Red Clover Extract Relieves Premenstrual Breast Pain
November 15, 2001—An isoflavone supplement extracted from red clover (Trifolium pratense) relieved premenstrual breast pain (cyclic mastalgia) in a small, double-blind trial,1 according to a report published online in The Breast, the official journal of the European Society of Mastology.
Eighteen women with cyclic mastalgia were selected to randomly receive placebo or a supplement containing either 40 mg or 80 mg of isoflavones per day (Promensil™, Novogen, Sydney, Australia). After three months of treatment, breast pain was reduced by 44% in the group taking 40 mg per day, by 31% in the group taking 80 mg per day, and by 13% in the group taking placebo. The reduction of pain in the 40 mg per day group was statistically significant. The inferior result in the 80 mg per day group is thought to be due to one participant who reported a marked increase of pain during the treatment period.
Cyclic mastalgia is a common condition in women living in Western, industrialized societies. It is thought to have a hormonal origin. Isoflavones found in red clover and soy are considered "phytoestrogens"—plant-derived substances that have weak estrogen-like or estrogen opposing activity, depending on hormone levels in the body. Phytoestrogens may bind to estrogen receptors, preventing overstimulation by the body’s own estrogens.
There have been no previous clinical trials of isoflavones for the treatment of mastalgia. The results of this trial are, therefore, encouraging. However, given the small size of the group studied, further trials are necessary to firmly establish the efficacy of isoflavones in treating this widespread and uncomfortable condition.
It should be noted that the study was designed and financed by Novogen Ltd., with the principal aim of evaluating one of their products (Promensil™), which indicates a potential conflict of interest. One of the coauthors of the study is Novogen’s clinical trials coordinator. However, the researchers state that, apart from occasional advice on protocol, the study and its analysis were conducted independently of Novogen, and that the company had no influence on the final decision to submit the study for publication.
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1. Ingram DM, Hickling C, West L, et al. A double-blind randomized controlled trial of isoflavones in the treatment of cyclical mastalgia. The Breast. In press. Available online at http://www.idealibrary.com/links/doi/10.1054/brst.2001.0353
Jeremy Appleton, ND, is a licensed naturopathic physician, writer, and educator in the field of evidence-based complementary and alternative medicine. Dr. Appleton is Chair of Nutrition at the National College of Naturopathic Medicine.
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