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Short-term effects and safety of a natural oral supplement containing glucosinolates, phytosterols, and citrus flavonoids compared with hormone treatment for the management of postmenopausal symptomatic women: a pilot single-center randomized phase 2 clinical trial.

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dc.contributor.author Villar-López, Martha
dc.contributor.author Soto-Becerra, Percy
dc.contributor.author Chedraui, Peter
dc.contributor.author Osorio-Manyari, Joel D.
dc.contributor.author Al-Kassab-Córdova, Ali
dc.contributor.author Osorio-Manyari, Angel A.
dc.contributor.author Fernandez-Sosaya, José L.
dc.contributor.author Moya-Silvestre, Edith
dc.contributor.author Rojas, Percy A.
dc.contributor.author Lugo-Martínez, Gabriela
dc.contributor.author Mezones-Holguín, Edward
dc.date.accessioned 2023-12-05T17:48:04Z
dc.date.available 2023-12-05T17:48:04Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/20.500.12866/14671
dc.description.abstract OBJECTIVE: This study aimed to evaluate the short-term efficacy and safety of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids for menopausal symptoms in comparison with estrogen plus progestogen therapy (EPT) among postmenopausal women. METHODS: This was a pilot single-blinded, three-armed phase II randomized clinical trial, controlled with EPT. Sixty participants were randomly assigned to receive treatment for 3 months: (1) an oral herbal supplement of 1,500 mg/d (G1, n = 20), (2) an oral herbal supplement of 3,000 mg/d (G2, n = 20), or (3) conjugated equine estrogens 0.625 mg/d plus medroxyprogesterone acetate of 5 mg/d (EPT group, n = 20). The primary endpoint was the intensity of menopausal symptoms as measured using the Menopause-Specific Quality of Life Questionnaire (global and domain scores). The Menopause-Specific Quality of Life Questionnaire uses a 7-point scale to rate the symptom intensity, with higher scores indicating severity. The secondary endpoints were hormonal, lipid, and safety profiles. RESULTS: Fifty-four participants (n = 54) completed the study. The mean, model-estimated, and global menopausal symptom scores at 3 months were 85.8 in the EPT group, 61.3 in G1, and 62.5 in G2. Participants treated with the herbal compound had lower global (13.7 [6.9-20.4], P < 0.001) and physical symptom scores (6.6 [1.6-11.5], P = 0.002) on the second month and lower psychosocial symptom scores (3.8 [1.3 to 6.3], P < 0.001) on the third month of follow-up, compared with EPT. Conversely, participants receiving EPT showed better outcomes on vasomotor symptoms since the first month of treatment (-6.1 [-8.3 to -4.0], P < 0.001). The EPT group exhibited higher values of estradiol and lower follicle-stimulating hormone and luteinizing hormone since the first month of follow-up. Also, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were significantly higher in this group than in G2. CONCLUSIONS: In this small single-blind exploratory trial, the oral herbal supplement was more efficacious in reducing global, physical, and psychosocial menopausal symptoms in the short term than EPT. However, further studies are needed to adequately assess the efficacy and safety of this herbal supplement in the treatment of menopausal symptoms. en_US
dc.description.sponsorship Este trabajo fue financiado por CONCYTEC. es_PE
dc.language.iso eng
dc.publisher Wolters Kluwer Health
dc.relation.ispartofseries Menopause
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Citrus flavonoids en_US
dc.subject Efficacy en_US
dc.subject Glucosinolates en_US
dc.subject Herbal supplement en_US
dc.subject Menopause en_US
dc.subject Phytosterols en_US
dc.subject.mesh Citrus
dc.subject.mesh Eficacia
dc.subject.mesh Glucosinolatos
dc.subject.mesh Suplementos Dietéticos
dc.subject.mesh Menopausia
dc.subject.mesh Fitosteroles
dc.title Short-term effects and safety of a natural oral supplement containing glucosinolates, phytosterols, and citrus flavonoids compared with hormone treatment for the management of postmenopausal symptomatic women: a pilot single-center randomized phase 2 clinical trial. en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1097/GME.0000000000002268
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.02
dc.relation.issn 1530-0374


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