Impact of (recurrent) bacterial vaginosis on quality of life and the need for accessible alternative treatments.

BACKGROUND: Bacterial vaginosis (BV) is one of the most common vaginal dysbiosis in women aged 15-44 years old. METHODS: We administered a cross-sectional, single timepoint survey to women ages 18 years or older and who have had bacterial vaginosis (BV). Women completed an anonymous online survey evaluating the impact of BV on their quality of life, how effective different types of treatments were and the amount of self-diagnosed vs. provider diagnosed BV episodes they had. RESULTS: 62 participants completed the anonymous online survey. With a self-reported median number of BV episodes in the past year was 4 (IQR 1-7). Among these women 69.8% reported BV had a negative impact on their sexual health, 67.7% on their physical health, 74.6% on their mental health. More than half of the respondents had used probiotics with oral Lactobacillus sp. (53.2%), mainly by oral route, and over a third had used vaginal boric acid (37.1%). Most women were unaware of Lactobacillus crispatus. Lactobacillus probiotics were more likely to be tried by women who were negatively impacted by BV for overall quality of life (p = 0.033), sexual health (p = 0.002), and mental health (p = 0.006) while boric acid use was more likely to be used by women who were negatively impacted by BV for their sexual health (p = 0.008). CONCLUSIONS: BV is associated with negative quality of life and the women most impacted are seeking alternative treatments such as probiotics (Lactobacillus) and boric acid. There needs to be improvements in BV treatment that include alternative therapy options that have demonstrated efficacy with standardized composition, formulation and dosage.

Lactobacillus plantarum Lp62 exerts probiotic effects against Gardnerella vaginalis ATCC 49154 in bacterial vaginosis.

The severe side-effects elicited by conventional antibiotic therapy and the recurrence of Bacterial vaginosis-associated bacteria and bacterial resistance have led to the development of novel alternative therapies, among which genital probiotics are widely used. In this study, we aimed to evaluate the antimicrobial activities of Lactobacillus plantarum Lp62 and its supernatant against Gardnerella vaginalis, using both in vitro and in vivo approaches. In vitro assays were used to evaluate the viability of the strain and the antimicrobial activities of the supernatant in different pH ranges. An in vivo assay was performed on female BALB/c mice, wherein the animals were divided into eight groups: four control groups and four treated groups (for curative and preventive therapies). After infecting and treating the mice, the animals were killed to quantify the bacterial load using qPCR, evaluate leucocyte cellular response, determine vaginal cytokine levels and perform cytokine tissue gene expression. Our analyses revealed significant activity of the strain and its supernatant against G. vaginalis. Preliminary in vitro tests showed that the strain grew with equal efficiency in different pH ranges. Meanwhile, the presence of halo and inhibition of pathogen growth established the significant activity of the supernatant against G. vaginalis. We observed that both micro-organisms are resident bacteria of mouse microbiota and that the lactobacilli population growth was affected by G. vaginalis and vice versa. We also observed that the treated groups, with their low bacterial load, absence of leucocyte recruitment, reduced cytokine levels in the vaginal lavage and normalized cytokine gene expression, successfully controlled the infection.

The reproductive tract microbiota in pregnancy.

The reproductive tract microbiota plays a crucial role in maintenance of normal pregnancy and influences reproductive outcomes. Microbe-host interactions in pregnancy remain poorly understood and their role in shaping immune modulation is still being uncovered. In this review, we describe the composition of vaginal microbial communities in the reproductive tract and their association with reproductive outcomes. We also consider strategies for manipulating microbiota composition by using live biotherapeutics, selective eradication of pathogenic bacteria with antibiotics and vaginal microbiota transplantation. Finally, future developments in this field and the need for mechanistic studies to explore the functional significance of reproductive tract microbial communities are highlighted.

Vaginal microbiota and the potential of Lactobacillus derivatives in maintaining vaginal health.

