Actaea racemosa L. Is More Effective in Combination with Rhodiola rosea L. for Relief of Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Study.

Lali Pkhaladze,Alexander G Panossian,Ramaz Shengelia,Nina Davidova,Archil Khomasuridze

doi:10.3390/ph13050102

Lali Pkhaladze, Alexander G Panossian + Show 3 more

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https://doi.org/10.3390/ph13050102

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Journal: Pharmaceuticals	Publication Date: May 21, 2020
Citations: 10	License type: CC BY 4.0

Affiliation: Tbilisi State Medical University

Abstract

Background: The aim of this study was to assess the efficacy and safety of a new herbal preparation (Menopause Relief EP®), the hybrid combination of Actaea racemosa L. (black cohosh, BC) and Rhodiola rosea L. (RR) root extracts, compared with the most effective dose of BC extract in women with menopausal complaints. Methods: A total of 220 women were randomly assigned to receive two capsules either BC (6.5 mg), BC500 (500 mg), Menopause Relief EP® (206,5), or placebo once per day for 12 weeks. The efficacy endpoints were relief of menopausal symptoms, measured using the Kupperman Menopausal Index (KMI), Menopause Relief Score (MRS), and menopause Utian Quality of Life (UQOL) index. Results: The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks. There was no statistically significant difference between the effects of BC and BC500 over time. RR-BC significantly improved the QOL index in patients, compared to BC, BC500, and placebo, mainly due to the beneficial effects on the emotional and health domains. Conclusions: BC is more effective in combination with RR in relief of menopausal symptoms, particularly psychological symptoms.

Highlights

Menopause is a normal transition state from the reproductive into the non-reproductive phase in women, presumably associated with a decline in the production of sex hormones [1]
Background: The aim of this study was to assess the efficacy and safety of a new herbal preparation (Menopause Relief EP®), the hybrid combination of Actaea racemosa L. and Rhodiola rosea L. (RR) root extracts, compared with the most effective dose of Black cohosh (BC) extract in women with menopausal complaints
Since the early 20th century, medical practitioners in the United States and Europe have used a tincture derived by macerating fresh black cohosh rhizome in a 50% alcohol solution for 10 days at a dose corresponding to 65 mg of the crude drug to reduce the frequency and severity of hot flushes and sweating in menopausal women [5]

Summary

Introduction

Menopause is a normal transition state from the reproductive into the non-reproductive phase in women, presumably associated with a decline in the production of sex hormones [1]. Rhizome preparations (e.g., dry genuine extract (DER) 4.5–8.5:1, extraction solvent ethanol 60%, v/v) are commonly known as herbal medicinal products with well-established uses in the relief of menopausal complaints such as hot flushes and profuse sweating, at a daily dose of 4.7–8.9 mg, corresponding to 40 mg of herbal substance [7,8]. Information on their posology has been derived from long-standing use, as well as recommendations contained in the German Commission E monograph (daily dose: 40 mg herbal substance) [9] and ESCOP monograph (daily dose: 40–140 mg herbal substance) [10], and has been confirmed in many clinical studies [2,8,9,10,11,12,13,14,15]. Conclusions: BC is more effective in combination with RR in relief of menopausal symptoms, psychological symptoms

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