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.Kira E. F., Korshakova N. Yu.
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).
There were no adverse events or adverse reactions to lactic acid.
Conclusion. Thus, the results of this investigation confirmed the previously predicted assumption that monotherapy with lactic acid as a natural biological antiseptic and an immunomodifier may be not only an effective means to restore normal vaginal microbiocenosis, but it may be also a real alternative to antibiotics.
Keywords
lactic acid
femalex
monotherapy
amino test
pH metry
key cells
References
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Received 12.04.2018
Accepted 28.04.2018
About the Authors
Kira Evgeniy Fedorovich, Honored worker of science of the Russian Federation, Honored doctor of the Russian Federation, Acad. RANS, MD, Prof.,head of the Department of Women’s Diseases and Reproductive Health, N.I. Pirogov National Medical and Surgical Center.
105203, Russia, Moscow, Nizhnyaya Pervomayskaya str. 65. Tel.: +74994645654. E-mail: profkira33@gmail.com
Korshakova N.Yu., N.I. Pirogov National Medical and Surgical Center, Ministry of Health of Russia.
105203, Russia, Moscow, Nizhnyaya Pervomayskaya str. 70
For citations: Kira E.F., Korshakova N.Yu. Open-label randomized placebo-controlled study of the efficiency and safety of vaginal lactic acid monotherapy for bacterial vaginosis.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (5): 96-101. (in Russian)
https://dx.doi.org/10.18565/aig.2018.5.96-101
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