Effect of Green Ocimum Basilicum Leaf Extract Capsule on the Quality of Life of Postmenopausal Women: A Randomized, Placebo-Controlled, Clinical Trial

Introduction: Menopause can make women more vulnerable and has different vasomotor, psychosocial, physical, and sexual domains, which can reduce women's Quality of Life (QOL). The use of medicinal plants containing phytoestrogens can reduce the symptoms of menopause. Objective: This study aimed to assess the effect of Green Ocimum Basilicum Leaf Extract (GOBLE) capsule on the QOL of postmenopausal women. Materials and Methods: This is a double-blind, randomized, controlled clinical trial conducted from November 2019 to May 2022 at a teaching hospital affiliated with Alborz University of Medical Sciences, Karaj, Iran. Eighty participants were allocated to the intervention (n=40) and control (n=40) groups using block randomization. The intervention group received 250 mg GOBLE capsules every 12 hours for eight weeks. In the control group, a placebo was used. Data were collected by the Menopause-Specific Quality of Life (MENQOL) questionnaire at three time points: before the intervention, one month after the intervention, and two months after the intervention. Independent t-test, paired t-test, Wilcoxon test, Mann-Whitney U test, Friedman’s test, and ANOVA were used for statistical analysis Results: The majority of women were aged 47-51 years (51.4% in the intervention group and 43.6% in the control group), and had an age at menopause of 48-52 years (55% in the intervention group and 59% in the control group). The total MENQOL score ranged from 29 to 232. In the intervention group, the results one month after the intervention showed a significant reduction only in vasomotor (from 14.1±6.4 to 10.5±5.5, P=0.01) and sexual (from 15.0±6.7 to 11.5±7.2, P=0.03) domains. The trend of changes two months after intervention showed significant between-group differences in vasomotor (P=0.01, h2=0.35) and sexual (P=0.001,h2 = 0.28) domains. There were no statistically significant differences in the control group. Conclusion: The GOBLE capsule administration can reduce the effect of vasomotor and sexual symptoms of menopause on the QOL of postmenopausal women. Therefore, this product may help alleviate hot flashes, sweating, and night sweats (vasomotor symptoms) and improve sexual desire, vaginal dryness, and sexual activity in postmenopausal women.