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Mayo Clinic Proceedings Feb 2022Vaginitis is a common concern for women across the lifespan. Vaginal symptoms may impact quality of life, and clinicians are challenged in the evaluation and management... (Review)
Review
Vaginitis is a common concern for women across the lifespan. Vaginal symptoms may impact quality of life, and clinicians are challenged in the evaluation and management of bacterial vaginosis, Candida vaginitis, trichomoniasis, desquamative inflammatory vaginitis, and genitourinary syndrome of menopause.
Topics: Anti-Bacterial Agents; Candidiasis, Vulvovaginal; Female; Humans; Quality of Life; Vagina; Vaginosis, Bacterial
PubMed: 35120697
DOI: 10.1016/j.mayocp.2021.09.022 -
The Cochrane Database of Systematic... Jan 2022Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published. (Review)
Review
BACKGROUND
Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published.
OBJECTIVES
The primary objective was to assess the effectiveness and safety of pharmacological and non-pharmacological treatments for RVVC. The secondary objective was to assess patient preference of treatment options.
SEARCH METHODS
We conducted electronic searches of bibliographic databases, including CENTRAL, MEDLINE, Embase, and CINAHL (search date 6 October 2021). We also handsearched reference lists of identified trials and contacted authors of identified trials, experts in RVVC, and manufacturers of products for vulvovaginal candidiasis.
SELECTION CRITERIA
We considered all published and unpublished randomised controlled trials evaluating RVVC treatments for at least six months, in women with four or more symptomatic episodes of vulvovaginal candidiasis in the past year. We excluded women with immunosuppressive disorders or taking immunosuppressant medication. We included women with diabetes mellitus and pregnant women. Diagnosis of RVVC must have been confirmed by presence of symptoms and a positive culture and/or microscopy. We included all drug and non-drug therapies and partner treatment, assessing the following primary outcomes: • number of clinical recurrences per participant per year (recurrence defined as clinical signs and positive culture/microscopy); • proportion of participants with at least one clinical recurrence during the treatment and follow-up period; and • adverse events.
DATA COLLECTION AND ANALYSIS
Two authors independently reviewed titles and abstracts to identify eligible trials. Duplicate data extraction was completed independently by two authors. We assessed risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions. We used the fixed-effects model for pooling and expressed the results as risk ratio (RR) with 95% confidence intervals (CI). Where important statistical heterogeneity was present we either did not pool data (I > 70%) or used a random-effects model (I 40-70%). We used the GRADE tool to assess overall certainty of the evidence for the pooled primary outcomes.
MAIN RESULTS
Studies: Twenty-three studies involving 2212 women aged 17 to 67 years met the inclusion criteria. Most studies excluded pregnant women and women with diabetes or immunosuppression. The predominant species found on culture at study entry was Candida albicans. Overall, the included studies were small (<100 participants). Six studies compared antifungal treatment with placebo (607 participants); four studies compared oral versus topical antifungals (543 participants); one study compared different oral antifungals (45 participants); two studies compared different dosing regimens for antifungals (100 participants); one study compared two different dosing regimens of the same topical agent (23 participants); one study compared short versus longer treatment duration (26 participants); two studies assessed the effect of partner treatment (98 participants); one study compared a complementary treatment (Lactobacillus vaginal tablets and probiotic oral tablets) with placebo (34 participants); three studies compared complementary medicine with antifungals (354 participants); two studies compared 'dermasilk' briefs with cotton briefs (130 participants); one study examined Lactobacillus vaccination versus heliotherapy versus ciclopyroxolamine (90 participants); one study compared CAM treatments to an antifungal treatment combined with CAM treatments (68 participants). We did not find any studies comparing different topical antifungals. Nine studies reported industry funding, three were funded by an independent source and eleven did not report their funding source. Risk of bias: Overall, the risk of bias was high or unclear due to insufficient blinding of allocation and participants and poor reporting. Primary outcomes: Meta-analyses comparing drug treatments (oral and topical) with placebo or no treatment showed there may be a clinically relevant reduction in clinical recurrence at 6 months (RR 0.36, 95% CI 0.21 to 0.63; number needed to treat for an additional beneficial outcome (NNTB) = 2; participants = 607; studies = 6; I² = 82%; low-certainty evidence) and 12 months (RR 0.80, 95% CI 0.72 to 0.89; NNTB = 6; participants = 585; studies = 6; I² = 21%; low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. We are very uncertain whether oral drug treatment compared to topical treatment increases the risk of clinical recurrence at 6 months (RR 1.66, 95% CI 0.83 to 3.31; participants = 206; studies = 3; I² = 0%; very low-certainty evidence) and reduces the risk of clinical recurrence at 12 months (RR 0.95, 95% CI 0.71 to 1.27; participants = 206; studies = 3; I² = 10%; very low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. Adverse events were scarce across both treatment and control groups in both comparisons. The reporting of adverse events varied amongst studies, was generally of very low quality and could not be pooled. Overall the adverse event rate was low for both placebo and treatment arms and ranged from less than 5% to no side effects or complications.
