Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women: An open label trial

doi:10.1016/j.tjog.2016.04.008

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Title:	Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women: An open label trial
Authors:	Chen, Fang-Ping Chang, Chee Jen Chao, An-Shine Huang, Hong-Yuan Huang, Jian-Pei Wu, Meng-Hsing Tsai, Ching-Chou Kung, Fu-Tsai Chang, Ching-Wen Tsai, Yung-Chieh
Contributors:	Chang Gung Mem Hosp, Dept Obstet & Gynecol Chang Gung Mem Hosp, Dept Obstet & Gynecol Chang Gung Mem Hosp, Dept Obstet & Gynecol Chang Gung Univ Chang Gung Univ, Clin Informat & Med Stat Res Ctr Mackay Mem Hosp, Dept Obstet & Gynecol Coll Med & Hosp, Dept Obstet & Gynecol Natl Cheng Kung Univ Taipei Med Univ Hosp, Dept Obstet & Gynecol Chi Mei Med Ctr Chia Nan Univ Pharm & Sci, Dept Sport Management
Keywords:	climacteric syndrome Femarelle hot flushes postmenopausal women rats
Date:	2016-06
Issue Date:	2018-01-18 11:38:59 (UTC+8)
Publisher:	Elsevier Taiwan
Abstract:	Objective: To assess the effects of 2 months of treatment with Femarelle for climacteric syndrome in Taiwanese postmenopausal women. Materials and methods: A multi-center, open-label trial of 260 postmenopausal women, age >= 45 years with vasomotor symptoms. Women were enrolled after obtaining a detailed medical history and a thorough physical examination. They then received Femarelle (640 mg/d) twice daily for 8 weeks. The primary outcome was the changes in the frequency and severity of hot flushes from baseline to 4 weeks (1 month) and 8 weeks (2 months). Changes of general climacteric syndrome were assessed using a modified climacteric scale designed by Greene. Results: The frequency and severity of hot flushes were significantly improved with Femarelle use (p < 0.001). After 8 weeks of treatment, the percentage of women with various climacteric syndromes was reduced (from 100% to 20.9% for hot flushes, from 97.7% to 87.9% for psychological symptoms, from 93.8% to 78.8% for somatic symptoms, and from 87.8% to 74.9% for sexual symptoms). General climacteric syndrome scores also significantly decreased, from 20.8 +/- 0.7 at the time of enrollment to 12.9 +/- 0.7 after 8 weeks of Femarelle treatment (p < 0.0001). Participants experienced improvement of various climacteric symptoms and signs after 8 weeks of treatment (75.1% for hot flushes, 68.7% for psychological symptoms, 70.6% for somatic symptoms, and 69.0% for sexual problems respectively). After 4 weeks and 8 weeks of treatment with Femarelle, patients showed statistically significant improvement in climacteric symptoms (p < 0.0001). Three women (1.2%) withdrew from the study after 4 weeks of treatment due to adverse effects. Conclusion: Femarelle significantly improved climacteric symptoms in Taiwanese postmenopausal women. However, further evaluation is needed regarding the safety of long-term consumption. Copyright (C) 2016, Taiwan Association of Obstetrics & Gynecology. Published by Elsevier Taiwan LLC.
Relation:	Taiwanese Journal of Obstetrics & Gynecology, v.55 n.3, pp.336-340
Appears in Collections:	[Dept. of Sports Management] Periodical Articles

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