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A study examines the efficacy of lower-than-conventional doses of estrogen in relieving vasomotor symptoms. Plus: What are the latest ACOG recommendations on water births?
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.
ACOG committee opinion recommends land not water birth
Birth on land rather than water is the recommendation of the American College of Obstetricians and Gynecologists (ACOG) in a new committee opinion. While acknowledging the potential benefits of water immersion during the first stage of labor, the document points to insufficient data on benefits or risks of the technique in the second stage of labor and delivery.
Also endorsed by the American Academy of Pediatrics, the committee opinion is based on a review of published dater on water immersion during labor and delivery, including a 2009 Cochrane systematic review. That analysis looked at 12 randomized controlled trials (RCT) of immersion during labor which included 3,243 women. In 9 of the trials, immersion was done during first-stage labor, in 2 trials, it was done in both first- and second-stage labor and in 1 RCT, immersion during the second stage was compared only with controls. The ACOG panel that reviewed the Cochrane data expressed concern about limitations of the 9 RCTs, such as lack of power, absence of blinding, and small sample size.
In describing the Cochrane data on water immersion during first-stage labor, the committee opinion notes that it “may be associated with shorter labor and decreased use of spinal and epidural analgesia.” The document says that in that setting, it can be offered to healthy women with uncomplicated pregnancies between 37 0/7 and 41 6/7 weeks’ gestation. ACOG does not recommend that women give birth in water because of insufficient data on benefits and risks of water immersion during second-stage labor and delivery. “Several serious neonatal complications have been reported, but the actual incidence has not been determined in population-based analyses,” the authors said.
The committee opinion goes on to recommend that ob/gyns counsel women who want to give birth in water about the lack of data on maternal and perinatal benefits and risks of the technique and also let them know about the “rare but serious neonatal complications associated with this choice.” Those include case reports and case series documenting major infection with Pseudomonas aeruginosa and Legionella pneumophila as well as the potential for neonatal water aspiration.