标题：Th e eff ect of a natural supplement versus tibolone on menopausal symptoms: A multi-center, doubleblind, non-inferiority randomized controlled trial
出版社：International Medical Journal Management and Indexing System
摘要：Introduction: Options for the treatment of menopausal symptoms include hormone replacement therapy, e.g. with Tibolone. However, an increased risk of adverse effects like vaginal bleeding, cardiovascular events or breast cancer has been observed. Well-designed randomized controlled trials proving the effectiveness and reduced risk profile of alternative therapies, such as natural supplements, are still rare. Research Hypothesis: The present study investigates whether a natural supplement (510 mg of β-sitosterol, glucosinolates, citroflavonoids) is non-inferior to Tibolone (standard dose of 2.5 mg) in improving menopausal symptoms while still maintaining a lower risk profile. Methods: In a multi-center, randomized controlled non-inferiority trial, n = 882 women 1-6 years after final menstrual period and diagnosed with symptomatic menopause are randomized either to a 1-year period of treatment with Tibolone or the natural supplement of glucosinolates, β-sitosterol and citroflavonoides. As primary outcome menopausal symptoms are assessed with the greene climacteric scale (GCS). Biochemical markers (e.g. estradiol, interleukin-6, 8, osteocalcin), the McCoy female sexuality questionnaire and the adverse events profile are assessed as secondary outcomes. Outcome variables are assessed at several time points (baseline, 1 month, 3, 6, 12 months). Feasibility: Given the use of a mixed strategy including advertising, collaboration with general physicians and gynecologists, and multiple study centers in Latin-America the present study is regarded to be feasible. Anticipated Results: It is assumed that both interventions show similar response rates as well as a similar total score in the GCS. The natural supplement is associated with a lower rate of negative side-effects.
