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Plastic and Reconstructive Surgery Nov 2020The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that...
BACKGROUND
The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that women are being harmed by laser and other energy-based devices. The goal of this systematic literature review was to assess existing data, determine gaps in evidence, and propose opportunities for continued investigation pertaining to laser and energy-based vaginal restoration techniques.
METHODS
A review of literature using PubMed, Cochrane Library databases, Embase, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature was conducted on January 9, 2019, and articles up to this point were considered. For inclusion, studies had to be available or translated in English and relate to clinical medicine, direct patient care, and nonsurgical energy-based vulvovaginal procedures.
RESULTS
The authors found five level I studies, 19 level II studies, four level III studies, and 46 level IV studies that used 15 different devices. Various degrees of improvement of symptoms were reported in all studies. Adverse events/side effects were noted in two of the 13 radiofrequency device studies, 15 of the 23 erbium:yttrium-aluminum-garnet device studies, and 17 of the 37 carbon dioxide device studies. The majority of adverse events were considered mild.
CONCLUSIONS
The majority of studies resulted in mild to no adverse side effects. However, there is a large gap in level I evidence. As a result, the authors emphasize the necessity of supplemental data surrounding this subject and suggest that additional randomized sham-controlled studies be conducted to further investigate vulvovaginal restoration devices in an effort to address women's health issues.
Topics: Device Approval; Evidence-Based Medicine; Female; Humans; Lasers, Gas; Lasers, Solid-State; Low-Level Light Therapy; Menopause; Radiofrequency Ablation; Treatment Outcome; United States; United States Food and Drug Administration; Vagina; Vaginal Diseases; Vulva; Vulvar Diseases
PubMed: 33141529
DOI: 10.1097/PRS.0000000000007236 -
The Cochrane Database of Systematic... Aug 2020Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis.
OBJECTIVES
The primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching.
SELECTION CRITERIA
We included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as recommended by Cochrane.
MAIN RESULTS
This review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high. There was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%. In terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials.
AUTHORS' CONCLUSIONS
Oral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low. The decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.
Topics: Acute Disease; Administration, Intravaginal; Administration, Oral; Antifungal Agents; Azoles; Bias; Candidiasis, Vulvovaginal; Cost-Benefit Analysis; Female; Humans; Randomized Controlled Trials as Topic
PubMed: 32845024
DOI: 10.1002/14651858.CD002845.pub3 -
Sexual Medicine Reviews Apr 2019Female sexual dysfunction (FSD) is a highly prevalent condition. Nevertheless, the scientific literature has only recently begun to accumulate evidence for treatment...
BACKGROUND
Female sexual dysfunction (FSD) is a highly prevalent condition. Nevertheless, the scientific literature has only recently begun to accumulate evidence for treatment modalities that address the underlying etiologies of FSD.
AIM
The purpose of this systematic review is to elucidate what treatments are effective across the various symptom complexes of FSD.
METHODS
Utilizing Meta-analysis of Observational Studies in Epidemiology guidelines, we conducted a systematic review of PubMed, EMBASE, clinicaltrials.gov, and the Cochrane Review databases. Eleven search strings, encompassing the terms "female sexual dysfunction" and "treatment," in combination with "vulvovaginal atrophy," "vaginismus," "vaginal atrophy," "vulvodynia," "vestibulitis," "hypoactive sexual desire," "arousal disorder," "sexual pain disorder," "genitourinary syndrome of menopause," and "orgasmic disorder" were utilized. 605 Relevant articles were retrieved. A total of 103 original studies met inclusion criteria.
OUTCOMES
We assess peer-reviewed literature.
RESULTS
42 Treatment modalities were utilized, including 26 different classes of medications. Although outcome measures varied, the most substantial improvement across multiple studies was noted with various hormonal regimens. The most common treatments included hormonal therapy (25 studies), phosphodiesterase type-5 inhibitors (9 studies), botulinum toxin A (5 studies), and flibanserin (5 studies). The psychotherapeutic approach was detailed in 36 articles while 3 studies utilized homeopathic treatments. Numerous treatments showed efficacy in a single case series, including the promising results associated with the micro-ablative carbon-dioxide laser. Despite the marked improvement in specific FSD domains, neither pharmacologic treatments nor psychotherapeutic interventions demonstrate consistent disease resolution.
CONCLUSIONS
Treatment of FSD is multi-factorial; medications alone do not resolve FSD. The wide variability of treatment and outcome measures across the literature attests to the complexity of FSD and the need for a treatment algorithm that addresses all 4 domains of FSD. Weinberger JM, Houman J, Caron AT, et al. Female Sexual Dysfunction: A Systematic Review of Outcomes Across Various Treatment Modalities. Sex Med Rev 2019;7:223-250.
Topics: Female; Humans; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Treatment Outcome
PubMed: 29402732
DOI: 10.1016/j.sxmr.2017.12.004 -
Menopause (New York, N.Y.) Apr 2019We updated a systematic review to evaluate the totality of evidence available for the efficacy and safety of vaginal estrogen products for the treatment of genitourinary...
