Journal Article & Summary

Citation: Bohbot, Jean-Marc et al. “Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomized phase III study comparing secnidazole and metronidazole.” Infectious diseases in obstetrics and gynecology vol. 2010 (2010): 705692.  doi:10.1155/2010/705692

Online link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2946572/

 
Abstract

Objective. Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment. Methods. A total of 577 patients were randomized to receive metronidazole (500 mg, b.i.d for seven days) or secnidazole (2 g, once). Therapeutic cure at D28 was defined as the resolution of vaginal discharge, positive KOH whiff test, vaginal pH >4.5 and Nugent score >7 on Gram-stained vaginal fluid. Results. According to this primary endpoint, the single-dose secnidazole regimen was shown to be at least as effective as the multiple-dose metronidazole regimen (60.1 % cured women vs 59.5% , 95% confidence interval with a noninferiority margin of 10%: [−0.082; 0.0094]). Safety profiles were comparable in both groups. Conclusion. The secnidazole regimen studied represents an effective, convenient therapeutic alternative that clinicians should consider in routine practice.

Key points:

–          In this article, 577 non-pregnant women ages 18-65 with diagnosis of BV were enrolled into this study and were placed in either the group with reference treatment (metronidazole) or the study treatment (secnidazole).

–          287 patients were placed in the secnidazole treatment group and 290 patients were placed in the metronidazole treatment group.

–          This was a double-blinded study where both the investigators and patients were blind to the study treatment.

–          In the secnidazole group, 77% of the patients achieved clinical cure and 70.3% of the patients achieved bacteriological cure. Similar results were seen in the metronidazole group, where 70% of patients achieved both clinical and bacteriological cure.

–          Three-quarters of patients in both metronidazole and secnidazole group reported disappearance of BV symptoms. However, in the metronidazole treatment group, BV symptoms disappeared in 7.12 days while in the secnidazole treatment group the symptoms disappeared in 6.83 days, which shows no significant difference.

–          When it came to adverse effects, participating patients in both treatment groups experienced at least one adverse event with no significant difference between the two.

–          Although metronidazole is considered the standard therapy for bacterial vaginosis (BV), one of its main drawbacks is it’s multiple-dose regimen which can diminish compliance and lead to incomplete cure of BV. On the contrary, secnidazole has a longer half-life than metronidazole, making it more suitable for single-dose therapy and potentially more suitable in those patients who can’t comply to a multiple-dose regimen.

–          This article concluded that secnidazole is as effective and safe when administered as a single-dose regimen as multiple-dose metronidazole regimen.

Skip to toolbar