Human vagina is colonised by a diverse array of microorganisms that make up the normal microbiota and mycobiota. Lactobacillus is the most frequently isolated microorganism from the healthy human vagina, this includes Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, and Lactobacillus jensenii. These vaginal lactobacilli have been touted to prevent invasion of pathogens by keeping their population in check. However, the disruption of vaginal ecosystem contributes to the overgrowth of pathogens which causes complicated vaginal infections such as bacterial vaginosis (BV), sexually transmitted infections (STIs), and vulvovaginal candidiasis (VVC). Predisposing factors such as menses, pregnancy, sexual practice, uncontrolled usage of antibiotics, and vaginal douching can alter the microbial community. Therefore, the composition of vaginal microbiota serves an important role in determining vagina health. Owing to their Generally Recognised as Safe (GRAS) status, lactobacilli have been widely utilised as one of the alternatives besides conventional antimicrobial treatment against vaginal pathogens for the prevention of chronic vaginitis and the restoration of vaginal ecosystem. In addition, the effectiveness of Lactobacillus as prophylaxis has also been well-founded in long-term administration. This review aimed to highlight the beneficial effects of lactobacilli derivatives (i.e. surface-active molecules) with anti-biofilm, antioxidant, pathogen-inhibition, and immunomodulation activities in developing remedies for vaginal infections. We also discuss the current challenges in the implementation of the use of lactobacilli derivatives in promotion of human health. In the current review, we intend to provide insights for the development of lactobacilli derivatives as a complementary or alternative medicine to conventional probiotic therapy in vaginal health.

Testing the regulatory framework in South Africa - a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis.

BACKGROUND: Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment. METHODS: Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment. RESULTS: The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product. CONCLUSION: Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered. TRIAL REGISTRATION: This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ).

Use of probiotics in medical devices applied to some common pathologies.

Probiotics, defined as "living microorganisms that, whether ingested in useful amount, may have beneficial effects on human body", are widely used in various products for human use, such as dietary supplements, medical devices and pharmaceutical products. The European Directive on medical devices (MDs) (DDM 93/42), also includes those MDs containing live microorganisms, particularly probiotics, that may have various destinations of use, including that of assisting the therapy of several human pathologies. In this brief note we analyzed the use of probiotics in MDs and how probiotics administration could represent one of the new frontiers of scientific research on the prevention and treatment of various diseases. We'll analyze the literature on probiotics based MDs, to review their major targets in the therapy of some of the most common human pathologies: bacterial vaginosis and vaginitis, atopic dermatitis, infantile colic, obesity, type 2 diabetes, and pharyngotonsillitis.

Lactobacillus plantarum NK3 and Bifidobacterium longum NK49 Alleviate Bacterial Vaginosis and Osteoporosis in Mice by Suppressing NF-κB-Linked TNF-α Expression.

Excessive expression of TNF-α worsens bacterial vaginosis (BV) and osteoporosis. Therefore, to understand whether probiotics could alleviate vaginosis and osteoporosis, we isolated anti-inflammatory Lactobacillus plantarum NK3 and Bifidobacterium longum NK49 from kimchi and human fecal lactic acid bacteria collection and examined their effects on Gardnerella vaginalis (GV)-induced vaginosis and ovariectomy-induced osteoporosis in female mice. Oral gavage of NK3 and/or NK49 significantly alleviated GV-induced vaginosis; these inhibited NF-κB activation and TNF-α expression in the vagina and uterus, and decreased the GV population in the vagina. Furthermore, treatment with NK3 and/or NK49 alleviated ovariectomy-induced osteoporosis and obesity; these increased blood calcium, phosphorus, and osteocalcin levels and suppressed body weight. GV-induced vaginosis and ovariectomy increased colonic myeloperoxidase activity, TNF-α expression, and fecal Proteobacteria population. NK3 and/or NK49 treatments reduced TNF-α expression and NF-κB activation in the colon. NK3 and NK49 treatment also restored GV- or ovariectomy-disrupted gut microbiota composition. In conclusion, NK3 and NK49 may simultaneously alleviate BV and osteoporosis by suppressing NF-κB-linked TNF-α expression through the regulation of gut microbiota population.

Bacterial Vaginosis: A Clinical Update with a Focus on Complementary and Alternative Therapies.

