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Journal of Clinical Medicine Jun 2022Sjögren's syndrome (SS) is a systemic chronic autoimmune disorder characterized by lymphoplasmacytic infiltration of salivary glands (SGs) and lacrimal glands, causing... (Review)
Review
Sjögren's syndrome (SS) is a systemic chronic autoimmune disorder characterized by lymphoplasmacytic infiltration of salivary glands (SGs) and lacrimal glands, causing glandular damage. The disease shows a combination of dryness symptoms found in the oral cavity, pharynx, larynx, and vagina, representing a systemic disease. Recent advances link chronic inflammation with SG fibrosis, based on a molecular mechanism pointing to the epithelial to mesenchymal transition (EMT). The continued activation of inflammatory-dependent fibrosis is highly detrimental and a common final pathway of numerous disease states. The important question of whether and how fibrosis contributes to SS pathogenesis is currently intensely debated. Here, we collect the recent findings on EMT-dependent fibrosis in SS SGs and explore clinical evidence of multi-organ fibrosis in SS to highlight potential avenues for therapeutic investigation.
PubMed: 35743618
DOI: 10.3390/jcm11123551 -
Maturitas May 2021The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.
OBJECTIVE
The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks.
STUDY DESIGN
Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days.
MAIN OUTCOME MEASURE
The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function.
RESULTS
Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001).
CONCLUSIONS
The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.
Topics: Aged; Atrophy; Double-Blind Method; Dyspareunia; Female; Glycogen; Glycyrrhetinic Acid; Hippophae; Humans; Hyaluronic Acid; Middle Aged; Plant Oils; Plant Preparations; Postmenopause; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulva; Vulvar Diseases
PubMed: 33832645
DOI: 10.1016/j.maturitas.2021.03.002 -
Expert Opinion on Drug Delivery Nov 2020Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, with symptoms of vaginal dryness, dyspareunia, and vulvar/vaginal irritation. Despite... (Review)
Review
INTRODUCTION
Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, with symptoms of vaginal dryness, dyspareunia, and vulvar/vaginal irritation. Despite the availability of various treatments, women express dissatisfaction with their options. An estradiol (E2; 4-µg and 10-µg) softgel vaginal insert was approved by the Food and Drug Administration (FDA) to treat moderate to severe dyspareunia, a symptom of VVA, due to menopause. These inserts were designed to treat VVA effectively and safely while avoiding some of the drawbacks of other administration methods.
AREAS COVERED
This article reviews the physical characteristics and pharmacokinetic data of the E2 softgel vaginal insert. Primary and secondary efficacy endpoints and safety data are reviewed from the pivotal REJOICE trial (NCT02253173), and substudies that explore response rates, changes in vaginal epithelium by visual assessment, efficacy in patient subgroups, effects on sexual function, and patient satisfaction compared with other treatments.
EXPERT OPINION
The E2 insert shows that vaginal drug delivery is an optimal route of administration for locally treating VVA. This E2 softgel vaginal insert is a safe and effective treatment for symptoms of postmenopausal VVA. The E2 insert's pharmacokinetic characteristics are related to its unique formulation, rapid dissolution, and minimal systemic absorption.
ABBREVIATIONS
AE: adverse event; AUC: area under the concentration-time curve; BMI: body mass index; C: average concentration; CI: confidence interval; C: maximum concentration; C: minimum concentration; E2: estradiol; FDA: Food and Drug Administration; FSFI: Female Sexual Function Index; GSM: genitourinary symptoms of menopause: MBS: most bothersome symptom; NAMS: North American Menopause Society; OR: odds ratio; PI: pulsatility index; PK: pharmacokinetic; REVIVE: Real Women's Views of treatment options for menopausal Vaginal changEs; RI: resistance index; ROC: receiver operating characteristic; TEAE: treatment-emergent adverse event; t: time to maximum concentration; VVA: vulvar and vaginal atrophy.
Topics: Administration, Intravaginal; Atrophy; Dyspareunia; Estradiol; Female; Humans; Postmenopause; Treatment Outcome; Vagina; Vaginal Diseases; Vulvar Diseases
PubMed: 32877254
DOI: 10.1080/17425247.2020.1810662 -
Sexual and Reproductive Health Matters 2021Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during... (Review)
Review
Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during intercourse. To inform WHO's self-care interventions guideline, we conducted a systematic review of the peer-reviewed literature to answer the question: does use of lubricants during or prior to sex result in improved sexual health and well-being. We searched PubMed, CINAHL, LILACS and EMBASE on 8 July 2020 for effectiveness, values and preferences, and cost data related to commercially available vaginal and anal lubricants. Data were systematically extracted and qualitatively synthesised. Effectiveness evidence was summarised in GRADE evidence profiles. Seven studies met the effectiveness review criteria. Two randomised trials found lubricant use led to improved female sexual well-being and had no impact on incidence of human papillomavirus (moderate certainty evidence). One observational study with gay and bisexual men showed lubricants were associated with increased reports of pain during receptive intercourse and no difference in pain during insertive intercourse, but a reduced degree of pain in both types of intercourse (low/very low certainty evidence). One observational study with female breast cancer survivors found better outcomes of vaginal dryness and dyspareunia with lubricant use (very low certainty evidence). Twenty-one values and preferences studies from diverse populations globally found that most individuals supported lubricant use for reasons of comfort/reduced pain and sexual pleasure. No cost studies were identified. Although evidence is limited, lubricants appear to offer an acceptable approach to improving sexual health and well-being.
