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Imiquimod for Cervical and Vaginal Intraepithelial Neoplasia: A Systematic Review and Meta-analysis.Obstetrics and Gynecology Aug 2023To evaluate the treatment efficacy and the risk of adverse events of imiquimod for cervical intraepithelial neoplasia (CIN) and vaginal intraepithelial neoplasia (VAIN),... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the treatment efficacy and the risk of adverse events of imiquimod for cervical intraepithelial neoplasia (CIN) and vaginal intraepithelial neoplasia (VAIN), compared with placebo or no intervention.
DATA SOURCES
We searched Cochrane, PubMed, ISRCTN registry, ClinicalTrials.gov , and the World Health Organization International Clinical Trials Registry Platform up to November 23, 2022.
METHODS OF STUDY SELECTION
We included randomized controlled trials and prospective nonrandomized studies with control arms that investigated the efficacy of imiquimod for histologically confirmed CIN or VAIN. The primary outcomes were histologic regression of the disease (primary efficacy outcome) and treatment discontinuation due to side effects (primary safety outcome). We estimated pooled odds ratios (ORs) of imiquimod, compared with placebo or no intervention. We also conducted a meta-analysis of the proportions of patients with adverse events in the imiquimod arms.
TABULATION, INTEGRATION, AND RESULTS
Four studies contributed to the pooled OR for the primary efficacy outcome. An additional four studies were available for meta-analyses of proportions in the imiquimod arm. Imiquimod was associated with increased probability of regression (pooled OR 4.05, 95% CI 2.08-7.89). Pooled OR for CIN in the three studies was 4.27 (95% CI 2.11-8.66); results of one study were available for VAIN (OR, 2.67, 95% CI 0.36-19.71). Pooled probability for primary safety outcome in the imiquimod arm was 0.07 (95% CI 0.03-0.14). The pooled probabilities (95% CI) of secondary outcomes were 0.51 (0.20-0.81) for fever, 0.53 (0.31-0.73) for arthralgia or myalgia, 0.31 (0.18-0.47) for abdominal pain, 0.28 (0.09-0.61) for abnormal vaginal discharge or genital bleeding, 0.48 (0.16-0.82) for vulvovaginal pain, and 0.02 (0.01-0.06) for vaginal ulceration.
CONCLUSION
Imiquimod was found to be effective for CIN, whereas data on VAIN were limited. Although local and systemic complications are common, treatment discontinuation is infrequent. Thus, imiquimod is potentially an alternative therapy to surgery for CIN.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42022377982.
Topics: Female; Humans; Imiquimod; Antineoplastic Agents; Prospective Studies; Aminoquinolines; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms
PubMed: 37411024
DOI: 10.1097/AOG.0000000000005256 -
Menopause (New York, N.Y.) Aug 2023Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA). (Meta-Analysis)
Meta-Analysis
Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis.
IMPORTANCE
Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA).
OBJECTIVE
The aim of the study is to perform a systematic literature review (SLR) and network meta-analysis (NMA) to assess the efficacy and safety of ospemifene compared with other therapies used in the treatment of VVA in North America and Europe.
EVIDENCE REVIEW
Electronic database searches were conducted in November 2021 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized or nonrandomized controlled trials targeting postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness and involving ospemifene or at least one VVA local treatment were considered. Efficacy data included changes from baseline in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia, as required for regulatory approval. Endometrial outcomes were endometrial thickness and histologic classifications, including endometrial polyp, hyperplasia, and cancer. For efficacy and safety outcomes, a Bayesian NMA was performed. Endometrial outcomes were compared in descriptive analyses.
