Objective: To compare the efficacy of different doses of 17 beta-estradiol
(E2) for relief of vasomotor symptoms in menopausal women.
Methods: This was a randomized, double-masked, placebo-controlled, 12-week
study in which 333 menopausal women with moderate or severe hat flushes wer
e assigned to treatment with 0.25 mg, 0.5 mg, 1 mg, or 2 mg oral micronized
17 beta-E2, or placebo. The number and severity of hot flushes were record
ed daily.
Results: There was a significant linear correlation between increased dosag
e of 17 beta-E2 and decreased moderate to severe hot flushes per week (P <
.001). Rapid reduction in moderate to severe hot flushes was only achieved
with 1 and 2 mg, showing a significant difference from placebo at week 4 (P
< .05). At week 4, half the women on placebo had reduced moderate to sever
e hot flushes of at least 52%; the corresponding figures were 56%, 69%, 86%
, and 91% for 0.25, 0.5, 1, and 2 mg, respectively. At week 12, all doses e
xcept 0.25 mg were significantly better than placebo for reducing moderate
to severe hot flushes (P < .001). Although there were no significant differ
ences, twice as many women in the 2-mg group discontinued treatment due to
adverse events, compared with the placebo group.
Conclusion: Oral micronized 17 beta-E2 showed a dose-response effect for re
ducing moderate and severe hot flushes in menopausal women. 17 beta-E21 mg
appeared to be the most useful initial dose. (C) 2000 by The American Colle
ge of Obstetricians and Gynecologists.