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Recently, both patients and health professionals have had concerns raised and have been seeking information about the appropriate role of hormone replacement therapy (HRT) for menopausal women. This concern was prompted by the announcement in the Journal of the American Medical Association on July 17, 2002 that investigators had halted part of the Women's Health Initiative (WHI). A major trial, the WHI is designed to determine whether the combination of estrogen and progesterone prevents the development of heart disease in menopausal women. Preliminary results indicated that not only was this treatment ineffective for prevention, but that there were also small, but real, increases in the risk of breast cancer, blood clots, gallbladder disease, and stroke.

These risks have long been recognized. It is important to note that the WHI trial was terminated not because of the risks themselves or even because the magnitude of the risks was unexpected, but because of the somewhat surprising finding that HRT does not seem to protect against heart disease as hoped. In the absence of the expected benefit, any risk, no matter how small, becomes unacceptable.

It is also important to realize that the implications of these data do not constitute an emergency situation and are not as universal as some news reports might have indicated. HRT remains the most appropriate treatment option for many women in many situations.

ICSI, as part of its commitment to continuously incorporate the best available evidence into our guidelines, had already undertaken an extensive revision of this guideline, 'Menopause and Hormone Replacement Therapy: Collaborative Decision Making and Management," in early 2002. This revision incorporated a large body of evidence that has accumulated in recent years, and our recommendations anticipated the concerns highlighted by the well-publicized WHI study. The revised version of this guideline is undergoing final review, and is expected to be posted on this website by November 2002.

In light of current data, ICSI and the members of the HRT guideline workgroup recommend:

1.   The implications of this information do not constitute a medical emergency
      and there is
      - No need to stop HRT immediately, and
      - No need to see your physician immediately.

2. The risks of HRT for any woman are very low, especially if she has been on
    HRT for less than five years.

3. The warnings that were publicized apply only to women in the WHI study
     who are taking a combination of oral estrogen 0.625 mg daily and oral
     progesterone 2.5 mg daily (marketed by Wyeth-Ayerst as two pills,
     Premarin® and Provera® or as a single combination pill, Prempro®). These
     warnings do not apply to women taking estrogen alone at this point.

4. Women should discuss their use of HRT with their healthcare providers at
     their next health maintenance visit. We recommend that this discussion
     highlight the:

a. Role of HRT for menopausal symptom relief
    - Consider HRT if it is still needed
    - Discuss whether alternatives to HRT might be effective
    - There is no danger in quitting HRT in this setting, although
       a regimen of gradual tapering may often be needed
       to minimize hot flashes

b. Role of HRT for prevention
   -  If taking solely for cardiovascular protection, stop (or do
      not start)
   -  If taking for osteoporosis prevention or bone health,       discuss both HRT and other options at your next visit

c. Risks associated with HRT
    - HRT may increase the risk of breast cancer, venous
      thrombosis (blood clot), gallbladder disease, or stroke, by a
      very small amount.

Access ICSI guideline on hormone replacement therapy

last updated: 8/5/2002