Year-end Sale % OFF 
Abstract
BackgroundThe primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure.MethodsWomen (n = 100) with bacterial vaginosis diagnosed by Amsel criteria were after informed consent offered vaginal clindamycin therapy followed by vaginal gelatine capsules containing either 109 freeze-dried lactobacilli or identical placebo capsules for 10 days during 3 menstrual cycles in a double-blind, randomized, placebo-controlled trial.ResultsThe initial intent to treat (ITT) analysis for the one-month cure rate was 64% in the lactobacilli group and 78% in the placebo group (p > 0.05). However, any patient with missing or unclassified smears at the initial visit who continued the study and whose next smear indicated a cure was included in the cured group; the study also excluded two of the patients in the lactobacilli group who reported that they did not take any vaginal capsules. With consideration to these population changes, the initial cure rate would be 77% in the lactobacilli group. The 76 cured women were followed for 6 menstrual cycles or until relapse within that time span. At the end of the study, 64.9% (24/37) of the lactobacilli treated women were still BV-free compared to 46.2% (18/39) of the placebo treated women. Comparison of the two groups regarding "Time from cure to relapse" was statistically significant (p = 0.027) in favour of the lactobacilli treatment. Adjuvant therapy with lactobacilli contributed significantly to avoidance of relapse with a proportional Hazard Risk ratio (HR) of 0.73 (0.54–0.98) (p < 0.05)ConclusionThe study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment, but for women initially cured, adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up.Trial registration numberISRCTN62879834
Highlights
The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure
The cure rate would be 74% (37/50), in the lactobacilli group versus 78% (39/50), in the placebo group (p = 0.82)
Any patient with missing or unclassified smears at the initial visit who continued the study and whose smear indicated a cure was included in the cured group and by omitting two of the patients in the lactobacilli group who reported that they did not take any vaginal capsules, the initial cure rate would be 37/48 (77%) in the lactobacilli group, there are no difference between the lactobacilli and the placebo group in the initial cure
Summary
The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure. Bacterial vaginosis (BV) is a disease with unknown aetiology, characterized by loss or reduction of lactobacilli and increased overgrowth of other bacteria. It is one of the most frequent vaginal infections, and its most common symptom is malodorous discharge. The recommended treatment regimes for BV are oral or vaginal metronidazole or vaginal clindamycin [2]. In a meta-analysis, the expected cure rate after one month was 70%–80% for metronidazol [3] and 82% for clindamycin [4]. In clinical practice these high efficacy rates have not been observed. There is a need for a BV treatment regime that will improve the rather low efficacy of the present therapy
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