Bacterial vaginosis is a prevalent vaginal infection that affects women of all ages. Presenting symptoms include a vaginal discharge that is thin and white and has a fishy odor. This infection is associated with the acquisition of other sexually transmitted infections as well as premature labor and preterm birth. Recurrence rates after treatment are high, and medication adverse effects are common, leading many women to seek alternative therapies to manage and prevent recurrence. Many of these treatments are searchable online, and ingredients are easily obtainable. The purpose of this article is to review the state of the science regarding the safety and efficacy of alternative therapies for the treatment of bacterial vaginosis in nonpregnant women.

Bacterial vaginosis: An insight into the prevalence, alternative treatments regimen and it's associated resistance patterns.

Bacterial Vaginosis (BV) is a complex polymicrobial infection of vagina that shifts the paradigms of vaginal flora from lactobacilli to opportunistic pathogens. BV is catagorized by greyish white discharge, pH greater than 4.5. It results in the preterm labor, abortion, pelvic inflammatory disorders, post cesarean infections. BV is associated with Sexually Transmitted Diseases (STDs) or immune deficiency disorders like Human Immunodeficiency Virus, Human Papilloma Virus, Herpes Simplex Virus 1 and 2, and Neisseria gonorrhoeae. The prevalence rate is about 21.2 million (29.2%) worldwide. BV is more frequent in black females as compared to white females, independent of geographical distribution. Globally, BV is treated with the current recommended antibiotic therapy including Metronidazole and Clindamycin. The recurrence rates are 76% and occur within 06 months of treatment due to antibiotic resistance against pathogenic bacteria and their biofilms. The antibiotic resistance is a global health issue which directs the attentions towards other treatments. One of these is the treatment of sex partners, thus helping to stop the recurrence rates in females. However, this method does not show any positive results. Probiotic therapy is an incorporation of Lactobacilli orally or intravaginally for the recolonization of healthy microbes. This therapy has exhibited promising results but some studies revealed that Probiotic therapy does not control the recurrence rate. The other methods are in trials period and none of them are used clinically or commercially available for the treatment. The thermoplastic polyurethane (TPU) intravaginal rings contain lactic acid and metronidazole showed promising results in trials of BV treatment. The vaginal acidifiers are used as an alternative method to maintain the vaginal pH but the process of douching is a major limitation. The activated charcoal is used to treat BV patients in clinical trials showed decrease in the pH with only 3.1% loss of lactobacilli. Phage therapy is a reemerging field to overcome the bacterial resistance. They are host specific and easier to handle. They can be used naturally, synthetically; phage cocktails and phage-antibiotics combination can be used. Phages show auspicious results for the treatment of bacterial infections as compared to antibiotics as they also treat biofilms. This is one of the promising therapy in future to treat infections with no side effects. Phage therapy can be used in pharmaceuticals according to Food and Drug Administration (FDA) guidelines. Taken together, it is suggested that large funding is required by pharmaceutical sector or government for further investigation of bacteriophages to be used against BV pathogenesis.

Vaginal Microbiota Transplantation: The Next Frontier.

The success of fecal microbiota transplantation (FMT) as a treatment for Clostrioides difficile infection (CDI) has stirred excitement about the potential for microbiota transplantation as a therapy for a wide range of diseases and conditions. In this article, we discuss vaginal microbiota transplantation (VMT) as "the next frontier" in microbiota transplantation and identify the medical, regulatory, and ethical challenges related to this nascent field. We further discuss what we anticipate will be the first context for testing VMT in clinical trials, prevention of the recurrence of a condition referred to as bacterial vaginosis (BV). We also compare clinical aspects of VMT with FMT and comment on how VMT may be similar to or different from FMT in ways that may affect research design and regulatory decisions.

Effect of vaginal suppository on bacterial vaginitis based on Persian medicine (Iranian traditional medicine): a randomised double blind clinical study.

