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Breast Cancer Research and Treatment Oct 2023To analyze serum estradiol (E2) and estrone (E1) during letrozole treatment and their association to Quality of Life (QoL) and side-effects. (Clinical Trial)
Clinical Trial
Effects of letrozole on serum estradiol and estrone in postmenopausal breast cancer patients and tolerability of treatment: a prospective trial using a highly sensitive LC-MS/MS (liquid chromatography-tandem mass spectrometry) method for estrogen measurement.
PURPOSE
To analyze serum estradiol (E2) and estrone (E1) during letrozole treatment and their association to Quality of Life (QoL) and side-effects.
METHODS
Postmenopausal breast cancer patients starting adjuvant letrozole were eligible. Serum samples were taken at baseline, three, and 12 months. E2 and FSH were measured with routine chemiluminescent immunoassays. E2 and E1 were analyzed after trial completion with a highly sensitive liquid chromatography-tandem mass spectrometry method (LC-MS/MS) with lower limits of quantification (LLOQ) of 5 pmol/L. QoL was measured at baseline and at 12 months with the EORTC QLQ-C30 and QLQ-BR23 and the Women's Health questionnaires, and menopause-related symptoms with the modified Kupperman Index.
RESULTS
Of 100 screened patients 90 completed the trial. Baseline mean LC-MS/MS E2 and E1 were 12 pmol/L (range < 5-57) and 66 pmol/L (< 5-226), respectively. E2 levels measured by immunoassay and LC-MS/MS showed no correlation. E2 and E1 were completely suppressed by letrozole except for one occasion (E1 11 pmol/L at 3 months). Pain, side effects of systemic therapy, vasomotor symptoms, joint and muscle aches, and vaginal dryness increased during letrozole treatment. A high baseline E2 was significantly associated with increased aching joints and muscles, but not with the other side effects.
CONCLUSIONS
Letrozole supresses E2 and E1 completely below the LLOQ of the LC-MS/MS in postmenopausal women. High pre-treatment E2 levels were associated with more joint and muscle pain during letrozole. Automated immunoassays are unsuitable for E2 monitoring during letrozole therapy due to poor sensitivity.
Topics: Female; Humans; Breast Neoplasms; Chromatography, Liquid; Estradiol; Estrogens; Estrone; Letrozole; Postmenopause; Prospective Studies; Quality of Life; Tandem Mass Spectrometry
PubMed: 37491651
DOI: 10.1007/s10549-023-07054-3 -
Cureus Jun 2023Introduction The use of virgin coconut oil (VCO) as an over-the-counter (OTC) treatment for vaginal dryness and dyspareunia (VDD) in the general population has increased...
Virgin Coconut Oil in Paste Form as Treatment for Dyspareunia and Vaginal Dryness in Patients With and Without Rheumatic Autoimmune Diseases: An Efficacy and Safety Assessment Pilot Study.
Introduction The use of virgin coconut oil (VCO) as an over-the-counter (OTC) treatment for vaginal dryness and dyspareunia (VDD) in the general population has increased worldwide despite the absence of evidence-based studies supporting its efficacy. The principal objective of our pilot study was to scientifically validate the significant benefits and safety of using intra- and peri-vaginal application of VCO in paste form (VCOPF) for the treatment of VDD in patients with and without rheumatic autoimmune diseases (RAD). Additionally, multiple psychosocial, sexuality, and disease activity variables were also assessed. Methods A survey study of patients with chronic VDD, with and without RAD, treated with a single proprietary brand of VCOPF via the 'CocoRelief' protocol continuously for at least six months in an outpatient rheumatology practice setting. We evaluated the comparison of group characteristics, treatment outcomes, and satisfaction questions by Fisher's exact test or chi-square test for independence for categorical variables and two-sample t-tests for continuous variables. Results Of the 53 respondents, 31 (58%) had an RAD and 22 (42%) did not. Rheumatoid arthritis and primary Sjogren's syndrome comprised 75% of the RAD group. The non-RAD cohort had both a higher baseline mean of intercourse pain (on a scale of 0-5) before VCOPF use (4.4 (SD 1.1) vs 3.9 (SD 1.0) (p = 0.094)) and a higher mean intercourse pain after VCOPF (2.0 (SD 1.3) vs 1.3 (SD 1.1) (p = 0.039)). VDD decreased by 55% in the non-RAD and 66% in the RAD population. Although not statistically significant (p = 0.195), VCOPF was at worst comparable to estrogen-containing therapies (ECT). No adverse events (AE) were documented. Conclusion A high percentage of women with VDD, with and without RAD, needlessly continue to experience quality-of-life-altering physical and psychosocial morbidity due to the underutilization and lack of awareness of VCO-containing therapy. The small sample size, non-blinded, non-randomized, pilot platform, and the use of a non-validated assessment tool represent the principal limiting factors. This study revealed that VCOPF, when used in paste form via the CocoRelief protocol, provided statistically significant long-term VDD-related efficacy not inferior to ECT without AE in patients with and without RAD. VCOPF is, therefore, likely to be a useful, cost-effective alternative in a substantial percentage of patients with and without RAD, particularly in women hesitant to utilize ECT due to cost and/or fear of adverse effects.
