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Title: Promensil, Rimostil, And Placebo Result In Similar Reductions In Hot Flashes Frequency

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JAMA 2003;290:2:207-214.
07/09/2003 11:38:46 AM
By Joene Hendry

Promensil and Rimostil, both isoflavone extracts derived from red clover, or placebo showed similar reductions in hot flash frequency over 12 weeks of treatment according to the findings of The Isoflavone Clover Extract Study. Jeffrey A. Tice, MD, of the University of California, San Francisco, United States and colleagues randomised 252 women to twice daily Promensil (82 mg total isoflavone per day), Rimostil (57 mg total isoflavone per day), or placebo to measure and changes in hot flash frequency. All women, 45 to 60 years of age, were menopausal (follicle- stimulating hormone levels of 30 mIU/mL) and reported at least 35 hot flashes per week. The mean reduction in hot flash count after 12 weeks was 41% in the Promensil group (n=84), 34% of the Rimostil group (n=83), and 36% for the placebo group (n=85). While the change in hot flash counts over the study period was significant for all 3 groups the reduction in hot flash counts in the Promensil and the Rimostil groups were not statistically different from placebo. Promensil, but not Rimostil, reduced the frequency of hot flashes more rapidly than placebo but women in all 3 groups were still experiencing more than 5 hot flashes per day at the end of the study. Reductions in hot flash frequency were most pronounced for women above the median body mass index (BMI) of 25.1, but the researchers note that it is unclear why phytoestrogens would have a greater efficacy in this group. The reduction in hot flashes was 49% for women over the median BMI compared with 30% for women under the median BMI who were taking Promensil. In the Rimostil group, those over the median BMI had a 45% reduction compared with a 22% reduction in hot flashes for women below the median BMI. Conversely, women in the placebo group over the median BMI reported a 32% reduction in hot flashes while women under the median BMI showed a 40% reduction. Adverse events, including headache and vaginal spotting, were reported in at least 3% of the study participants but there was no statistically significant association between adverse events and either of the phytoestrogen supplements. The researchers conclude that while this study provides some evidence for a biological effect of Promensil, "neither supplement had a clinically significant effect on hot flashes or other menopausal symptoms when compared with placebo."

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