The effect of oral Curcumin capsule on serum levels of some oxidative stress biomarkers and menopausal symptoms in postmenopausal women: A randomized, triple-blinded controlled trial

Abstract

In postmenopausal women, decreased estrogen production cause various symptoms such as vasomotor symptoms including hot flashes and night sweats, breast tenderness, vaginal dryness, mood swings, vaginal atrophy, osteoporosis, and heart disease. Due to the side effects of hormone therapy, it is recommended to use healthier treatments with fewer side effects. One of these treatments is curcumin, which is made from the powdered roots of the Curcumalonga plant. The aim of this study was to determine the effect of curcumin oral capsule on serum levels of some indicators of oxidative stress and early menopausal symptoms in postmenopausal women. Materials and Methods: This is a clinical trial study. The target population in this study included all postmenopausal women aged 40-60 years who referred to health complexes in Tabriz. Participants were randomly assigned to two groups (31 in the intervention group and 31 in the control group: placebo) using RAS software using random blocking method with 4 and 6 blocks and with a 1:1 allocation ratio. The intervention group received 500 mg oral curcumin capsules twice daily (one every 12 hours with food) for eight weeks and the control group received the same placebo. To collect data from the checklist of inclusion and exclusion criteria, demographic-social profile questionnaire, standard questionnaire of early menopausal symptoms of Green and recording the number of flushing, checklist of side effects, a test record sheet (serum level MDA, TAC), daily drug registration checklist and a checklist of satisfaction measurement were used. Results: 79 patients were excluded from the study based on exclusion criteria and finally 62 postmenopausal women were randomly divided into intervention and control (placebo) groups and entered the study. The mean age in the intervention and control groups was 52 years and 52.1 years, respectively. The mean menopausal age of the intervention and control groups was 49.3 years and 48.6 years, respectively. In the intervention group, the mean level of MDA and TAC after 8 weeks of intervention significantly decreased (mean difference: -0.5, confidence interval: -0.8 to -0.1, P = 0.009) and increased (Mean difference: 0.2, confidence interval: 0.1 to 0.3, P <0.001) but did not change significantly in placebo group (P> 0.05). The mean total score of menopausal symptoms and its subdomains (except for the sexual subdomain in the curcumin group) and the number of flushing decreased significantly in both groups 8 weeks after the intervention (P <0.05). There was no significant difference between the groups in terms of the studied variables (P> 0.05).