Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial

Abstract

BackgroundThis multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV).MethodsPatients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5–6 (I, II, II bis – if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18–50-year-old women who were randomised.ResultsBV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment.ConclusionThis study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters.Trial registrationNCT01993524; 20 November 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s12905-015-0246-6) contains supplementary material, which is available to authorized users.

High‐dose nifuratel for simple and mixed aerobic vaginitis: A single‐center prospective open‐label cohort study

“…With regard to the disturbance in the levels of lactobacilli, it is notable that lyophilized lactobacilli have been reported to be as effective as metronidazole for the treatment of BV and AV . A recent study also showed that the use of oral probiotics lengthened remission in patients with BV or AV . It will be interesting to determine in future studies whether vaginal administration of lyophilized lactobacilli or oral administration of probiotics will play a role, perhaps as an adjunct therapy, in the treatment of AV.…”

The Effect of Supplementation of Standard Antibiotic Therapy with Oral Probiotics for Bacterial Vaginosis

“…Probiotic use also reduced and maintained low vaginal pH and Nugent score and increased vaginal Lactobacillus counts following standard treatment. [14] According to Marcone et al, the safe and effective long term vaginal administration of Lactobacillus rhamnosus appears to be a useful complementary approach in the management of bacterial vaginosis. [2] It was concluded from the study that there was significant improvement in patients of bacterial vaginosis who were supplemented with oral probiotic along with antibiotics as compared to antibiotics alone during 6 week study period.…”

Probiotics: Past, Present and Future Challenges

“…The standard treatment with antibiotic for BV and AV has succeed in about 50%. The oral use of probiotic containing three Lactobacillus strains for 10 days in association with antibiotic treatment for women with BV or AV demonstrated favorable effects in the prevention of recurrent symptoms in up to 51% compared to placebo [47]. Candida species commonly cause vulvovaginal candidiasis (VVC) in women, mostly married and pregnant, with symptoms profile similar to bacterial vaginitis [46].…”

“…In addition, to the recent high rates of vaginal candidiasis that demonstrates resistance to the treatment associated with the wide use of fluconazole [46]. The long-term use of vaginal probiotics capsules containing two Lactobacillus strains with antibiotic administration demonstrated significant prevention of rVVC for long time [47]. A study by Murina, et al (2014) reported that the use of the long term two strains of Lactobacillus species as a vaginal slow release tablet has prevented the rVVC in 86% of patients for 10 weeks, and has also resulted in the inhibition of the rVVC for 7 months after discontinuing the probiotics in 72.3% of patients [48].…”