FINDINGS
A total of 44 controlled trials met the eligibility criteria ( N = 12,637 participants). Network meta-analysis results showed that ospemifene was not statistically different from other active therapies in most efficacy and safety results. For all treatments, including ospemifene, the posttreatment endometrial thickness values (up to 52 wk of treatment) were under the recognized clinical threshold value of 4 mm for significant risk of endometrial pathology. Specifically, for women treated with ospemifene, endometrial thickness ranged between 2.1 and 2.3 mm at baseline and 2.5 and 3.2 mm after treatment. No cases of endometrial carcinoma or hyperplasia were observed in ospemifene trials, nor polyps with atypical hyperplasia or cancer after up to 52 weeks of treatment.
CONCLUSIONS AND RELEVANCE
Ospemifene is an efficacious, well-tolerated, and safe therapeutic option for postmenopausal women with moderate to severe symptoms of VVA. Efficacy and safety outcomes with ospemifene are similar to other VVA therapies in North America and Europe.
Topics: Female; Humans; Dyspareunia; Vagina; Hyperplasia; Bayes Theorem; Network Meta-Analysis; Vulva; Atrophy; Tamoxifen; Selective Estrogen Receptor Modulators; Vaginal Diseases; Endometrial Neoplasms
PubMed: 37369079
DOI: 10.1097/GME.0000000000002211 -
Clinical Breast Cancer Dec 2023Vulvo-vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) is a common condition among breast cancer (BC) patients, especially those undergoing... (Meta-Analysis)
Meta-Analysis Review
Vulvo-vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) is a common condition among breast cancer (BC) patients, especially those undergoing antiestrogen therapy. Despite being an option in refractory cases, the safety of hormonal treatment remains uncertain in this population. The aim of this study was to review the safety and serum estrogen levels of hormonal therapy in patients with BC history presenting with VVA symptoms. Pubmed, Embase, and Cochrane were searched for studies comparing different hormonal treatment options for VVA in breast cancer survivors. Statistical analysis was performed using a random effects model and heterogeneity using Cochran's Q-statistic and the I2 index. We included 17 studies, of which 5 were randomized controlled trials (RCTs). Treatment modalities included in this study were topical vaginal estradiol and estriol preparations, vaginally applied testosterone, DHEA, and ospemifene. We found that, among patients treated with the estriol and estradiol preparations, there was an average increase of 7.67 pg/mL (SMD 7.67 pg/mL; 95% CI -1.00, 16.35; p < .001). Analysis of the testosterone group found temporary peaks of serum estradiol levels, but 1 study showed persistent elevation above normal postmenopausal levels. One study with prasterone revealed no elevation of serum estradiol concentration. One study with ospemifene demonstrated no increase in the risk of BC recurrence. In conclusion, among treatments available for BC survivors, low-dose vaginal estrogen showed the smallest changes in serum estradiol levels and had the most evidence, but safety remains unclear, especially for patients on aromatase inhibitors. Alternative treatments such as ospemifene need more data supporting safety and efficacy. These results suggest that concerns related to cancer recurrence should keep aiming for the lowest possible concentration.
Topics: Female; Humans; Breast Neoplasms; Cancer Survivors; Neoplasm Recurrence, Local; Vaginal Diseases; Vagina; Estradiol; Survivors; Testosterone; Estrogens; Atrophy; Estriol
PubMed: 37806915
DOI: 10.1016/j.clbc.2023.08.003 -
Children (Basel, Switzerland) Aug 2023Genital graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation (HSCT) is an underdiagnosed manifestation of chronic GVHD. Few articles have been... (Review)
Review
Genital graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation (HSCT) is an underdiagnosed manifestation of chronic GVHD. Few articles have been published in pediatric populations, and there are no established guidelines for the management of this condition in children. This study aims to provide a systematic literature review of the published studies and cases of genital (vulvovaginal) GVHD in girls and adolescents post HSCT, with a focus on the time of diagnosis and clinical manifestations. The authors searched for English-language articles published after 1990, which included full patient details. Thirty-two cases of female patients under 20 years of age were identified. The median time of diagnosis was 381 days (IQR: 226-730 days), and 83% of patients developed Grade 3 vulvovaginal GVHD. Based on these observations, an early pediatric gynecologic examination of these patients, soon within the first year after HSCT, could be suggested for early diagnosis, treatment initiation and prevention of long-term complications.
