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Wednesday, July 31, 2019

Menopause

Sexual pain in the menopausal patient: individualizing treatment still best
No abstract available

Understanding the unmet sexual health needs of women with breast cancer
No abstract available

Vaginal laser treatment—first, do no harm
No abstract available

Sexual frequency and pain in a randomized clinical trial of vaginal estradiol tablets, moisturizer, and placebo in postmenopausal women
imageObjective: To evaluate the efficacy of two common interventions for bothersome postmenopausal vaginal symptoms on improving sexual frequency and pain. Methods: This is a post-hoc analysis of data from a 12-week double-blind placebo-controlled trial that randomized postmenopausal women (ages 45-70 years) with moderate-severe genitourinary discomfort to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), placebo tablet plus vaginal moisturizer (n = 100), or dual placebo (n = 100). Outcomes were proportion of sexually active women at 12 weeks, frequency of sexual activity, and pain severity with sexual activity (0-3 scale). Consistent with the original study design, comparisons were made between each active arm and the dual placebo arm. Results: Most women enrolled in the trial, 294/302 (97%), had sufficient data to be included in this analysis. Mean age of participants was 61 years, most were white (88%), college educated (66%), and most reported sexual activity in the month before enrollment (81%). After 12 weeks of treatment, a similar proportion of women in the vaginal estrogen and dual placebo groups reported sexual activity in the past week (50% and 40%; P = 0.10) and the past month (78% and 84%, P = 0.52). Mean (standard deviation) pain with sexual activity scores at 12 weeks were similar between vaginal estrogen (1.0 [1.0]) and placebo (0.9 [0.9], P = 0.52] groups. The proportion sexually active at 12 weeks (35%) and mean (standard deviation) pain severity in the vaginal moisturizer group (1.1 [0.9]) did not differ from placebo (P = 0.36). Conclusions: Compared to placebo, neither low-dose vaginal estradiol nor vaginal moisturizer treatment over 12 weeks resulted in significantly greater increases in the proportions of women reporting sexual activity or improvement in pain scores with sexual activity. Trial registration: Clinical trials.gov: NCT02516202.

Partner status moderates the relationships between sexual problems and self-efficacy for managing sexual problems and psychosocial quality-of-life for postmenopausal breast cancer survivors taking adjuvant endocrine therapy
imageObjective: Past studies indicate that >90% of breast cancer survivors taking adjuvant endocrine therapy (AET) experience menopausal symptoms including sexual problems (eg, vaginal dryness, dyspareunia); however, research examining the impact of these problems on quality-of-life is limited. This cross-sectional study examined (1) the impact of sexual problems and self-efficacy for coping with sexual problems (sexual self-efficacy) on quality-of-life (ie, psychosocial quality-of-life and sexual satisfaction), and (2) partner status as a moderator of these relationships. Methods: Postmenopausal breast cancer survivors taking AET completed measures of sexual problems (Menopause-Specific Quality-of-Life [MENQOL] sexual subscale], sexual self-efficacy, psychosocial quality-of-life (MENQOL psychosocial subscale), and sexual satisfaction (Functional Assessment of Cancer Therapy-General item). Results: Bivariate analyses showed that women reporting greater sexual problems and lower sexual self-efficacy had poorer quality-of-life and less sexual satisfaction (all P-values < 0.05). Partner status moderated the relationship between sexual problems and psychosocial quality-of-life (P = 0.02); at high levels of sexual problems, unpartnered women experienced poorer psychosocial quality-of-life than partnered women. Partner status also moderated the relationship between self-efficacy and psychosocial quality-of-life (P = 0.01). Self-efficacy was unrelated to psychosocial quality-of-life for partnered women; for unpartnered women, low self-efficacy was associated with poorer quality-of-life. Partner status did not moderate the relationships between sexual problems or self-efficacy with sexual satisfaction. Conclusions: Greater sexual problems and lower sexual self-efficacy were associated with poorer psychosocial quality-of-life and sexual satisfaction among postmenopausal breast cancer survivors taking AET. Interventions to address sexual problems and sexual self-efficacy, particularly among unpartnered women, may be beneficial for improving the well-being of postmenopausal breast cancer survivors on AET.

Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial
imageObjective: The aim of this study was to compare the effects of fractional CO2 laser therapy, promestriene, and vaginal lubricants on genitourinary syndrome treatment and sexual function in postmenopausal women. Methods: We performed a randomized clinical trial including 72 postmenopausal women over the age of 50 years. The women were randomized into three intervention groups to receive one of the following treatments: three sessions of intravaginal fractional CO2 laser therapy; 10 mg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone. Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI) were evaluated at baseline and after 14 weeks of therapy. Results: We observed an improvement in the vaginal elasticity, volume, moisture, and pH in the CO2 laser and promestriene groups. The VHI score at 14 weeks was higher in the CO2 laser group (mean score 18.68) than in the promestriene (15.11) and lubricant (10.44) groups (P < 0.001). Regarding vaginal maturation, basal cells were reduced and superficial cells were increased after treatment. This improvement was more significant in the CO2 laser group (P <0.001). The FSFI score only showed improvement in the desire and lubrication domains in the CO2 laser group. There were no differences in total FSFI score among the three treatment groups. There were no adverse effects associated with any of the treatments. Conclusions: The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.

Women's Health Initiative clinical trials: potential interactive effect of calcium and vitamin D supplementation with hormonal therapy on cardiovascular disease
imageObjective: Data in humans and nonhuman primates have suggested a possible synergistic effect of vitamin D and calcium (CaD) and estrogen on the cardiovascular disease (CVD) risk factors. Using randomized trial data we explored whether the effect of menopausal hormone therapy (HT) on CVD events is modified by CaD supplementation. Methods: A prospective, randomized, double-blind, placebo-controlled trial was implemented among postmenopausal women in the Women's Health Initiative. A total of 27,347 women were randomized to the HT trials (0.625 mg/d of conjugated equine estrogens [CEE] alone for women without a uterus vs placebo; or 0.625 mg of CEE in addition to 2.5 mg of medroxyprogesterone acetate daily [CEE + MPA] for women with a uterus vs placebo). After 1 year, 16,089 women in the HT trial were randomized to the CaD trial and received either 1,000 mg of elemental calcium carbonate and 400 IU of vitamin D3 daily or placebo. The mean (SD) duration of follow-up after CaD randomization was 6.2 (1.3) years for the CEE trial and 4.6 (1.1) years for the CEE + MPA trial. CVD and venous thromboembolism events evaluated in this subgroup analysis included coronary heart disease, stroke, pulmonary embolism, all-cause mortality, plus select secondary endpoints (total myocardial infarction, coronary revascularization, deep venous thrombosis, cardiovascular death, and all CVD events). Time-to-event methods were used and models were fit with a Cox proportional hazards regression model. Results: In the CEE trial, CaD significantly modified the effect of CEE on stroke (P interaction = 0.04). In the CaD-placebo group, CEE's effect on stroke was harmful (hazard ratio [95% confidence interval] = 2.19[1.34-3.58]); however, it was neutral in the CaD-supplement group (hazard ratio [95% confidence interval] = 1.07[0.66-1.73]). We did not observe significant CEE-CaD interactions for coronary heart disease, total CVD events, or any of the remaining endpoints. In the CEE + MPA trial, there was no evidence that the effect of CEE + MPA on any of CVD endpoints was modified by CaD supplementation. Conclusions: CaD did not consistently modify the effect of CEE therapy or CEE + MPA therapy on CVD events. However, the increased risk of stroke due to CEE therapy appears to be mitigated by CaD supplementation. In contrast, CaD supplementation did not influence the risk of stroke due to CEE + MPA.

Confirmatory factor analysis of the Insomnia Severity Index (ISI) and invariance across race: a pooled analysis of MsFLASH data
imageObjective: Women's sleep at menopause is widely reported to be problematic. The Insomnia Severity Index (ISI) is a commonly used tool for quantifying sleep problems in clinical and research settings, but psychometric properties in postmenopausal women have not been reported. Our study aim was to examine the factor structure of the ISI in a large and diverse sample of midlife women with hot flashes. Methods: Baseline data were from 899 women enrolled in one of the three clinical trials using similar entry criteria conducted by the Menopause Strategies Finding Lasting Answers to Symptoms and Health research network. We conducted confirmatory factor analyses for the total sample and within strata defined by race/ethnicity (black and white women). Results: The ISI had two factors in the total sample. The two-factor structure was consistent across black and white women, with the exception of one item "difficulty falling asleep." Conclusions: The ISI in midlife women with hot flashes is composed of two factors that capture dimensions of the insomnia severity and daytime impact. The instrument is a psychometrically sound scale appropriate for use in research and clinical practice to capture the severity and daytime impact of insomnia symptoms in diverse samples of midlife women with hot flashes. An abbreviated screening of two items could be considered to determine if further evaluation is needed of sleep complaints.

