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Antiseizure Drug May Ease Hot Flashes
July 5, 2006 --The antiseizure drug Neurontin may be as good as estrogen at easing women's hot flashes.
So says a study published in July's issue of the journal Obstetrics & Gynecology. The researchers included Sireesha Reddy, MD, of New York's University of Rochester School of Medicine and Dentistry.
One of Reddy's colleagues -- Thomas Guttuso Jr., MD, of the University of Buffalo -- holds a patent for Neurontin's use in the treatment of hot flashes, the journal notes.
Guttoso had previously reported that Neurontin seemed to help ease postmenopausal hot flashes. So Reddy, Guttoso, and colleagues pitted Neurontin against estrogen -- a hormone which drops during menopause and is often used to ease hot flashes and other menopausal symptoms -- in a head-to-head test.
For comparison, the study also included placebo pills lacking medicine, hormones, or other active ingredients.
Hot Flashes: Before and After Treatment
Reddy's team studied 60 postmenopausal women who had had at least 50 moderate to severe hot flashes every week for more than two months.
The researchers gave the women daily doses of Neurontin, estrogen, or placebo pills for three months. The women didn't know which type of pill they were taking.
The women kept diaries of their hot flashes during the study. They recorded the frequency and severity of their hot flashes. The researchers created a hot flash composite score for each woman, based on her ratings of her hot flashes' frequency and severity.
By the end of the study, the placebo group's average hot flash composite score was 54% lower than it had been at the study's start. The average hot flash composite score fell even further for the Neurontin group (down 71%) and estrogen group (down 72%).
"Despite the small scale of this study, [Neurontin] appears to be as effective as estrogen" in treating postmenopausal hot flashes, the researchers write.
Placebo Effect?
Reddy and colleagues note the "large placebo effect," meaning that the women in the placebo group saw big improvements in their hot flashes, even though the placebo lacked any active ingredients.
More work should be done to figure out how the placebo effect impacts hot flash treatments, the researchers note. For instance, they point out that people who enroll in hot-flash-treatment trials may make changes in their lives that curb their hot flashes. However, no lifestyle changes were noted in Reddy's study.
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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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