This trial was conducted on 127 women aged 18-50 years with bacterial vaginosis to compare the vaginal suppository of metronidazole with Forzejeh, a vaginal suppository of herbal Persian medicine combination of Tribulus terrestris, Myrtus commuis, Foeniculum vulgare and Tamarindus indica. The patients (63 in metronidazole group and 64 in Forzejeh group) received the medications for 1 week. Their symptoms including the amount and odour of discharge and cervical pain were assessed using a questionnaire. Cervical inflammation and Amsel criteria (pH of vaginal discharge, whiff test, presence of clue cells and Gram staining) were investigated at the beginning of the study and 14 days after treatment. The amount and odour of discharge, Amsel criteria, pelvic pain and cervical inflammation significantly decreased in Forzejeh and metronidazole groups (p = <.001). There was no statistically significant difference between the metronidazole and Fozejeh groups with respect to any of the clinical symptoms or the laboratory assessments. This study showed that Forzejeh, which is an herbal Persian medicine preparation, has a therapeutic effect the same as metronidazole in bacterial vaginosis. Impact statement What is already known on this subject? Bacterial vaginosis (BV) is a common problem in women. Common antibiotics for the treatment of BV include: metronidazole, tinidazole and clindamycin. Unfortunately, treatments often occur with a recurrence and failure. Therefore, alternative treatments are necessary. Many natural treatments are recommended for this condition in Persian Traditional Medicine sources. One of them is the vaginal suppository "Forzejeh" which is the combination of Tribulus terrestris, Myrtus commuis, Foeniculum vulgare and Tamarindus indica. These plants have antimicrobial activities. Forzejeh has been used for the treatment of BV in folk medicine for many years and has been formulated and standardised recently. What do the results of this study add? This study showed that the therapeutic effect of Forzejeh on bacterial vaginosis is similar to metronidazole. What are the implications of these findings for clinical practice and/or further research? A clinical study with a longer follow-up time is suggested for assessing the recurrence of BV after treatment with Forzejeh metronidazole.

Probiotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol.

INTRODUCTION: Bacterial vaginosis (BV) is a highly prevalent vaginal polymicrobial disorder commonly encountered in women of childbearing age. Therapy with only recommended antibiotics results in low cure rates and unacceptably high recurrence rates. The use of probiotics as a complementary approach for use with antibiotics for the treatment of BV remains unclear. This review aims to assess the efficacy of lactobacilli administered intravaginally in conjunction with antibiotics for the treatment of BV. METHODS AND ANALYSIS: The Cochrane Central Register of Controlled Trials in The Cochrane Library, Cochrane Library of Systematic Reviews, Medline/PubMed and Embase will be used to search for articles from database inception to November 2016. Randomised controlled clinical trials using lactobacilli administered intravaginally in conjunction with antibiotics to treat BV will be included. Primary outcome will be the BV cure rate. The recurrence rate will be examined as secondary outcome. Two reviewers will independently select trials and extract data from the original publications. The risk of bias will be assessed according to the Cochrane Risk of Bias tool. We will perform data synthesis using the Review Manager (RevMan) software V.5.2.3. To assess heterogeneity, we will compute the I2 statistic. ETHICS AND DISSEMINATION: This study will be a review of published data and it is not necessary to obtain ethical approval. Findings of this systematic review will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: International Prospective Register of Systematic Reviews 2014: CRD42014015079.

Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review.

INTRODUCTION: Probiotics are a complementary and integrative therapy useful in the treatment and prevention of urogenital infections in women. This study extends the work of researchers who systematically investigated the scientific literature on probiotics to prevent or treat urogenital infections. METHODS: A systematic review was conducted to determine the efficacy of probiotics for prevention and/or treatment of urogenital infections in adult women from January 1, 2008, through June 30, 2015. We searched in CINAHL, MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, Dissertations and Theses, and Alt-HealthWatch. After removing duplicates and studies that did not meet inclusion criteria, 20 studies were reviewed. All included at least one species of Lactobacillus probiotic as an intervention for treatment or prevention of urogenital infections. Data extracted included samples, settings, study designs, intervention types, reported outcomes, follow-up periods, and results. We evaluated all randomized controlled trials for risk of bias and made quality appraisals on all studies. RESULTS: Fourteen of the studies focused on bacterial vaginosis (BV), 3 on urinary tract infections (UTIs), 2 on vulvovaginal candidiasis, and one on human papillomavirus (HPV) as identified on Papanicolaou test. Studies were heterogeneous in terms of design, intervention, and outcomes. Four studies were of good quality, 9 of fair, and 7 poor. Probiotic interventions were effective for treatment and prevention of BV, prevention of recurrences of candidiasis and UTIs, and clearing HPV lesions. No study reported significant adverse events related to the probiotic intervention. DISCUSSION: The quality of the studies in this systematic review varied. Although clinical practice recommendations were limited by the strength of evidence, probiotic interventions were effective in treatment and prevention of urogenital infections as alternatives or co-treatments. More good quality research is needed to strengthen the body of evidence needed for application by clinicians.

