Open randomized placebo-controlled study of the effectiveness and safety of monotherapy of bacterial vaginosis by vaginal application of lactic acid

Objective. To investigate the efficiency and safety of bacterial vaginosis (BV) monotherapy with 100 mg of lactic acid as vaginal suppositories. Subjects and methods. In 2015 to 2016, an open-label randomized placebo-controlled study was conducted to investigate the efficacy and safety of vaginal suppositories containing 100 mg of lactic acid (femilex), by covering 116 women diagnosed with BV, which were divided into 2 representative groups. Group 1 (a study group) consisted of 64 women with BV who received monotherapy with one lactic acid (femilex) suppository intravaginally once daily (overnight) for 10 days. A comparison (control) group included 52 patients who used placebo vaginal suppositories without lactic acid (containing only polyethylene oxide as their base) in the same cycle schedule. All the patients underwent conventional gynecological examination. Results. A posttreatment analysis of main indicators established that in Group 1 the changes from the vaginal pH level to the normal one were convincing at relevant visits: 6.84, 4.28, and 4.34 (p < 0.001) while the pH level did not change significantly in the control group. The same can be said for the detection rate of a positive amino test at relevant visits: 95.3, 0, and 3.13% in Group 1 (p < 0.001) and 92.3 and 86.54% in Group 2 (p > 0.05). There was a similar trend in the detection of key cells by microscopy of vaginal smears: 100, 7.81, and 10.94% in the study group (p < 0.001) and 98.1 and 94.23% in the control group (p > 0.05).

lactic acid, femalex, monotherapy, amino test, pH metry, key cells