To the Editor:
As a certified menopause practitioner and practicing gynecologist, who serves as a regular thesis adviser to students of Yale's physician associate program, I would like to offer some thoughts about the article, “Is black cohosh a safe and effective substitute for hormone replacement therapy?” which was published in the September 2009 issue (page 54).
Authors Becker, Letham, and Stoehr ask some very important questions about therapy for menopausal hot flashes. They are indeed correct that hot flashes are a very significant problem for many women, and many women are concerned about any potential downside risks from hormonal intervention. I would like to offer a few nonmedical suggestions for their patient. The authors comment that their patient drinks one glass of wine nightly; I might suggest that she stop that, as many women find that wine is a significant hot flash trigger. And although she eats a healthy diet, we do not know what her body mass index is. One half of obese women suffer from significant hot flashes; only a third of women who are of normal body weight suffer significantly.
Unfortunately, most medical options for hot flashes have significant potential side effects; and the efficacy of these methods have also been questioned. There is substantial literature on selective serotonin-reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants; however, the loss of libido and weight gain attendant with many of these medications make these drugs unattractive options for perimenopausal women.
Black cohosh has been used for more than 50 years in Germany as a safe and effective option for hot flashes. Although the FDA has not commented on it, black cohosh is well discussed in the German Commission E monograph on herbal preparations, and is discussed as both safe and effective. In Germany, the most widely studied preparation is Remifemin, the isopropanolic extract of certified Cimicifuga racemosa. In studying herbal preparations, both the source of the botanical product and the extraction method are crucial for evaluating efficacy and safety; indeed, not all herbal product variations are created equal.
There have been several studies published in the English language literature on Remifemin, demonstrating both efficacy and safety, for therapy of hot flashes. The major safety question raised has been about hepatic toxicity; conferences in both the United States and Europe have reported no significant risk to the liver.
As far as the concern about breast safety, several German studies have shown that there is no increased risk in breast cancer. Although the exact mechanism of action of black cohosh is not known, we do know that it is not through a plant-estrogen effect. Indeed, a study of Remifemin use in breast cancer survivors in Germany actually showed a longer time to recurrence of cancer (in those patients with recurrences) in women who took black cohosh. And a study in the Philadelphia area on alternative therapies for hot flashes showed that the Remifemin users had a lower incidence of breast cancer.
Therefore, I would suggest that it is very reasonable to offer a trial of Remifemin to the patient who suffers from hot flashes, cannot or does not wish to use hormone replacement therapy, and prefers a holistic approach, along with lifestyle modifications that may prove helpful to her. I would also reassure her that if this approach is not successful, you can offer her other options from a more pharmaceutical approach.
Mary Jane Minkin, MD
Clinical Professor of Obstetrics and Gynecology
Yale University School of Medicine