[The influence of balneo- and peloid therapy on the characteristics of the hormonal regulation in the women presenting with bacterial vaginosis].

AIM: The objective of the present work was to study the influence of balneo- and peloid therapy on the characteristics of the hormonal regulation in the women presenting with bacterial vaginosis. MATERIAL AND METHODS: The immunoenzymatic assay (ELISA) was used to study characteristics of hormonal regulation in 128 women presenting with bacterial vaginosis and normal prolactin level and 58 women with bacterial vaginosis and concomitant hyperprolactinemia. The study included the evaluation of dynamics of the clinical and laboratory parameters under the influence of peloidtherapy. RESULTS: The application of the sulfide-containing siltypeloids was shown to have positive clinical effect on the adrenal and ovarian function and to exert the modulating action on the levels of the pituitary and sex hormones in women with bacterial vaginosis and normal prolactin levels. In contrast, the same treatment of the women with bacterial vaginosis and hyperprolactinemia causes a further deterioration of hormonal imbalance, increases the initially elevated prolactin level, aggravates disorders in the pituitary and ovarian regulation, and decreases the effectiveness of the treatment. CONCLUSION: The results of the study suggest the necessity of the differential approach to the prescription of balneo- and peloid therapy to the patients with gynecological problems associated with hormonal disorders taking into account the level of prolactinemia.

[SLOW RELEASED LOCAL PROBIOTICS].

The probiotics are live microorganisms which embedded in adequate quantities have a healthy influence on the recipient. The current local probiotics get on medical practice at the beginning of the last decade and quickly become part of the current therapy of vaginal disbacteriosis and infections. A lot of studies show their microbiological and clinic effectiveness in prevention and treatment of the most met vaginal pathogens, usually together with on after pathogenetic or ethiological treatment. Slow release probiotics are the newest generation of probiotic products. Due to their limited and complicated pharmaceutical production, there are very few clinical trials on their microbiological and clinical effectiveness in the treatment of vaginal disbacteriosis and infections. Our expections for their useful application remain high, because of the already achieved good results.

Eficacia, tolerancia y seguridad de una combinación de metronidazol, miconazol, centella asiática, polimixina y neomicina en cápsula blanda para uso vaginal en el tratamiento de la vaginosis bacteriana / Efficacy, tolerability, and safety of a combination including metronidazole, miconazole, Gotu kola, polymixin, and neomycin in soft vaginal capsules for the treatment of bacterial vaginosis

Introducción: La vaginosis bacteriana (VB) es un síndrome polimicrobiano, en la cual la flora dominante de lactobacilos normales es sustituida por una flora polimicrobiana. La prevalencia de VB en Perú varía entre 27 y 43,7%. El Centro de Control y Prevención de Enfermedades (DCD) sugiere el tratamiento de VB en mujeres sintomáticas con metronidazol oral/gel o clindamicina crema. Se planteó en el presente estudio evaluar la eficacia, tolerancia y seguridad de la combinación de metronidazol, miconazol, centella asiática, polimixina y neomicina en cápsula blanda para el tratamiento de VB. Material y Métodos: El presente estudio de tipo abierto, observacional, prospectivo, permitió evaluar la eficacia, tolerancia y seguridad en la aplicación de la combinación de metronidazol, miconazol, centella asiática, polimixina y neomicina en cápsula blanda. Resultados: Se incluyó a 61 pacientes con edad promedio de 29.28 años (rango 18-48) de las cuales 93,4% tenía historia previa de flujo vaginal anormal. Se realizaron dos visitas durante el estudio, la primera para diagnóstico e inicio de tratamiento y la segunda de control post tratamiento. Tres pacientes no tuvieron segunda visita y 8 no tenían registrada toda la información para definir la respuesta terapéutica. La segunda visita se realizó a los 21 días en promedio. Los principales signos y síntomas en la primera visita de diagnóstico fueron flujo vaginal (100,0%), disconfort vaginal (85,2%), dispareunia (70,5%) y dolor abdominal bajo (57,4%), las cuales disminuyeron en forma significativa (p<0,05) a la segunda visita post tratamiento. La prueba de aminas resultó positiva en el 93,4% de los casos en la primera visita y en el 15,5% de los casos en la segunda visita (p<0,05). De la población inicial de estudio, solo 53 mujeres son evaluables para eficacia terapéutica...

