THERAPY OF BACTERIAL VAGINOSIS USING EXOGENOUSLY-APPLIED LACTOBACILLI-ACIDOPHILI AND A LOW-DOSE OF ESTRIOL - A PLACEBO-CONTROLLED MULTICENTRIC CLINICAL-TRIAL

The efficacy of vaginal tablets (Gynoflor(R)) containing 50 mg of a ly ophilisate of viable, H2O2-producing Lactobacillus acidophilus (at lea st 10(7) colony forming units/tablet) and 0.03 mg estriol (CAS 50-27-1 ) for the treatment of bacterial vaginosis (BV) was tested in a multic entric, randomised, placebo-controlled clinical trial with parallel-gr oup design. 32 non-menopausal women with positive diagnoses for BV, in cluding intermediate cases, participated in the trial. Patients were d iagnosed using the classical clinical parameters of BV according to Am sel and using microscopic analysis of the Gram-stained vaginal smear. A positive clinical diagnosis of BV required at least 2 of the followi ng 4 clinical criteria to be positive: greyish-white, homogeneous leuk orrhea; vaginal pH > 4.5; KOH test for volatile amines; presence of cl ue cells. Microscopic diagnosis of BV, on the other hand, was obtained if examination of the Gram-stained vaginal smear showed less than 6 l actobacilli per field of view (1000 x magnification). This corresponds to another definition of BV as ''lactobacilli deficiency syndrome''. The efficacy of the 6-day therapy with 1-2 vaginal tablets daily was e valuated using both clinical and microscopic analysis. Using Amsel's c lassical clinical parameters of BV, the cure rate (defined as less tha n or equal to 1 of the 4 clinical criteria positive) two weeks after t he start of therapy was 77% in the verum group and 25% in the placebo group. Four weeks after the start of therapy, the cure rate was 88% in the verum group and 22% in the placebo group. At both control examina tions, the cure rate for the test group was significantly higher than that for the placebo group (p < 0.05, Fisher's exact test, 2-sided, si gnificance level 0.05). In addition, the trial showed that after 6 day s of treatment with the test preparation, the lactobacilli were capabl e of recolonising the vagina. A significant increase in the number of lactobacilli was observed in the Gram-stained vaginal smear for the pa tient group treated with the test preparation compared to the placebo patient group (p < 0.05, Fisher's exact test, 2-sided, significance le vel 0.05), two and four weeks after the start of the B-day treatment.