J Womens Health (Larchmt). 2006 May;15(4):369-78

Wegienka G, Havstad S, Kelsey JL.

Background: In July 2002, the Women's Health Initiative (WHI) published results that led to early termination of the randomized controlled trial of estrogen plus progestin in postmenopausal women with an intact uterus. Subsequently, the trial of estrogen only also was terminated early, and the results were published in April 2004. The present study examines the impact of both sets of results on menopausal hormone therapy (MHT) prescription patterns, as well as the characteristics of women who did and did not change their MHT behavior after publication of results. Methods: We examined the number of MHT prescriptions filled in the months before and after each set of results was published, using claims data from 24,446 women aged 50-79 years continuously enrolled in a health maintenance organization (HMO) at Henry Ford Health System from January 2000 through December 2004. Results: After July 2002, a statistically significant (p < 0.05) drop occurred in the rate of MHT prescriptions filled; 29% of the women stopped MHT for at least 4 months, but 24% of these women resumed use by December 2004. Successful stoppers tended to be older. Twentyone percent of users in April 2004 stopped in May 2004 for at least 4 months; 25% of these had restarted by December. Women continued to initiate MHT after July 2002, but at lower rates in 2003 and 2004 (73% and 77% decreases, respectively, compared with 2001). The types of MHT prescriptions obtained by new users changed after 2001: fewer initiated MHT with oral Premarin (Wyeth, St. David's, PA) and Prempro or Premphase (Wyeth-Ayerst, Philadelphia, PA), and more initiated MHT with Premarin and Estrace (Warner Chilcott, Rockaway, NJ) creams. Conclusions: Regardless of the goals of the WHI study, the publication of results on estrogen plus progestin in July 2002 impacted overall rates of MHT use, as did, to a lesser extent, the estrogen only results published in May 2004. Although women continued to initiate MHT after the results were published, they were less likely to use the formulations from the WHI and instead used formulations for which there is less information about effectiveness and long-term health consequences.

Acta Obstet Gynecol Scand. 2006;85(4):387-93.

Haimov-Kochman R, Hochner-Celnikier D.

Department of Obstetrics and Gynecology, Hadassah University Medical Center. Jerusalem. Israel.

The publication of the Women's Health Initiative (WHI) study had significant impact on the attitude of physicians and patients towards the use of hormones in the menopause. It has been estimated that 40-83% of patients using hormones ceased treatment on their own initiative following publication of the WHI results. While in the pre-WHI period, use of hormones in the menopause was termed 'hormone-replacement therapy' (HRT) with an emphasis on replacement; 'HRT' has now been replaced with the term 'hormone therapy' (HT), focusing on the therapy's status as a treatment with defined risks and benefits. Following the publication of the WHI study, many caregivers concluded that HT had absolutely no role in clinical practice. However, the decision to begin HT for the symptomatic, healthy, newly postmenopausal woman should be based on whether the WHI study addresses all the issues that must be taken into consideration before initiation of HT, whether there are effective alternatives available to relieve climacteric symptoms, and also whether HT is better able to prevent cardiovascular disease (CVD) and Alzheimer's disease (AD) than to halt atherosclerotic lesions. Every postmenopausal woman should have an individual risk-benefit evaluation to determine whether HT suits her needs. Until the effectiveness of HT for primary prevention of CVD and AD is established or disproved, there is no justification for HT use in the asymptomatic postmenopausal woman. However, symptomatic newly menopausal women might experience relief of their climacteric symptoms following HT use without exposing themselves to unreasonable risks.

Menopause. 2006 Jan-Feb;13(1):139-47

Manson JE, Bassuk SS, Harman SM, Brinton EA, Cedars MI, Lobo R, Merriam GR, Miller VM, Naftolin F, Santoro N.

Observational studies suggest that postmenopausal hormone therapy (HT) prevents coronary heart disease, whereas randomized clinical trials have not confirmed a cardioprotective effect. Although observational studies may have overestimated the coronary benefit conferred by postmenopausal hormone use, there are other plausible explanations for the apparent discrepancy between previous results and the less favorable findings from clinical trials such as the large Women's Health Initiative. There is now a critical mass of data to support the hypothesis that age or time since menopause may importantly influence the benefit-risk ratio associated with HT, especially with respect to cardiovascular outcomes, and that the method of administration, dose, and formulation of exogenous hormones may also be relevant. Although the weight of the evidence indicates that older women and those with subclinical or overt coronary heart disease should not take HT, estrogen remains the most effective treatment currently available for vasomotor symptoms, and its effects on the development of coronary disease in newly postmenopausal women remain unclear. Moreover, effects of HT on quality of life and cognitive function in recently postmenopausal women merit further study. These unresolved clinical issues provide the rationale for the design of the Kronos Early Estrogen Prevention Study, a 5-year randomized trial that will evaluate the effectiveness of low-dose oral estrogen and transdermal estradiol in preventing progression of atherosclerosis in recently postmenopausal women.