Confirmation of the efficacy of ERr 731 in perimenopausal women with menopausal symptoms.

OBJECTIVE: In a previous study, the special extract ERr 731 of Rheum rhaponticum significantly reduced vasomotor and other menopausal symptoms associated with perimenopause. This trial was conducted to confirm the efficacy of ERr 731. DESIGN: A multicenter, randomized, placebo-controlled, clinical trial with 112 perimenopausal women with menopausal symptoms receiving either 1 enteric-coated tablet of ERr 731 (n = 56) or placebo (n = 56) daily for 12 weeks. Primary outcome criterion for efficacy of ERr 731 compared to placebo was the change of the Menopause Rating Scale (MRS) total score from day 0 to day 84. Other efficacy assessments analyzed included the number and severity of hot flushes, individual symptoms of the MRS, treatment outcome, and various safety parameters. RESULTS: By 12 weeks, ERr 731 caused a highly significant reduction of the MRS total score from 27.0 +/- 4.7 points to 12.4 +/- 5.3 points when compared to the placebo-induced decrease from 27.0 +/- 5.3 points to 24.0 +/- 6.2 points (P < .0001). A significant reduction in each individual MRS item score, in hot flushes and the hot flush weekly weighted score, together with a marked improvement in treatment outcome were also observed (P < .0001). These results confirm the efficacy of ERr 731 in alleviating menopausal symptoms in perimenopausal women. Fourteen adverse events were reported in total: 11 by 5 women receiving ERr 731 and 3 by 3 women receiving placebo. ERr 731 was well tolerated by the majority of the women. CONCLUSION: ERr 731 was confirmed to be effective for the treatment of menopausal symptoms in perimenopause.

The special extract ERr 731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.

OBJECTIVE: To investigate the efficacy of the special extract ERr 731 from the roots of Rheum rhaponticum compared with placebo on anxiety, health state, and general well-being in perimenopausal women. DESIGN: This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial, in which 109 perimenopausal women with climacteric complaints and anxiety received either 1 enteric coated tablet of ERr 731 (n=54) or placebo (n=55) daily for 12 weeks. The Hamilton Anxiety Scale, the Menopause Rating Scale II, the Women's Health Questionnaire, and the Psychological General Well-Being Index were used to measure anxiety, health state, and subjective psychological well-being. RESULTS: The results demonstrate that ERr 731 is highly effective in reducing anxiety in perimenopausal women compared with placebo. After 12 weeks, the Hamilton Anxiety Scale total score decreased significantly with ERr 731 (from 27.5+/-6.8 to 9.4+/-4.2 points) compared with placebo (from 25.1+/-6.0 to 21.6+/-8.6 points). ERr 731 also reduced the Hamilton Anxiety Scale factor scores for somatic and psychic anxiety. After 12 weeks, a reduction in the severity of anxiety from "moderate" or "severe" to "slight" was observed in 33 of 39 ERr 731 women completing the double-blind phase, which correlated well with the reduction in number and severity of hot flushes. This was reflected by a high rate of ERr 731 women reporting a marked improvement in health state and general well-being. CONCLUSIONS: ERr 731 is an effective medication for women with menopause-related anxiety and improves their health state and general well-being.