GREEN BAY, Wis., March 1, 2007 /PRNewswire via COMTEX/ -- Recent studies have linked hormone replacement therapy (HRT) with major risk indicators for breast cancer, including endometrial thickening, increased breast density, and breast cell proliferation. A new safety study by Hirschberg, et al., on Remifemin(R) black cohosh extract -- the leading natural therapy for treating menopausal symptoms -- looked at these specific risk factors and found no adverse effects. The research was published in Menopause: The Journal of The North American Menopause Society, Vol. 14, No. 1, 2007.
"Hirschberg's 6-month study adds to the body of 90 scientific papers and 15 published studies on the proprietary Remifemin(R) black cohosh extract showing efficacy in reducing hot flashes, night sweats and irritability, as well as possessing an excellent safety profile," said Dr. Eckehard Liske, Director of the International Medical Department, Schaper & Bruemmer GmbH & Co KG, Salzgitter, Germany. "The research suggests that Remifemin(R) does not augment breast cancer risk factors as HRT does, and is safe -- especially for women who should not take estrogen."
In Hirschberg's research, 74 naturally postmenopausal women with climacteric symptoms were treated with Remifemin(R) (5 mg dry extract per day, corresponding to 40 mg herbal substance), and 65 women completed the study. Mammograms were performed and breast cells were collected by fine needle aspiration biopsies at baseline and after 6 months. Mammographic density was quantified according to the Wolfe classification or a percentage scale. Breast cell proliferation was assessed using the Ki-67/MIB-1 monoclonal antibody. Safety was monitored by adverse event reporting, laboratory assessments, and measurement of the endometrium by vaginal ultrasound.
"None of the women studied showed any increase in mammographic breast density," explained Dr. Liske. "Furthermore, there was no increase in breast cell proliferation. The findings suggest that Remifemin(R) black cohosh does not cause adverse effects on breast tissue. And, the data do not indicate any endometrial or general safety concerns during 6 months of treatment."
Breast density has been implicated as a primary risk factor for breast cancer. Women with high breast density have a 5-fold increased risk for breast cancer compared to women with low density. HRT has been shown to increase breast density by 30-50 percent. Hormones also have been found to triple or even quintuple breast cell proliferation, as well as thicken endometrial tissues -- all serious warning signs for breast or endometrial cancer.
"Not all black cohosh is the same," concluded Dr. Liske. "Remifemin(R) is produced using a proprietary standardized extract (uniform dosage) of pure black cohosh root called RemiSure(TM) that yields a more complete spectrum of active compounds than other extraction methods. The body of published research on Remifemin(R) demonstrates consistent positive results, unlike other black cohosh preparations." Remifemin(R) is the most OB/GYN-recommended, non- prescription menopausal therapy. For more information, visit www.remifemin.com .