09.01.03
Indication: Hot flashes
Source: JAMA, July 2003;290(2):207-214.
Research: The objective of the study was to compare the efficacy and safety of two dietary supplements derived from red clover with placebo in symptomatic menopausal women. A randomized, double-blind, placebo-controlled trial of menopausal women, aged 45 to 60 years, who were experiencing at least 35 hot flashes per week was conducted. The study included women who were recently postmenopausal and were experiencing eight hot flashes per day. Women were excluded if they were vegetarians, consumed soy products more than once per week or took medications affecting isoflavone absorption. After a two-week placebo run-in, 252 participants were randomly assigned to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total isoflavones per day) or an identical placebo, and followed up for 12 weeks.
Results: Of 252 participants, 246 (98%) completed the 12-week protocol. The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil, Rimostil and placebo groups. In comparison with the placebo group, participants in the Promensil group, but not in the Rimostil group reduced hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in the three groups. The study’s authors concluded that although the study provided some evidence for a biological effect of Promensil, neither supplement had a clinically important effect on hot flashes or other symptoms of menopause.
Source: JAMA, July 2003;290(2):207-214.
Research: The objective of the study was to compare the efficacy and safety of two dietary supplements derived from red clover with placebo in symptomatic menopausal women. A randomized, double-blind, placebo-controlled trial of menopausal women, aged 45 to 60 years, who were experiencing at least 35 hot flashes per week was conducted. The study included women who were recently postmenopausal and were experiencing eight hot flashes per day. Women were excluded if they were vegetarians, consumed soy products more than once per week or took medications affecting isoflavone absorption. After a two-week placebo run-in, 252 participants were randomly assigned to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total isoflavones per day) or an identical placebo, and followed up for 12 weeks.
Results: Of 252 participants, 246 (98%) completed the 12-week protocol. The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil, Rimostil and placebo groups. In comparison with the placebo group, participants in the Promensil group, but not in the Rimostil group reduced hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in the three groups. The study’s authors concluded that although the study provided some evidence for a biological effect of Promensil, neither supplement had a clinically important effect on hot flashes or other symptoms of menopause.