Evaluation of Efficacy and Safety of EstroG-100® in Alleviating Menopausal Symptoms in Postmenopausal Women in India: A Prospective, Single-center, Single-arm, Interventional Study

Abstract

ABSTRACT Background: Menopause is a natural stage in a woman’s life marked by the cessation of menstrual periods. Common symptoms include hot flashes, mood swings, and vaginal discomfort, among others. These climacteric symptoms lead to a compromised quality of life affecting physical, biological, psychological, and social well-being. There are concerns with long-term clinical use of Hormone replacement therapy (HRT) and alternative therapies that are devoid of adverse risks are required. This study aimed to evaluate the safety and efficacy of EstroG-100®, containing a mixture of standardized extracts of Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas, on menopausal symptoms and its impact on quality of life. Methodology: This was a prospective, single-center, single-arm, interventional study. Sixty female subjects, with confirmed menopause and moderate-to-severe symptoms, were enrolled and treated with EstroG-100® twice daily, for 12 weeks. Improvement in the climacteric symptoms was evaluated using the Menopause Rating Scale-11 and Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). All the results were evaluated by the SPSS software version 23.0. Results: A significant improvement was noticed in the somatic, urogenital, and psychological climacteric symptoms from baseline to 6 weeks (P = 0.001) and a highly significant improvement after 12 weeks (P = 0.0001) of treatment. 96.5% of patients were satisfied with the treatment outcome evaluated by the MS-TSQ. No changes in blood pressure and body mass index were reported. No side effects were reported during the study. Conclusion: The first study of EstroG-100® in Indian menopausal women demonstrated a statistically significant improvement in climacteric symptoms. A 12-week treatment proved safe and effective in enhancing postmenopausal women’s quality of life. The remedy was well-tolerated and effectively alleviated menopausal symptoms.