PubMed: 37761424
DOI: 10.3390/children10091463 -
Aesthetic Plastic Surgery Dec 2023Injection treatments have been proposed as novel treatment options for Vulvovaginal Atrophy of Menopause (VVA) also known as Genitourinary Syndrome of Menopause (GSM)....
BACKGROUND
Injection treatments have been proposed as novel treatment options for Vulvovaginal Atrophy of Menopause (VVA) also known as Genitourinary Syndrome of Menopause (GSM). However, to date data about these treatments are poor.
OBJECTIVE
To assess all available injection treatments for VVA.
METHODS
A systematic review was performed by searching five electronic databases for peer-reviewed studies that assessed injection treatments for VVA.
RESULTS
Eight studies (7 observational and 1 randomized) with 236 women were included. Assessed injection materials were: autologous platelet-rich plasma (PRP) + hyaluronic acid (HA), not cross-linked HA plus calcium hydroxyapatite (NCLHA + CaHA), micro-fragmented adipose tissue (MFAT), hyaluronan hybrid cooperative complexes (HCC), crosslinked HA, microfat and nanofat grafting + PRP, and PRP alone. Improvement in GSM symptoms after treatment was assessed through Visual Analogic Scale (VAS) for GSM symptoms or patient satisfaction, several validated questionnaires (FSFI, VHI, FSD, SF12, ICIQ UI SF, PGI-I, FSDS-R, VSQ), symptoms severity, changes in vaginal mucosa thickness, flora, pH, and expression on vaginal mucosal biopsies of Procollagen I and III and ki67 immunofluorescence or COL1A1 and COL3A1 mRNA. Injection treatments showing significant improvement in GSM-related symptoms were: (i) HCC in terms of VAS for GSM symptoms and FSFI score; (ii) Crosslinked HA in terms of VAS for GSM symptoms, FSFI and VHI score, COL1A1 and COL3A1 mRNA expression on vaginal mucosal biopsies; (iii) NCLHA + CaHA in terms of FSFI score; (iv) PRP + HA in terms of VHI, FSD and SF12 score; (v) microfat and nanofat grafting + PRP in terms of VHI score and FSDS-R score; (vi) PRP alone in terms of VHI and VSQ scores.
CONCLUSIONS
All assessed injection treatments except for MFAT seem to lead to significant improvement in VVA symptoms on validated questionnaires. Further studies are necessary in the field.
LEVEL OF EVIDENCE II
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Topics: Female; Humans; Atrophy; Menopause; Patient Satisfaction; Randomized Controlled Trials as Topic; RNA, Messenger; Treatment Outcome; Vagina
PubMed: 37580562
DOI: 10.1007/s00266-023-03550-5 -
Patient Education and Counseling Jan 2024This systematic review aims to identify what is known about patient and healthcare professional experiences of managing recurrent vulvovaginal thrush by synthesising... (Review)
Review
OBJECTIVE
This systematic review aims to identify what is known about patient and healthcare professional experiences of managing recurrent vulvovaginal thrush by synthesising published findings.
METHODS
Five databases were searched for studies on patient and healthcare professional experiences managing recurrent thrush. Two reviewers independently screened and quality assessed qualitative, quantitative, and mixed-methods studies. Findings from eligible studies were thematically synthesised.
RESULTS
720 papers were identified, and 29 were included. Four descriptive themes were developed to depict the repeated management of recurrent thrush. These themes were: (re)experiencing impacts, (re)identifying recurrent thrush, (re)considering consultations, and (re)trying treatments. An analytic high-order frame of 'interwoven and reoccurring uncertainties' was used to understand these themes.
CONCLUSIONS
Patients and healthcare providers face uncertainties when managing recurrent thrush. The inconsistencies raised across papers suggests an unaddressed gap in knowledge about patient experiences and their informational and support needs; this includes insights about this condition's diagnosis, management, treatment, impacts, and meaning.
