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Clinical Breast Cancer Dec 2019Atrophic vaginitis is a relatively common adverse effect of aromatase inhibitors used as an adjunctive treatment for breast cancer. Vaginal estrogen therapy is a... (Meta-Analysis)
Meta-Analysis
The Safety of Local Hormonal Treatment for Vulvovaginal Atrophy in Women With Estrogen Receptor-positive Breast Cancer Who Are on Adjuvant Aromatase Inhibitor Therapy: Meta-analysis.
Atrophic vaginitis is a relatively common adverse effect of aromatase inhibitors used as an adjunctive treatment for breast cancer. Vaginal estrogen therapy is a treatment option, but the safety of its use in estrogen receptor-positive breast cancer remains understudied. The aim of our study was to determine the safety of local hormonal treatment of vulvovaginal atrophy in women treated with aromatase inhibitors. Our meta-analysis was based on a systematic search of the literature and selection of high-quality evidence. The safety of local hormonal therapy of vaginal atrophy in women on aromatase inhibitors were summarized using calculators built by the authors; heterogeneity was assessed by the Cochrane Q test and I values. Several types of bias were assessed; publication bias was calculated by a funnel plot and the Egger regression. Eleven studies fulfilled the inclusion criteria for our study. After 8 weeks of local hormonal treatment, there was no change in the serum levels of luteinizing hormone and estradiol, whereas sex hormone binding globulins were low, and follicle stimulating hormone was almost doubled compared with the baseline. Adverse effect rates of vaginal discharge, facial hair growth, urinary tract or yeast infection, and vaginal or vulvar itching and/or irritation did not show significant changes in the sensitivity analysis, with exception of a single trial. Current evidence suggests that vaginal estrogen administration in postmenopausal women with a history of breast cancer is not associated with systemic absorption of sex hormones and may provide indirect evidence for the safety of their use.
Topics: Aromatase Inhibitors; Atrophy; Breast Neoplasms; Female; Hormone Replacement Therapy; Humans; Prognosis; Receptors, Estrogen; Vaginal Diseases; Vulvar Diseases
PubMed: 31522958
DOI: 10.1016/j.clbc.2019.07.007 -
Maturitas Jan 2021Breast cancer survivors (BCS) usually receive treatments which lead to persistent oestrogen suppression, which may cause atrophic vaginitis in a large proportion of...
Breast cancer survivors (BCS) usually receive treatments which lead to persistent oestrogen suppression, which may cause atrophic vaginitis in a large proportion of these women. The most effective treatments for vulvovaginal atrophy (VVA) are based on local oestrogen therapy. However, these treatments are restricted in BCS due to the controversy over their use in women who had hormone-dependent tumours. Therefore, it is common to find untreated symptoms that affect sexual function and quality of life in BCS, thereby leading to the discontinuation of anti-oestrogenic treatments. This systematic review aims to discuss the current treatment options available for the genitourinary syndrome of menopause (GSM) in BCS. A comprehensive literature search was conducted electronically using Embase and PubMed to retrieve studies assessing treatment options for GSM or VVA in BCS up to April 2020. Studies evaluating treatments in different BCS cohorts were excluded. A total of 29 studies were finally included in the review. Non-hormonal treatments are the first-line treatment for VVA, but when these are not effective for symptom relief, other options can be considered, such as local oestrogen, erbium laser or CO2 laser and local androgens. The present data suggest that these therapies are effective for VVA in BCS; however, safety remains controversial and a major concern with all of these treatments.
Topics: Breast Neoplasms; Cancer Survivors; Female; Female Urogenital Diseases; Humans; Menopause; Observational Studies as Topic; Randomized Controlled Trials as Topic; Syndrome
PubMed: 33308636
DOI: 10.1016/j.maturitas.2020.08.010 -
Ecancermedicalscience 2019Women who have been treated for breast cancer may experience vulvo-vaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM). This is a progressive condition and...
Women who have been treated for breast cancer may experience vulvo-vaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM). This is a progressive condition and will not improve without treatment. Whilst vaginal oestrogen is the most effective treatment for GSM, many breast cancer survivors and clinicians remain reluctant to use it. Laser therapy is emerging as an alternative treatment for this condition but there is little evidence available as to its value in this setting. We undertook a systematic literature review to identify available evidence for the use of laser therapy for VVA in women with breast cancer. There are a number of small studies which suggest an improvement in vaginal health in this group. However, these are all small, non-randomised studies and there are a number of key questions which need to be answered before this treatment can be implemented into practice.
