title: Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness.
abstract: The effectiveness for vasomotor symptoms and sleep disorders plus the long-term safety of a nutraceutical combination ofagnus-castusand magnolia extracts combined with soy isoflavones (SI) and lactobacilli were assessed in postmenopausal women. A controlled study was carried out in menopausal women comparing this nutraceutical combination (ESP group) with a formulation containing isoflavones alone (C group) at the dosage recommended. The Kuppermann index, The Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36) were determined at baseline, three, six and 12 months. Endometrial thickness, mammary density and liver function were evaluated at baseline and after 12 months. One hundred and eighty women were enrolled in the study (100 in the ESP group and 80 in the C group). At the end of the treatment, mammary density, endometrial thickness, and hepatic function did not show substantial differences between groups. The Kuppermann index and particularly the tendency for hot flashes progressively and significantly decreased in frequency and severity during ESP versus C treatment. At the same time, a significant increase in sleep quality and psychophysical wellness parameters was observed in the ESP versus C groups. No adverse events were observed.Agnus-castusand 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. The endometrium, mammary glands and liver function were unaffected after 12 months of treatment.
authors.affiliation: Department of Woman, Child and General and Specialized Surgery-Second University of Naples, Largo Madonna delle Grazie, 1, 80138 Naples, Italy. pasquale.defranciscis@unina2.it.
authors.forename: Pasquale
authors.initials: P
authors.lastname: De Franciscis
authors.affiliation: Department of Woman, Child and General and Specialized Surgery-Second University of Naples, Largo Madonna delle Grazie, 1, 80138 Naples, Italy. flaviograuso@live.it.
authors.forename: Flavio
authors.initials: F
authors.lastname: Grauso
authors.affiliation: Department of Woman, Child and General and Specialized Surgery-Second University of Naples, Largo Madonna delle Grazie, 1, 80138 Naples, Italy. anna-luisi@hotmail.it.
authors.forename: Anna
authors.initials: A
authors.lastname: Luisi
authors.affiliation: Department of Woman, Child and General and Specialized Surgery-Second University of Naples, Largo Madonna delle Grazie, 1, 80138 Naples, Italy. mariateresa.sche@gmail.com.
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Schettino
authors.affiliation: Department of Woman, Child and General and Specialized Surgery-Second University of Naples, Largo Madonna delle Grazie, 1, 80138 Naples, Italy. marco.torella@unina2.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Torella
authors.affiliation: Department of Woman, Child and General and Specialized Surgery-Second University of Naples, Largo Madonna delle Grazie, 1, 80138 Naples, Italy. nicola.colacurci@unina2.it.
authors.forename: Nicola
authors.initials: N
authors.lastname: Colacurci
mesh_terms: D000368:Aged; D019587:Dietary Supplements; D004717:Endometrium / Q000187:drug effects / Q000378:metabolism; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage*; D007778:Lactobacillus / Q000378:metabolism; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D031566:Magnolia / Q000737:chemistry*; D042361:Mammary Glands, Human / Q000187:drug effects / Q000378:metabolism; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000494:pharmacology; D017698:Postmenopause / Q000187:drug effects*; D011446:Prospective Studies; D012890:Sleep / Q000187:drug effects*; D013025:Glycine max / Q000737:chemistry*; D020950:Vitex / Q000737:chemistry*
chemical_list: D007529:Isoflavones; D028321:Plant Preparations
keywords: endometrial thickness; isoflavones; liver function; mammary density; menopause management; plant extracts