Topics: Bisexuality; Coitus; Female; Humans; Lubricants; Male; Observational Studies as Topic; Sexual Behavior; Sexual Health
PubMed: 35315312
DOI: 10.1080/26410397.2022.2044198 -
Przeglad Menopauzalny = Menopause Review Sep 2018Premature ovarian insufficiency (POI) is defined by amenorrhoea and decreased serum levels of oestrogens associated with increased serum gonadotropins concentrations... (Review)
Review
Premature ovarian insufficiency (POI) is defined by amenorrhoea and decreased serum levels of oestrogens associated with increased serum gonadotropins concentrations before the age of 40 years. Patients suffering from POI present with irregular menses, either secondary or (less common) primary amenorrhoea, and subfertility. POI affects approximately 1 in 100 women by the age 40 years and 0.1% by 30 years of age. Both spontaneous and iatrogenic causes may induce POI, although up to 90% of POI cases are idiopathic. Impairment of sexual function is a common problem affecting women suffering from POI. Premature loss of gonadal function is particularly traumatic in young women and affects many aspects of physical and social life. POI patients suffer from genital pain due to vaginal dryness and diminished sexual arousal. Additionally, POI patients report increased anxiety, depressed mood, and have impaired interactions with their peers, which leads to feeling less feminine and having decreased self-esteem. Moreover, they have significantly decreased physical and psychological well-being when compared to age-matched controls. Systemic hormonal replacement therapy and topical oestrogen therapy as well as vaginal moisturisers may be used in the treatment of POI patients' sexual impairment.
PubMed: 30357022
DOI: 10.5114/pm.2018.78557 -
Journal of Contemporary Brachytherapy Dec 2018To evaluate vaginal toxicity (primary endpoint) and local control (secondary endpoint) in patients with endometrial cancer who underwent primary surgery and adjuvant... (Review)
Review
PURPOSE
To evaluate vaginal toxicity (primary endpoint) and local control (secondary endpoint) in patients with endometrial cancer who underwent primary surgery and adjuvant high-dose-rate (HDR) endovaginal brachytherapy (BT).
MATERIAL AND METHODS
In September 2017, the authors conducted a comprehensive literature search of the following electronic databases: PubMed, Web of Science, Scopus, and Cochrane library. In this systematic review, the authors included randomized trials, non-randomized trials, prospective studies, retrospective studies, and cases. The time period of the research included articles published from September 1997 to September 2017.
RESULTS
Acute endovaginal toxicity occurred in less than 20.6% and all acute toxicities were G1-G2. The most common early side effects due to HDR-BT treatment were vaginal inflammation, vaginal irritation, dryness, discharge, soreness, swelling, and fungal infection. G1-G2 late toxicity occurred in less than 27.7%. Finally, G3-G4 late vaginal occurred in less than 2%. The most common late side effects consisted of vaginal discharge, dryness, itching, bleeding, fibrosis, telangiectasias, stenosis, short or narrow vagina, and dyspareunia.
CONCLUSIONS
The data suggest that HDR endovaginal brachytherapy, with or without chemotherapy, is very well tolerated with low rates of acute and late vaginal toxicities. Further prospective studies with higher numbers of patients and longer follow-up are necessary to evaluate acute and late toxicities after HDR endovaginal brachytherapy.
PubMed: 30662479
DOI: 10.5114/jcb.2018.79713 -
FP Essentials Apr 2022(GSM) is a term that describes the genital, urinary, and sexual changes that occur in women because of a lack of estrogen. This most commonly is because of menopause,...
(GSM) is a term that describes the genital, urinary, and sexual changes that occur in women because of a lack of estrogen. This most commonly is because of menopause, but can be because of a hypoestrogenic state caused by hyperprolactinemia, oophorectomy, premature ovarian failure, chemotherapy, or radiation. GSM describes a group of signs and symptoms that affect quality of life and progress over time, including vaginal dryness, dyspareunia, dysuria, urinary urgency, and frequent urinary tract infections. GSM is underdiagnosed. It affects 65% of women 1 year after the onset of menopause, and 84% of women 6 years after menopause. Physicians routinely should ask all perimenopausal and postmenopausal women about GSM symptoms. The diagnosis is made clinically, based on the history and physical examination. Use of nonhormonal lubricants and vaginal moisturizers should be recommended as first-line therapies. Vaginal estrogen is the most effective treatment. Other therapies include vaginal dehydroepiandrosterone (DHEA), ospemifene, systemic estrogen therapy, and pelvic floor physical therapy.
