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Medicine Jun 2024Flibanserin, approved for the treatment of hypoactive sexual desire disorder (HSDD) in females, has demonstrated diverse therapeutic and adverse effect (AE) prospects in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Flibanserin, approved for the treatment of hypoactive sexual desire disorder (HSDD) in females, has demonstrated diverse therapeutic and adverse effect (AE) prospects in the extant randomized controlled trials (RCTs). This meta-analysis aimed to characterize the outcomes of flibanserin use in these patients comprehensively.
METHODS
RCTs involving women with HSDD receiving flibanserin in the intervention arm and placebo in the control arm were sought after throughout the electronic databases. The primary outcomes were the changes from baseline in satisfying sexual events (SSE) per month and sexual desire score per month measured using an electronic diary (eDiary).
RESULTS
From 478 initially screened articles, data from 8 RCTs involving 7906 women with HSDD were analyzed. In premenopausal women, flibanserin 100 mg was superior to placebo in improving the number of SSE per month (mean difference, MD 0.69, 95% CI [0.39, 0.99]), eDiary sexual desire score (MD 1.71, 95% CI [0.43, 2.98]), Female Sexual Function Index (FSFI) desire domain (FSFI-d) score (MD 0.30, 95% CI [0.29, 0.31]), FSFI total score (MD 2.51, 95% CI [1.47, 3.55]), Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (MD -0.30, 95% CI [-0.31, -0.29]), and FSDS-R total score (MD -3.30, 95% CI [-3.37, -3.23]). Compared to placebo, a higher number of premenopausal women using flibanserin 100 mg achieved improvements in the Patient's Global Impression of Improvement score (OR 1.93, 95% CI [1.58, 2.36], P < .00001) and responded positively at Patient Benefit Evaluation (PBE) (odds ratio, OR 1.76, 95% CI [1.34, 2.31], P < .0001). Postmenopausal women receiving flibanserin 100 mg also benefited in terms of the number of SSE per month, FSFI-d and total scores, FSDS-R Item 13 and total scores, and PBE response. Although flibanserin use was associated with higher risks of dizziness, fatigue, nausea, somnolence, and insomnia, these adverse events were mild in nature; the serious AEs and severe AEs were comparable between the flibanserin and placebo groups.
CONCLUSION
While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of AEs.
Topics: Female; Humans; Benzimidazoles; Libido; Premenopause; Randomized Controlled Trials as Topic; Sexual Dysfunctions, Psychological; Treatment Outcome
PubMed: 38905407
DOI: 10.1097/MD.0000000000038592 -
Maturitas Jun 2024Globalization and international migration movements have massively changed the population structure of most industrial nations in recent decades. The ever-increasing... (Review)
Review
Menopause in a globalized world - A systematic literature review focussing on the challenge of health problems associated with menopausal transition among women with a migration background.
Globalization and international migration movements have massively changed the population structure of most industrial nations in recent decades. The ever-increasing proportion of people with a migration background also poses a challenge for the medical sector. A particular problem is the stressful phase of the menopausal transition, which - although not a pathological phenomenon but part of the female life history - can lead to psychological and physical symptoms due to hormonal changes, which significantly impair the quality of life of the women affected. However, treatment concepts, as well as access to medical facilities and information, are geared towards Western women from high-income countries. Women with a history of voluntary or forced migration originating from non-Western countries represent a particularly vulnerable group. To enable personalized treatment, studies on menopausal transition in women with a migration background are required. The present review shows that studies on menopausal women with a migration background have been conducted primarily in classic immigration countries such as the USA, Australia, or the UK, but that there is a lack of such studies in countries with no long tradition as an immigration country, such as Austria or Germany. This is becoming a growing problem, as the number of menopausal women with a migration background is increasing.
PubMed: 38870679
DOI: 10.1016/j.maturitas.2024.108045 -
BMC Psychiatry Jun 2024Depression is a prevalent mental health problem in postmenopausal women. Given its significant impact on the quality of life and overall well-being of postmenopausal... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Depression is a prevalent mental health problem in postmenopausal women. Given its significant impact on the quality of life and overall well-being of postmenopausal women, there is need for a comprehensive review and meta-analysis of the existing research globally. This systematic review and meta-analysis evaluated the global prevalence of depression and potential associated factors in postmenopausal women.