Introduction: Bacterial vaginosis (BV) is a polymicrobial syndrome, in which the normal dominant flora consisting in Lactobacillus is replaced by polymicrobial flora. The prevalence of BV in Peru varies between 27 and 43.7%. The Centers for Disease Control and Prevention suggest therapy for BV in symptomatic women should include oral/gel metronidazole or clindamycin cream. We proposed in this study to evaluate the efficacy, tolerability and safety of the combination of metronidazole, miconazole, Gotu kola (Centella asiatica), polymixin, and neomycin in soft capsules, for the treatment of BV. Material and Methods: This investigation was an open, observational, and prospective study, which allowed us to evaluate the efficacy, tolerability and safety of the aforementioned combined therapy administered in soft capsules. Results: The study included 61 patients with a mean age of 29.28 years (range, 18-48) and 93.4% had a history of abnormal vaginal discharge. Two visits took place during the study, the first for making the diagnosis and initiating therapy, and the second was the post-treatment control. Three patients did not have a second visit and 8 did not record all the information required to define the therapeutic response. The second visit took place after 21 days on average. The main signs and symptoms at the first visit were vaginal discharge at diagnosis (100.0%), vaginal discomfort (85.2%), dyspareunia (70.5%) and lower abdominal pain (57.4%), which were significantly reduced (p <0.05) in the second visit after treatment. The amine test was positive in 93.4% of cases in the first visit and in 15.5% of cases in the second visit (p <0.05). From the initial population in the study, only 53 women are evaluable for efficacy. An overall response rate in 44 women (83.02%) was achieved with the soft capsule combination treatment. Adverse events were reported in only one case...

Long-term vaginal administration of Lactobacillus rhamnosus as a complementary approach to management of bacterial vaginosis.

OBJECTIVE: To investigate the advantages of long-term vaginal administration of Lactobacillus rhamnosus after oral treatment with metronidazole to prevent the recurrence of bacterial vaginosis (BV). METHODS: A total of 49 women with a diagnosis of BV were randomized into 2 groups. Group A was treated with a twice daily dose of 500 mg oral metronidazole for 7 days. Group B was treated with the same schedule followed by a once-weekly vaginal application of 40 mg of Lactobacillus rhamnosus for 6 months. A non-parametric analysis of variance for repeated measures was used to test whether there were significant changes in the vaginal ecosystems in the 2 groups. RESULTS: During the first 6 months of follow-up, a constant percentage (96%) of patients in group B had a balanced vaginal ecosystem. Follow-up over 12 months showed no statistically significant difference among vaginal ecosystems in patients in group B (P=0.40), whereas in group A there was a significant increase in the number of women with abnormal flora over time (P=0.01). CONCLUSION: The vaginal administration of the probiotic Lactobacillus rhamnosus allows stabilization of the vaginal ecosystem and reduces the recurrence of BV.

Probiotics for the treatment of bacterial vaginosis.

