Efficacy And Safety of Nifuratel-Nystatin in The Treatment of Mixed Vaginitis, in Pregnant Women From Quindío, 2013-2017. Randomized Clinical Trial

Abstract

Introduction: Women with abnormal vaginal discharge usually suffer from bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonas vaginitis (TV) or any combination of these. Objective: To compare the efficacy and safety of the combination nifuratel-nystatin with metronidazole -nystatin in the treatment of mixed vaginitis in pregnant women, and its adverse effects. Materials and methods: Randomized, double-blind, parallel-group clinical trial in 153 pregnant women, diagnosed with mixed vaginitis; in a complex private medical institution in Armenia (Colombia), between 2013 and 2017. The patients were randomized 1:1 to receive a daily intravginal egg for six days: nifuratel (500mg) - nystatin (200,000 IU) (Group "A") and metronidazole (500mg) - nystatin (100,000 IU) (Group "B"). A follow-up of the healing of symptoms was determined at one week and an evaluation of the microbiological negativization at one month. Safety was assessed based on reports of adverse events. Descriptive statistics were used. Results: The mean age of the population was 27.59±3.71 years. The mean gestational age in group "A" was 18.56±2.87 weeks compared to 19.57±2.95 weeks in group "B" (p=0.87). The clinical cure rates at 7 days in group "A" were 84.61% vs. 81.33% in group "B", (p=0.91) The microbiological negativization at one month was 91.02% in group "A" vs. 86.66% in group "B", (p=0,072) The recurrence rate was 1.28% in group "A" vs. 5.33% in group "B", (p=0.37) Adverse events were present in the metronidazole-nystatin group, which were mild and self-limited. Conclusion: Both drugs have comparable efficacy and similar safety results in the treatment of mixed vaginitis in pregnant women; therefore, they can be used interchangeably. Studies in larger populations with a control group and random assignment are required to provide better evidence regarding this management.