Accuracy of the Menopause Rating Scale and the Menopause Quality of Life Questionnaire to discriminate menopausal women with anxiety and depression
imageObjective: The aim of the study was to evaluate the accuracy of the Menopause Rating Scale (MRS) and the Menopause Quality of Life Questionnaire (MENQOL) to discriminate women suffering from anxiety (AD) and depression disorder (DD). Methods: A cohort of 416 women aged 45 to 65 years (51.7 ± 3.8) completed the MRS, MENQOL and Hospital Anxiety and Depression Scale, plotting receiver operator curves to assess the diagnostic accuracy of the MRS and MENQOL items related to anxiety and depression. Results: Both the MRS6 (area under the ROC curve [AUC] 0.773, 95% confidence interval [CI] 0.721-0.824) and MENQOL5 (AUC: 0.772, 95% CI 0.723-0.822) proved to be accurate tools to identify individuals with anxiety or with a likelihood to develop AD. Likewise, the items MRS4 (AUC: 0.771, 95% CI 0.625-0.797) and MENQOL8 (AUC: 0.744, 95% CI 0.668-0.821) appeared to be suitable to discriminate individuals with DD. Two cut-off points were established for each item in the different scales to optimize their capacity to detect and discriminate problems of anxiety and depression. Lower cut-off values (MRS ≥ 1; MENQOL ≥ 2) were established to detect AD and DD, the sensitivity of which varied between 76.0% and 84.6%% and a negative predictive value varying between 86.7% and 95.3%. A more specific cut-off was established for the discrimination of AD and DD (MRS ≥ 2; MENQOL ≥ 7), with a specificity ranging from 86.2% to 99.4% and a positive predictive value varying between 68.6% and 92.6%. Conclusions: The MRS and MENQOL display moderate accuracy in discriminating menopausal women with symptoms of anxiety and depression. The intensity of the symptoms appears to be related to the probability of detecting a probable or definitive disorder.

Tamoxifen use as a malignancy risk factor in postmenopausal women with endometrial polyps
imageObjective: We analyzed tamoxifen use as a malignancy risk factor in women with endometrial polyps. Methods: This retrospective study included 675 women who underwent hysteroscopic polypectomy in 2010 to 2015 at the University of Campinas. Women were divided into tamoxifen use (n = 169) and no tamoxifen use (n = 506) groups. The primary outcome was endometrial cancer prevalence. Dependent variables included age, parity, years since menopause, presence of abnormal uterine bleeding, endometrial pattern on hysteroscopy, and endometrial thickness. Results: There were seven cases of endometrial cancer in the tamoxifen use group (4.14%) and 41 in the no tamoxifen use group (8.1%; P = 0.083). On performing multivariate analysis, tamoxifen use was not a risk factor for endometrial cancer (prevalence ratio 0.51, 95% confidence interval [CI] 0.23-1.14, P = 0.101). The no tamoxifen use group had an increased prevalence of malignancy when women presented with abnormal uterine bleeding (prevalence ratio 3.9, 95% CI 2.08-7.29, P < 0.001), age >60 years (prevalence ratio 2.1, 95% CI 1.12-3.93, P = 0.021), or nulliparous status (prevalence ratio 3.13, 95% CI 1.55-6.35, P = 0.002). The tamoxifen use group had increased prevalence of malignancy when women were >60 years (prevalence ratio 7.85, 95% CI 1.05-58.87, P = 0.006) or nulliparous (prevalence ratio 8.36, 95% CI 2.32-30.11, P < 0.001). Conclusion: Tamoxifen use was not related with a higher prevalence of endometrial cancer in women with endometrial polyps. Abnormal uterine bleeding, age > 60 years, and nulliparous status were associated with malignancy.

Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos
Crete.Greece.72100
2841026182
6948891480

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