Abstract
BackgroundTo determine if oral metronidazole (MTZ-400mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence.MethodsDouble-blind placebo-controlled parallel-group single-site study with balanced randomization (1∶1∶1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7–10 or ≥3 Amsel's criteria and NS = 4–10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV recurrence (NS of 7–10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groups by Chi-squared statistics. Kaplan-Meier, log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups.Results450 18–50 year old females were randomized and 408 (91%), equally distributed between groups, provided ≥1 NS post-randomization and were included in analyses; 42 (9%) participants with no post-randomization data were excluded. Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7–10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6% (13/135) in the MTZ-Clind, MTZ-Prob and MTZ-Placebo groups respectively, p = 0.13. Hazard ratios (HR) for BV recurrence at one-month, adjusted for adherence to vaginal therapy, were 0.43 (95%CI 0.15–1.22) and 0.75 (95% CI 0.32–1.76) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively. Cumulative 6-month BV recurrence was 28.2%; (95%CI 24.0–32.7%) with no difference between groups, p = 0.82; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac, adjusted for adherence to vaginal therapy were 1.09(95% CI = 0.70–1.70) and 1.03(95% CI = 0.65–1.63), respectively. No serious adverse events occurred.ConclusionCombining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic, does not reduce BV recurrence.Trial RegistrationANZCTR.org.au ACTRN12607000350426
Highlights
Bacterial vaginosis (BV) is the commonest cause of abnormal vaginal discharge in women of reproductive age, with a prevalence of 29% in 17–49 year old North American women [1]
High bacterial vaginosis (BV)-recurrence rates after monotherapy, and differing antibiotic susceptibilities of BV-associated bacteria, led researchers to investigate whether combining oral metronidazole and vaginal clindamycin was more effective than metronidazole monotherapy
The aim of our study was to determine whether the combination of oral metronidazole with either 2% vaginal clindamycin cream or a commercially-available vaginal-probiotic reduced rates of BV-recurrence over 6 months compared to oral metronidazole with a vaginal-placebo
Summary
Bacterial vaginosis (BV) is the commonest cause of abnormal vaginal discharge in women of reproductive age, with a prevalence of 29% in 17–49 year old North American women [1]. High BV-recurrence rates after monotherapy, and differing antibiotic susceptibilities of BV-associated bacteria, led researchers to investigate whether combining oral metronidazole and vaginal clindamycin was more effective than metronidazole monotherapy. We chose a commercially available vaginal-probiotic containing Lactobacillus acidophilus KS400 and 0.03 mg of oestriol to evaluate with metronidazole. The inclusion of oestriol in the product is supported by the protective effect against BV observed in women using combined hormonal contraceptives such as the oral contraceptive pill and NuvaringH in observational studies [4,8,9,10,11]. To determine if oral metronidazole (MTZ-400mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence
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