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Combined Hormone Replacement Therapy May Increase Risk Of Dementia In Postmenopausal Women

In postmenopausal women over the age of 65 years, oestrogen plus progestin therapy not only increases the risk of probable dementia, but does not offer any protection of cognitive function or prevent mild cognitive impairment (MCI), according to 2 newly released studies.

The randomised controlled trials are part of The Women's Health Initiative Memory Study, an arm of the Women's Health Initiative hormone therapy trial discontinued on July 8, 2002, due to increased health risks in the study cohort receiving combined oestrogen and progestin therapy.

Sally A. Shumaker, Ph.D., of Wake Forest University Health Sciences in Winston-Salem, North Carolina, United States, and colleagues used the Modified Mini-Mental State Examination (3MSE) to analyse the incidence of probable dementia and mild cognitive impairment in 4532 postmenopausal women free of probable dementia. Study participants received either 1 daily tablet of 0.625 mg conjugated equine oestrogen plus 2.5 mg medroxyprogesterone acetate (n=2229) or placebo (n=2303).

The researchers found that the risk of being diagnosed with MCI did not differ statistically between the treatment and placebo groups (hazard ratio 1.07; P=.72). However, the risk of probable dementia for women in the treatment group was twice that of women receiving placebo (hazard ratio 2.05; P=.01), the researchers report. Overall, 40 women in the treatment group compared with 21 in the placebo group were diagnosed with probable dementia. The investigators noted that, "evidence of an increased risk began to appear as early as 1 year after randomisation, with differences persisting over 5 years of follow-up."

They report similar patterns of results for all-cause dementia as well as for specific classifications of probable dementia such as Alzheimer disease, vascular dementia and other aetiologies. The researchers also found that neither controlling for prior statin use nor censoring for onset of statin use after randomisation altered the effects of treatment compared with placebo in the study population.

"Oestrogen plus progestin therapy increases older women's risk for probable dementia [and] does not protect against MCI," Dr. Shumaker and colleagues conclude. They add that, "oestrogen plus progestin should not be prescribed with the expectation that it will enhance cognitive performance in postmenopausal women."

In a related study, Stephen R. Rapp, Ph.D., of Wake Forest University School of Medicine also in Winston-Salem, and colleagues analysed 3MSE scores in 2145 women receiving 1 daily tablet of 0.625 mg conjugated equine oestrogen with 2.5 mg medroxyprogesterone acetate therapy versus 2236 women taking placebo. All 4381 women provided a baseline and at least 1 follow-up 3MSE score over an average follow-up of 4.2 years.

Most women scored high on their baseline 3MSE and mean scores in both study groups continued to improve through the fourth year of follow-up. However, the researchers note that the mean rate of change in 3MSE scores was slightly less favourable (P=.03) in the treatment group compared with the placebo group.

The researchers report that 6.7% of women receiving oestrogen plus progestin, versus 4.8% of those on placebo, showed declines of 2 standard deviations or more in at least one follow-up 3MSE score compared with baseline.

Dr. Rapp and colleagues conclude that results of this study do not support the use of oestrogen plus progestin therapy to protect cognition in older women and suggest that some women experience a clear detrimental cognitive decline with such therapy.

Related Link: Estrogen Plus Progestin and the Incidence of Dementia and Mild Cognitive Impairment in Postmenopausal Women: The Women's Health Initiative Memory Study: A Randomized Controlled Trial (JAMA 2003;289:20:2651-2662).
JAMA 2003;289:20:2651-2662. "Effect of Estrogen Plus Progestin on Global Cognitive Function in Postmenopausal Women: The Women's Health Initiative Memory Study: A Randomized Controlled Trial"

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