AUTHORS' CONCLUSIONS
In women with RVVC, treatment with oral or topical antifungals may reduce symptomatic clinical recurrences when compared to placebo or no treatment. We were unable to find clear differences between different treatment options (e.g. oral versus topical treatment, different doses and durations). These findings are not applicable to pregnant or immunocompromised women and women with diabetes as the studies did not include or report on them. More research is needed to determine the optimal medication, dose and frequency.
Topics: Antifungal Agents; Candidiasis, Oral; Candidiasis, Vulvovaginal; Female; Humans; Immunosuppressive Agents; Pregnancy
PubMed: 35005777
DOI: 10.1002/14651858.CD009151.pub2 -
Frontiers in Cellular and Infection... 2021Mixed vaginitis is the simultaneous presence of at least two types of vaginitis, contributing to an abnormal vaginal milieu and leading to vaginal symptoms and signs.... (Review)
Review
Mixed vaginitis is the simultaneous presence of at least two types of vaginitis, contributing to an abnormal vaginal milieu and leading to vaginal symptoms and signs. However, associations between symptoms and the type of mixed vaginitis have not been clearly elucidated, and research on mixed vaginitis is still in the preliminary stage. Therefore, the pathogenic mechanism of mixed vaginitis remains understudied. Mixed vaginitis generally involves the formation of mixed biofilms. The study of polymicrobial interactions and mixed biofilms will provide a new idea for the understanding of mixed vaginitis. Moreover, this review summarizes some effective management and laboratory diagnosis of mixed vaginitis to avoid inappropriate therapy, recurrence, and reinfection. It is of high clinical importance to obtain relevant clinical data to improve clinical knowledge about mixed vaginitis.
Topics: Candidiasis, Vulvovaginal; Female; Humans; Vulvovaginitis
PubMed: 34796129
DOI: 10.3389/fcimb.2021.759795 -
Journal of Midwifery & Women's Health 2024
Topics: Humans; Female; Candidiasis, Vulvovaginal; Antifungal Agents; Pregnancy
PubMed: 38738848
DOI: 10.1111/jmwh.13650 -
Probiotics and Antimicrobial Proteins Oct 2023Vaginitis is a common problem in women. Candida albicans is responsible for more than 85% of vaginal fungal infections. The aim of this study was to compare the effects... (Randomized Controlled Trial)
Randomized Controlled Trial
Vaginitis is a common problem in women. Candida albicans is responsible for more than 85% of vaginal fungal infections. The aim of this study was to compare the effects of probiotic and fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). This triple-blinded randomized controlled trial was conducted on 80 married women, aged 18-49 years, with VVC, as confirmed by clinical and laboratory diagnosis. The participants were allocated into two groups using blocked randomization method. The fluconazole-treated group received a single dose of fluconazole (150 mg) supplemented with 30 placebo capsules of probiotic, and the probiotic-treated group got 30 probiotic capsules containing 1 × 10 CFU/g LA-5 with 1 fluconazole placebo capsule. The samples were taken from patients to evaluate the vaginal pH and microbiological tests before, 30-35 days, and 60-65 days after starting the treatment. The signs and symptoms were assessed before the intervention and the first and second follow-ups. Chi-square, Fisher's exact, independent t, and ANCOVA tests were then used for data analysis. There was no statistically significant difference between the two groups (p = 0.127) in the frequency of negative culture 30-35 days after starting the treatment, but the frequency of negative culture 60-65 days after starting treatment in the fluconazole group was significantly higher than that of the probiotic group (p = 0.016). The abnormal discharge and vulvovaginal erythema in the first and second follow-ups and also pruritus in the second follow-up in the fluconazole group were significantly lower than those in the probiotic group (p < 0.05). There was, however, no statistically significant difference in burning, frequent urination, dysuria, and dyspareunia between the groups (p > 0.05). Lactobacillus acidophilus supplementation had an effect similar to that of fluconazole in treating most symptoms of VVC, but it was less effective than the latter in preventing recurrence. Trial Registration: Iranian Registry of Clinical Trials (IRCT): IRCT20110826007418N5. Date of registration: 3 March 2021; URL: https://en.irct.ir/trial/50819 ; Date of first registration: 10 March 2021.