PubMed: 37461787
DOI: 10.7759/cureus.40501 -
Cureus Jul 2023Introduction Sexual dysfunction is rarely studied in Indonesian patients with breast cancer. We aimed to assess the prevalence of sexual dysfunction symptoms following...
Introduction Sexual dysfunction is rarely studied in Indonesian patients with breast cancer. We aimed to assess the prevalence of sexual dysfunction symptoms following chemotherapy, as well as the pattern and the associated factors. Methods This cross-sectional study included 135 female breast cancer patients receiving primary chemotherapy. The present study measured the prevalence of sexual dysfunction symptoms using an e-questionnaire containing Common Toxicity Criteria for Adverse Events (CTCAE) version 4 at different time points. Other data included sociodemography, clinicopathology, treatment, and other concurrent symptom characteristics. Bivariate and multivariate logistic regression tests were used to analyze any association among variables. Results In the whole panel, 86 (63.7%) of 135 cases experienced sexual dysfunction. The most common symptom was vaginal dryness (45.9%), followed by decreased libido (45.2%), dyspareunia (13.3%), delayed orgasm (11.1%), and anorgasmia (8.9%). When observed at five different time points, the frequency of symptoms increased during chemotherapy and persisted until six months after completing treatment. Chemotherapy duration of >120 days was associated with a higher probability of vaginal dryness (p=0.012) and decreased libido (p=0.033). Spouse age ≥55 years old and body mass index (BMI) ≥23 kg/m were associated with a reduced probability of decreased libido (p=0.033 and 0.025, respectively). The presence of comorbidity was associated with a reduced probability of delayed orgasm (p=0.034). Conclusions A significant proportion of patients with breast cancer had sexual dysfunction following chemotherapy. Vaginal dryness, decreased libido, and dyspareunia were the commonest symptoms observed. Duration of chemotherapy, spouse age, BMI, and comorbidity were associated with the risk of sexual dysfunction occurrence.
PubMed: 37449290
DOI: 10.7759/cureus.41744 -
American Family Physician Jul 2023Menopausal symptoms are widespread and significantly impact quality of life. Common symptoms of menopause are vasomotor (i.e., hot flashes and night sweats) and...
Menopausal symptoms are widespread and significantly impact quality of life. Common symptoms of menopause are vasomotor (i.e., hot flashes and night sweats) and genitourinary (e.g., vulvovaginal irritation and dryness, dyspareunia, urinary problems), although women may also experience changes in sexual function, mood, and sleep. Estrogen-containing hormone therapy is effective treatment for vasomotor symptoms. Nonhormonal medications for vasomotor symptoms include selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and gabapentin. Selective serotonin reuptake inhibitors should not be administered to women taking tamoxifen. Cognitive behavior therapy and clinical hypnosis are effective for short-term reduction of vasomotor symptoms and associated sleep disturbances, but data are lacking to support the effectiveness of other nonpharmacologic treatments such as herbal or botanicalsupplements, exercise, and acupuncture. Hormone-free vaginal moisturizers are noninferior to estrogen-based therapies for treating genitourinary syndrome of menopause. Other treatment options for vaginal dryness and dyspareunia associated with menopause include ospemifene and intravaginal dehydroepiandrosterone. Management of menopausal symptoms should involve shared decision-making that is informed by the best available evidence and individual risks and preferences.
Topics: Female; Humans; Selective Serotonin Reuptake Inhibitors; Dyspareunia; Quality of Life; Menopause; Hot Flashes; Estrogens
PubMed: 37440735
DOI: No ID Found -
International Urogynecology Journal Nov 2023Collagen is a protein that confers robustness and resilience to several tissues. In the female reproductive system, collagen plays a critical role in maintaining the...