METHODS
The Cochrane Library, PubMed, EMBASE, Web of Science, MEDLINE, and PsycINFO databases were systematically searched from inception to March 22, 2023. The meta-analysis used the random-effects model to calculate the prevalence of depression rates and associated factors. In addition, subgroup analysis and sensitivity analysis were performed. Publication bias was assessed using funnel plots, Egger's test, and nonparametric trim-and-fill tests.
RESULTS
The meta-analysis included 50 studies that involved 385,092 postmenopausal women. The prevalence of depression in postmenopausal women was 28.00% (95% CI, 25.80-30.10). Among the factors relevant to depression among postmenopausal women, marital status (OR: 2.03, 95%CI: 1.33-3.11), history of mental illness (OR: 2.31, 95%CI: 1.50-3.57), chronic disease (OR: 3.13, 95%CI: 2.20-4.44), menstrual cycle (OR: 1.42, 95%CI: 1.17-1.72), abortion numbers (OR: 1.59, 95%CI: 1.40-1.80), menopausal symptoms (OR: 2.10, 95%CI: 1.52-2.90), and hormone replacement therapy (OR: 1.76, 95%CI: 1.31-2.35) were risk factors, while physical activity (OR: 0.56, 95%CI: 0.53-0.59), number of breastfed infants (OR: 0.43, 95%CI: 0.19-0.97), menopause age (OR: 0.44, 95%CI: 0.37-0.51) were preventive factors.
CONCLUSIONS
This study demonstrated that the prevalence of postmenopausal depression is high, and some risk factors and protective factors associated with it have been identified. It is necessary to improve screening and management and optimize prevention and intervention strategies to reduce the harmful effects of postmenopausal depression.
Topics: Humans; Postmenopause; Female; Prevalence; Risk Factors; Depression; Depressive Disorder
PubMed: 38858633
DOI: 10.1186/s12888-024-05875-0 -
BMC Pregnancy and Childbirth Jun 2024However, misoprostol is often used to terminate a pregnancy, but it can also cause side effects. Isosorbide mononitrate (ISMN) can help the cervix mature by increasing... (Meta-Analysis)
Meta-Analysis Comparative Study
Efficacy and safety of isosorbide mononitrate plus misoprostol compared to misoprostol alone in the management of the first and second trimester abortion: a systematic review and meta-analysis.
BACKGROUND
However, misoprostol is often used to terminate a pregnancy, but it can also cause side effects. Isosorbide mononitrate (ISMN) can help the cervix mature by increasing the production of prostaglandin E2 and vasodilation. Considering that the results of studies in this field are contradictory, it is the purpose of this study to evaluate the efficacy and safety of vaginal ISMN plus misoprostol compared to misoprostol alone in the management of first- and second-trimester abortions.
METHOD
The search process was conducted for MEDLINE through the PubMed interface, Scopus, Web-of-Science, Science Direct, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform until November 10, 2023. Our assessment of bias was based on version 2 of the risk-of-bias tool (RoB2) for randomized trials and our level of evidence quality was determined by GRADE. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1.
RESULT
Seven randomized clinical trials were included in the systematic review and three in the meta-analysis, with mixed quality. The results of the meta-analysis revealed that in the second-trimester abortion, the inclusion of ISMN in conjunction with vaginal misoprostol results in a noteworthy reduction in the induction abortion interval, specifically by 4.21 h (95% CI: -7.45 to -0.97, P = 0.01). The addition of vaginal ISMN to misoprostol, compared to vaginal misoprostol alone, increased the odds of a completed abortion by 3.76 times. (95% CI: 1.08 to 13.15, P = 0.04).
CONCLUSION
The findings of this study can offer valuable insights aimed at enhancing counseling and support for non-surgical methods of medication abortion within professional settings. Moreover, it improves the effectiveness of clinical treatment and reduces the occurrence of unnecessary surgical interventions in the abortion management protocol.
