Preliminary results of a single-arm pilot study to assess the safety and efficacy of visnadine, prenylflavonoids and bovine colostrum in postmenopausal sexually active women affected by vulvovaginal atrophy

Laganà, Antonio Simone; Vitale, Salvatore Giovanni; Stojanovska, Lily; Lambrinoudaki, Ιrene; Apostolopoulos, Vasso; Chiofalo, Benito; Rizzo, Laura; F, Basile

doi:10.1016/j.maturitas.2017.12.015

Cited by 30 publications

(14 citation statements)

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“…Although menopause is a normal and natural physiological process in a woman's life, it can negatively affect [2,3] the one-third of their lifetime after menopause [4]. Studies have shown the negative impacts of menopausal symptoms on health-related quality of life (HRQOL) [5][6][7][8][9]. Almost all women experience multiple symptoms, such as hot flushes, sweats, sleep disorders, depression, and vaginal dryness.…”

Section: Introductionmentioning

confidence: 99%

The psychometric properties of the Persian menopause rating scale

et al. 2020

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Background: To measure the severity of menopausal complaints and determine the pattern of menopausal symptoms, a valid and reliable instrument is needed in women's healthcare. The Menopause Rating Scale (MRS) is one of the best-known tools in response to the lack of standardized scales. The purpose of this study was to examine the psychometric properties of the MRS in an Iranian example. Methods: Participants were randomly selected from women referred to healthcare centers in Miandoab, West Azerbaijan, Iran. A total of 330 questionnaires were completed (response rate of 96.9%). Two samples were considered for analysis in the validation process. An exploratory factor analysis (EFA) was conducted on the first sample (n 1 = 165), and a confirmatory factor analysis (CFA) was done using a second study sample (n 2 = 165). The psychometric properties process was concluded with assessment of internal consistency and test-retest reliability. Results: The EFA with Principal Component Analysis extracted three factors explaining 75.47% cumulative variance. The CFA confirmed a three-factor structure of the 11-items MRS. All fit indices proved to be satisfactory. The relative chi-square (χ2/df) was 3.686 (p < .001). The Root Mean Square Error of Approximation (RMSEA) of the model was .04 (90% CI = .105-.150). All comparative indices of the model, including the Comparative Fit Index, Normed Fit Index, and Relative Fit Index, were more than .80 (.90, .87, and .80, respectively). For the overall scale, Cronbach's alpha was .931, whereas the alpha for the subscales ranged from 0.705-0.950. The intraclass correlation was .91 (95% CI = .89-.93), p < 0.001. Conclusion: The results of the study indicate that the Persian model of the MRS is a valid and reliable scale. As a screening tool, the Persian MRS could be used to identify the pattern of symptoms among menopausal, premenopausal, and postmenopausal women to care for and educate them on how to identify and treat the symptoms.

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Section: Introductionmentioning

confidence: 99%

The psychometric properties of the Persian menopause rating scale

et al. 2020

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“…It has been estimated that between 15% and 25% of gynecologists in the United States perform office hysteroscopy and, thanks to an easy-to-improve learning curve, the amount of young and senior operators is still increasing [6]. Nonetheless, hysteroscopy plays a crucial role in the most challenging topics of women's health, from infertility diagnostic work-up [7,8] to post-menopausal abnormal uterine bleeding and uterine pathologies [9,10]. Currently, available technologies allow one to perform several diagnostic and operative procedures without the need for anesthesia and without any pain or distress for the patient [11,12].…”

Section: Introductionmentioning

confidence: 99%

Concordance between the Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

et al. 2019

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The goal of this paper is to assess the concordance between the clinical diagnosis of Endometrial Hyperplasia (EH), suspected by senior gynecologists throughout outpatient office hysteroscopy, and the results from histopathological examination, in order to evaluate hysteroscopic accuracy for EH. A prospective cohort study was done at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause and endometrial thickening in pre-or post-menopause. Patients underwent office hysteroscopy with a 5 mm continuous-flow hysteroscope, and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis. This study was approved by the local ethical and registered in the ClinicalTrials.gov registry (ID no. NCT03917147). In 424 cases, 283 clinical diagnoses of EH were determined by senior surgeons. A histopathological diagnosis was then confirmed in 165 cases (58.3%; p = 0.0001). Furthermore, 14 endometrial carcinoma and atypical hyperplasia were found. The sensitivity, positive predictive value, and negative predictive values for EH were, respectively, 90.4, 58.4, and 86.6%. Subdivided by clinical indication, the sensitivity was higher in patients with post-menopause endometrial thickening. The diagnostic accuracy of office hysteroscopy in the diagnosis and prediction of endometrial hyperplasia was high. Senior operators could foresee EHs in more than half the cases.

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“…40 Management strategies should include empowering women to participate in their care that will improve their sense of control and overall care, 41,42 together with exercise and diet recommendations, including isoflavones, calcium and vitamin D which may have favorable effects on menopausal symptoms and quality of life 43 and sexual health. 44 The gold standard treatment for women that seek control of their symptoms is hormone replacement therapy (HRT), but the optimal course of treatment is unclear due to mixed results from studies. 45,46 Initial interpretation of the Women's Health Initiative in the early 2000s saw a rapid decrease in HRT use, though current thinking appears to show that women under the age of 60 at the onset of menopause have a favorable risk-benefit profile when taking HRT for short-term relief of vasomotor symptoms.…”

Section: Resultsmentioning

confidence: 99%

<p>Healthcare Utilization and Prevalence of Symptoms in Women with Menopause: A Real-World Analysis</p>

Moser

Chodick²,

Bar-On³

et al. 2020

IJWH

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Self-reported studies estimated that as many as 50-75% of women experience symptoms during menopause; however, limited real-world clinical data are available to support this observation. The electronic databases of Maccabi Healthcare Services were used to describe the prevalence of menopause symptoms in Israel and to characterize patients with regard to socioeconomic status, comorbidities and use of healthcare services. Methods: Females aged 45-54 years diagnosed with menopausal symptoms (N=17,046, cumulative incidence of 8% during the study period) were identified from the Maccabi Healthcare Services electronic database and matched to female members without menopause symptoms, one-to-one on birth year and enumeration area. Results: Symptomatic peri-and post-menopausal women, and particularly those under 52 years, were more likely to have a higher prevalence of comorbid conditions such as depression, anxiety, osteoporosis and insomnia in the year following index. Correspondingly, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors and hypnotic drug use were significantly higher in symptomatic women as was healthcare utilization including hospitalization (OR=1.10; 95% CI=1.00-1.20), primary care visits (1.90; 1.73-2.08), gynecologist visits (24.84; 22.36-27.59) and hysterectomy procedures (2.26; 1.63-3.14). Conclusion: Medically documented menopausal symptoms are associated with increased burden of disease (particularly among women diagnosed with menopausal symptoms prior to age 52 years), healthcare utilization and greater likelihood of undergoing hysterectomy within one year of diagnosis. This burden is expected to rise further as awareness and social acceptance of peri-and post-menopausal symptoms increase.

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Preliminary results of a single-arm pilot study to assess the safety and efficacy of visnadine, prenylflavonoids and bovine colostrum in postmenopausal sexually active women affected by vulvovaginal atrophy

Cited by 30 publications

References 5 publications

The psychometric properties of the Persian menopause rating scale

The psychometric properties of the Persian menopause rating scale

Concordance between the Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

<p>Healthcare Utilization and Prevalence of Symptoms in Women with Menopause: A Real-World Analysis</p>

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