Long-term efficacy and safety of the special extract ERr 731 of Rheum rhaponticum in perimenopausal women with menopausal symptoms.

OBJECTIVE

To investigate the long-term efficacy and safety of ERr 731 in perimenopausal women with menopausal symptoms.

DESIGN

This was a multicenter, prospective, 48-week observational study (OS) (OS I) followed by a 48-week OS II in perimenopausal women with menopausal symptoms taking ERr 731. Of 109 women participating in a previous randomized, placebo-controlled trial (RCT), 39 women receiving ERr 731 and 41 women receiving placebo participated in OS I. Fifty-one women continued to take ERr 731 in OS II (23 women from the ERr 731 group and 28 women from the placebo group). The primary outcome criterion for long-term efficacy of ERr 731 was the change in the Menopause Rating Scale II score after 48 and 96 weeks. Several efficacy and safety parameters were also assessed.

RESULTS

Women in the ERr 731 group in the RCT experienced a further decrease in their symptoms during OS I. Women who received placebo during the RCT and started taking ERr 731 in OS I reported a significant decrease in menopausal symptoms. After 18 weeks in OS I, their symptom scores were comparable to those of women who had taken ERr 731 for 12 weeks during the RCT. The symptom scores further decreased slightly in all women during OS II. At the end of OS II, all women had on average less than 1.4 slight hot flushes per day. There was no clinically relevant change in safety parameters, and no adverse events were observed with relation to the long-term use of ERr 731.

CONCLUSIONS

ERr 731 is effective and safe in the long-term treatment of menopausal symptoms in perimenopausal women.