Single-Dose Secnidazole Versus 7-Day Metronidazole for Treatment of Bacterial Vaginosis in Non-Pregnant Women – A Non-Inferiority Randomized Controlled Trial

Faculty Medicine Year: 2018
Type of Publication: ZU Hosted Pages:
Authors:
Journal: Journal of Women's Health, Gynecology & Obstetrics Arvinmed International Volume:
Keywords : Single-Dose Secnidazole Versus 7-Day Metronidazole , Treatment    
Abstract:
Objective: This study aims to evaluate the efficacy and safety of single-dose secnidazole in comparison to the standard 7-day course of metronidazole in treatment of BV in non-pregnant women. Methods: The current randomized controlled trial was conducted at Al Zahraa hospital, Jeddah, KSA during the interval between September 2016 and July 2018. The study included non-pregnant women with a diagnosis of BV by presence of at least 3 out of the 4 Amsel’s Criteria. Diagnosis was objectively confirmed by Gram staining. A Nugent’s score ≥ 7 of Gram staining should be present to diagnose BV in included women. Participating women were randomly allocated into one of the two groups: group I, included women who received oral secnidazole 2 g in a single dose, and group II, included women who received oral metronidazole 500 mg twice per day for 7 days. Recruited women were evaluated on days 7, 14 and 28 after initiation of treatment both clinically and bacteriologically. Results: The results showed that single-dose secnidazole treatment was non-inferior to the 7-day metronidazole treatment course, as the clinical, bacteriological and composite cure rates were all comparable in both groups of women on days 7, 14 and 28 after initiation of treatment. As regards the adverse effects, headache was encountered in a significantly higher proportion of women in group I [Secnidazole] when compared to women of group II [Metronidazole]. Nausea, metallic taste, and abdominal pain were encountered in a significantly higher rates among women of group II [Metronidazole] when compared to those of group I [Secnidazole]. Conclusion: Single-dose secnidazole treatment seems to be effective and safer alternative to the standard 7-day course of metronidazole in treatment of BV in non-pregnant women.
   
     
 
       

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