Abstract：
BACKGROUND: Perimenopause is a time of transition in a woman\'s life that links her reproductive years to the cessation of ovulation, or menopause. For many women, this time is characterized by a variety of physiological and lifestyle changes, including increasing irregularity in menstrual bleeding, frequency and severity of vasomotor symptoms, etc. Therapies evaluated specifically for the perimenopausal women are very limited. This study aimed to evaluate the effectiveness and safety of Amberen® (a succinate-based non-hormonal supplement) combined with a Smart B® (vitamin B) complex in women with typical (without complications) mild to moderate climacteric syndrome during perimenopause.
METHODS: Women up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.
RESULTS: A total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.
CONCLUSIONS: The use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.
RESULTS:
UNASSIGNED: NCT03897738.
METHODS: Women up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.
RESULTS: A total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.
CONCLUSIONS: The use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.
RESULTS:
UNASSIGNED: NCT03897738.
摘要：
背景：围绝经期是女性生命中的一个过渡时期，将她的生育年龄与停止排卵联系起来，或更年期。对很多女人来说,这个时期的特点是各种生理和生活方式的改变，包括增加月经出血的不规则性，血管舒缩症状的频率和严重程度，等。专门评估围绝经期妇女的治疗方法非常有限。这项研究旨在评估Amberen®（一种基于琥珀酸盐的非激素补充剂）与SmartB®（维生素B）复合物结合在围绝经期患有典型（无并发症）轻度至中度更年期综合征的女性中的有效性和安全性。
方法：50岁以下的女性，在围绝经期,有血管舒缩和更年期综合征心身症状的患者被纳入研究.该试验是随机的，双盲,安慰剂对照,比较,和前瞻性。
结果：共有106名参与者参加了试验，根据协议，105完成了审判。我们观察到大多数Greene更年期症状的统计学显着改善，状态特质焦虑量表(STAI)，医院焦虑和抑郁量表（HADS），和幸福，活动,和情绪（WAM）得分。干预措施耐受性良好，几乎没有不良反应，报告为轻度和短暂的。
结论：使用这种膳食补充剂是安全的，可以消除或改善围绝经期妇女的血管舒缩和更年期症状的心身症状：它可以改善睡眠和认知能力，降低抑郁和焦虑，改善情绪和幸福感，并积极影响生活质量。
结果：
■NCT03897738。
方法：50岁以下的女性，在围绝经期,有血管舒缩和更年期综合征心身症状的患者被纳入研究.该试验是随机的，双盲,安慰剂对照,比较,和前瞻性。
结果：共有106名参与者参加了试验，根据协议，105完成了审判。我们观察到大多数Greene更年期症状的统计学显着改善，状态特质焦虑量表(STAI)，医院焦虑和抑郁量表（HADS），和幸福，活动,和情绪（WAM）得分。干预措施耐受性良好，几乎没有不良反应，报告为轻度和短暂的。
结论：使用这种膳食补充剂是安全的，可以消除或改善围绝经期妇女的血管舒缩和更年期症状的心身症状：它可以改善睡眠和认知能力，降低抑郁和焦虑，改善情绪和幸福感，并积极影响生活质量。
结果：
■NCT03897738。
