(Reuters Health) - New research throws a wet blanket on an earlier study that showed women in menopause might get dramatic relief from hot flashes by taking the antidepressant Lexapro.
http://www.reuters.com/article/2011/05/26/us-hot-flashes-idUSTRE74P5DK20110526
According to the new findings, Forest Laboratories' Lexapro, also called escitalopram, reduces neither the severity nor frequency of hot flashes associated with menopause.
Robert Freedman, a behavioral scientist at Wayne State University in Detroit who led the work, says he was "disappointed" by the results.
"We wouldn't have done the study if we had not expected an effect" from the drug, Freedman told Reuters Health.
Roughly 75 percent of women in menopause experience hot flashes, and nearly half of them report severe episodes. Hormone replacement therapy has long been the standard treatment for the bothersome symptoms, but millions of women stopped using the drugs after it became clear that they increase the risk of cancer and heart disease.
Given this backdrop, the previous study suggesting that Lexapro might halve the number of hot flashes generated a lot of buzz.
The key difference between the two trials, which used the same doses of drug over the same time period, is how they measured hot flashes, Freedman said.
In the earlier study, women were asked to keep a diary of each episode, while Freedman and his colleagues had volunteers wear a battery-powered hot flash detector on their skin.
The quarter-sized device measures humidity to record hot flash activity even during sleep, he said. It also can detect hot flashes when women aren't aware they are experiencing them -- making it much more reliable than personal accounts, said Freedman, who holds a patent on the technology.
The Michigan researchers conducted two trials with escitalopram, both lasting eight weeks. In the first, they gave 10 milligrams a day of the drug or dummy pills to 10 women in menopause.
When the researchers found no effect of escitalopram on the number of hot flashes women had, they repeated the trial in 26 more women and upped the dose to 20 milligrams per day. Again, the frequency of hot flashes did not seem to change, hovering at about 19 to 20 per week.
During the final week of the trial, women taking escitalopram had an average of about 17 hot flashes a day, down 14 percent from the first week. Those taking dummy pills experienced a seven-percent increase in hot flashes from the start of the study, but Freedman said the difference between the two groups wasn't "clinically significant."
Freedman's group reported its findings in the journal Menopause.
Ellen W. Freeman, a menopause expert at the University of Pennsylvania in Philadelphia, and a co-author of the earlier Lexapro study, acknowledged that hot flash activity differs considerably when recorded by a monitor and reported by women themselves. But that, she said, may not be the most important issue for patients or their doctors.
"Clinicians treat the woman's complaint of hot flashes, and the degree to which they are bothersome or distressing," Freeman told Reuters Health. "An objective monitor has scientific appeal but may not relate to the clinical problem."
SOURCE: bit.ly/k53Fgm Menopause, online April 30, 2011
http://journals.lww.com/menopausejournal/pages/articleviewer.aspx?year=9000&issue=00000&article=99027&type=abstract
http://www.reuters.com/article/2011/05/26/us-hot-flashes-idUSTRE74P5DK20110526
According to the new findings, Forest Laboratories' Lexapro, also called escitalopram, reduces neither the severity nor frequency of hot flashes associated with menopause.
Robert Freedman, a behavioral scientist at Wayne State University in Detroit who led the work, says he was "disappointed" by the results.
"We wouldn't have done the study if we had not expected an effect" from the drug, Freedman told Reuters Health.
Roughly 75 percent of women in menopause experience hot flashes, and nearly half of them report severe episodes. Hormone replacement therapy has long been the standard treatment for the bothersome symptoms, but millions of women stopped using the drugs after it became clear that they increase the risk of cancer and heart disease.
Given this backdrop, the previous study suggesting that Lexapro might halve the number of hot flashes generated a lot of buzz.
The key difference between the two trials, which used the same doses of drug over the same time period, is how they measured hot flashes, Freedman said.
In the earlier study, women were asked to keep a diary of each episode, while Freedman and his colleagues had volunteers wear a battery-powered hot flash detector on their skin.
The quarter-sized device measures humidity to record hot flash activity even during sleep, he said. It also can detect hot flashes when women aren't aware they are experiencing them -- making it much more reliable than personal accounts, said Freedman, who holds a patent on the technology.
The Michigan researchers conducted two trials with escitalopram, both lasting eight weeks. In the first, they gave 10 milligrams a day of the drug or dummy pills to 10 women in menopause.
When the researchers found no effect of escitalopram on the number of hot flashes women had, they repeated the trial in 26 more women and upped the dose to 20 milligrams per day. Again, the frequency of hot flashes did not seem to change, hovering at about 19 to 20 per week.
During the final week of the trial, women taking escitalopram had an average of about 17 hot flashes a day, down 14 percent from the first week. Those taking dummy pills experienced a seven-percent increase in hot flashes from the start of the study, but Freedman said the difference between the two groups wasn't "clinically significant."
Freedman's group reported its findings in the journal Menopause.
Ellen W. Freeman, a menopause expert at the University of Pennsylvania in Philadelphia, and a co-author of the earlier Lexapro study, acknowledged that hot flash activity differs considerably when recorded by a monitor and reported by women themselves. But that, she said, may not be the most important issue for patients or their doctors.
"Clinicians treat the woman's complaint of hot flashes, and the degree to which they are bothersome or distressing," Freeman told Reuters Health. "An objective monitor has scientific appeal but may not relate to the clinical problem."
SOURCE: bit.ly/k53Fgm Menopause, online April 30, 2011
http://journals.lww.com/menopausejournal/pages/articleviewer.aspx?year=9000&issue=00000&article=99027&type=abstract
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