| Ultra-low-dose estriol and lactobacilli in the local treatment of postmenopausal vaginal atrophy: a double-blind randomized trial followed by open-label maintenance therapy. | |
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MedLine Citation:
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PMID: 23347400 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Abstract Objective: The aim of this study was to demonstrate the efficacy of an ultra-low dose 0.03 mg vaginal estriol in combination with viable Lactobacillus acidophilus KS400 (Gynoflor(®) vaginal tablets) in the short-term therapy and to investigate the long-term maintenance dose in the treatment of vaginal atrophy. Methods: This was a double-blind, randomized placebo-controlled study (Controlled phase - initial therapy) followed by an open-label follow-up (Open phase - test medication initial and maintenance therapy). Included were postmenopausal women with vaginal atrophy symptoms and Vaginal Maturation Index (VMI) of ≤ 40 %. Method of treatment was initial therapy with test medication (or placebo in first phase) 1 vaginal tablet daily for 12 days followed by maintenance therapy 1 tablet on 2 consecutive days weekly for 12 weeks. Results: A total of 87 women completed the study. The Controlled phase results for a change in VMI demonstrated superiority of 0.03mg-estriol-lactobacilli combination to placebo (p<0.001). In the test group a positive change in VMI was 35.2%, compared to 9.9% in the placebo group. In the Open phase after the initial therapy the VMI was increased to 55.4% and during maintenance therapy stayed at a comparable level (52.8% - 49.4%). The maturation of epithelium was followed by improvement of clinical symptoms and normalisation of vaginal ecosystem. Conclusions: The ultra-low dose vaginal 0.03 mg-estriol-lactobacilli combination (Gynoflor(®)) was superior to placebo with respect to change in VMI after the 12-day initial therapy and the maintenance therapy of 2 tablets weekly was sufficient to prevent the relapse of vaginal atrophy. |
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Authors:
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Unnop Jaisamrarn; Surang Triratanachat; Sukanya Chaikittisilpa; Philipp Grob; Valdas Prasauskas; Nimit Taechakraichana |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2013-1-24 |
Journal Detail:
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Title: Climacteric : the journal of the International Menopause Society Volume: - ISSN: 1473-0804 ISO Abbreviation: Climacteric Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-1-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9810959 Medline TA: Climacteric Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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