Topics: Humans; Misoprostol; Female; Pregnancy; Pregnancy Trimester, Second; Isosorbide Dinitrate; Abortion, Induced; Abortifacient Agents, Nonsteroidal; Pregnancy Trimester, First; Drug Therapy, Combination; Administration, Intravaginal; Treatment Outcome
PubMed: 38858628
DOI: 10.1186/s12884-024-06614-9 -
Breast Cancer Research and Treatment Jul 2024Vaginal oestrogens can be used to treat genitourinary symptoms in women with early breast cancer. Studies evaluating vaginal oestrogens have commonly measured serum...
PURPOSE
Vaginal oestrogens can be used to treat genitourinary symptoms in women with early breast cancer. Studies evaluating vaginal oestrogens have commonly measured serum oestrogen levels as a surrogate marker of safety, but methods vary. We sought to summarise the data on serum oestrogen measurement in women with breast cancer using vaginal oestrogens to better understand the methods, levels and reliability.
METHODS
We searched Medline, Embase, CENTRAL, SCOPUS and CINAHL from inception to October 2023 for clinical studies where serum oestrogen was measured in women with a history of early breast cancer using vaginal oestrogens. Studies with a reported testing methodology were included.
RESULTS
Nine studies met the inclusion criteria for this systematic review. Methods used to measure oestradiol and oestriol in selected studies included mass spectrometry and immunoassays; several studies used more than one with variable concordance. Mass spectrometry detected oestradiol levels down to a lower limit between 1.0 pg/mL and 3.0 pg/mL. Immunoassays such as ELISA (enzyme-linked immunosorbent assay), ECLIA (enhanced chemiluminiscence immunoassay) and RIA (radioimmunoassay) had lower detection limits ranging between 0.8 pg/mL and 10 pg/mL. Studies were heterogeneous in testing techniques used, timing of testing, and the population including with subsequent varying results in the effect on oestrogens reported.
CONCLUSIONS
Adopting consistent and standardised methods of measuring oestrogens in clinical trials involving women with early breast cancer on vaginal oestrogens is critical. Serum oestrogens are used as a surrogate marker of safety in this population, and good-quality data are necessary to enable clinicians and patients to feel confident in prescribing and taking vaginal oestrogens. Mass spectrometry, although more expensive, gives more reliable results when dealing with very low levels of oestrogens often found in women on aromatase inhibitors, compared to immunoassays.
Topics: Female; Humans; Administration, Intravaginal; Breast Neoplasms; Cancer Survivors; Estradiol; Estriol; Estrogens; Vagina
PubMed: 38780887
DOI: 10.1007/s10549-024-07364-0 -
Frontiers in Pharmacology 2024The CDK 4/6 inhibitors, including palbociclib and ribociclib, are the standard first-line treatment for hormone receptor-positive (HR+) and human epidermal growth factor...
BACKGROUND
The CDK 4/6 inhibitors, including palbociclib and ribociclib, are the standard first-line treatment for hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. Proton pump inhibitors are one of the most globally prescribed types of medications as part of the treatment for gastroesophageal reflux and heartburn complaints. Medication interactions have been demonstrated, leading to a decrease in the effectiveness of chemotherapy drugs such as capecitabine and pazopanib. However, their role and interaction with targeted therapies such as CDK inhibitors are still poorly understood.
METHODS
We searched PubMed, Embase and Web of Science databases for studies that investigated the use of PPI with CDK 4/6 inhibitors versus CDK4/6 alone for advanced or metastatic breast cancer. We systematically searched for the currently available CDK inhibitors: palbociclib, ribociclib and abemaciclib. We computed hazard ratios (HRs), with 95% confidence intervals (CIs). We used DerSimonian and Laird random-effect models for all endpoints. Heterogeneity was assessed using I statistics. R, version 4.2.3, was used for statistical analyses.
