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
CONTACTS:
Sarah Oetgen
SENSEI Health
202-337-4582
soetgen@senseihealth.com
Malesia Dunn
GlaxoSmithKline
412-928-1105
malesia.a.dunn@gsk.com