PubMed: 32010212
DOI: 10.3332/ecancer.2019.988 -
Mycoses Jan 2019The current number of fungal infections occurring each year in Turkey is unknown. We estimated the burden of serious human fungal diseases based on the population at...
The current number of fungal infections occurring each year in Turkey is unknown. We estimated the burden of serious human fungal diseases based on the population at risk, existing epidemiological data from 1920 to 2017 and modelling previously described by the LIFE program (http://www.LIFE-worldwide.org). Among the population of Turkey (80.8 million in 2017), approximately 1 785 811 (2.21%) people are estimated to suffer from a serious fungal infection each year. The model used predicts high prevalences of allergic fungal rhinosinusitis episodes (312 994 cases) (392/100 000), of severe asthma with fungal sensitisation (42 989 cases) (53.20 cases/100 000 adults per year), of allergic bronchopulmonary aspergillosis (32 594 cases) (40.33/100 000), of fungal keratitis (26 671 cases) (33/100 000) and of chronic pulmonary aspergillosis (5890 cases) (7.29/100 000). The estimated annual incidence for invasive aspergillosis is lower (3911 cases) (4.84/100 000 annually). Among about 22.5 million women aged 15-50 years, recurrent vulvovaginal candidiasis is estimated to occur in 1 350 371 (3342/100 000) females. The burden of three superficial fungal infections was also estimated: tinea pedis (1.79 million), tinea capitis (43 900) and onychomycosis (1.73 million). Given that the modelling estimates reported in the current study might be substantially under- or overestimated, formal epidemiological and comprehensive surveillance studies are required to validate or modify these estimates.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Cost of Illness; Female; Humans; Infant; Infant, Newborn; Male; Middle Aged; Models, Statistical; Mycoses; Prevalence; Turkey; Young Adult
PubMed: 30107069
DOI: 10.1111/myc.12842 -
Menopause (New York, N.Y.) Nov 2019Genitourinary syndrome of menopause affects up to 50% of postmenopausal women and has negative impacts on the women's quality of life. In this systematic review, we...
OBJECTIVE
Genitourinary syndrome of menopause affects up to 50% of postmenopausal women and has negative impacts on the women's quality of life. In this systematic review, we aimed to identify and assess the measurement properties of all existing patient-reported outcome measures (PROMs) specific for genitourinary symptoms that were developed and/or validated for measuring patient-reported outcomes in postmenopausal women.
METHODS
Studies which evaluated, described, or compared measurement properties of PROMs were considered as eligible. We performed a systematic literature search in MEDLINE, EMBASE, and Web of Science. The methodological quality of each study was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. Furthermore, predefined quality criteria for good measurement properties were applied and the quality of the evidence was graded.
RESULTS
Nine articles reporting on four PROMs were included. Two instruments, the Vulvovaginal Symptoms Questionnaire and the Day-to-Day Impact of Vaginal Aging Questionnaire, can be further recommended for use. Both showed moderate to high quality of evidence for sufficient structural validity, internal consistency, and construct validity. The two other instruments, urogenital atrophy quality of life (UGAQoL) and the Urogenital Symptom Scale, cannot be recommended for use, whereby the UGAQoL still has the opportunity to be recommended if the authors gave access to the instrument and further validation studies were conducted.
CONCLUSIONS
Both Vulvovaginal Symptoms Questionnaire and Day-to-Day Impact of Vaginal Aging Questionnaire can be recommended for use and results obtained with these two instruments can be seen as trustworthy. Future validation studies should focus on those two instruments.
Topics: Adult; Checklist; Female; Female Urogenital Diseases; Humans; Menopause; Middle Aged; Patient Reported Outcome Measures; Psychometrics; Quality of Life; Reproducibility of Results; Surveys and Questionnaires; Symptom Assessment; Syndrome
PubMed: 31688581
DOI: 10.1097/GME.0000000000001390 -
Menopause (New York, N.Y.) Jul 2024The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for...
OBJECTIVE
The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects.
METHODS
We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome.
RESULTS
A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice.
CONCLUSIONS
Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.
Topics: Humans; Female; Menopause; Patient Reported Outcome Measures; Female Urogenital Diseases; Quality of Life; Sexual Dysfunction, Physiological; Surveys and Questionnaires; Middle Aged
PubMed: 38743907
DOI: 10.1097/GME.0000000000002369 -
Gynecologie, Obstetrique, Fertilite &... May 2021For some patients, local hormonal or non-hormonal treatments for genitourinary syndrome of menopause (SGUM) are contraindicated or insufficiently effective. Different...
