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August 21, 2005
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| Dr. Greg Plotnikoff checks Beverly Fiman's vital signs. Fiman took part in Plotnikoff's study of an herbal remedy for menopausal hot flashes. (MPR Photo/Lorna Benson) |
Minneapolis, Minn. — The herbal concoction is called Keishi bukuryo gan. The name literally means cinnamon mushroom tablet. It's very popular in Japan, where about 40 million doses are prescribed each year.
Keishi bukuryo gan has been an approved prescription medication there since 1976, and it's a covered drug benefit under Japan's national health plan.
University of Minnesota physician Greg Plotnikoff came across the herbal remedy while at Keio University in Tokyo. He's been a visiting professor at that university's medical school for the past three years.
During his time there, Plotnikoff discovered that nearly all Japanese gynecologists commonly prescribe Keishi bukuryo gan for hot flashes. So he tried it on his Japanese patients.
"I said, 'Wow. This is so different, and no one knows about it in the United States,'" says Plotnikoff. Keishi bukuryo gan has been around for centuries. It was first discovered in an ancient Chinese text that dates back 1800 years. Today one Japanese company owns the formula for the drug, and its manufacturing process is strictly regulated by the government.
Still, Plotnikoff says Keishi bukuryo gan hasn't been studied much in Japan. He says doctors there just accept that it's effective.
"The traditional understanding in Japan has been that these ingredients work together to enhance positive effects and to minimize negative effects," he says.
But Plotnikoff says he knew that explanation wouldn't satisfy U.S. doctors. So he contacted the Food and Drug Administration, and received FDA permission to proceed with the first clinical trial of Keishi bukuryo gan in the U.S.
So far about 100 women are enrolled in his study at the U of M. Beverly Fiman, 54, is one of them. For the past 13 weeks Fiman has taken five tiny pills a day, in hopes of eliminating her hot flashes.
Fiman says her sudden, intense rise in body temperature has plagued her for nearly four years. Fiman says it's been quite disorienting and frustrating at times.
"You go through your daily life ... hoping to present ourselves a certain way, hoping to present ourselves as cool, competent -- especially women my age," says Fiman. "You don't want to appear flustered, unkempt. That's not what you want to give a sense that you are."
Fiman says Keishi bukuryo gan has changed all that.
"It worked. It just worked. The hot flashes just went away. It was great," Fiman says.
But it could be coincidence. Since Fiman is participating in a scientific study, it's possible that researchers did not give her Keishi bukuryo gan. She could be among the one-third of Plotnikoff's research subjects who received a placebo pill containing no medicine at all.
Plotnikoff doesn't know if Fiman has received the drug either. He will have to wait until at least January before he begins seeing some of the results from his study.
Plotnikoff says he hopes then he will have the proof to back up his belief that Keishi bukuryo gan is a legitimate hot flash medication.
But Plotnikoff says it will probably take many more studies to persuade those who don't put much stock in herbal medicine.
"Because it did not come out of a western model, many physicians find it very hard to believe," says Plotnikoff. "As one said the other day, 'Herbal medicine, I wouldn't believe it even if it were true.' It just doesn't fit our way of thinking about how science should proceed."
Plotnikoff says even if western doctors want to ignore alternative therapies, they can't -- because their patients are interested in them. He says the scare over hormone replacement therapy, which has been linked to cancer and strokes, has prompted many menopausal women to seek out natural remedies on their own.
Plotnikoff says U.S. researchers should be more willing to study these alternatives, so they can treat their menopausal patients more effectively.
Plotnikoff says he will continue enrolling patients in his study until October 2005.
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