Preprint Article Version 1 NOT YET PEER-REVIEWED

Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances besides Postmenopausal Vasomotor Symptoms: Long Term Safety and Effectiveness

Version 1 : Received: 27 October 2016 / Approved: 27 October 2016 / Online: 27 October 2016 (12:21:59 CEST)

A peer-reviewed article of this Preprint also exists.

De Franciscis, P.; Grauso, F.; Luisi, A.; Schettino, M.T.; Torella, M.; Colacurci, N. Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness. Nutrients 2017, 9, 129. De Franciscis, P.; Grauso, F.; Luisi, A.; Schettino, M.T.; Torella, M.; Colacurci, N. Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness. Nutrients 2017, 9, 129.

Journal reference: Nutrients 2017, 9, 129
DOI: 10.3390/nu9020129

Abstract

Long-term safety of a nutraceutical combination based on agnus castus and magnolia extracts combined with soy isoflavones (SI) and lactobacilli, and effectiveness on vasomotor symptoms and sleep disorders in postmenopausal women, were assessed. A controlled study was carried-out in menopausal women comparing this nutraceutical combination (ESP group) with formulation containing isoflavones alone (C group), at the dosage recommended. Kuppermann index, PSQI, and SF-36 were determined at baseline, 3, 6 and 12 months. Endometrial thickness, mammary density and liver function were evaluated at baseline and after 12 months. 180 women (100 in ESP group and 80 in C group, mean age 55.5 years, in menopause for about 36 months) were enrolled in the study. At the treatment end, mammary density, endometrial thickness, and hepatic function did not show substantial differences between groups. Kuppermann index, and particularly hot flushes, were progressively and significantly decreased in frequency and severity during ESP versus C treatment. No adverse events were observed. Agnus castus and magnolia, combined with SI + lactobacilli, can effectively and safely be used in symptomatic postmenopausal women, mainly when quality of sleep is the most disturbing complaint. Endometrium, mammary glands and liver function, were unaffected after 12 months treatment.

Subject Areas

isoflavones; menopause management; endometrial thickness; mammary density; liver function; plant extracts

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