RESULTS
A total of 2,737 patients with advanced breast cancer in 9 studies were included, with six studies described the status menopausal as 217 (7.9%) pre-menopause and 1851 (67.6%) post-menopause, for endocrine sensitivity only five studies described1489 (54.4%) patients were endocrine-sensitive and 498 (182%) endocrine-resistent, 910 (33.2%) patients used PPIs. The overall Progression-Free Survival was in favor of the PPI non-users (HR 2.0901; 95% CI 1.410-2.9498; < 0.001). As well as the subgroup taking palbociclib, revealing statistical relevance for the PPI non-users (HR 2.2539; 95% CI 1.3213-3.8446; = 0.003) and ribociclib subgroup with a slight decrease in hazard ratio (HR 1.74 95% CI 1.02-2.97; = 0.04; I = 40%). In the multivariate analysis, there was no statistical signifance with ECOG (HR 0.9081; 95% CI 0.4978-16566; p 0.753) and Age (HR 1.2772; 95% CI 0.8790-1.8559; = 0.199). Either, the univariate analysis did not show statistical significance.
CONCLUSION
Women with HR+ and HER2-advanced metastatic breast undergoing treatment with targeted therapies, specifically CDK 4/6 inhibitors, should be monitored for the use of proton pump inhibitors. Therefore, the use of PPIs should be discussed, weighing the advantages and disadvantages for specific cases. It should be individualized based on the necessity in clinical practice for these cases.
SYSTEMATIC REVIEW REGISTRATION
identifier CRD42023484755.
PubMed: 38769999
DOI: 10.3389/fphar.2024.1352224 -
European Review For Medical and... May 2024Endometriosis means the presence of tissue similar to normal endometrium outside the uterus. Although surgical, hormonal, and analgesic treatment relieves symptoms and...
OBJECTIVE
Endometriosis means the presence of tissue similar to normal endometrium outside the uterus. Although surgical, hormonal, and analgesic treatment relieves symptoms and improves fertility, it is associated with side effects and a high recurrence rate. Alternative medicines like medicinal plants have been used for the treatment of chronic diseases. Given the global importance of endometriosis as a chronic disease affecting over 15% of all women in their fertile period, this systematic review aimed to give a comprehensive view of research on medicinal plants.
MATERIALS AND METHODS
Comprehensive searches were performed on three databases, including PubMed/MEDLINE, Web of Science Core Collection (Indexes = SCI-EXPANDED, SSCI, A, and HCI Timespan), and Scopus, to identify papers published until June 2023. Keywords, such as "Endometriosis" and "Herbal Medicine", were used to search. A manual search of valid journals followed by a manual search of the references of the retrieved full-text articles was performed. All retrieved articles were imported into a database into Endnote X9. Articles that did not meet the inclusion criteria were excluded from the study, and the full texts of all the articles that met the inclusion criteria were assessed. Studies that evaluated the effects of herbal compounds on various aspects of endometriosis treatment were included in the review.
RESULTS
In total, 11 studies were included in the present study. The evidence showed that in addition to safety, drugs available alongside treatments could play an effective role in improving the symptoms associated with endometriosis. In this study, the positive results of using Chinese treatments were reported in aspects such as fertility rate, pain, endometriosis recurrence rate, quality of life, sexual function, CA-125 level, and menopause symptoms.
CONCLUSIONS
A wide range of preclinical and clinical studies evaluated the effectiveness and safety of medicinal plants in the treatment of endometriosis symptoms. Thus, alternative treatments for endometriosis with no or low side effects should be included in the holistic treatment of endometriosis upfront. However, there is still a need for well-designed trials to investigate standard interventions and specific and safe doses of herbal medicines.
Topics: Endometriosis; Humans; Female; Plants, Medicinal; Phytotherapy; Plant Preparations
PubMed: 38766794
DOI: 10.26355/eurrev_202405_36182 -
Journal of Biomedical Research Apr 2024Menopause is characterized by various physical, mental and emotional symptoms. ERr 731 is a standardized extract from root and has been clinically studied for its role...