OBJECTIVE
We updated a systematic review to evaluate the totality of evidence available for the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause (GSM) based on published randomized controlled trials.
METHODS
We searched the Cochrane Library, Ovid, PubMed, Medline, Embase, and Clinicaltrials.gov for English-language articles from database inception to June 2018. Our search consolidated 2,086 potential sources to 53 full-text articles that were reviewed and found relevant to our systematic review.
RESULTS
We identified 53 studies that met the inclusion criteria that evaluated the efficacy and safety of vaginal estrogen versus placebo or other hormone and nonhormone controls. Compared with placebo, all vaginal estrogens demonstrated superiority in objective endpoints and subjective endpoints of GSM, whereas some trials demonstrated superiority versus placebo in urogenital symptoms. No significant difference was observed between various dosages and dosage forms of vaginal estrogen products. Vaginal estrogen showed superiority over vaginal lubricants and moisturizers for the improvement of objective clinical endpoints of vulvovaginal atrophy but not for subjective endpoints. Unopposed vaginal estrogens seemed safe, although studies were not powered to detect a long-term estrogenic side effect.
CONCLUSION
Estrogen products were found to be clinically effective for the treatment of GSM with doses as low as 4 μg. Vaginal estrogen products seem to be safe with few adverse effects, although there is a lack of long-term controlled clinical trial safety data. This review supports the use of commercially available vaginal estrogen therapies as an effective and safe first-line therapy for the treatment of moderate-to-severe GSM.
Topics: Administration, Intravaginal; Atrophy; Estriol; Estrogen Replacement Therapy; Estrogens; Female; Humans; Hyaluronic Acid; Lubricants; Menopause; Vagina
PubMed: 30363010
DOI: 10.1097/GME.0000000000001221 -
The Australian & New Zealand Journal of... Apr 2018Following menopause, up to 49% of women will experience genitourinary symptoms such as vaginal itching, dryness, dyspareunia and incontinence as a result of oestrogen...
Following menopause, up to 49% of women will experience genitourinary symptoms such as vaginal itching, dryness, dyspareunia and incontinence as a result of oestrogen deficiency. Treatments such as vaginal lubricants and moisturisers only temporarily relieve symptoms, while local oestrogen treatments are often unacceptable or unsafe for many women. Recently, a novel laser treatment has been proposed as a non-invasive, long-term solution to vulvo-vaginal and urinary symptoms. While preliminary histological results have been promising, its therapeutic, clinical effect has yet to be determined. However, despite the scarcity of evidence for its safety and long-term benefit, laser treatments are widely marketed for a range of genitourinary symptoms, with high uptake by both clinicians and women alike. This review aims to examine the evidence for laser treatments to the vulvo-vagina and to evaluate its safety and efficacy. Our results include 17 studies investigating the effect of laser therapy for vulvo-vaginal symptoms, seven for its effects on urinary incontinence and four for histology. These are limited to non-randomised, observational data with small sample sizes between 15 to 175 women and follow-up duration from none to two years. As such, strong evidence for laser efficacy and safety is limited and warrants more robust, placebo-controlled, randomised trials before widespread implementation.
Topics: Female; Humans; Laser Therapy; Postmenopause; Vaginal Diseases; Vulvar Diseases
PubMed: 29067688
DOI: 10.1111/ajo.12735 -
Menopause (New York, N.Y.) Feb 2018This systematic review of the literature was undertaken to investigate the prevalence of sexual symptoms in women in Asia in relation to their menopause status.
OBJECTIVE
This systematic review of the literature was undertaken to investigate the prevalence of sexual symptoms in women in Asia in relation to their menopause status.
METHODS
MEDLINE, EMBASE, PsycINFO, CINAHL, SCOPUS, and Google scholar were searched systematically for relevant population-based prevalence studies published between 1988 and 2016. The included studies were assessed for risk of bias using a risk-of-bias tool developed explicitly for the systematic review of prevalence studies.
RESULTS
A total of 34 articles, comprising 24,743 women, were included. In Asia, diminished sexual desire appears to be highly prevalent amongst postmenopausal women. Vulvovaginal atrophy symptoms are common after menopause in some Asian countries, but are either less common or under-reported in other Asian countries. The review highlights the paucity of data pertaining to menopause and sexual well-being in Asia, and the lack of prevalence studies that have assessed sexual function using a validated questionnaire. Most of the included studies had a high risk of bias, especially in the four items that pertain to external validity.
CONCLUSIONS
The available data, despite its limitations, suggests that after menopause, lowered sexual desire and vulvovaginal atrophy symptoms, including dryness, irritation, soreness, and dyspareunia, are common in women in Asia. The extent to which such symptoms cause women distress is not known. Studies of representative samples of premenopausal, perimenopausal, and postmenopausal women that use robustly translated and culturally appropriate validated questionnaires, and that collect detailed demographic data are still needed to determine the prevalence of sexual symptoms in relation to menopause in women in Asia.
Topics: Asia; Atrophy; Dyspareunia; Female; Humans; Libido; Postmenopause; Prevalence; Sexual Dysfunction, Physiological; Sexual Health; Vagina; Vulva
PubMed: 28858028
DOI: 10.1097/GME.0000000000000967 -
BJOG : An International Journal of... Dec 2019Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole.
