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.