Topics: Estrogens; Female; Humans; Lubricants; Menopause; Quality of Life; Syndrome
PubMed: 35420405
DOI: No ID Found -
Mayo Clinic Proceedings Dec 2017Genitourinary syndrome of menopause (GSM), previously known as atrophic vaginitis or vulvovaginal atrophy, affects more than half of postmenopausal women. Caused by low... (Review)
Review
Genitourinary syndrome of menopause (GSM), previously known as atrophic vaginitis or vulvovaginal atrophy, affects more than half of postmenopausal women. Caused by low estrogen levels after menopause, it results in bothersome symptoms, including vaginal dryness, itching, dyspareunia, urinary urgency and increased frequency, and urinary tract infections. Even though women with GSM can have sexual dysfunction that interferes with partner relationships, women are often embarrassed to seek treatment, and health care professionals do not always actively screen for GSM. As a result, GSM remains underdiagnosed and undertreated. Several effective treatments exist, but low-dose vaginal estrogen therapy is the criterion standard. It is effective and safe for most patients, but caution is suggested for survivors of hormone-sensitive cancers. Newer treatment options include selective estrogen receptor modulators, vaginal dehydroepiandrosterone, and laser therapy. Nonprescription treatments include vaginal lubricants, moisturizers, and dilators. Pelvic floor physical therapy may be indicated for some women with concomitant pelvic floor muscle dysfunction. Sex therapy may be helpful for women with sexual dysfunction. This concise review presents a practical approach to the evaluation and management of GSM for the primary care physician.
Topics: Atrophic Vaginitis; Estrogen Replacement Therapy; Female; Humans; Menopause; Middle Aged; Quality of Life; Syndrome; Urinary Incontinence; Vaginal Diseases; Vulvar Diseases; Women's Health
PubMed: 29202940
DOI: 10.1016/j.mayocp.2017.08.019 -
JCO Clinical Cancer Informatics Feb 2022To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically... (Review)
Review
PURPOSE
To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data.
MATERIALS AND METHODS
The GST was developed on the basis of a comprehensive review of the literature, multidisciplinary expert opinion, and feedback from women with a history of gynecologic cancer. It is composed of 17 questions addressing six main categories-gynecologic health (abnormal bleeding/pain), lymphedema, vaginal/vulvar dryness, sexual health, menopause (hot flushes/sleep difficulties), and bowel/urinary issues. An electronic version using the Memorial Sloan Kettering Cancer Center Engage platform was piloted in two clinics for patients with endometrial or cervical cancer. Health information was generated into clinical summaries and identified concerns for actionable response. Associations of symptom and survey time point were assessed by longitudinal models using generalized estimating equations.
RESULTS
From January 1, 2019, to February 29, 2020, 3,357 GST assessments were assigned to 1,405 patients, with a 71% completion rate (90% within 5 minutes). Sixty-eight percent were performed at home via a patient portal, 32% at follow-ups using a clinic iPad. The most common symptoms were bowel problems, swelling/fluid, pain during examination, vaginal or vulvar dryness, and vaginal bleeding. Implementation challenges included improving patient compliance and ensuring that reports were reviewed by all clinical teams. We developed screening e-mails detailing patients whose assessments were due, planned training sessions for multidisciplinary teams, and incorporated feedback on methods for reviewing symptoms reports.
CONCLUSION
The GST demonstrated feasibility, a high completion rate, and minimal time commitment. It was an effective electronic reporting mechanism for patients, enabling the medical team to develop specific strategies for alleviating bothersome symptoms during follow-up.
Topics: Female; Genital Neoplasms, Female; Humans; Pain; Surveys and Questionnaires; Survivorship; Uterine Cervical Neoplasms
PubMed: 35239413
DOI: 10.1200/CCI.21.00154 -
Managing Genitourinary Syndrome of Menopause in Breast Cancer Survivors Receiving Endocrine Therapy.Journal of Oncology Practice Jul 2019Patients with breast cancer receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and... (Review)
Review
Patients with breast cancer receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM). GSM can decrease quality of life and is undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy because of unknown levels of systemic absorption of estradiol. In this article, we review the available literature for treatment of GSM in patients with breast cancer and survivors, including nonhormonal, vaginal hormonal, and systemic hormonal therapy options. First-line treatment includes nonhormonal therapy with vaginal moisturizers, lubricants, and gels. Although initial studies showed significant improvement in symptoms, the US Food and Drug Administration recently issued a warning against CO laser therapy for treatment of GSM until additional studies are conducted. In severe or refractory GSM, after discussing risks and benefits of vaginal hormonal therapy, the low-dose 10-μg estradiol-releasing intravaginal tablet or lower-dose 4 μg estrogen vaginal insert and intravaginal dehydroepiandrosterone (prasterone) are options for treatment, because studies show minimal elevation in serum estradiol levels and significant improvement in symptoms. The decision to offer vaginal estrogen therapy must be individualized and made jointly with the patient and her oncologist.
Topics: Aromatase Inhibitors; Breast Neoplasms; Cancer Survivors; Dehydroepiandrosterone; Estrogens; Female; Female Urogenital Diseases; Humans; Laser Therapy; Lubricants; Menopause; Syndrome; Testosterone
PubMed: 31291563
DOI: 10.1200/JOP.18.00710