Menopause is characterized by various physical, mental and emotional symptoms. ERr 731 is a standardized extract from root and has been clinically studied for its role in reducing menopausal symptoms. The current systematic review and meta-analysis aimed to evaluate the efficacy of ERr 731 supplementation in alleviating the severity of menopausal symptoms. In this review, we searched across three online databases up to March 2023, evaluated the quality of the included studies by the Physiotherapy Evidence Database scale, and assessed the risk of bias by the Cochrane Risk of Bias tool. We then performed a meta-analysis using RevMan software to estimate the pooled mean difference (MD). The study protocol was registered in the Prospective Register of Systematic Reviews (CRD42023416808). After screening and evaluation, we included four high-quality studies (a total of 390 participants; the ERr 731 group: 193 participants; the control group: 197 participants) in the meta-analysis. The results showed that ERr 731 supplementation significantly reduced the Menopause Rating Scale score (MD: -15.12; < 0.001), compared with control therapy. Sensitivity analysis revealed no effect of individual studies on the overall pooled estimate or overall observed heterogeneity. The current review provides evidence that ERr 731 supplementation is effective in reducing menopause symptoms. Potential bias and high heterogeneity in the results warrant further clinical studies.
PubMed: 38646867
DOI: 10.7555/JBR.37.20230219 -
Journal of Affective Disorders Jul 2024For many women, menopause transition can be a period of emotional and physical changes, with different menopausal stages associated with varied risk for depressive... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
For many women, menopause transition can be a period of emotional and physical changes, with different menopausal stages associated with varied risk for depressive symptoms and diagnosis. This review aimed to conduct a systematic review and meta-analyses to provide an estimate for the risk of developing a) clinical depression and b) depressive symptoms at different menopausal stages.
METHODS
We searched Medline, PsycInfo, Embase and Web of Science from inception to July 2023. Seventeen prospective cohort studies with a total of 16061 women were included in the review, and risk of bias was assessed using the Quality in Prognosis Studies tool (QUIPS). Seven papers with a total of 9141 participants were included in meta-analyses, using random effects models and pooled odds ratios (OR) calculated for depressive symptoms and diagnoses.
RESULTS
Perimenopausal women were found to be at a significantly higher risk for depressive symptoms and diagnoses, compared to premenopausal women (OR = 1.40; 95 % CI: 1.21; 1.61, p < .001). We did not find a significantly increased risk for depressive symptoms or diagnoses in post-menopausal, compared to pre-menopausal women.
LIMITATIONS
Studies used different criteria to classify the menopausal stages and different measures for depression, which may have contributed to the heterogeneity seen in some models. We were unable to include a model that compared peri to post-menopause, due to a lack of longitudinal studies comparing the two stages.
CONCLUSIONS
The risk of depression in perimenopause, shown in an ethnically diverse sample; highlights the clinical need for screening and support in this potentially vulnerable group.
Topics: Humans; Female; Menopause; Depression; Risk Factors; Middle Aged; Perimenopause; Premenopause
PubMed: 38642901
DOI: 10.1016/j.jad.2024.04.041 -
Health Science Reports Apr 2024Menopause is one of the most significant stages in women's life. It is accompanied by many complications and a serious challenge. This study aimed to assess the...
BACKGROUND AND AIMS
Menopause is one of the most significant stages in women's life. It is accompanied by many complications and a serious challenge. This study aimed to assess the menopause experiences of Iranian women and compatibility strategies.
METHODS
We searched PubMed, Web of Science (ISI), Scopus, Ovid, and the Iranian Clinical Trial Registry and Magiran, SID, from January 1990 to January 2021.
RESULTS
Psychological effects, sexual disorders, physical problems, bone pain, insomnia, fatigue, and hot flashes are all menopause experiences. Cultural factors, lifestyle, social factors, education level, employment and economic status, marital status, and the number of pregnancies and births can influence this experience. It is important that menopausal women are aware how menopausal compatibility and prepare for this period. Many factors have affected menopausal adopting strategies. Negative emotions, negative attitudes, worry, and anxiety, and their psychological effects exacerbate the annoying experiences of menopause and decelerate menopausal adoption.
CONCLUSIONS
Social support and educational intervention were the practical menopausal adopting strategies. It will guarantee the health of menopausal women in the last third of their lives.
PubMed: 38633735
DOI: 10.1002/hsr2.1968