Herbal research spurred on by HRT risk

The University of Illinois at Chicago is to investigate the effectiveness of the herbals black cohosh and red clover for relief of menopause symptoms. The one-year study is driven by strong demand for an alternative to HRT, the accepted treatment for hot flashes, but recently associated with significant health risks.

Red clover, native to Europe, Central Asia and northern Africa, contains isoflavones, linked in some studies to a reduction in hot flashes. However evidence supporting the effects of isoflavones, whether from soy or red clover, is conflicting. A study in JAMA​ this week found a red clover supplement to be no more effective than placebo for relieving hot flashes. Previous research on the same supplement has however determined a significant effect.

Stacie Geller, assistant professor of obstetrics and gynecology and director of the UIC​ National Center of Excellence in Women's Health, said: "This study is designed to see whether botanicals can take the place of HRT, which is still the gold standard for the short-term relief of hot flashes, or at least provide enough relief to improve women's quality of life."​

"We'll also examine whether black cohosh and red clover help reduce a wide range of other symptoms associated with menopause, including sleep and mood disturbances and sexual dysfunction."​

She added that while lots of women are looking for alternatives, "there's very little scientific information on the botanicals and dietary supplements currently on the market".​

Black cohosh, a wildflower native to forests in North America, was an ingredient of Lydia Pinkham's Vegetable Compound, a patented remedy for 'female complaints' that was popular in the early 1900s. Recent studies in Europe suggest that the herb can be used to treat menopausal symptoms, but none of those studies met strict guidelines for clinical trials, claim the researchers.

Just over 100 healthy menopausal women are being recruited to participate in the study. They will be randomly assigned to one of four groups taking black cohosh, red clover, Prempro (a combined estrogen and progestin hormone replacement drug) or a placebo. Health effects will be monitored over 14 clinic visits.

The researchers will try to take the body of research on these herbs one step further, looking for a reduction in frequency and intensity of hot flashes or other menopausal symptoms, including insomnia, joint pain and fatigue. They will also examine whether the botanicals help treat sexual problems associated with menopause, such as vaginal dryness, pain during sex, decreased libido and difficulty achieving orgasm.

Lipid levels, bone turnover and effects on the endometrial tissue in the uterus will be monitored, as well as any longer-term effects and possible risks associated with use of the botanicals.

A Phase I clinical trial of the two herbal medicines in 30 women demonstrated that the compounds were safe for use in an expanded trial.

The study is funded by the National Center for Complementary and Alternative Medicine at the National Institutes of Health.