OBJECTIVES
To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy.
SEARCH STRATEGY
A systematic literature search was conducted to identify relevant studies published from inception until April 2019.
SELECTION CRITERIA
Relevant English-language citations using the terms oral fluconazole and pregnancy in humans.
DATA COLLECTION
Two reviewers independently abstracted data and assessed study quality.
MAIN RESULTS
Oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99-1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high-dose users (>150 mg) (OR 1. 19, 95% CI 1.01-1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09-1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1-1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71-6.74, P < 0.001; n = 2) in the offspring. In addition, exposure to fluconazole was significantly associated with an increased risk of spontaneous abortion (OR 1.99, 95% CI 1.38-2.88, P < 0.001; n = 3).
CONCLUSIONS
Oral fluconazole use during the first trimester of pregnancy appears to be associated with heart malformations and spontaneous abortion, but a causal link cannot be proven.
TWEETABLE ABSTRACT
Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.
Topics: Abnormalities, Drug-Induced; Administration, Oral; Antifungal Agents; Candidiasis, Vulvovaginal; Craniofacial Abnormalities; Female; Fluconazole; Humans; Patient Safety; Pregnancy; Pregnancy Trimester, First
PubMed: 31446677
DOI: 10.1111/1471-0528.15913 -
British Journal of Cancer Jan 2019High-risk human papilloma viruses (HPV) are a causative agent of anogenital and oropharyngeal cancers. Patients treated for a preinvasive or invasive HPV-associated... (Meta-Analysis)
Meta-Analysis
BACKGROUND
High-risk human papilloma viruses (HPV) are a causative agent of anogenital and oropharyngeal cancers. Patients treated for a preinvasive or invasive HPV-associated cancer may be at increased risk of a second such malignancy.
METHODS
We performed a systematic review and random effects meta-analysis to estimate the risk of HPV-associated cancer after prior diagnosis. Studies reporting second cancers at anogenital and oropharyngeal sites after prior diagnoses (preinvasive/invasive HPV-associated cancer) were identified. Studies reporting standardised incidence ratios (SIRs) were included in formal meta-analyses of second cancer risk. (PROSPERO ID: CRD42016046974).
RESULTS
Searches returned 5599 titles, including 60 unique, eligible studies. Thirty-two (98 comparisons) presented SIRs for second cervical, anal, vulvo-vaginal, penile, and/or oropharyngeal cancers, included in the meta-analyses. All studies (and 95/98 comparisons) reported increased cancers in the population with previous HPV-associated cancer when compared to controls. Pooled SIRs for second primary cancers ranged from 1.75 (95% CI 0.66-4.67) for cervical cancer after primary anal cancer, to 13.69 (95% CI 8.56-21.89) for anal cancer after primary vulvo-vaginal cancer.
CONCLUSIONS
We have quantified the increased risk of second HPV-associated cancer following diagnosis and treatment for initial cancer or preinvasive disease. This has important implications for follow-up, screening, and future therapeutic trials.
Topics: Anus Neoplasms; Carcinoma in Situ; Female; Head and Neck Neoplasms; Humans; Male; Neoplasms, Second Primary; Oropharyngeal Neoplasms; Papillomaviridae; Papillomavirus Infections; Penile Neoplasms; Risk Factors; Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms
PubMed: 30482913
DOI: 10.1038/s41416-018-0273-9 -
Post Reproductive Health Mar 2020
Topics: Disease Management; Female; Female Urogenital Diseases; Humans; Postmenopause; Syndrome
PubMed: 31387514
DOI: 10.1177/2053369119866341 -
Breast Care (Basel, Switzerland) Dec 2020To analyse all available evidence to validate the effectiveness of a local intervention in the treatment of dyspareunia in breast cancer survivors (BCS).
OBJECTIVE
To analyse all available evidence to validate the effectiveness of a local intervention in the treatment of dyspareunia in breast cancer survivors (BCS).
METHODS
We searched the Institute of Scientific Information Web of Knowledge, MEDLINE, PubMed, Scopus, and Cochrane databases for all articles published in peer-reviewed journals up to April 2019. The PICOS standards were: (population) BCS with dyspareunia; (intervention) any type of vulvovaginal treatment; (main outcome) frequency and severity of dyspareunia; (study design) clinical studies.
RESULTS
The literature search strategy identified 252 articles, of which 233 were excluded at various stages of the search. Finally, we systematically reviewed 19 studies, 8 with local hormonal therapies, 7 with local non-hormonal therapies, 3 with laser therapy, and 1 with other interventions. Of the studies, 7 were randomized control trials and 11 were prospective observations. Most of the interventions were shown to be effective and safe in the improvement of dyspareunia.
CONCLUSION
In addition to the traditional options already analysed in other current reviews, other interesting options are highlighted (such as laser or local dehydroepiandrosterone [DHEA]). Further work on dyspareunia should make use of high-quality trials with large numbers of samples to obtain evidence that could adequately demonstrate key methodological characteristics and harmful effects.
PubMed: 33447234
DOI: 10.1159/000506148