Randomized double-blind placebo-controlled trial of the effect of Morus nigra L. (black mulberry) leaf powder on symptoms and quality of life among climacteric women.

ABSTRACT

OBJECTIVE: To test the efficacy of Morus nigra L. (MN) leaf powder for treating climacteric symptoms by comparison with hormone therapy (HT) and placebo. METHODS: A randomized controlled trial among 62 climacteric women attending Hospital of the Federal University of Maranhão, Brazil. Women were divided into MN, HT, and placebo groups, and received 250 mg of MN leaf powder, 1 mg of estradiol, or placebo for 60 days. Primary outcomes were the Blatt-Kupperman index (BKI) for climacteric symptoms and SF-36 health questionnaire scores. RESULTS: Baseline sociodemographic variables, BKI scores, symptoms, and SF-36 domains did not differ among the groups. There was a reduction in mean BKI in the MN (17.5 vs 9.7, P<0.001), HT (15.4 vs 8.6, P=0.001), and placebo (16.1 vs 12.4, P=0.040) groups. Analysis of quality of life (QoL) showed that functional capacity (P=0.006), vitality (P=0.031), mental health (P=0.017), and social aspect (P<0.01) improved after treatment in the MN group. The HT group showed improvement in emotional limitation (P=0.040), and the placebo group showed better functional capacity (P=0.030) after treatment. CONCLUSIONS: Climacteric symptoms and QoL improved after administration of 250 mg of MN leaf powder for 60 days, similar to the effects of HT. The trial is registered in the Brazilian Registry of Clinical Trials (REBEC) under registration number RBR-9t4xxk.