To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints.
A multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 (n = 54) or placebo (n = 55) daily for 12 weeks. Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks. Other efficacy assessments analyzed number and severity of hot flushes, menopause-specific quality of life, number of bleeding/spotting days, and treatment outcome.
By 12 weeks, the MRS II total score and each MRS II symptom significantly decreased in the ERr 731 group compared to the placebo group (P < 0.0001). After 4 weeks, ERr 731 also significantly decreased the number and severity of hot flushes (P < 0.0001). After 12 weeks, the overall menopause-specific quality of life was significantly better in women treated with ERr 731 compared with placebo (P < 0.05). Treatment outcome assessed by investigators and participants was better in the ERr 731 group, and ERr 731 was better tolerated than placebo. There were no differences in gynecological findings including endometrial biopsies, bleeding, weight, blood pressure, pulse, and laboratory safety parameters between the treatment groups. No adverse events were classified as being related to the investigational medication.
Compared to placebo, ERr 731 significantly reduces the occurrence and severity of climacteric complaints in perimenopause. It is also safe and well tolerated.
The special extract ERr 731 of the roots of Rheum rhaponticum significantly reduces the occurrence and severity of climacteric complaints and the number of hot flushes in perimenopausal women. It is also safe and well tolerated.
From the 1Health Research Services Ltd., St. Leon-Rot, Germany; 2National Medical University A.A. Bogomolets, Kiev, Department of Obstetrics and Gynecology, Kiev, Ukraine; 3Health Research Services Ltd., Kiev, Ukraine; and 4Chemisch-Pharmazeutische Fabrik Goeppingen, Carl Müller, Apotheker, GmbH u. Co. Goeppingen, Germany.
Received November 28, 2005; revised and accepted January 19, 2006.
Address correspondence to: Marietta Kaszkin-Bettag, PhD, Health Research Services Ltd., Opelstr. 8a, 68789 St. Leon-Rot, Germany. E-mail: firstname.lastname@example.org.