Results recently released by the Women's Health Initiative (WHI) showing an association between combination hormone therapy and cardiovascular and breast cancer risks have prompted revisions in guidelines for the use of hormone therapy. The revised guidelines suggest limiting the use of combination hormone therapy to short-term treatment of menopausal symptoms or for prophylaxis of osteoporosis if other alternatives are not suitable. Previous randomized trials on the effects of hormones on quality of life have had conflicting results and have been notable for a substantial placebo effect. Hays and other investigators from the WHI report on health-related quality-of-life data in relation to use of combination hormone therapy.

As part of the WHI, quality-of-life surveys were completed by the 16,608 postmenopausal women who were randomly assigned to receive a combination of estrogen and progestin or placebo. Any woman already using hormone supplements before the study underwent a three-month washout period before enrollment. If patients reported moderate to severe menopausal symptoms during the washout period, they were discouraged, but not excluded, from trial participation. Women from minority ethnic groups constituted 16 percent of the study population. The mean age of the total population was 63.2 years. Quality-of-life surveys included specific scoring assessment of depression, sleep disturbance, sexual function, cognitive function, and menopausal symptoms. Data were available at one-year follow-up on almost all study enrollees, and a subgroup of 1,511 women was resurveyed after three years of trial participation. Discontinuation of the assigned study medication was similar in those randomized to hormones (9.7 percent) and placebo (6.6 percent).

Overall, quality-of-life scores were not substantially different at one year of follow up in any of the life areas surveyed. The large number of trial participants allowed small survey score changes to achieve statistical significance in some cases. However, no rating scale changed by more than 2 points out of a 100-point scale, thereby demonstrating no clinically significant advantage to use of hormones.

In the subgroup of 1,511 women resurveyed after three years of study participation, there were again no clinically significant changes associated with hormone use. Age, ethnicity, body mass index, and previous use of hormones had no effect on outcomes. If the data analysis was limited to only the most recently menopausal women (i.e., those younger than 54 years) who also reported moderate-to-severe vasomotor symptoms before the trial, an improvement in sleep disturbance was noted, but no other quality-of-life assessment changed with use of combination hormone therapy.

The authors conclude that there were no clinically significant quality-of-life advantages apparent after one or three years of hormone use in this study population of postmenopausal women.