INTRODUCTION AND HYPOTHESIS
Collagen is a protein that confers robustness and resilience to several tissues. In the female reproductive system, collagen plays a critical role in maintaining the health and function of the vaginal walls. Aging leads to collagen reduction, which may cause vaginal dryness, irritation, and prolapse. We aim to analyze the structure and profile of collagen in the anterior vaginal wall of healthy pre-menopausal (pre-M) and post-menopausal (post-M) women under a scanning electron microscope (SEM).
METHODS
Fragments of the anterior vaginal wall were collected and processed for light and scanning electron microscopy. Histological preparations were performed at first with Weigert's resorcin-fuchsin stain. Decellularized preparations were conducted, and the specimens were placed under an SEM to allow observation of the 3D organization of collagen.
RESULTS
Decellularized preparations of the pre-M specimens showed a vaginal wall with an irregular subepithelial layer, organized with ECM projections. The subepithelium evidenced the network of collagen fibrils, which seemed to support the epithelium as a basal layer. In specimens of post-M, a fusion of a network of fibrils from different direction axes was evidenced, with plate formation observed in the subepithelial plane, disfiguring the structural organization of fibrils.
CONCLUSIONS
Older specimens showed a remodeling of collagen organization in comparison with younger samples of the anterior vaginal wall.
Topics: Female; Humans; Microscopy, Electron, Scanning; Collagen; Aging; Extracellular Matrix; Pelvic Organ Prolapse
PubMed: 37436435
DOI: 10.1007/s00192-023-05598-y -
Journal of Women's Health (2002) Sep 2023Cancer survivors are often reluctant to discuss sexual complaints with their oncologists and treatment is frequently unsatisfactory due to paucity of controlled studies... (Randomized Controlled Trial)
Randomized Controlled Trial
Comparable Efficacy of Submucosal Platelet-Rich Plasma and Combined Platelet-Rich Plasma Noncrosslinked Hyaluronic Acid Injections in Vulvovaginal Atrophy: A Cancer Survivorship Issue.
Cancer survivors are often reluctant to discuss sexual complaints with their oncologists and treatment is frequently unsatisfactory due to paucity of controlled studies and inapplicability of vaginal estrogen. We aimed to evaluate efficacy and tolerability of platelet-rich plasma (PRP) injections alone or in combination with noncrosslinked hyaluronic acid compared with standard therapy with topical hyaluronic acid gel in the management of cancer therapy-induced or aggravated vulvovaginal atrophy. This prospective, parallel-group comparative study was conducted on 45 female patients with a history of cancer and complaining of symptoms of vulvovaginal atrophy either induced or aggravated by cancer treatment. Patients were randomly divided into three groups (A, B, and C). Group A patients received two submucosal vaginal PRP injections, group B patients received two similar injections of PRP combined with noncrosslinked hyaluronic acid, and group C received a topical vaginal hyaluronic acid gel applied three times weekly for 2 months. Main outcome measures were vulvovaginal atrophy symptom severity and vaginal health index (VHI) scores before treatment (v0), 1 month from baseline (v1), 2 months from baseline (v2), and 3 months after the last visit (v3). Both groups A and B showed greater improvement of frequency of intercourse avoidance than group C. Group A showed greater improvement of dyspareunia than group C. Groups A and B demonstrated greater improvement of vaginal pH, fluid volume, and total VHI scores than group C. Short-term topical hyaluronic acid (HA) was not associated with any significant improvement of vaginal elasticity. Group B showed greater improvement of vaginal dryness and moisture scores than group C. Reported adverse events were injection-related pain in all patients of groups A and B and vaginal spotting in groups A and B. Both PRP and PRP-HA have comparable efficacy and patient-reported treatment satisfaction. PRP injections were better tolerated by patients than PRP-HA. Clinical trial registration number: NCT05782920.
