Efficacy and safety of the combination nifuratel-nystatin and clindamycin-clotrimazole, in the treatment of bacterial vaginosis. Randomized controlled clinical trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 147 participants or records.
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