Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study

Background: Interest in herbal medicines and non-hormonal therapies for the treatment of menopausal symptoms has increased since the publication of adverse effects of estrogen replacement therapy. Vasomotor symptoms are the most characteristic and notable symptoms of menopause. Objective: To investi...

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Main Authors: Sasikala M. Chinnappan, Annie George, Malkanthi Evans, Joseph Anthony
Format: Article
Language:English
Published: Swedish Nutrition Foundation 2020-09-01
Series:Food & Nutrition Research
Subjects:
Online Access:https://foodandnutritionresearch.net/index.php/fnr/article/view/3665/11180
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author Sasikala M. Chinnappan
Annie George
Malkanthi Evans
Joseph Anthony
author_facet Sasikala M. Chinnappan
Annie George
Malkanthi Evans
Joseph Anthony
author_sort Sasikala M. Chinnappan
collection DOAJ
description Background: Interest in herbal medicines and non-hormonal therapies for the treatment of menopausal symptoms has increased since the publication of adverse effects of estrogen replacement therapy. Vasomotor symptoms are the most characteristic and notable symptoms of menopause. Objective: To investigate the changes in the frequency and severity of hot flush and associated vasomotor symptoms experienced by peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising Labisia pumila (SLP+®) and Eurycoma longifolia (Physta®) or placebo. Design: Randomised, double-blind, placebo-controlled, 24-week study enrolled 119 healthy women aged 41–55 years experiencing peri-menopausal or menopausal symptoms and supplemented with Nu-femme™ or placebo. The primary endpoint was comparative changes between treatment groups in the change in the frequency and severity of hot flushes. The secondary objectives were to assess the changes in the frequency and severity of joint pain, Menopause Rating Scale (MRS) and Menopause-Specific Quality of Life (MENQOL) questionnaire domain scores. Concentrations of serum hormone, lipid profile, bone markers, sleep quality and vitality were also studied as secondary objectives. Results: At week 12, significant (P < 0.01) improvements in hot flush symptoms were observed in Nu-femme™ and placebo groups. Even though there was no significant difference between groups, higher percentage of improvement, 65%, was seen in Nu-femme™ compared to 60% in placebo. Significant improvements (P < 0.001) in MRS and MENQOL scores at weeks 12 and 24 were observed in both groups, respectively. Luteinising hormone and follicle-stimulating hormone levels were significantly reduced (P < 0.05) at weeks 12 and 24, respectively, compared to baseline in the Nu-femme™ group, with no significant changes observed in the placebo group. There were significant (P < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group. At the end of week 24, changes in haematology and clinical chemistry parameters remained within normal clinical ranges in both groups. Conclusion: Herbal formulation consists of L. pumila and E. longifolia (Nu-femme™) may support reduction in hot flushes and improvements in hormone and lipid profile in healthy peri-menopausal and menopausal women.
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spelling doaj.art-8c88ed924a3045049046b1e8417b477f2022-12-21T19:26:00ZengSwedish Nutrition FoundationFood & Nutrition Research1654-661X2020-09-0164011510.29219/fnr.v64.36653665Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled studySasikala M. Chinnappan0Annie George1Malkanthi Evans2Joseph Anthony3Biotropics Malaysia Berhad, Section U1Hicom Glenmarie, Industrial Park Shah Alam, Selangor, MalaysiaBiotropics Malaysia Berhad, Section U1Hicom Glenmarie, Industrial Park Shah Alam, Selangor, MalaysiaKGK Science, London, ON, CanadaKGK Science, London, ON, CanadaBackground: Interest in herbal medicines and non-hormonal therapies for the treatment of menopausal symptoms has increased since the publication of adverse effects of estrogen replacement therapy. Vasomotor symptoms are the most characteristic and notable symptoms of menopause. Objective: To investigate the changes in the frequency and severity of hot flush and associated vasomotor symptoms experienced by peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising Labisia pumila (SLP+®) and Eurycoma longifolia (Physta®) or placebo. Design: Randomised, double-blind, placebo-controlled, 24-week study enrolled 119 healthy women aged 41–55 years experiencing peri-menopausal or menopausal symptoms and supplemented with Nu-femme™ or placebo. The primary endpoint was comparative changes between treatment groups in the change in the frequency and severity of hot flushes. The secondary objectives were to assess the changes in the frequency and severity of joint pain, Menopause Rating Scale (MRS) and Menopause-Specific Quality of Life (MENQOL) questionnaire domain scores. Concentrations of serum hormone, lipid profile, bone markers, sleep quality and vitality were also studied as secondary objectives. Results: At week 12, significant (P < 0.01) improvements in hot flush symptoms were observed in Nu-femme™ and placebo groups. Even though there was no significant difference between groups, higher percentage of improvement, 65%, was seen in Nu-femme™ compared to 60% in placebo. Significant improvements (P < 0.001) in MRS and MENQOL scores at weeks 12 and 24 were observed in both groups, respectively. Luteinising hormone and follicle-stimulating hormone levels were significantly reduced (P < 0.05) at weeks 12 and 24, respectively, compared to baseline in the Nu-femme™ group, with no significant changes observed in the placebo group. There were significant (P < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group. At the end of week 24, changes in haematology and clinical chemistry parameters remained within normal clinical ranges in both groups. Conclusion: Herbal formulation consists of L. pumila and E. longifolia (Nu-femme™) may support reduction in hot flushes and improvements in hormone and lipid profile in healthy peri-menopausal and menopausal women.https://foodandnutritionresearch.net/index.php/fnr/article/view/3665/11180labisia pumilaeurycoma longioliamenopausehot flushhormonal imbalance
spellingShingle Sasikala M. Chinnappan
Annie George
Malkanthi Evans
Joseph Anthony
Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study
Food & Nutrition Research
labisia pumila
eurycoma longiolia
menopause
hot flush
hormonal imbalance
title Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study
title_full Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study
title_fullStr Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study
title_full_unstemmed Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study
title_short Efficacy of Labisia pumila and Eurycoma longifolia standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study
title_sort efficacy of labisia pumila and eurycoma longifolia standardised extracts on hot flushes quality of life hormone and lipid profile of peri menopausal and menopausal women a randomised placebo controlled study
topic labisia pumila
eurycoma longiolia
menopause
hot flush
hormonal imbalance
url https://foodandnutritionresearch.net/index.php/fnr/article/view/3665/11180
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