BACKGROUND: The dominance of lactobacilli in healthy vaginal microbiota and its depletion in bacterial vaginosis (BV) has given rise to the concept of oral or vaginal instillation of probiotic Lactobacillus strains for the management of this condition. OBJECTIVES: To ascertain the efficacy of probiotics in the treatment of BV. SEARCH STRATEGY: We searched electronic databases irrespective of publication status or language. These included: Cochrane Central Register of Controlled Trials (CENTRAL), the HIV/AIDS and STD Cochrane Review Groups' specialized registers, the Cochrane Complementary Medicine Field's Register of Controlled Trials, MEDLINE (1966 to 2008), EMBASE (1980 to 2007), ISI science citation index (1955 to 2007), CINAHL (Cumulative Index to Nursing & Allied Health Literature (1982 to 2007).We handsearched of specialty journals, conference proceedings and publications list on the website of the International Scientific Association of Probiotics and Prebiotics (http://www.isapp.net/default.asp).For unpublished studies or ongoing trials, we contacted authors from relevant publications, nutraceutical companies and probiotic-related scientific associations. We searched electronic databases on ongoing clinical trials. SELECTION CRITERIA: Randomized controlled trials using probiotics for the treatment of women of any age diagnosed with bacterial vaginosis, regardless of diagnostic method used. The probiotic preparation could be single or "cocktail" of strains, any preparation type/dosage/route of administration. Studies comparing probiotics with placebo, probiotics used in conjunction with conventional antibiotics compared with placebo or probiotics alone compared with conventional antibiotics were eligible for inclusion. DATA COLLECTION AND ANALYSIS: We screened titles and abstracts , obtained full reports of relevant trialsand independently appraised them for eligibility. A data extraction form was used to extract data from the four included studies. For dichotomous outcomes, odds ratios (OR) and 95% confidence intervals (CI) were derived for each study using RevMan (versions 4.2 and 5). We did not perform meta-analysis due to significant differences in the probiotic preparations and trial methodologies. MAIN RESULTS: Analysis suggests beneficial outcome of microbiological cure with the oral metronidazole/probiotic regimen (OR 0.09 (95% CI 0.03 to 0.26)) and the probiotic/estriol preparation (OR 0.02, (95% CI 0.00 to 0.47)). For the probiotic/estriol preparation, the OR and 95% CI for physician-reported resolution of symptoms was OR 0.04 (95% CI 0.00 to 0.56). AUTHORS' CONCLUSIONS: The results do not provide sufficient evidence for or against recommending probiotics for the treatment of BV. The metronidazole/probiotic regimen and probiotic/estriol perparation appear promising but well-designed randomized controlled trials with standardized methodologies and larger patient size are needed.

Influencia da eletroestimulação intravaginal e na qualidade de vida da mulheres com incontinencia urinaria / The influence of intravaginal electrical stimulation on vaginal ecosystem and quality of life on female urinary incontinence

Avaliar o ecossistema vaginal e a qualidade de vida (QV) de mulheres com incotinência urinária (IU) submetidas a tratamento fisioterápico com eletroestimulção intravaginal (EEIV). Métodos: Estudo de ensaio clínico realizado entre setembro de 2006 a novembro de 2008 envolveu 67 mulheres com queixa clínica de IU. O tratamento fisioterápico consistiu de 8 sessões (2x/semana) de EEIV (frequência=35Hz, largura de pulso=0,5ms e tempo=20min), orientações comportamentais e exercícios de fortalecimento do assoalho pélvico. O ecossistema vaginal foi avaliado quanto ao tipo de flora, inflamação e pH da mucosa vaginal antes e após a EEIV. O conteúdo coletado do terço médio vaginal foi corado pela técnica de Gram e analisado sob microscopia óptica em flora bacilar ou normal, intermediária e, cocóide/ cocobacilar ou vaginose bacteriana (VB). A intensidade da inflamação foi determinada contando-se o número médio de células de defesa (polimorfonucleares neutrófilos e linfócitos) encontradas em 10 campos de grande aumento (400X). A QV foi avaliada pelo questionário "Consultation on Incontinence Questionnaire-Short Form" antes e após o tratamento. Os dados foram coletados pelo mesmo investigador e analisados por apenas um microbiólogo de forma cega. O estudo foi aprovado pelo Comitê de Ética em Pesquisa etodas as pacientes assinaram termo de consentimento livre e esclarecido. Resultados: Foram selecionadas 78 mulheres, sendo 11 excluídas para a análise microbiológica e 6 para análise da QV. Das 67 mulheres incluídas, a média de idade foi de 51,3 (±11,8) anos, a maioria branca, do lar, pós-menopausada e com sintomas de IUM (76,4%) e IUE (23,6%). Antes da EEIV, 43 mulheres apresentaram microbiota normal, 24 intermediária e nenhum caso de VB...

