Efficacy of the special extract ERr 731 from rhapontic rhubarb for menopausal complaints: a 6-month open observational study.

BACKGROUND: The special extract ERr 731 from the roots of rhapontic rhubarb has been in widespread use in Germany since 1993, and the current regulations have required an evaluation of its risk:benefit ratio in daily use.

OBJECTIVE: To demonstrate the efficacy and tolerability ofERr 731 in menopausal women in everyday practice.

DESIGN: Three hundred sixty-three menopausal women with menopausal symptoms were enrolled at 70 German gynecological practices and received ERr 731 for 6 months. Women visited the practices for a baseline assessment and after 3 and 6 months.

MAIN OUTCOME MEASURES: Primary outcome criterion was the change of the Menopause Rating Scale (MRS) total score after 6 months. Other assessments included compliance, tolerability, health-related quality of life, and occurrence of adverse events.

RESULTS: After 6 months of treatment with ERr 731 in 252 women, there was a significant decrease of the MRS total score from 14.5 points at baseline to 6.5 points (P<.0001). The reduction of the MRS score was more pronounced in women with a score of > or =18 points at baseline. One tablet per day was sufficient to reduce the symptoms significantly in the majority of women. The health-related quality of life improved markedly. A good or very good treatment outcome was reported by the majority of the participating women. One adverse event was reported that was assessed as having no relation to ERr 731 intake.

CONCLUSION: ERr 731 is a well-tolerated and safe medication for the successful treatment of menopausal symptoms in peri- and postmenopausal women.