The effect of prebiotic vaginal gel with adjuvant oral metronidazole tablets on treatment and recurrence of bacterial vaginosis: a triple-blind randomized controlled study.

Hakimi, Sevil; Farhan, Faranak; Farshbaf-Khalili, Azizeh; Dehghan, Parvin; Javadzadeh, Yousef; Abbasalizadeh, Shamsi; Khalvati, Bagher

<bold>Purpose: </bold>Bacterial vaginosis is a change in the normal vaginal bacterial flora that leads to loss of hydrogen peroxide producing lactobacilli and overgrowth of predominantly anaerobic bacteria. The present study was conducted to compare the effects of prebiotic vaginal gel with oral metronidazole tablet and metronidazole tablet alone on treatment and recurrence of bacterial vaginosis.<bold>Methods: </bold>The present triple-blind randomized clinical trial was conducted in Sadatmandi Hospital in Robat-Karim town, where 100 patients were randomly divided into intervention (receiving a 5 mg prebiotic vaginal gel applicator plus three 250 mg metronidazole tablets per day for 7 days) and control (receiving a 5 mg placebo vaginal gel applicator and three 250 mg metronidazole tablets per day for 7 days) groups. Then, patients were assessed for bacterial vaginosis on 90 ± 3 day after treatment. Data collected were analyzed in SPSS-21 using Chi square, repeated measures, and student's t tests at a significance level of P < 0.05.<bold>Results: </bold>The results obtained showed no significant difference between the two groups in terms of personal and social characteristics, clinical complaints, or laboratory markers. On the 10th day, healing rate based on Amsel and Nugent criteria was 76% in the intervention group and 30% in the control group [odds ratio (OR) 4.3; 95% confidence interval (CI) 2.7-9.4]. On the 90th day, healing rate was 84% in the intervention group and 62% in the control group (OR 3.7; 95% CI 1.3-8.9).<bold>Conclusions: </bold>Adjuvant treatment with prebiotic vaginal gel improves the efficacy of bacterial vaginosis treatment.

BACTERIAL vaginitis; HYDROGEN peroxide; METRONIDAZOLE; VAGINA physiology; PLACEBOS; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STATISTICAL sampling; EVALUATION research; VAGINAL medication; RANDOMIZED controlled trials; PREBIOTICS; PHARMACODYNAMICS; THERAPEUTICS

Archives of Gynecology & Obstetrics, 2018, Vol 297, Issue 1, p109

0932-0067

Academic Journal

10.1007/s00404-017-4555-x