Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Background Menopausal symptoms severely reduce the quality of life of post-menopausal women worldwide. Nutraceuticals are widely prescribed as a viable and safer alternative and complementary approach to standard therapies. The aim of this study was to evaluate the clinical efficacy and safety of a nutraceutical in post-menopausal women. Methods The study was designed as a randomized, double-blinded, placebo-controlled clinical trial. Post-menopausal women aged 45-60 years old were enrolled and randomly assigned to either treatment ( n = 50) or placebo group ( n = 51). The intervention, a proprietary combination of soy isoflavone, black cohosh, chasteberry and evening primrose oil extracts, and the placebo, were administered to each group for total of 12 weeks. Menopausal symptoms, endocrine profiles, and blood chemistry were evaluated at baseline, 6 weeks, and 12 weeks of the study. Results Nutraceutical supplementation demonstrated a statistically significant reduction in hot flushes and sweating ( p p p = 0.0004) and irritability symptoms ( p Conclusion These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women.