Results of the study of the efficiency and safety of vaginal ornidazole in the treatment of bacterial vaginosis


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Abstract

Objective. To optimize the efficiency and safety of bacterial vaginosis (BV) therapy with combinations of metronidazole or ornidazole and a drug containing lactic acid and glycogen. Subjects and methods. An open-label multicenter randomized trial was conducted to study the efficiency and safety of vaginal ornidazole and its combination with lactagel versus oral metronidazole and its combination with lactagel. Four representative groups were made up from 142 reproductive-age patients (18-45 years old) included into the trial. These were: 1) oral metronidazole (n = 39); 2) vaginal ornidazole (n = 34); 3) oral metronidazole + vaginal lactagel (n = 35); 4) vaginal ornidazole + vaginal lactagel (n = 34). The investigators made objective gynecological examination, pH-metry, vaginal smear microscopy using the Nugent scoring system, key cell detection, an amino test (Amsel’s criteria), and PCR: florocenosis for diagnosing BV and AmpliSens-NCMT for detecting C. trachomatis, N. gonorrhoeae, M. genitalium, and T. vaginalis. The findings were statistically analyzed. Results. There were positive vaginal pH changes in all the groups, but they were signif icantly fewer in Groups 3 and 4. After a month of treatment completion, this indicator remained stable (<4.5) in the majority of women in Groups 2, 3, and 4 whereas Group 1 exhibited its increase >4.5. There was a similar tendency in the detection rate for key cells in the smears and in the amino test. By analyzing the eff iciency of treatment according Amsel’s criteria, the investigators could not reveal statistically significant differences (p = 0.544): 95, 94, 97, and 100% in Groups 1, 2, 3, and 4, respectively. At visit 2, the Nugent scores were significantly lower in Groups 3 and 4; a score of > 8 (BV) was seen only in Groups 1 and 2. The posttreatment Nugent scores were significantly lower in Groups 3 and 4. Prior to treatment, all the groups were matched for the levels of Gardnerella vaginalis detected at equally high concentrations (= 109 GE/ml) in all the patients. Following treatment, the concentration of G. vaginalis was decreased in all the groups, but it was significantly lower in groups 3 and 4 (p = 0.022). On the contrary, there was a consecutive rise in the number of lactobacilli during treatment. After treatment, the concentration of lactobacilli was significantly higher in Groups 3 and 4. In Groups 1 and 2, lactobacilli levels were also increased but to a lesser extent. Adverse reactions occurred in each group; however, they were not a reason for medication discontinuation in any of the cases or for exclusion of the patients from the trial. Conclusion. There is evidence that two-component treatment using metronidazole and ornidazole with lactic acid is more effective in treating BV than monotherapy with 5-nitroimidazole drugs.

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About the authors

Eugene F. Kira

N.I. Pirogov National Medical and Surgical Center, Ministry of Health of Russia

Email: dr-kira@mail.ru
MD, professor, member of Russian Academy of Natural Sciences, Honored Doctor of the Russian Federation, the chief obstetrician-gynecologist

S. I Rogovskaya

Russian Medical Academy of Postgraduate Education

Email: srogovskaya@mail.ru
MD, professor of obstetrics and gynecology RMAPO, vice president of the Russian Association of genital infections and neoplasia Ragin; City Clinical Hospital № 72.

N. V Artymuk

Kemerovo State Medical Academy

Email: artymuk@gmail.com
MD, professor, member of the All-Russian Association of gynecologists-endocrinologists, Head of the Department of Obstetrics and Gynecology

Alevtina Mikhailovna Savicheva

D.O. Ott Research Institute of Obstetrics and Gynecology

MD, Professor, corr. member Academy of Natural Sciences, Head of the Laboratory of Microbiology

Alexander E. Gushchin

D.O. Ott Research Institute of Obstetrics and Gynecology

Email: aguschin1965@pcr.ru
PhD, head of the laboratory of molecular diagnostics and epidemiology of infections of reproductive organs

Tatiana Andreevna Rumyantseva

Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare

Email: Ivanovatatiana86@yandex.ru
researcher at the Laboratory of Molecular Diagnostics and Epidemiology of infections of reproductive organs; obstetrician-gynecologist of Scientific Advisory clinical and diagnostic center

Olga V. Ivanova

Chelyabinsk State Medical Academy

Email: iv.olga.06@mail.ru
MD, a gynecologist-endocrinologist of highest category, Department of Obstetrics and Gynecology

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