Topics: Humans; Female; Fluconazole; Candidiasis, Vulvovaginal; Antifungal Agents; Capsules; Iran; Probiotics
PubMed: 36198994
DOI: 10.1007/s12602-022-09997-3 -
American Journal of Obstetrics and... Dec 2022Recurrent vulvovaginal candidiasis affects nearly 138 million women globally each year. In the United States, fluconazole is considered the standard of care for acute... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Recurrent vulvovaginal candidiasis affects nearly 138 million women globally each year. In the United States, fluconazole is considered the standard of care for acute vulvovaginal candidiasis, but until recently there was no US Food and Drug Administration-approved drug for the treatment of recurrent vulvovaginal candidiasis. Oteseconazole is a novel oral selective inhibitor of fungal lanosterol demethylase (sterol 14α-demethylase cytochrome P450, an enzyme required for fungal growth) approved for the treatment of recurrent vulvovaginal candidiasis.
OBJECTIVE
This study was conducted to evaluate the efficacy and safety of oral oteseconazole (VT-1161) in the prevention of recurrent culture-verified acute vulvovaginal candidiasis episodes through 50 weeks in participants with recurrent vulvovaginal candidiasis and to compare the efficacy of oteseconazole and fluconazole in the treatment of the presenting acute vulvovaginal candidiasis episode.
STUDY DESIGN
Women and postmenarcheal girls aged ≥12 years with a history of recurrent vulvovaginal candidiasis (N=219) were enrolled at 38 US sites. Eligible participants presenting with an active vulvovaginal candidiasis infection entered an induction phase in which they were randomly assigned 2:1 to receive 600 mg oral oteseconazole on day 1 and 450 mg on day 2, with matching placebo capsules, or to 3 sequential 150-mg oral doses (once every 72 hours) of fluconazole, with matching placebo capsules. Following the 2-week induction phase, the 185 participants with resolved acute vulvovaginal candidiasis infection (a clinical signs and symptoms score of <3) entered the maintenance phase and received 150 mg of oteseconazole or placebo weekly for 11 weeks. Participants were observed for an additional 37 weeks.
RESULTS
In the induction phase, oteseconazole was noninferior to fluconazole in the proportion of participants in the intent-to-treat population with resolved acute vulvovaginal candidiasis infection at the week 2 (day 14) test-of-cure visit, with 93.2% of participants on oteseconazole vs 95.8% on fluconazole achieving resolution. In the maintenance phase, oteseconazole was superior to placebo in the proportion of participants in the intent-to-treat population with ≥1 culture-verified acute vulvovaginal candidiasis episode through 50 weeks, 5.1% compared with 42.2%, respectively (P<.001). Overall, treatment-emergent adverse event rates were similar in both groups: 54% for participants who received oteseconazole in the induction and maintenance phases vs 64% for participants who received fluconazole in the induction phase and placebo in the maintenance phase. Most treatment-emergent adverse events in each group were mild or moderate, with 3.4% of treatment-emergent adverse events graded as severe or higher in the OTESECONAZOLE/oteseconazole group vs 4.2% in FLUCONAZOLE/placebo group.
CONCLUSION
In participants with recurrent vulvovaginal candidiasis, oteseconazole was safe and efficacious in the treatment and prevention of recurrent acute vulvovaginal candidiasis episodes and was noninferior to vulvovaginal candidiasis standard-of-care fluconazole in the treatment of the presenting acute vulvovaginal candidiasis infection.
Topics: Female; Humans; Candidiasis, Vulvovaginal; Fluconazole; Administration, Oral; Antifungal Agents; Infections
PubMed: 35863457
DOI: 10.1016/j.ajog.2022.07.023 -
Science Translational Medicine Dec 2023causes an estimated half-billion cases of vulvovaginal candidiasis (VVC) every year. VVC is most commonly caused by , which, in this setting, triggers nonprotective...
causes an estimated half-billion cases of vulvovaginal candidiasis (VVC) every year. VVC is most commonly caused by , which, in this setting, triggers nonprotective neutrophil infiltration, aggressive local inflammation, and symptomatic disease. Despite its prevalence, little is known about the molecular mechanisms underpinning the immunopathology of this fungal infection. In this study, we describe the molecular determinant of VVC immunopathology and a potentially straightforward way to prevent disease. In response to zinc limitation, releases a trace mineral binding molecule called Pra1 (pH-regulated antigen). Here, we show that the gene is strongly up-regulated during vaginal infections and that its expression positively correlated with proinflammatory cytokine concentrations in women. Genetic deletion of prevented vaginal inflammation in mice, and application of a zinc solution down-regulated expression of the gene and also blocked immunopathology. We also show that treatment of women suffering from recurrent VVC with a zinc gel prevented reinfections. We have therefore identified a key mediator of symptomatic VVC, giving us an opportunity to develop a range of preventative measures for combatting this disease.