Topics: Humans; Female; Hyaluronic Acid; Cancer Survivors; Treatment Outcome; Prospective Studies; Injections, Intra-Articular; Pain; Platelet-Rich Plasma; Atrophy; Neoplasms
PubMed: 37417970
DOI: 10.1089/jwh.2023.0144 -
Menopause (New York, N.Y.) Aug 2023The aim of the study is to describe the location, severity, and frequency of genitourinary symptoms in postmenopausal women enrolled in a randomized trial of treatment... (Randomized Controlled Trial)
Randomized Controlled Trial
The complexity of genitourinary syndrome of menopause: number, severity, and frequency of vulvovaginal discomfort symptoms in women enrolled in a randomized trial evaluating treatment for genitourinary syndrome of menopause.
OBJECTIVE
The aim of the study is to describe the location, severity, and frequency of genitourinary symptoms in postmenopausal women enrolled in a randomized trial of treatment for vulvovaginal discomfort.
METHODS
This is a post hoc analysis of enrollment responses for participants in the MsFLASH Vaginal Health Trial. Participants were asked about the severity (0-3), frequency (in days per week) and location (vulvar or vaginal) of itch, dryness, pain/soreness, irritation, as well as severity and frequency of pain with penetration, vaginal discharge, urinary incontinence, and urinary urgency.
RESULTS
A total of 302 participants were enrolled, with a mean age of 60.9 ± 4.1 years. The mean number of moderate-severe vulvovaginal symptoms experienced by trial participants in the month before enrollment was 3.4 ± 1.5, with a range from 1 to 7. The most commonly reported symptom across all severity categories was vaginal dryness (285/302, 94%), but the one most frequently rated as severe was pain with vaginal penetration (121/302, 40%). Vaginal dryness was the symptom with highest frequency; 53% of participants with that symptom reported experiencing it ≥4 d/wk. For vaginal symptoms, 80% of participants (241/302) reported that at least one of these symptoms occurred during or after sex while only 43% (158/302) reported that at least one vulvar symptom occurred during or after sex. Urinary incontinence (202/302, 67%) and urinary frequency (128/302, 43%) were the two most commonly reported urinary issues.
CONCLUSIONS
Our data highlight the complexity of genitourinary syndrome of menopause symptoms in quantity, severity, and frequency, suggesting that measuring distress, bother, or interference may be the most comprehensive measure.
Topics: Female; Humans; Middle Aged; Aged; Menopause; Vaginal Diseases; Vagina; Vulva; Urinary Incontinence; Atrophy
PubMed: 37402281
DOI: 10.1097/GME.0000000000002212 -
Mymensingh Medical Journal : MMJ Jul 2023Menopause is a normal physiological period that is characterized by the completely stoppage of endometrial cycles in women between the age of 45-55 years due to lack of...
Menopause is a normal physiological period that is characterized by the completely stoppage of endometrial cycles in women between the age of 45-55 years due to lack of ovarian follicular function. Several postmenopausal syndromes such as hot flushes, night sweats, vaginal dryness, depression, irritability, headache, and sleep disturbance can occur more frequently in this period which hampers the standard of life. This study was done to assess body mass index and fasting serum glucose changes in postmenopausal women in contrast with reproductive women. This cross-sectional analytical type of study was conducted in the Department of Physiology, Mymensingh Medical College, Bangladesh from January 2021 to December 2021. Total 140 women subject's age ranged between 25-65 years were involved in this study. Among them 25-45 years aged 70 (Seventy) reproductive women were involved as control group (Group I) and 45-65 years aged 70 (Seventy) postmenopausal women were taken as study group (Group II). By Anthropometric measurements, Body Mass Index (BMI) such as height and weight were taken in meter and kilogram respectively and fasting serum glucose was measured by GOD-PAP method. Results were expressed as mean (±SD) and by unpaired Student's 't' test, statistical significance of difference among the group was calculated. The mean±SD of BMI of Group I and Group II were 23.05±4.43kg/m² and 29.01±3.12kg/m² respectively. The mean±SD of body mass index is notably increase in study group in contrast with control group. The mean±SD of fasting serum glucose of control Group I and study Group II were 4.77±2.04mmol/l and 6.11±1.61mmol/l respectively. In study Group II fasting serum glucose was increased. Due to increased fasting serum glucose caused by lower level of female sex hormones specially estrogen hormone increased chance of cardiovascular diseases in postmenopausal women. Assessment of these parameters are important for early detection and prevention of complication related to high BMI and fasting serum glucose level for leading a better life.
Topics: Female; Humans; Middle Aged; Adult; Aged; Body Mass Index; Cross-Sectional Studies; Postmenopause; Fasting; Glucose
PubMed: 37391954
DOI: No ID Found -
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