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.

IF 1.2 Q3 OBSTETRICS & GYNECOLOGY
Journal of Mid-life Health Pub Date : 2023-10-01 Epub Date: 2024-02-23 DOI:10.4103/jmh.jmh_220_23
Hepzibah Kirubamani, Prachi Ahire, C Stalin
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引用次数: 0

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.

评估 EstroG-100® 缓解印度绝经后妇女更年期症状的有效性和安全性:一项前瞻性、单中心、单臂干预研究。
背景:更年期是女性生命中的一个自然阶段,以月经停止为标志。常见症状包括潮热、情绪波动和阴道不适等。这些更年期症状会导致生活质量下降,影响身体、生理、心理和社会福祉。长期临床使用激素替代疗法(HRT)令人担忧,因此需要无不良风险的替代疗法。本研究旨在评估EstroG-100®的安全性和疗效,EstroG-100®含有茜草、伞形花序和当归的标准化提取物混合物,可改善更年期症状并提高生活质量:这是一项前瞻性、单中心、单臂干预研究。60 名女性受试者已确认绝经并出现中度至重度症状,她们接受了 EstroG-100® 的治疗,每天两次,为期 12 周。更年期评分量表-11和更年期症状治疗满意度问卷(MS-TSQ)对更年期症状的改善情况进行了评估。所有结果均由 SPSS 软件 23.0 版进行评估:从基线到治疗 6 周,患者的躯体、泌尿生殖系统和心理更年期症状均有明显改善(P = 0.001),治疗 12 周后,患者的躯体、泌尿生殖系统和心理更年期症状均有非常明显的改善(P = 0.0001)。通过 MS-TSQ 评估,96.5% 的患者对治疗效果表示满意。血压和体重指数均无变化。研究期间未发现副作用:EstroG-100®在印度更年期妇女中的首次研究表明,在统计学意义上,更年期症状得到了显著改善。为期 12 周的治疗证明对提高绝经后妇女的生活质量安全有效。该疗法耐受性良好,可有效缓解更年期症状。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Mid-life Health
Journal of Mid-life Health Social Sciences-Health (social science)
CiteScore
1.70
自引率
9.10%
发文量
39
审稿时长
43 weeks
期刊介绍: Journal of mid-life health is the official journal of the Indian Menopause society published Quarterly in January, April, July and October. It is peer reviewed, scientific journal of mid-life health and its problems. It includes all aspects of mid-life health, preventive as well as curative. The journal publishes on subjects such as gynecology, neurology, geriatrics, psychiatry, endocrinology, urology, andrology, psychology, healthy ageing, cardiovascular health, bone health, quality of life etc. as relevant of men and women in their midlife. The Journal provides a visible platform to the researchers as well as clinicians to publish their experiences in this area thereby helping in the promotion of mid-life health leading to healthy ageing, growing need due to increasing life expectancy. The Editorial team has maintained high standards and published original research papers, case reports and review articles from the best of the best contributors both national & international, consistently so that now, it has become a great tool in the hands of menopause practitioners.
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