequate vitamin D intake is required for optimal calcium absorption. Adequate calcium and vitamin D are deemed essential for the prevention of osteoporosis in general, including postmenopausal osteoporosis. There is a link between lower dietary intake of calcium and symptoms of premenstrual syndrome. Calcium supplementation has been suggested in various clinical trials to decrease overall symptoms associated with PMS, such as depressed mood, water retention and pain.

Sage (Salvia officinalis) may contain compounds with mild estrogenic activity. In theory, estrogenic compounds may decrease the symptoms of menopause. Sage has been tested against menopausal symptoms with promising results.

Soy (Glycine max) products containing isoflavones have been studied for the reduction of menopausal symptoms such as hot flashes. The scientific evidence is mixed in this area, with several human trials suggesting a reduced number of hot flashes and other menopausal symptoms, but more recent research reporting no benefits. Overall, the scientific evidence does suggest benefits, although better quality studies are needed in this area in order to form a firm conclusion.

Integrative therapies with fair negative evidence in the treatment of menopause include boron, evening primrose oil and wild yam.

Boron is a trace mineral found in soil, water and some foods. It has been proposed that boron affects estrogen levels in post-menopausal women. However, preliminary studies have found no changes in menopausal symptoms.

Available studies do not show evening primrose (Oenothera biennis) oil to be helpful with these potential complications of menopause. Small human studies do not report that evening primrose oil is helpful for the symptoms of PMS.

Despite popular belief, no natural progestins, estrogens or other reproductive hormones are found in wild yam. Its active ingredient, diosgenin, is not converted to hormones in the human body. Artificial progesterone has been added to some wild yam products. The belief that there are hormones in wild yam may be due to the historical fact that progesterone, androgens and cortisone were chemically manufactured from Mexican wild yam in the 1960s. From Natural Standard

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