Efficacy and safety of the special Extract Rheum rhaponticum (ERr 731®) in perimenopausal women with climacteric complaints

• Published in: Zeitschrift für Phytotherapie
• Main Authors: Kaszkin-Bettag, M, Rettenberger, R, Heger, PM
• Format: Conference Proceeding
• Language: German
• Published: 23.11.2006
• ISSN: 0722-348X; 1438-9584
• DOI: 10.1055/s-2006-954885

Perimenopause is the time until the last menstruation, when women experience irregular menstruation and climacteric symptoms. Due to an increased risk of breast cancer with hormone therapy in this phase, alternative treatments for climacteric complaints are highly desirable. A special extract from the roots of Rheumrhaponticum , referred to as ERr 731® (Phytoestrol® N), has been prescribed for climacteric complaints since 1993. It consists of rhaponticin, desoxyrhaponticin and their aglycones rhapontigenin and desoxyrhapontigenin, being structurally related to resveratrol. Objective To evaluate the efficacy and safety of ERr 731® compared to placebo in perimenopausal women with climacteric complaints. Design A 12 week, multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial with 109 patients with climacteric complaints, receiving 1 tablet daily of ERr 731® (n=54) or placebo (n=55). Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks. Moreover, the effects on hot flushes, menopause-specific quality of life, bleeding/spotting days and treatment outcome were assessed. Results By 12 weeks, the MRS II total score and each MRS II symptom significantly decreased with ERr 731® compared to placebo (p<0.0001). ERr 731® also significantly decreased the number and severity of hot flushes (p<0.0001) and improved the menopausespecific quality of life (p<0.05). Treatment outcome assessed by investigators and patients was better in the ERr 731® group. There were no differences in gynaecological findings (endometrial biopsies, bleeding) between the treatment groups and no adverse events being related to ERr 731®. 1 and 2 year observational studies confirm the efficacy and safety of ERr 731®. Conclusions Compared to placebo, ERr 731® significantly reduces climacteric complaints in perimenopausal women. It is also safe and well tolerated.