Efficacy and safety of the combination nifuratel-nystatin and clindamycin-clotrimazole, in the treatment of bacterial vaginosis. Randomized controlled clinical trial

Introduction: Bacterial vaginosis (BV) is the most frequent gynecological infection in women of reproductive age, thus driving the search for effective and safe treatments. Objective: To compare the efficacy and safety of the combination nifuratel-nystatin and clindamycinclotrimazole, in the treatment of bacterial vaginosis. Materials and Methods: Randomized controlled clinical trial in 147 single women (18 to 39 years old), non-pregnant and sexually active, with a diagnosis of BV according to the Amsel clinical criteria and the Nugent score; between 2016 and 2018. In a highly complex private clinic in Armenia, Colombia. Women were randomized into two groups: "A" (73 participants: nifuratel (500 mg) - nystatin (100,000 IU) and "B" (74 participants: clindamycin (100 mg) - clotrimazole (200 mg)); both groups were treated with vaginal ovules, "A" for six days and "B" for three days. All participants were followed-up for clinical and microbiological healing at 7 and 30 days, respectively, after completion of treatment, the STATA® 14.0 program was used. Results: The mean age of women was 28.35±5.79 years. The clinical cure rate with the nifuratelnystatin combination was 93.15%, and that of clindamycin-clotrimazole 97.29%, (p=0.123). The microbiological cure rate with the nifuratel-nystatin combination was 87.67%, and that of clindamycin-clotrimazole 93.24%, (p=0.102). Regarding safety, there were also no significant differences between the two groups (p=0.144); Mild adverse reactions were observed. Recurrence in group "A" was 12.32% compared to 6.75% in group "B" (p>0.05). Conclusions: In this study, the combinations nifuratel (500 mg) -nystatin (100,000 IU) and clindamycin (100 mg)-clotrimazole (200 mg), reported that both are equally effective and safe options in the treatment of BV. It is necessary to evaluate the effect and safety of other combinations in order to implement timely interventions. Keywords: Vaginosis; Bacterial; Efficacy; Safety; Nifuratel; Nystatin; Clindamycin; Clotrimazole.