New non-hormonal hot flash treatment set for clinical trial
BUFFALO, N.Y. -- A novel non-estrogen-based therapy for hot flashes will be tested for effectiveness in a clinical trial conducted by researchers at the University at Buffalo that is set to begin in February.
The trial will assess the effectiveness of an amino acid, an all-natural, non-hormonal dietary supplement, to eliminate the sudden flushes that plague many postmenopausal women.
The study is funded by a $665,550 grant from the National Center for Complimentary and Alternative Medicine of the National Institutes of Health.
Amino acids are the molecules that combine to make proteins, the body's building blocks. Many amino acids are acquired through the diet. The UB researchers theorize that doses higher than can be achieved in a normal diet of certain amino acids will reduce hot flash activity.
Amino acid therapy appears to act on the hypothalamus, the part of the brain that regulates temperature.
Thomas Guttuso, Jr., M.D., UB assistant professor of neurology and principal investigator on the clinical trial, conducted a small study in 2004 using the amino acid treatment with 15 postmenopausal women.
"The study showed very promising results in decreasing hot flashes among these women, indicating the treatment deserved further investigation," Guttuso related. He now is preparing to conduct a 12-week study involving 100 women with hot flashes.
Half the women will get the active treatment in capsule form, and half will receive an inactive capsule. Participants will report the number of hot flashes a day and their intensity in a diary throughout the trial to determine the treatment's effectiveness.
Guttuso discovered the potential of amino acid treatment for hot flashes accidentally while treating a patient for migraine headaches.
"I placed a woman who was complaining of migraines on an amino-acid-based prescription treatment called gabapentin that has been shown to help prevent migraine headaches. A week later she called to tell me her hot flashes were gone.
"This certainly was an unexpected effect of the medication," he said. "It made me start to think that perhaps some of the all-natural amino acids may also be effective hot flash therapies."
The gold standard hot-flash therapy for years has been hormone replacement therapy, or HRT, but more information has come to light showing that HRT might have some dangerous side effects.
"Since there were not many non-hormonal hot flash therapies available, and because the number of women with hot flashes is so large -- about 30 million women in the U.S. -- the University of Rochester, where I was working at the time, patented the discovery."
Guttuso, meanwhile, published the first paper on this new use of an amino acid in the journal Neurology in 2000. He followed that with a paper in Obstetrics & Gynecology in 2003 reporting on the successful use of gabapentin for hot flashes in a randomized clinical trial involving 59 women.
The amino acid to be tested in the upcoming trial, while not gabapentin, is known to work through the same mechanism.
Guttuso will begin recruiting women for the study in February. Potential participants may call 716-829-2482 for more information.
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