There are two straightforward ways to respond to the publications from the Women’s Health Initiative (WHI). One is to accept the results as definitive and unequivocal and the other is to continue to counsel women unencumbered by the WHI. Obviously, neither approach is acceptable. The WHI has had and will continue to have an impact on both clinicians and patients, but at the same time, we are coming to understand the limitations and applicability of the WHI data. Rather than resolving controversies and simplifying the practice of hormone therapy, the WHI has made it more difficult. It will be months, if not years, to distill the real meaning of the WHI and to reach a practical, clinical consensus.
Currently, there is at least one area with little controversy, and that is the beneficial impact of hormone therapy on postmenopausal quality of life, and this is despite the WHI publication reporting little beneficial effect of estrogen-progestin therapy on postmenopausal quality of life. In my view, the reported results of the WHI on quality of life do not apply to the majority of women for whom we prescribe hormone therapy. Remember that the participants in the WHI had an average age of 63 years and were 18 years distant from their menopause. The WHI investigators like to point out that the group of women in their early 50s in the WHI presented similar findings.
Women with significant menopausal symptoms were excluded from the study to avoid an exceedingly high dropout rate in the placebo group. About 12.5% of the participants reported vasomotor symptoms upon entry, but were willing to be assigned to placebo, and therefore, their symptoms were unlikely to have had a major disturbing effect. This exclusion means that only a small number of women in the WHI were close to their age of menopause; the analysis of women age 50 to 54 years was based on about 50 women in the treated group and 225 in the placebo group. The WHI was a study of older women who were relatively homogenous with a relatively good quality of life upon entry. This is a good example of why it is appropriate to question whether the WHI conclusions can be applied to all postmenopausal women.
This issue of the newsletter provides an up-to-date assessment of the effect of hormone therapy on quality of life. This information is the foundation upon which the clinicianpatient dialogue can be based, with the ultimate goal of helping the individual patient to make the appropriate decision to meet her needs.