Bacterial Vaginosis (BV) is a disorder of unknown etiology, characterized by a foul smelling vaginal discharge, loss or reduction of the normal vaginal Lactobacilli, and overgrowth of other anaerobic bacteria. Thus, it presents a formidable problem for clinicians as well as microbiologists researching its etiology, clinical course, treatment, and epidemiology. The present work focuses on the unresolved issues of the epidemiology and treatment of BV in order to provide valid methods for treatment studies of this condition and to describe the prevalence of BV in defined populations.

The first study validates the use of PAP-stained smears in the diagnosis of BV. The study assesses the methods of Amsel’s clinical criteria and Nugent criteria on Gram-stain smears, against Pap-stained smears and also validates different observers. The result shows that the PAP-staining of vaginal smears is a good method in BV diagnosis; the kappa value is 0.86 (interobserver weighted kappa index) compared to 0.81 for Gram-stained smears, and 0.70 for rehydrated air-dried smears using the mean Nugent score as the criterion standard. This enables population based studies on archived PAP-stained smears from the screening of cervical cancer.

In the second study, we use the knowledge gained from study one to investigate the prevalence of BV in a cohort from the population of Åland. The prevalences of BV on the Åland Islands were: 15.6 %, 11.9 %, 8.7 %, and 8.6% in 1993, 1998, 2003, and 2008, respectively. This means that the prevalence of BV decreased between1993-2008 from 15.6% to 8.6%. The confidence intervals are not overlapping, thus indicating a significant decrease in prevalence from 1993 to 2008.

The third study is a prospective, double-blind placebo controlled treatment study of BV. After conventional treatment with clindamycin, the patients were treated with adjuvant treatment of Lactobacilli-loaded tampons or placebo. The study showed no differences between the treatment and the placebo group, indicating that the tampon does not work at all. There are a variety of possible explanations for the result, which are analyzed in this thesis.

The fourth study aimed to evaluate whether clindamycin is retained for a long time in the vaginal mucosa, thus disturbing the Lactobacilli in an attempt to reimplant Lactobacilli in the probiotic treatment studies. In conventional treatment, it is also useful to know whether clindamycin is retained, especially when considering the pressure from antibiotics on the antimicrobial sensitivity pattern. In the study, we found that the clindamycin disappears rapidly.

Conclusion: BV research requires effort from many different scientific disciplines and the riddle of this condition and its treatment can only be resolved by concerted actions in research and treatment. The vision for the future includes, among other factors, better molecular biology based diagnostic tools, and knowledge of population based bacterial floras.

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Since bacterial vaginosis (BV) is characterized by a lack of, or very few, lactobacilli and high numbers of small, mostly anaerobic bacteria, an obvious treatment modality would be eradication of the BV-associated bacterial flora followed by reintroduction of lactobacilli vaginally. As probiotic treatment with lactobacilli is one tool for improving the cure rate when treating BV, it is necessary to know the length of time after treatment that clindamycin can be found in the vagina and if this could interfere with the growth of the probiotic lactobacilli. We evaluated the vaginal concentration of clindamycin in 12 women for 8 days to obtain data on the concentration of clindamycin in the vagina after intravaginal treatment with the drug. The participants were examined five times between two menstrual periods: before treatment, the day after treatment was finished, and 3, 5 and 8 days post-treatment. The first day post-treatment clindamycin 0.46 x 10-3 to 8.4 x 10-3 g/g vaginal fluid (median 2.87 x 10-3) was found. Thereafter, the concentration of clindamycin decreased rapidly. In 10 patients clindamycin was found after 3 days. A very low concentration was still present 5 days after treatment in four patients. After 8 days no clindamycin was found. Clindamycin is rapidly eliminated from the vagina, within 3-8 days, after local administration. Our results indicate that treatment with probiotic lactobacilli could be problematic if carried out within 5 days after cessation of clindamycin treatment.

The aim of the study was to describe the prevalence and age distribution of bacterial vaginosis (BV) during an observation period of 15 years in a population study with cross-sectional samples of adult women living on the Aland Islands. The Aland Islands form an archipelago in the Baltic Sea and are a province of Finland. Every fifth year, specific age groups in the adult female population are invited to participate in a screening program for early diagnosis of cervical cancer using a papanicolaou (PAP)-stained vaginal smear. Women in the age groups of 20, 25, 30, 35, 40, 45, 50, 55, and 60 years are called each year. BV diagnosis of the PAP-stained smears uses the classification according to Nugent. The PAP-stained smears from the screening program of cervical cancer 1993, 1998, 2003, and 2008 were used in this study. A total of 3456 slides were investigated and 271 women could be followed for the 15-year observation period. The prevalence of BV declined from 15.6% in 1993 to 8.6% in 2008. The highest prevalence occurred among the age groups of 35 and 50 years. Among the 271 women who could be followed for the 15-year observation period, two-third showed normal/intermediate flora and one-third were infected with BV at least once. As this is a cross-sectional population study spanning 15 years, the prevalence of BV in the female adult population of the Aland Islands can be estimated. The prevalence has declined between 1993 and 2008 from 15.6% to 8.6%.

The expected 4-week cure rate after conventional treatment of bacterial vaginosis are only 65-70%. In an attempt to improve the cure rate by adding probiotic lactobacilli we performed a double-blind placebo-controlled study of adjuvant lactobacilli treatment after an open treatment with vaginal clindamycin ovules. Women with bacterial vaginosis as defined by Amsel's criteria were treated with clindamycin ovules. Vaginal smears were collected and analysed according to Nugent's criteria. During the following menstruation period the women used, as an adjuvant treatment, either lactobacilli-prepared tampons or placebo tampons. The lactobacilli tampons were loaded with a mixture of freeze-dried L. fermentum, L. casei var. rhamnosus and L. gasseri. The cure rate was recorded after the second menstruation period. There was no improvement in the cure rate after treatment with lactobacilli-containing tampons compared to placebo tampons, the cure rates as defined by Amsel's criteria were 56% and 62%, respectively, and 55% and 63%, as defined by Nugent's criteria. This is the first study to report cure rates for women with 'intermediate' wet smear ratings according to Nugent's classification and this group had an overall cure rate of 44%. The cure rate of treatment of bacterial vaginosis was not improved by using lactobacilli-prepared tampons for one menstruation.