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Plant Estrogen Pill Gets Menopause Test
July 29, 2005 -- In a recent test, a pill containing soy and black cohosh was no better at curbing menopause symptoms than a fake pill.
The researchers don't dismiss plant estrogens (phytoestrogens). Instead, they raise a lot of questions in their report in Menopause.
Did the two plant estrogens they studied -- soy isoflavones and black cohosh -- cancel each other out? Did patients' hopes trigger a "placebo effect?" Was the study long enough?
Those issues will likely get more attention, with many women seeking menopausal treatments without prescription hormone replacement therapy, write the researchers.
They included Marieke Verhoeven, MD, of the obstetrics and gynecology department of Amsterdam's VU University Medical Center.
Testing Alternatives
Verhoeven's study included 124 healthy women who had at least five menopausal hot flashes daily.
The women randomly got a phytoestrogen supplement or a fake pill (placebo) that only contained olive oil. They didn't know which pill they'd gotten.
The supplement contained soy extract, black cohosh, evening primrose oil, calcium, vitamin D, and vitamin E. The pills looked, smelled, and tasted exactly the same.
The women took the pills for 12 weeks. Data came from their menopausal symptom diaries, blood tests, and quality-of-life surveys.
Similar Results for Both Groups
Women in both groups reported similar improvements. The supplement apparently offered no advantage over the placebo.
That's why the researchers write that "the supplement was not effective" in easing the women's hot flashes.
Most women had taken the pills as instructed (89% of the placebo group and 97% of the supplement group), write Verhoeven and colleagues.
Placebo Effect?
Daily hot flashes dropped 36% in women taking the fake pill.
Other phytoestrogen studies have also shown high response rates to placebos, write the researchers.
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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