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.
Subject(s)
Phytosterols , Postmenopause , Female , Humans , Glucosinolates , Flavonoids , Quality of Life , Single-Blind Method , Estrogens/adverse effects , Estrogens, Conjugated (USP) , Progestins , Cholesterol, HDL , Estrogen Replacement TherapyABSTRACT
Objetivos. Cuantificar los polifenoles, la capacidad antioxidante y el factor de protección solar de las hojas y flores de Borago officinalis L. dispensadas en las farmacias naturales de EsSalud. Materiales y métodos. Se prepararon tres extractos fluidos en etanol (96%, 70% y 40%) y dos extractos acuosos (decocto e infuso), se concentraron bajo vacío hasta obtener extractos secos (ES). Los polifenoles fueron cuantificados utilizando el método analítico de Folin-Ciocalteu, dichos valores fueron expresados como equivalentes de ácido gálico (EAG), la capacidad antioxidante fue determinada por el método de DPPH (1,1-difenil-2- picrilhidracilo), expresada en equivalentes de ácido ascórbico (EAA), del mismo modo como equivalentes de butilhidroxitolueno (EBHT). El factor de protección solar (FPS) se evaluó por el método espectrofotométrico en el rango de 290 a 320 nm. Resultados. Se cuantificaron polifenoles en el rango de 157,487 ± 3,628 y 66,777 ± 0,734 mg EAG/g ES del extracto fluido de 70 y 96%, respectivamente; la capacidad antioxidante entre 198,631 ± 5,636 y 73,699 ± 5,946 mg EAA/g ES del infuso y decocto, respectivamente, así como 388,694 ± 10,591 y 153,919 ± 11,174 mg EBHT/g ES del infuso y decocto; el FPS en el rango de 8,91 ± 0,07 y 5,53 ± 0,02 para el extracto fluido de 40% e infuso, respectivamente. Conclusiones. El infuso de Borago officinalis L. dispensada en las farmacias naturales de EsSalud, reportó polifenoles con la mayor capacidad antioxidante, y el extracto fluido de 40% presentó el mayor valor de FPS.
Objectives. Quantitation of polyphenols, antioxidant capacity and the sun protection factor of the leaves and flowers of Borago officinalis L. dispensed in Natural Pharmacies of EsSalud. Materials and methods. Three extracts were prepared with ethanol (96%, 70% and 40%) and two aqueous extracts (decoction and infusion), were removed volatile solvents under vacuum until obtaining dry extract (DE). Polyphenols were quantified by using analytic method referred as Folin-Ciocalteu, such values were expressed as gallic acid equivalents (GAE). On the other hand, the antioxidant capacity was determined by DPPH (1,1-diphenyl- 2-picrylhydracil) method, as well as values expressed in ascorbic acid equivalents (AAE) and butylated hydroxytoluene equivalents (BHTE). The sun protection factor values (SPF) were evaluated by using spectrophotometric method which values were in the range 290 to 320 nm. Results. Polyphenols were quantified in the range of 157.487 ± 3.628 and 66.777 ± 0.734 mg GAE/g DE of the redissolved and dilute extract of 70% and 96%, respectively. The antioxidant capacity was found between 198.631 ± 5.636 and 73.699 ± 5.946 mg AAE/g DE of the infusion and decoction, respectively, as well as 388.694 ± 10.591 and 153.919 ± 11.174 mg BHTE/g DE of the infusion and decoction; the SPF in the range 8.91 ± 0.07 and 5.53 ± 0.02 for the fluid extract of 40% and infusion, respectively. Conclusions. Infusion extract of Borago officinalis L. dispensed at the Natural Pharmacies of EsSalud, reported high concentration of polyphenols with the highest antioxidant activity. And the 40% redissolved and dilute extract was found a high SPF value.
