Effect of Nigella Sativa Oil on Early Menopausal Symptoms and Serum Levels of Oxidative Markers in Menopausal Women: A Randomized, Triple-Blind Clinical Trial

Abstract

Background: The declining levels of estrogen during menopause is linked with numerous somatic and psychological complications. Objectives: This study aimed to investigate the effect of soft Nigella sativa oil capsules on early menopausal symptoms and serum levels of some oxidative markers in postmenopausal women. Methods This randomized controlled trial was conducted on 72 menopausal women aged 45-60 years. Participants were randomly allocated to control and intervention groups with an equal allocation ratio (1:1). Patients received either one N. sativa oil capsule (1000 mg) (experimental group) or a placebo capsule (control group) at night for eight weeks. Data were collected through the demographics questionnaire, the Greene Climacteric Scale, and the Hot Flash Related Daily Interference Scale (HFRDIS) also by measuring the serum levels of TAC (Total Antioxidant Capacity) and MDA (Malondialdehyde) before and eight weeks after the intervention. Data were analyzed in SPSS-16 using the independent t-test, chi-square, Mann-Whitney U, Friedman, and repeated-measures ANOVA. Results: The participants were matched in baseline values. The mean total Greene’s score (Mean Difference (MD) Log 10=-0.31; 95% Confidence Interval (CI): -0.41 to -0.22; p<0.001) and the number of hot flashes (MD Log 10 =-0.37; 95%CI: -0.48 to -0.26; p=0.001) significantly decreased in the N. Sativa group after the intervention. This decrease in total Greene score (adjusted MD Log 10=-0.16 (-0.29 to -0.05); p=0.019) and the number of hot flashes ((aMD Log 10=-0.13 (-0.25 to -0.02); p=0.020) was statistically significant compared to the control group. There were no significant differences between two groups in the subscales of Greene (p>0.05). No significant difference was observed between the groups in serum levels of TAC (p=0.250) and MDA (p=0.444). Conclusion: N. Sativa reduced the total score of Greene’s menopausal symptoms and hot flashes in menopausal women; however, it had no significant effect on serum levels of oxidative stress markers.