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AAFP: Dilemma Surrounding Hormone Replacement Therapy Remains Unresolved

By Mike Fillon

NEW ORLEANS, LA -- October 15, 2003 -- Family physicians face a dilemma about whether to prescribe hormone replacement therapy (HRT) for menopausal and post-menopausal patients, despite negative findings from the Women's Health Initiative Estrogen Plus Progestin Study (WHI).

Barbara Apgar, MD, MS, clinical professor, family medicine, University of Michigan, Ann Arbor, United States, offered her thoughts during her lecture here on October 4^th at the 55^th Annual Scientific Assembly of the American Academy of Family Physicians.

In the summer of 2002, the WHI study announced findings that began to offer women some guidance about hormone use. The postmenopausal hormone-therapy clinical trial has two parts. The first part involved 16,608 postmenopausal women with a uterus who took either oestrogen plus progestin therapy or a placebo. The second part of the study involved 10,739 women who have had a hysterectomy and are taking oestrogen alone or a placebo.

The study was to have continued until 2005, but it was stopped in July 2002 because the study's Data and Safety Monitoring Board (DSMB) found an increased risk of breast cancer associated with hormone therapy, and concluded that, overall, risks from the use of the hormones outweighed and outnumbered the benefits.

More recently, two large observational studies indicated that long-term oestrogen use increases the risk of ovarian cancer.

Additional findings:
- For heart attack, the risk began to increase in the first year of oestrogen plus progestin use, and became more pronounced in the second year.
- Oestrogen plus progestin was shown to cause more strokes in healthy women. By the end of the study, the oestrogen plus progestin group had 41% more strokes than the placebo group -- or 8 more strokes each year for every 10,000 women.
- Oestrogen plus progestin reduced hip fractures by 34% -- or 5 fewer hip fractures for every 10,000 women.
- The therapy also lowered the risk of colorectal cancer by 37% -- or 6 fewer colorectal cancers each year for every 10,000 women. This reduction appeared after 3 years of hormone use, and became more significant thereafter. The number of colorectal cancer cases, however, was relatively small.

Dr. Apgar framed her lecture around the findings of the WHI. "There hasn't been anything that's been very promising about using HRT except for initial studies showing there is a reduction in total fractures and colorectal cancers as a result of hormone therapy," said Dr. Apgar. "So the goal for all clinicians should be to get all women off hormone-replacement therapy."

Clinicians urging patients to stop HRT have little guidance for the best protocols to use, Dr. Apgar said. Whether they immediately drop HRT or attempt to taper the treatment, women face a resumption of symptoms.

"The process is very tricky," she admitted. "Because the patients may come off abruptly and have a return of the flashes and other symptoms, and you may need to bring them back on HRT. "There are no good data that say abruptly stopping is better than tapering it."

Compounding the problem, she said, is the fact that many women have turned to unproven natural alternatives.

"None of the alternatives such as black cohosh and soy have been shown in large clinical studies to be effective," said Dr. Apgar. "But women are buying all these substitutes thinking they're safer. We don't know how much you can [consume] and be safe. Is it possible you may take too much and run into the same problems we've seen in WHI?"

Options include prescribing lower-dose hormones -- a practice she encourages -- or changing to transdermal patches, Dr. Apgar said. Many family physicians are not sure about these solutions, however, because the health risks are still unknown.

Despite the discouraging situation, she said family physicians can interpret WHI for their patients' benefit. HRT has no preventive value, for example, for cardiovascular disease or osteoporosis, and caries a high risk for some postmenopausal women, especially those with chronic diseases.

Also, an individual's risk of being harmed by HRT is actually quite small. Still, each patient has a one-tenth of 1% risk for any single major health risk, and the cumulative risks of HRT should prompt cancer and cardiovascular screenings.

"Even though there are no good recommendations about how to wean patients off of HRT [and no good] research on alternatives, we need to recognize some women are going to be very symptomatic," advised Dr. Apgar. "We need to help them through this."


[Study title: HRT Dilemma. Abstract 012]