INTRODUCTION
For some patients, local hormonal or non-hormonal treatments for genitourinary syndrome of menopause (SGUM) are contraindicated or insufficiently effective. Different physical therapies such as vaginal laser therapy, radiofrequency therapy, photobiomodulation therapy and local injection of hyaluronic acid, autologous fat (lipofilling) and platelet rich plasma (PRP) have been proposed as alternatives.
OBJECTIVE
The objective of this review was to elaborate guidelines for clinical practice regarding the physical therapies proposed for management of vulvovaginal atrophy (AVV).
METHODS
A systematic review of the literature on AVV management with physical therapies was conducted on Medline between January 2014 and December 2020.
RESULTS
Regarding vaginal laser therapy, there are few randomized controlled trials and no formal conclusions can be drawn. The fractional CO2 laser did not demonstrate its superiority over local estrogen therapy. The ERBIUM:YAG laser has not been studied in randomized controlled trials. The lack of follow-up on the vaginal laser and the series of cases reporting risks of vaginal stenosis or chronic pain do not encourage recommending it as a first-line treatment. The literature concerning other physical treatments of AVV is weak concerning the genital area.
CONCLUSION
CO2 or ERBIUM:YAG vaginal lasers are not the first-line treatment for AVV (grade C). In patients with a contraindication to local hormonal treatments, treatment with vaginal CO2 laser or ERBIUM:YAG may be considered after information about the risks (burn, stenosis, pain) (expert opinion). The other physical treatments of SGUM have to be evaluated.
Topics: Atrophy; Constriction, Pathologic; Female; Humans; Physical Therapy Modalities; Postmenopause; Vagina
PubMed: 33757917
DOI: 10.1016/j.gofs.2021.03.021 -
Journal of Lower Genital Tract Disease Apr 2019In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary...
In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. Most of the available studies are limited by their design; for example, they lack a control group, patients are not randomized, follow-up is short term, series are small, LASER is not compared with standard treatments, and most studies are industry sponsored. Because of these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration after LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, although short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. Therefore, at this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.
Topics: Adolescent; Adult; Child; Female; Humans; Laser Therapy; Middle Aged; Practice Guidelines as Topic; Vaginal Diseases; Vulvar Diseases; Young Adult
PubMed: 30789385
DOI: 10.1097/LGT.0000000000000462 -
Taiwanese Journal of Obstetrics &... May 2024The present study aims to conduct a comprehensive meta-analysis of randomized controlled trials (RCTs) investigating the efficacy of probiotics as an adjunct treatment... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The present study aims to conduct a comprehensive meta-analysis of randomized controlled trials (RCTs) investigating the efficacy of probiotics as an adjunct treatment for preventing and treating gynecological infections.
MATERIALS AND METHODS
The study adopted a systematic review of scientific databases including PubMed, Cochrane, and EMBASE, using defined MeSH terms. The inclusion and exclusion criteria were set to refine the search, with the data extraction and quality assessment being conducted by two independent investigators.
RESULTS
A total of 35 articles, comprising 3751 patients, were included in the meta-analysis. The application of probiotics demonstrated a notable increase in the cure rates of bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) as compared to control groups. A significant BV cure rate (OR: 5.972; 95% CI: 2.62-13.59; p-value: 0.01) was noted with probiotic use, which was even more pronounced when used as an adjunctive treatment with antibiotics (OR: 2.504; 95% CI: 1.03-6.06; p-value: 0.04). Additionally, probiotic use significantly reduced the recurrence rates of BV (OR: 0.34; 95% CI: 0.167-0.71; p-value: 0.004). For VVC, a significant increase in the cure rate was observed in the probiotic group (OR: 3.425; 95% CI: 2.404-4.879; p-value: 0.01), along with a lower recurrence rate (OR: 0.325; 95% CI: 0.175-0.606; p-value: 0.01).
CONCLUSION
Our findings underscore the potential role of probiotics as a beneficial adjunctive treatment for gynecological infections, indicating an improved cure rate and decreased recurrence. However, additional well-designed studies are necessary to corroborate these findings.
Topics: Humans; Probiotics; Female; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Randomized Controlled Trials as Topic; Anti-Bacterial Agents; Treatment Outcome; Combined Modality Therapy; Recurrence
PubMed: 38802199
DOI: 10.1016/j.tjog.2024.03.004 -
Journal of Lower Genital Tract Disease Jul 2024
Meta-Analysis
PubMed: 38941561
DOI: 10.1097/LGT.0000000000000823