Objectives: To evaluate vaginal ecosystem and quality of life (QOL) of women submitted to intravaginal electrical stimulation (IVES) as physicaltherapy treatment. Methods: A clinical trial was carried out from September 2006 to November 2008 including 67 women presenting IU as symptom. Physicaltherapy treatment consisted in 8 IVES sessions during 4 weeks (frequency=35Hz, pulse width=0,5ms, duration=20min), pelvic floor muscle exercises (PFME) and behavioral orientation. Vaginal ecosystem was assed concerning type of flora, inflammation and pH before and after treatment. Vaginal bacterioscopy swab was collected from e middle third of the vagina (vaginal smear was collected for subsequent Gram stain). The inflammatory process intensity was determined by the average number of white defense cells (neutrophils and limphocytes) found in 10 observation fields (magnified 400X). Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was used to asses QoL. All data was collected by a single investigator and analyzed by the same microbiologist. This study was approved by Institutional Ethitics Committee and every patient signed an agreement term. Results: 78 women were selected and 11 were excluded from microbiologic analyzes and 6 from QoL analyses. Of the 67 women included, the mean age was 51.3(+-12.2), most were white, housewives, post menopausal, presenting symptoms of MUI (76.4 per cent) and SUI (23.6 per cent). Before IVES 43 women had a normal vaginal flora, 24 presented intermediary flora and none had bacterial vaginoses(BV) or vaginal candidiasis(VC).After 8 sessions of IVES no significant alteration was noticed, 43 were unaltered, 36 remained in the same category, 5 showed intermediary microbiota and were identified as having VB...

Antiinfectives and low-level light: a new chapter in photomedicine.

OBJECTIVE: The purpose of this study was to identify synergistic effects in the interaction of light with biosystems in the presence of chemical agents. Their systematic analysis promises therapeutic strategies. BACKGROUND DATA: Light intensities around 1000 Wm(2) potentially induce density variations in nanoscopic water layers adhering to surfaces in air or subaquatically. In permeable nanoscopic compartments in the interior of biosystems, this could result in powerful flow processes and bidirectional flows for repetitive applications of light. Consequently, external stimulation with light will force microorganisms and cells to incorporate a suitable antiinfective. Nanoscale biosystems, which respond to both light stimulation and antibiotics, are nanobacteria. Responses include growth, inhibition, and slime secretion. Slime secretion was provoked in vitro by gentamycin, an agent proposed for in vivo eradication, and blocked by light. Depending on the field of action, co-operative effects between light and an antiinfective can be exploited by considering two properties of the drug: transmission of light and resorption by the tissue. Antiinfectives can be administered in an active form or via drug delivery systems. In the latter case, a double action of the light could be exploited: stimulated release from the carrier and subsequent uptake by the targeted biosystem. METHODS: The attenuation of laser light (670 nm) by antiinfectives was measured in films of different thickness of a vaginal suppository. The effect of 670-nm laser light - not absorbed by water - on nanoscopic water layers was examined by comparing the evaporation time of irradiated drops of water-based nanosuspensions with non-irradiated controls. RESULTS: The 6-microm-thick suppository films were virtually transparent to the laser light, and the 1-mm-thick films totally attenuated it. Nanosuspension drops irradiated with 670-nm light needed more time to evaporate than controls. CONCLUSION: Low-level light (LLL) therapy is compatible with antiinfectives, and even capable of boosting effects of superficially applied and/or absorbed antiinfectives. Temporal coordination between light treatment and drug administration maximizes drug effects and minimizes possible adverse effects. Irradiation should start when the drug concentration has reached its maximum in the desired field of action. Light-induced flow in nanoscale cavities could represent one mechanism of LLL therapy.