PRACTICE IMPLICATIONS
This review has implications for patient education, health promotion, and communication between patients and providers. Our interpretations suggest the need for more research and resources to help support patients and clinicians in managing this condition to promote more understanding, communication, and collaborative care.
Topics: Humans; Health Personnel; Communication; Delivery of Health Care; Qualitative Research
PubMed: 37826917
DOI: 10.1016/j.pec.2023.108004 -
Ethiopian Journal of Health Sciences Sep 2023Vulvovaginal candidiasis is one of the most common vaginal infections worldwide. We conducted this systematic review and meta-analysis to determine the effect of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vulvovaginal candidiasis is one of the most common vaginal infections worldwide. We conducted this systematic review and meta-analysis to determine the effect of probiotics in the treatment of vulvovaginal candidiasis.
METHODS
A comprehensive search of databases including PubMed, Scopus, Cochrane, Scientific Information Database (SID), IranMedex, and Google Scholar search engine was performed. The search was conducted from inception to 1 October 2022, to identify published English or Persian language randomized control trials (RCTs) of women with vulvovaginal candidiasis who received probiotics as medical treatment. The quality of the included studies was assessed using the Oxford Center for Evidence Based Medicine checklist All statistical analyses were performed using Comprehensive Meta-analysis (CMA) version 2.
RESULTS
Six RCTs were included in this review. The results showed that treatment with probiotic was not different from placebo regarding the rate of positive culture (OR: 1.12; 95% CI: 0.390 to 3.26, P=0.825); treatment with probiotic was more effective compared to placebo regarding the rate of recurrence. (OR: 0.14; P= 0.01; 95 % CI: 0.028-0.7).
CONCLUSION
Probiotics have a beneficial effect in the treatment of women with vulvovaginal candidiasis. Our results provide evidence for an alternative treatment modality for vaginal candidiasis using probiotics.
Topics: Candidiasis, Vulvovaginal; Probiotics; Humans; Female; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 38784519
DOI: 10.4314/ejhs.v33i5.18 -
Brazilian Journal of Microbiology :... Mar 2024To evaluate the relationship between fungal infection in the female genital tract and infertility. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the relationship between fungal infection in the female genital tract and infertility.
DATA SOURCES
A systematic review was carried out, and the search was conducted in Medline, Embase, Web of Science, Google Scholar, and Cochrane Library databases until August 2022. The search strategy used standardized keywords such as "candidiasis" and "infertility," combined with their respective synonyms. The search was limited to human studies, with no language restrictions.
STUDY ELIGIBILITY CRITERIA
Primary articles that evaluated women of reproductive age with and without infertility and related to the presence or absence of candidiasis were included.
STUDY APPRAISAL AND SYNTHESIS METHODS
For the analyses, the odds ratio association measure was used with a confidence interval of 95% using RevMan software (version 5.4).
RESULTS
Eight studies, published between 1995 and 2021 in different countries around the world, were included in this systematic review. Two studies were excluded after sensitivity analysis. A total of 909 participants were included in the group of infertile women and 2363 women in the control group. The age of the evaluated women varied between 18 and 50 years. The random effect model was used and showed no significant difference when comparing candidiasis between fertile and infertile women (odds ratio: 1.44; 95% confidence interval 0.86, 2.41 p= 0.17).
CONCLUSIONS
There was no association between candidiasis and female sterility.
Topics: Female; Humans; Adolescent; Young Adult; Adult; Middle Aged; Candidiasis, Vulvovaginal; Infertility, Female; Candidiasis
PubMed: 38153623
DOI: 10.1007/s42770-023-01225-6 -
Heliyon Nov 2023Recurrent Vulvovaginal Candidiasis (RVVC) is defined as 3 or more episodes of symptomatic Vulvovaginal Candidiasis (VVC) within a year. Out of 75 % of women with VVC,...
