NEW RESEARCH CONFIRMS SAFETY AND EFFICACY OF REMIFEMIN FOR MENOPAUSAL
SYMPTOMS
Report in The Journal of Women's Health and Gender-Based Medicine Shows
Standardized Herbal Supplement Works without Affecting Hormone Levels
PITTSBURGH, March 25 - A study published in the current issue of The
Journal of Women's Health and Gender-Based Medicine heralds good news
for women who are looking for natural, estrogen-free options to relieve
menopausal symptoms.
The study, conducted by Eckehard Liske, PhD and colleagues, shows that
the commercially available dose of RemiFemin® Menopause, an exclusive
extract of black cohosh available over-the-counter, works differently
from estrogens and plant estrogens to relieve menopausal symptoms.
"This data confirms that RemiFemin provides a safe and effective
option for women who want to relieve menopause symptoms naturally,"
said Eckehard Liske, PhD, lead author of the study. "The product
reduces menopause symptoms such as hot flashes, mood swings, night sweats
and occasional sleeplessness without affecting hormone levels or specific
cell lines associated with some female cancers."
In addition to examining the product's lack of estrogenic effect, the
study compared the effectiveness and safety of two dosage forms of RemiFemin
Menopause. After six months, the currently recommended daily dose (40
mg) showed similar benefits compared to a three-fold higher dose. Specifically,
the study showed that the majority of women saw a 70% reduction in their
physical and emotional menopausal symptoms when they took RemiFemin
twice daily for 12 weeks. The results also show that doses above 40
mg per day do not demonstrate any significant therapeutic advantages
nor does the higher dose result in a significantly greater number of
side effects.
"These findings add to the large body of evidence that the currently
available dose of RemiFemin Menopause results in statistically significant
improvements in both physical and emotional menopausal symptoms in women,"
said Steven Weisman, PhD, a pharmacologist and herbal expert.
Study Design and Methods
This controlled, randomized, double blind, multi-center trial
was conducted at four gynecological clinics in Poland in accordance
with the Good Clinical Practice Guideline. The study included 150 peri-
and postmenopausal women between the ages of 42 and 60 with moderate
to severe menopause symptoms. The study was conducted over a 12-week
treatment period, with the majority of women enrolling in a continuation
study to 24 weeks. A number of scales were used to measure menopause
symptoms, including the Kupperman Menopause Index and the Self-Rating
Depression Scale.
Background
A third of American women - more than 35 million - are now
perimenopausal, and between 50-80% of them will experience acute symptoms,
such as hot flashes, mood swings and sleeplessness. As many as 85% of
women who experience hot flashes have them for more than one year, and
25 to 50% have them for up to five years. As such, many women seek medical
attention to alleviate their menopause symptoms.
Hormone replacement therapy (HRT) is a commonly prescribed treatment
for relief of distressing menopausal symptoms. While HRT has been used
for years to relieve menopause symptoms and also protect bone health,
there are a number of possible side effects associated with HRT that
raise questions regarding the safety of HRT use in all women. Because
HRT is contraindicated in certain populations, particularly in patients
with estrogen sensitive cancers of the breast and uterus, natural, herbal
treatments are gaining popularity for the relief of short-term symptoms
of menopause.
While many herbal remedies have not been widely studied, there is an
abundance of rigorous scientific data that support the safety and efficacy
of black cohosh (Cimicifuga racemosa) extracts - sold under the name
RemiFemin Menopause in the United States - for the treatment of menopause
symptoms. The German Commission E, a regulatory body established by
the German Federal Health Authorities similar to the FDA, has approved
black cohosh as a treatment for menopausal symptoms, and the American
College of Obstetrics and Gynecology has issued guidelines on the use
of botanical menopause treatments, which consider black cohosh to be
helpful for hot flashes.
RemiFemin Menopause is the most studied black cohosh supplement and
has been the subject of numerous clinical trials as well as open-label
studies monitoring its effects in physicians' practices. More than 20
trials have been completed spanning more than 40 years. No serious drug
interactions have been reported in 40 years of use under physicians'
supervision and adverse events have been limited to mild, transient
stomach upset.
This research was funded by Schaper & Brümmer, which manufactures
RemiFemin for sale in the United States, Europe, Asia, Australia and
Africa. RemiFemin is marketed in the United States by GlaxoSmithKline
Consumer Healthcare. The product is widely available in U.S. supermarkets,
pharmacies, drug stores chains, discount department stores and health
food stores nationwide.
GlaxoSmithKline -
one of the world's leading research-based pharmaceutical and healthcare
companies - is committed to improving the quality of human life by enabling
people to do more, feel better and live longer.
For a full bibliography of research on RemiFemin, visit www.remifemin.com/professional