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YT1(美诺拉克托)对改善更年期症状的影响:一项随机、双盲、安慰剂对照临床试验。

The Effect of YT1 (MENOLACTO) on Improving Menopausal Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

作者信息

Lim Eun Yeong, Lee So-Young, Shin Hee Soon, Lee Jaekwang, Nam Young-Do, Lee Dong Ock, Lee Ji Young, Yeon Sung Hum, Son Rak Ho, Park Chae Lee, Heo Yun Haeng, Kim Yun Tai

机构信息

Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.

Department of Food Biotechnology, Korea University of Science & Technology, Daejeon 34113, Korea.

出版信息

J Clin Med. 2020 Jul 9;9(7):2173. doi: 10.3390/jcm9072173.

Abstract

This study evaluated the efficacy of YT1 (MENOLACTO) for alleviating menopausal symptoms. This study was a multi-center, randomized, double-blinded, placebo-controlled clinical trial involving female subjects (ages: 40-60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20. Subjects were administered 1 × 10 CFU/day MENOLACTO or placebo, with the primary endpoint being total KMI score, and the effect of secondary endpoints on alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire). After 12 weeks, total KMI scores decreased significantly, demonstrating improved menopausal symptoms relative to placebo along with improved modified KMI scores. Additionally, quality of life, according to the MENQOL questionnaire, significantly improved in all four symptoms-physical, psychosocial, vasomotor, and sexual symptoms. Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness. These results demonstrated that MENOLACTO alleviated menopausal symptoms without notable side effects and improved quality of life, suggesting its efficacy as an alternative supplement to alleviate menopausal symptoms in women ineligible for hormonal therapy.

摘要

本研究评估了YT1(MENOLACTO)缓解更年期症状的疗效。本研究是一项多中心、随机、双盲、安慰剂对照的临床试验,纳入了年龄在40 - 60岁之间、有更年期症状且库珀曼指数(KMI)评分≥20的女性受试者。受试者每天服用1×10 CFU的MENOLACTO或安慰剂,主要终点为总KMI评分,次要终点为根据改良KMI的各个类别缓解更年期症状的效果,以及生活质量问卷(MENQOL问卷)。12周后,总KMI评分显著下降,表明相对于安慰剂,更年期症状得到改善,同时改良KMI评分也有所提高。此外,根据MENQOL问卷,在身体、心理社会、血管舒缩和性症状这四个症状方面,生活质量均显著改善。而且,我们观察到两组之间无显著差异,血卵泡刺激素、雌二醇水平及子宫内膜厚度也无显著变化。这些结果表明,MENOLACTO可缓解更年期症状且无明显副作用,并能改善生活质量,提示其作为一种替代补充剂,对不适于激素治疗的女性缓解更年期症状具有疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c90/7408745/24a377ca2e79/jcm-09-02173-g001.jpg

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