Effect of Lyophilized Lactobacilli and 0.03 mg Estriol (Gynoflor®) on Vaginitis and Vaginosis with Disrupted Vaginal Microflora: A Multicenter, Randomized, Single-Blind, Active-Controlled Pilot Study

Abstract

Objectives: To evaluate the efficacy of lyophilized lactobacilli in combination with 0.03 mg estriol when compared to metronidazole in the treatment of bacterial vaginal infections. Setting: Multicenter, randomized, single-blind, active-controlled pilot study in 3 independent gynecological practices in Belgium. Methods: Forty-six, 18- to 50-year-old premenopausal women with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis, aerobic vaginitis) were included, provided that fresh phase-contrast microscopy of the vaginal fluid showed lactobacillary flora grade 2B or 3. Patients were given a blinded box with either 12 vaginal tablets of Gynoflor® (study medication) or 6 vaginal suppositories containing 500 mg metronidazole (control medication). Eight efficacy variables were studied to assess the status of the vaginal flora at entry, 3–7 days (control 1), 4–6 (control 2) weeks and 4 months after the end of therapy. Results: At control 1, the combined variables equally improved in the lactobacilli group as in the metronidazole group. At control 2, the lactobacillus preparation showed slightly inferior results when compared to metronidazole. At 4 months, this analysis could not be performed due to low numbers, but analysis of recurrence rate and extra medication needed was not different between both groups. Conclusion: Lyophilized lactobacilli in combination with low-dose estriol are equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month. Further studies are required to evaluate the long-term efficacy of lactobacilli when applied repeatedly.

The Threat of Aerobic Vaginitis to Pregnancy and Neonatal Morbidity

“…The administration of probiotic lactobacilli employed in recent studies restores the disrupted microflora of the vagina and offers a safer alternative to the prolonged prophylactic use of antibiotics which may present with side effects 83,84 . As with most endogenous infections, species prevalence differs among the different geographical regions with some reporting S. aureus as the most prevalent 85,19,9, followed by E. coli 85,86 Enterococcus 85,87 and GBS 86 .…”

Use of lactobacilli and estriol combination in the treatment of disturbed vaginal ecosystem: a review

“…The therapeutic cure rate observed in this study was similar to cure rates of metronidazole and clindamycin. Donders et al (38) evaluated the efficacy of L. acidophilus-0.03 mg estriol-combination in comparison to metronidazole in the treatment of bacterial vaginal infections in a multi-centre, randomised, active-controlled pilot study. Forty six, pre-menopausal women between 18 to 50 years of age with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis and/or aerobic vaginitis) were included.…”

SilTech: A New Approach to Treat Aerobic Vaginitis

“…In extreme cases, therefore, AV has a similar appearance as the so-called desquamative inflammatory vaginitis [11]. For above reasons, treatment of AV may include local estrogens administration, with or without probiotic lactobacilli in cases where atrophy dominates (increased number of parabasal cells) [12] [13].…”