Women in the New York City and Washington, D.C. areas are now being recruited to participate in the first U.S. clinical trial of Chinese herb treatment for menopausal hot flashes. The study was announced Sept. 22 at the North American Menopause Society Meeting in San Francisco.
The College of Physicians & Surgeons at Columbia-Presbyterian Medical Center, in collaboration with Georgetown's Medical Center and the Taoist Health Institute, are conducting a trial study the effectiveness of an herb formula in reducing the frequency and severity of menopausal hot flashes. The formula has been used to treat hot flashes in China for centuries.
The 13-month trial will enroll menopausal women, aged 45 to 65, who experience at least 6 hot flashes a day. Hot flashes are the recurrent, often disabling episodes of intense heat sensation, profuse sweating and rapid heart beat that occur in about seventy-five percent of American women at menopause.
The principle investigator is Fred Kronenberg, the country's leading researcher on menopausal hot flashes and director of the Richard and Hinda Rosenthal Center for Alternative Complementary Medicine at the College of Physicians and Surgeons. In Washington, D.C., researchers and clinicians at the Taoist Health Institute, a traditional Chinese medicine clinic and Georgetown University's Medical Center, will collaborate on the study. Georgetown's James Simon, chief of reproductive endocrinology and infertility, will supervise the Washington arm of the study. The trial is funded by a pilot grant from the National Institute of Health Office of Alternative Medicine and a grant from the Teresa and H. John Heinz III Fund of the Heinz Family Foundation.
For most women, hot flashes are mild and disappear within a rew years. But for about 4 million to 5 million American women over age 50, severe hot flashes may persist for as many as 20 to 40 years. Women seek medical assistance for hot flashes more often than for any other menopausal complaint. Estrogen therapy is the most effective and widely used treatment in the United States for hot flashes. However, for some women, such as those with estrogen-sensitive breast cancers, estrogen is not recommended. Other women, concerned about the unresolved relationship between estrogen therapy and breast cancer, choose not to take estrogen.
There is little else that Western medicine currently has to offer these women, said Kronenberg. Many of them experiment on their own with vitamin E, or various herbal preparations that they hear of by word of mouth. These preparations have not been studied in a systematic way for their effect on hot flashes or for possible adverse effects. It is important to explore natural medicinals used in other cultures, since we may find new ways to help those women for whom hot flashes are so disabling.
The Columbia study will be the first double blind, placebo-controlled crossover clinical trial to assess the effect of Chinese herbs on the frequency and severity of hot flashes. Women in the study will be randomly assigned to receive the herbal formula or placebo in capsule form. At the end of each treatment period, those who received herbs will be crossed over to placebo and those who received placebo will receive herbs. Herbs and placebo capsules will look and taste alike and their identity will be unknown to subjects and investigators until the end of the study.
Both the herbs and the placebo will be formulated at East Earth Herb Inc. of Eugene, Ore.
The herb formula to be studied was described in 1253, then modified in 1508 by Sue Ji in Annotations on Good Prescriptions for Women. Consultants for the study are Wu Jing Nuan, Chinese medicine practitioner for 20 years and founder of the Taoist Health Institute; Taoist consulting physician Adriane Fugh Berman, and Elaine Stern, certified acupuncturist and Chinese herbalist in private practice in New York City.
Participants will be required to keep a diary during the study in which they will record the time of day of all hot flashes and the intensity of each flash.
Evaluations for all participants will include blood chemistry, urinalysis, weight and blood pressure.
Subjects in New York will also undergo physiological measurements that include skin and internal body temperatures, heart rate, phytoestrogens and blood levels of hormones and cholesterol.