NEW RESEARCH INDICATES SAFETY OF REMIFEMIN FOR MENOPAUSAL SYMPTOMS
IN BREAST CANCER PATIENTS
Data Published in Breast Cancer Research and Treatment Shows Standardized
Herbal Supplement Has No Estrogenic Effects on the Breast
PITTSBURGH, October 2 – A study published in the current issue
of Breast Cancer Research and Treatment suggests that RemiFemin®
Menopause can be used safely to relieve menopausal symptoms in women
with a history of breast cancer who cannot take estrogen. The study
adds to the growing body of evidence showing that RemiFemin relieves
symptoms without exerting an estrogenic effect. This is welcome news
for the many women who cannot or who choose not to take hormone replacement
therapy (HRT).
“This is promising news for all women, especially those with
a history of breast cancer, who are looking for estrogen-free alternatives
to treat menopausal symptoms.” said Susan Love, MD, internationally
recognized authority on women’s health, Adjunct Professor of Surgery
at UCLA, and the author of several books, including, the best selling
Dr. Susan Love’s Hormone Book and Dr. Susan Love’s Breast
Book.
Study Design and Methods
The research, conducted by Johannes Freudenstein, PhD and colleagues,
was designed to evaluate the safety of RemiFemin Menopause, a standardized
black cohosh supplement, as an alternative for estrogen-sensitive patients
for whom HRT is contraindicated. The study examined and compared the
effects of black cohosh extract, estrogen, tamoxifen (an anti-estrogen)
and a placebo control on estrogen-sensitive breast cancer cells.
To evaluate the safety and estrogenic activity of RemiFemin, Dr. Freudenstein
and colleagues performed experiments using cultured estrogen receptor-positive
MCF-7 cells. The experiments tested for potential estrogen-like activity
of RemiFemin by examining the rate of growth of MCF-7 cells exposed
to black cohosh extract as compared to both negative (placebo) and positive
(estrogen) controls, as well as tamoxifen.
When black cohosh was introduced to the cell model it, in contrast
to estrogen, did not stimulate growth. In fact, dilutions comparable
to the commercially available dose of black cohosh extract (RemiFemin)
resulted in significant inhibition of MCF-7 cell growth. Furthermore,
black cohosh was found to enhance the inhibitory effect of tamoxifen,
a commonly prescribed drug for treatment of breast cancer, which, as
expected, significantly reduced cell proliferation.
“Unlike estrogen, which stimulated cancerous cell growth in the
human-breast cell system studied, RemiFemin did not have such a proliferative
effect, confirming its safety in patients with a history of breast cancer.
These data provide important evidence that black cohosh works differently
than estrogens and phytoestrogens to relieve the symptoms of menopause,”
noted Steven Weisman, PhD, a pharmacologist and herbal expert.
This research was funded by Schaper & Brümmer, a leading herbal
company based in Salzgitter, Germany.
Background
Hormone replacement therapy (HRT) is a commonly prescribed treatment
for relief of menopausal symptoms, which affects a third of American
women – more than 35 million – each year. However, recent
reports from the Women’s Health Initiative question its ability
to improve women’s overall health on a long-term basis and raise
concerns about long-term safety. While HRT still remains a valuable
option for women who want short-term relief of menopausal symptoms,
many women cannot or choose not to take HRT. In addition, experts recommend
that women with estrogen-sensitive cancers seek alternative methods
for alleviating menopausal symptoms.
Herbal treatments are gaining popularity for relieving symptoms of
menopause. However, data on the effectiveness of phytoestrogens, including
soy and red clover, are uncertain. In addition, phytoestrogens, based
on their mechanisms of action, may have effects that are similar to
estrogen in women at increased risk of female cancers.
Unlike estrogens and phytoestrogens, RemiFemin Menopause has been shown
to relieve menopause symptoms without estrogen-like activity —
this data supports the non-estrogenic effects of Remifemin in the breast,
which was also demonstrated in a study published in the June issue of
Cancer Research.
RemiFemin is the most studied herbal supplement for menopause. Its
overall safety and efficacy has been established through numerous clinical
trials as well as open clinical monitoring trials in physicians’
practices. More than 20 clinical trials have been done spanning more
than 40 years with over 3,000 subjects. Additionally, the March 2002
issue of the Journal of Women’s Health and Gender-Based Medicine
presented the results of a controlled, randomized, double blind, clinical
trial that showed RemiFemin decreased physical and emotional menopause
symptoms in most women by 70% after 12 weeks of twice-daily use, without
altering hormone levels or affecting estrogen receptor tissues.
RemiFemin has been evaluated and approved by the German Commission
E, a regulatory body similar to the U.S. FDA, as a treatment for menopausal
symptoms, including hot flashes, mood swings, night sweats, irritability
and related occasional sleeplessness. 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.
Schaper & Brümmer 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 store chains,
discount department stores and health food stores nationwide, in the
women’s supplement section near calcium supplements such as Os-cal.
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.