BACKGROUND
Recurrent Vulvovaginal Candidiasis (RVVC) is defined as 3 or more episodes of symptomatic Vulvovaginal Candidiasis (VVC) within a year. Out of 75 % of women with VVC, this debilitating infection is experienced by 9 % of women. Although standard guidelines recommend oral and topical fluconazole as its treatment regimen, approval of another drug Oteseconazole has drawn the attention because of its better safety profile and lower recurrence rate by its use.
AIM
The purpose of our Meta-analysis is to evaluate the safety and efficacy of Oteseconazole (Vivjoa) (VT-1161) in the treatment of Recurrent Vulvovaginal Candidiasis (RVVC).
METHODOLOGY
Four databases namely PubMed, Google Scholar, Cochrane CENTRAL and Clinical Trial.gov were used from inception till June 2023. Studies that met the predefined inclusion criteria were statistically analyzed on RevMan (Version 5.4). A random effect model was used to pool the studies. A p value of less than 0.05 was considered significant and results were presented as Odds ratio with 95 % Confidence Intervals (CIs).
RESULT
The pooled analysis of our selected studies showed that Oteseconazole was associated with significantly reduced incidence of Recurrent Vulvovaginal Candidiasis (OR = 0.07; 95 % CI = 0.05-0.11; p < 0.00001, I = 0 %) through week 48. Additionally, Vivjoa has also been shown by our analysis to reduce incidence of RVVC through week 24. (OR = 0.05; 95 % CI = 0.03-0.09; p < 0.00001, I = 0 %) Furthermore, Oteseconazole was non-significantly associated with developing serious adverse effects during the treatment for Recurrent Vulvovaginal Candidiasis in comparison to the placebo (OR = 0.79; 95 % CI = 0.33-1.89; p = 0.60, I2 = 0 %).
CONCLUSION
The available evidence suggests Oteseconazole to be safer and more efficacious. However, limited patient population points towards the need of further large and dedicated trials for definitive conclusion.
PubMed: 37920530
DOI: 10.1016/j.heliyon.2023.e20495 -
Cureus Apr 2024Urinary tract infections (UTIs) are a significant health concern globally, with a pronounced impact on women's health in India. This systematic literature review aims to... (Review)
Review
Urinary tract infections (UTIs) are a significant health concern globally, with a pronounced impact on women's health in India. This systematic literature review aims to elucidate the factors associated with UTIs among women of reproductive age in India and focus on demographic, behavioral, and physiological factors to inform targeted public health and clinical interventions. A systematic literature search was conducted on PubMed and Google Scholar using specific MeSH terms and preferred reporting items for systematic literature reviews and meta-analyses (PRISMA) guidelines to investigate the correlates of UTIs among Indian women. Studies were selected based on their relevance to the correlates of UTIs among Indian women, including risk factors, prevention strategies, and treatment outcomes. The review identified a significant prevalence of UTIs among pregnant women, with being the most common causative agent. Younger women, particularly those pregnant, were found to be at a higher risk, likely due to physiological changes during pregnancy and increased sexual activity. Behavioral and lifestyle factors, such as inadequate water intake and poor sanitation practices, were strongly associated with increased risks for UTIs. Factors that increase the risk of UTIs in women include frequent sexual activity, involvement with a new sexual partner, spermicide use that can potentially alter vaginal pH and impact its bacterial composition, and vulvovaginal atrophy. Additionally, nearly 60% of women globally with recurrent UTIs experienced sexual dysfunction, indicating the broader implications of UTIs on women's sexual health and quality of life. UTIs among women in India are influenced by a complex interplay of factors. There is a critical need for enhanced public health initiatives focusing on sanitation, hydration, and hygiene, alongside holistic clinical management strategies that address both the infection and its broader health impacts. Future research should aim at developing innovative prevention and treatment strategies, with a particular focus on high-risk groups such as pregnant women, to mitigate the burden of UTIs in India.
PubMed: 38774177
DOI: 10.7759/cureus.58681