The special extract ERr 731 from the root of rhapontic rhubarb (Rheum rhaponticum): Efficacy in headache/migraine and further climacteric complaints in women in the perimenopause

Abstract

Background: Menopause is associated with neuroendocrine changes and a variety of climacteric symptoms. While hormone replacement therapy (HRT) remains a standard treatment, safety concerns increase global interest in non-hormonal alternatives like ERr 731®, an extract from Rheum rhaponticum to alleviate climacteric complaints. Objective: To evaluate the long-term effectiveness of ERr 731® in reducing menopausal climacteric symptoms during a 12-week randomized controlled (RCT) trial followed by a 52-week open-label observational study (OS). Methods: One hundred and twelve perimenopausal women (aged 45–55 years) with climacteric complaints (Menopausal Rating Scale (MRS) ≥18) participated in this RCT while eighty-nine of these study participants continued in the OS. During the RCT patients received either ERr 731® (4 mg daily) or a placebo. During the OS, all participants received ERr 731® and were assessed every 13 weeks for headache/migraine, dizziness, paresthesia, fluor vaginalis, and general well-being. Descriptive statistics and exploratory t-tests compared symptom severity between day 0 and day 84 as well as day 364. Results: During the RCT, climacteric complaints were significantly reduced in the ERr 731® group compared to placebo. Symptom severity also decreased across all domains from baseline to week 52 of the OS. Headache/migraine and paresthesia improvements were notable. Since all participants received ERr 731® during the OS, no significant differences between the prior ERr 731® and placebo groups were present (p > 0.05). Dizziness reduction remained significant between groups (p = 0.0086). General well-being improved markedly, with >90% of participants reporting to be "good" or "very good spirits" at week 52. Conclusion: ERr 731® demonstrated sustained symptom relief and improved well-being over 52 weeks, supporting its role as a non-hormonal option for managing climacteric complaints in perimenopausal women.