Topics: Female; Humans; Animals; Mice; Candidiasis, Vulvovaginal; Zinc; Vagina; Candida albicans; Inflammation
PubMed: 38055800
DOI: 10.1126/scitranslmed.adi3363 -
Sexually Transmitted Diseases Dec 2019A retrospective chart review characterized clinicians' use of maintenance intravaginal boric acid for women with recurrent vulvovaginal candidiasis or bacterial...
A retrospective chart review characterized clinicians' use of maintenance intravaginal boric acid for women with recurrent vulvovaginal candidiasis or bacterial vaginosis. Average length of use was 13 months with high patient satisfaction and few adverse events. Prospective studies are needed to evaluate the efficacy of maintenance boric acid for these conditions.
Topics: Administration, Intravaginal; Adult; Anti-Infective Agents, Local; Boric Acids; Candidiasis, Vulvovaginal; Drug Administration Schedule; Female; Humans; Middle Aged; Patient Satisfaction; Recurrence; Retrospective Studies; Treatment Outcome; Vaginosis, Bacterial
PubMed: 31663976
DOI: 10.1097/OLQ.0000000000001063 -
Frontiers in Cellular and Infection... 2022Recurrent vulvovaginal candidosis (RVVC) is a chronic, difficult to treat vaginal infection, caused by species, which affects women of all ages and ethnic and social... (Review)
Review
Recurrent vulvovaginal candidosis (RVVC) is a chronic, difficult to treat vaginal infection, caused by species, which affects women of all ages and ethnic and social background. A long-term prophylactic maintenance regimen with antifungals is often necessary. In most clinical practice guidelines, oral fluconazole is recommended as the first-line treatment. Although clinical resistance to antifungal agents remains rare, overexposure to azoles may increase the development of fluconazole-resistant . strains. In addition, are frequently dose-dependent susceptible or resistant to fluconazole and other azoles, and their prevalence is rising. Available therapeutic options to treat such fluconazole-resistant and low susceptibility non- strains are limited. Ten experts from different European countries discussed problematic issues of current RVVC diagnosis and treatment in two audiotaped online sessions and two electronic follow-up rounds. A total of 340 statements were transcribed, summarized, and compared with published evidence. The profile of patients with RVVC, their care pathways, current therapeutic needs, and potential value of novel drugs were addressed. Correct diagnosis, right treatment choice, and patient education to obtain adherence to therapy regimens are crucial for successful RVVC treatment. As therapeutic options are limited, innovative strategies are required. Well- tolerated and effective new drugs with an optimized mechanism of action are desirable and are discussed. Research into the impact of RVVC and treatments on health-related quality of life and sex life is also needed.
Topics: Antifungal Agents; Azoles; Candida; Candida albicans; Candidiasis, Vulvovaginal; Female; Fluconazole; Humans; Microbial Sensitivity Tests; Quality of Life
PubMed: 36159646
DOI: 10.3389/fcimb.2022.934353 -
Drugs Jun 2022Oteseconazole (VIVJOA™) is an orally administered azole antifungal agent developed by Mycovia Pharmaceuticals for the treatment of fungal infections. It inhibits... (Review)
Review
Oteseconazole (VIVJOA™) is an orally administered azole antifungal agent developed by Mycovia Pharmaceuticals for the treatment of fungal infections. It inhibits cytochrome P450 (CYP) 51, thereby affecting the formation and integrity of the fungal cell membrane, but has a low affinity for human CYP enzymes due to its tetrazole metal-binding group. Oteseconazole is the first agent to be approved (in April 2022) for recurrent vulvovaginal candidiasis (RVVC) in the USA, where it is indicated to reduce the incidence of RVVC in females with a history of RVVC who are NOT of reproductive potential. Clinical development for the treatment of onychomycosis, and invasive and opportunistic infections is ongoing. This article summarizes the milestones in the development of oteseconazole leading to this first approval for reducing the incidence of RVVC in females with a history of RVVC who are NOT of reproductive potential.
Topics: Antifungal Agents; Azoles; Candidiasis, Vulvovaginal; Female; Humans; Incidence; Recurrence
PubMed: 35713845
DOI: 10.1007/s40265-022-01734-y