The study, titled “Effects of A Breast-Health Herbal Formula Supplement on Estrogen Metabolism in Pre- and Post-Menopausal Women not Taking Hormonal Contraceptives or Supplements: A Randomized Controlled Trial,” took into account the beneficial estrogen metabolism and breast cancer risk effects of indole-3-carbinol and dietary lignans. Citing the lack of published literature on the effects of a product that combined the two supplements, the researchers set out to determine whether a breast health supplement “containing indole-3-carbinol and hydroxymatairesinol lignan would alter estrogen metabolism … and reduce breast cancer risk and risk for other hormonally-related cancers.”
Forty-seven pre-menopausal and 49 post-menopausal women were randomly assigned to receive either a placebo or a supplement containing HMR lignan, indole-3-carbinol, calcium glucarate, milk thistle, Schisandra chinesis and stinging nettle. Each woman consumed either treatment or placebo for 28 days.
Blood and urine samples revealed that the herbal formula significantly increased hydroxylation of the female hormone estrogen, which is linked with a reduction in the risk of hormone-sensitive breast cancer, and more significant results were witnessed in pre-menopausal women than in the post-menopausal women.
“For both pre- and post-menopausal women, we were pleasantly surprised by the magnitude of increase in the 2-OHE estrogen metabolite levels, with relatively easy consumption of the test product,” commented the study’s lead researcher Maggie Laidlaw, PhD, director of the clinical trials division of Nutrasource Diagnostics Inc. (NDI), Guelph, ON, Canada. “The 2-OHE metabolite level more than doubled (6.34 vs. 13.29) in pre-menopausal women, and almost doubled in post-menopausal women (9.22 vs. 17.37), before and after supplementation.
“Our carcinogenic ratio was a novel biomarker we devised in order to fully assess the relative amounts of pro-carcinogenic and anti-carcinogenic estrogens/estrogen metabolites,” she continued. “Although our sample size was relatively small, we were amazed to see a statistically significant 57% reduction in this ratio in the women in our trial. In summary, we believe that this is the first NHP to illustrate the possibility of beneficially affecting estrogen metabolism in a variety of ways.”
Dr. Laidlaw expressed optimism when asked if she thought the supplement used in the study could someday be translated into a real preventative treatment option for women at risk for breast cancer. “Given that greater than 90% of breast cancer cases are estrogen dominant, and therefore have nothing to do with hereditary factors, the very nature of the formulation, and our subsequent findings, addresses this alarming statistic,” she told Nutraceuticals World. “The next step would be to track this trial prospectively in a long-term (e.g., five years or more) epidemiological study that is government-funded. If we can significantly reduce the incidence/prevalence of breast cancer in women, we can save millions of dollars in healthcare costs that are currently required for women with breast cancer (not to mention the reduction in pain and suffering for women).”
Dr. Laidlaw said Nutrasource Diagnostics was contracted to carry out the study by femMED, a Toronto-based formulator and marketer of a range of products formulated specifically for women’s most common health concerns. The supplement used in the study was assembled by femMED’s team of formulators, master herbalist, holistic pharmacist and integrative medical practitioners, with Nutrasource Diagnostics performing a literature review, and preparing a Rationale for Combination document.
“The Breast Health study was the first of several of their products to undergo a full clinical trial,” she said. “With breast cancer affecting one in eight women, and nothing in the marketplace available to address prevention, we were excited by the ground-breaking potential of such a unique and essential formula for women, as well as the potential benefits for women, so we were pleased to take this on.”
Looking ahead, femMED has already enlisted Nutrasource Diagnostics to research the remaining 12 products in their line. “NDI is already in the beginning stages of clinical trials for the next two femMED products—Menopause Relief and Libido,” said Dr. Laidlaw. “It is gratifying to see a company that manufactures natural health products for women ready and willing to fund clinical trials to prove that their products are both efficacious and safe.”