Evaluation of the efficacy and safety of rheum rhaponticum root extract (err 731) for menopausal symptoms in perimenopausal indian women: An interim analysis

Abstract

Background: Hormonal therapy for menopause has been found to be the most efficacious treatment, but it may be associated with adverse effects in some of the women. Rheum rhaponticum root extract (”ERr 731”), which is available worldwide, is a natural, reliable, effective, and well-tolerated remedy for women in perimenopausal women with menopausal symptoms (MSs), but there is no Indian study demonstrating its efficacy, safety, and tolerability till date. Objective: This study aimed to evaluate the efficacy and safety of ERr 731 in alleviating MSs in perimenopausal Indian women. Patients and Methods: In this open-labeled prospective study, 129 perimenopausal women were treated with tablet containing 4 mg of Rr dried root extract once daily for 12 weeks. The Menopause Rating Scale (MRS) II score, endometrial thickness (ET), blood pressure, glycemic status, lipid profile, and high-sensitivity C-reactive protein (hs-CRP) level were periodically assessed and compared. Results: A significant reduction (67% by 12 th week) in the mean MRS II score was observed from baseline till the end of 12 weeks (18.1; 95% confidence interval [CI]: 17.0–19.2; P < 0.001). A monotonic reduction in the mean total MRS II score over time was found (1.51 units/week; 95% CI: 1.42–1.60 units/week; P < 0.001) noticeable. There was a reduction in the mean ET from baseline till the end of 12 weeks, although the change was not significant. There were significant reductions in the mean fasting (6.3 mg/dl; 95% CI: 1.7–11.0 mg/dl; P = 0.008) and postprandial (6.3 mg/dl; 95% CI: 1.0–11.7; P = 0.021) blood glucose levels and glycated hemoglobin level (0.30%; 95% CI: 0.085–0.520; P = 0.007) at 12 weeks. No significant changes were noted in terms of blood pressure, lipid profile, and hs-CRP level. The drug was found to be safe. Conclusion: ERr 731 was well tolerated and was found to be efficacious and safe in alleviating MSs in Indian perimenopausal women.

The 2023 nonhormone therapy position statement of The North American Menopause Society

“…147 Another open-label, single-arm study in Indian perimenopausal women over 12 weeks reported improved menopause symptoms. 148 Given the extremely low retention rate in clinical trials and the open-label study design in one study, the conclusions are limited. (Level II; not recommended)…”

Efficacy evaluation of standardized <i>Rheum rhaponticum</i> root extract (ERr 731^®) on symptoms of menopause: A systematic review and meta-analysis study

“…The hormonal changes during menopause result in various physical, psychological, and emotional changes that manifest as different symptoms, including hot flashes, night sweats, mood swings and irritability, vaginal dryness and discomfort during sexual intercourse, sleep disturbances, weight gain, slowed metabolism, joint pain, muscle pain and stiffness, memory and concentration problems, urinary incontinence, frequent urination, and loss of libido and sexual function [ 5 ] . Additionally, various studies have demonstrated that metabolic syndrome significantly increases the severity of menopause symptoms [ 1 ] .…”

“…1 ), which is believed to reduce the severity of climacteric symptoms [ 9 ] . ERr 731 ® is a standardized R. rhaponticum root extract that has been clinically evaluated for its potential use in the management of menopausal symptoms [ 5 ] . However, the literature lacks a dedicated systematic review and meta-analysis to evaluate the effectiveness of ERr 731 ® supplementation in reducing the severity of menopausal symptoms.…”

“…During this transition period, significant hormonal fluctuations are observed, primarily in the levels of estrogen and progesterone, which sharply decline at menopause and result in various physical, mental and emotional symptoms collectively termed climacteric symptoms [1][2][3] . Menopause generally occurs between the ages of 45 and 55, and more than 70% of the subjects have impaired quality of life (QoL) [4] . All these lines of evidence suggest that a large population of women live with menopausal symptoms from an early age and will have to spend almost 30 years of their lives dealing with all the menopausal complications.…”