Lower-than-conventional doses of oral or transdermal estrogen may be very effective in treating vasomotor symptoms in menopausal women, according to a new study in Menopause.
The study looked at 727 women aged 42 to 58 who were within 3 years of their final menstrual period. They were randomized to receive oral conjugated estrogens (o-CEE) 0.45 mg (n = 230), transdermal estradiol (t-E2) 50 [mu]g (n = 225; both with micronized progesterone 200 mg for 12 days each month), or placebos (PBOs; n = 275). Symptoms of menopause were recorded at the time of screening and at 6, 12, 24, 36, and 48 months postrandomization. Exact [chi]2 tests in an intent-to-treat analysis were used to compare the differences in proportion of women with symptoms at baseline and at each follow up. The difference in effect created by body mass index (BMI) and race/ethnicity was tested with generalized linear mixed effects modeling.
Researchers found that both night sweats (from 35% at baseline to 19% for PBO, 5.3% for t-E2, and 4.7% for o-CEE) and severe vasomotor symptoms (from 44% at baseline to 28.3% for PBO, 7.4% for t-E2, and 4.2% for o-CEE) were significantly reduced by 6 months in women who were randomized to either active hormone when compared with the placebo (P < 0.001 for both symptoms). Neither treatment arm was significantly different from the other. All groups saw a decrease in irritability and insomnia from baseline to 6 months postrandomization. Further into follow-up, an intermittent reduction in insomnia was seen in both arms of treatment versus placebo: o-CEE was more effective at 36 and 48 months (P = 0.002 and 0.05) and t-E2 was more effective at 48 weeks (P = 0.004). No difference was seen between either treatment and placebo during the longer follow up for irritability. Race/ethnicity and BMI did not significantly change symptom relief for active treatment versus placebo.
The researchers concluded that a lower-than-conventional dose of oral or transdermal estrogen was associated with similar and substantial reductions in vasomotor symptoms in women who were recently postmenopausal. The reductions were sustained during 4 years.