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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
| Content Provider | Semantic Scholar |
|---|---|
| Author | Jaisamrarn, Unnop Triratanachat, Surang Chaikittisilpa, Sukanya Grob, Philipp Prasauskas, Valdas Taechakraichana, Nimit |
| Copyright Year | 2013 |
| 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. C lim ac te ri c D ow nl oa de d fr om in fo rm ah ea lth ca re .c om b y U ni ve rs ity o f W as hi ng to n on 0 2/ 07 /1 3 Fo r pe rs on al u se o nl y. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://www.tahomaclinic.com/Private/Articles1/Estriol/Jaisamrarn%202013%20-%20Ultra-low-dose%20estriol%20and%20lactobacilli%20in%20the%20local%20treatment%20of%20postmenopausal%20vaginal%20atrophy.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
