When the press reported on the FDA stopping the
"Women's Initiative study" on estrogen alone (Feb 2004), a double blind
study with 11,000 participants, they informed us that the study was stopped
because of a slightly higher risk of stroke among those taking estrogen
alone and that the estrogen had neither worsened or prevented heart disease.
I thought perhaps there might be more to the story and there was. They
apparently found a significant rate of -estrogen caused- DEMENTIA in those
women over 65 taking it and/or also, cognitive impairment. This was NOT
reported in the news but can be found on the NHIBI.NIH.GOV website about
this study. Excerpts from a couple of articles follow:
>>>> A separate report will contain
information on probable dementia and/or mild cognitive impairment in the
women age 65 and older who participated in the estrogen-alone WHI-Memory
Study (WHIMS), an ancillary study of the WHI Hormone Trials. Preliminary
data suggest that for the WHIMS participants who were on estrogen alone
when compared to the women who were taking the placebo, there was a
trend toward increased risk of probable dementia and/or mild cognitive
impairment.<<<<
Premarin and Prempro were the medications, by the way, which were used in
this (now halted) study.
http://www.nhlbi.nih.gov/new/press/04-03-02.htm
From the "black box" warning to physicians:
>>>> In February 2004, the FDA
additionally requested that manufacturers should include WHIMS data in the
existing Black Box that contains WHI data on cardiovascular risks.
WHIMS found an increased risk of developing probable dementia in
postmenopausal women age 65 years of age or older during 4 years of
treatment with oral conjugated estrogens plus medroxyprogesterone
acetate compared to placebo. It is unknown whether this finding applies to
younger postmenopausal women taking estrogen alone. FDA also advised
manufacturers to add the WHIMS data to the clinical studies section, and
to specify the lowest effective dose of their drug (or state that the
lowest effective dose has not been determined).<<<<<
http://www.nhlbi.nih.gov/whi/e-a_advisory.htm
This definitely may be the time to consider going another path to help
menopause. The natural progesterone cream has never shown any side effects
and works to halt unnecessary bleeding as well as to really diminish hot
flashes. |