Efeito do extrato de Morus Nigra L. no tratamento de sintomas vasomotores em mulheres com síndrome climatérica – um estudo randomizado, placebo - controlado

Abstract

Introduction: Hormone replacement therapy (HRT) is the standard treatment for climacteric symptoms; however, there are contraindications to its use. In this context, the use of phytoestrogens has been a common practice, since they decrease the incidence of these symptoms. There are no clinical data about the use of Morus nigra L. for the treatment of climacteric symptoms. Objective: To compare the efficacy of leaf extract of Morus nigra L. for the treatment of climacteric symptoms with HRT (standard comparative group) and a placebo group (simple control). Methods: A randomized (computer generated), double-blind clinical trial was performed with 62 climacteric women, divided into three groups: Morus nigra (MN) Group - capsule with Morus nigra L. powder 250 mg (n = 20), HRT-estradiol 1 mg or estradiol 1 mg + norethisterone acetate 0.5 mg (n = 20) and Placebo (n = 22) for 60 days. The response variable was the mean score of the Blatt-Kuppermann Index (BKI). Quality of life (QoL) through the SF-36 questionnaire, oncotic colpocitology, colposcopy and biochemical and hormonal dosages were also evaluated (fasting glycemia, HDL, LDL, triglycerides, total cholesterol, AST, ALT, urea, creatinine, uric acid, alkaline phosphatase, ultra-sensitive RCP, estradiol, FSH, TSH and free T4). The level of significance was set at 5% and analysis performed by intention to treat (ITT). Data were analyzed using SPSS 25.0 software. Results: The groups presented a homogenous sociodemographic profile, close to 50 years of age, brown, full high school, general services auxiliary, without alcoholism, or smoking, and did not have regular practice of physical activity. There was a mean reduction in BKI scores in the MN group (18.0 for 10.0, p <0.001) and HRT (14.0 for 5.0, p = 0.001), except to the Placebo group (10.5 for 9, P = 0.083). When analyzing whether there was an individual improvement in symptoms, the MN group presented a 46% increase in the probability of improvement of the climacteric symptoms, compared to the Placebo group (p = 0.043). About the QoL, the MN group showed improvement in the functional capacity (p = 0.006), vitality (p = 0.030), mental health (p = 0.017) and social aspect (p = 0.003); the HRT group presented improvement in the emotional limitation domain (p = 0.040) and the Placebo group in the functional capacity (p = 0.007), physical limitation (p = 0.031) and mental health domains (p = 0.028). Regarding the adverse effects that arose during the treatments, the breast tenderness and spotting manifested only in the HRT group (p < 0.001 and p = 0.003, respectively). There was no significant difference among the three groups regarding the results of oncotic colpocitology and colposcopy. Analysis of the biochemical tests revealed that fasting glycemia increased in the three groups (MN: p = 0.030, HRT: p = 0.0001 and Placebo: p = 0.003). In the MN group there was elevation of the free T4 and estradiol hormones (p = 0.011 and p = 0.031, respectively), without changes in hepatic and renal function. Conclusions: There was improvement of the climacteric symptoms with the use of the extract of Morus nigra L. 250 mg for 60 days. The use of Morus nigra L. did not cause adverse and toxic effects during the treatment period.