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The effectiveness of live lactobacilli in combination with low dose oestriol (Gynoflor) to restore the vaginal flora after treatment of vaginal infections
Author(s) -
Ozkinay Erdinc,
Terek Mustafa Cosan,
Yayci Murat,
Kaiser Renato,
Grob Philipp,
Tuncay Gungor
Publication year - 2005
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/j.1471-0528.2004.00329.x
Subject(s) - vaginal flora , bacterial vaginosis , medicine , trichomoniasis , placebo , adverse effect , vaginal disease , flora (microbiology) , vagina , gynecology , surgery , biology , bacteria , genetics , alternative medicine , pathology
Objective To evaluate the effectiveness of live lactobacilli in combination with low dose oestriol for restoration of the vaginal flora after anti‐infective treatment. Design The study was designed as a single centre, randomised, placebo‐controlled, double‐blind clinical trial. Setting University Hospital. Sample Three hundred and sixty women out of 1750 were randomised. Methods Three hundred and sixty women with the complaints of vaginal infections (bacterial vaginosis, candidiasis, trichomoniasis or fluor vaginalis) were randomly assigned two to seven days after the end of the anti‐infective therapy, to therapy with live lactobacilli in combination with low dose oestriol (study group, n = 240) or placebo ( n = 120). The follow up visits occurred three to seven days and four to six weeks after the end of the restoration therapy. Main outcome measures The Normal Flora Index (NFI), which consists of numbers of lactobacilli, pathogenic microorganisms, leucocytes and vaginal pH, was used as the primary outcome of the study. Secondary outcomes included the total symptoms score, the degree of purity of the vaginal flora and the global assessment of the treatment by the investigator and the women. Results During restoration therapy, the NFI increased significantly more in the study group than in the control group in both first and second control visits ( P = 0.002 and P = 0.006, respectively). The degree of purity of the vaginal flora also increased significantly more in the study group compared with the control group ( P < 0.0001 and P = 0.001, respectively). No serious adverse event was reported during restoration therapy. Conclusion Restoration of the vaginal flora can be significantly enhanced by the administration of live lactobacilli in combination with low dose oestriol.