Efficacy and Safety of Vitex Extract on Menopausal Symptoms and Quality of Life in Postmenopausal Women: A Randomized Placebo-Controlled Trial

Introduction: Postmenopausal women often experience vasomotor and hormonal symptoms due to a decline in estradiol levels, which affects their quality of life (QOL).Botanical extracts like Vitex extract, known for their estrogen-and progesterone-like actions, may offer a safe and effective approach for alleviating postmenopausal symptoms and improving overall quality of life.Methods: The current study was a prospective, randomized, double-blind, placebo-controlled, monocenter clinical study to evaluate the safety and efficacy of Vitex extract in postmenopausal women aged 40-65 years.Sixty eligible participants were randomized to either the Vitex extract or placebo group equally and instructed to take one capsule daily after breakfast for 60 days.The primary endpoints included changes in the Blatt-Kupperman Index (BKI), Menopause-Specific Quality of Life Questionnaire (MENQOL), Menopause Rating Scale (MRS), and overall QOL scores.The study was prospectively registered with the Clinical Trials Registry of India (CTRI/2025/03/082025).Results: After 60 days, Vitex extract supplementation led to clinically and statistically significant improvements compared with placebo in all primary outcomes.Notable reductions were observed in BKI, MENQOL, and MRS scores, reflecting better control of vasomotor, psychosocial, physical, and sexual symptoms.Improvements were also seen in the reduction in joint and muscle pain, stress levels, and serum cortisol.Hormonal regulation of luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol, and thyroid function, along with reduced rheumatoid factor, indicated anti-inflammatory and endocrine benefits.No adverse effects or lab abnormalities were reported.Conclusions: In this single-center study, Vitex extract appeared effective and was well tolerated, suggesting its potential as a safe, non-hormonal option for relieving menopausal symptoms and improving quality of life in postmenopausal women.However, these findings should be confirmed in larger, multi-center trials before broader clinical recommendations can be made.