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Climacteric : the Journal of the... Jun 2024This systematic review and meta-analysis investigated the efficacy and safety of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis investigated the efficacy and safety of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. PubMed, Cochrane Library, Embase and Web of Science were searched for randomized controlled trials (RCTs) published from inception to June 2023, comparing fezolinetant to placebo in postmenopausal women suffering from moderate-to-severe VMS. The mean difference and risk ratio were calculated for continuous and binary outcomes, respectively. R software was used for the statistical analysis, and RoB-2 (Cochrane) to assess the risk of bias. We performed subgroup analysis based on different dosing regimens. Five RCTs comprising 3302 patients were included. Compared with placebo, at 12-week follow-up, fezolinetant significantly reduced the daily frequency of moderate-to-severe VMS (weighted mean difference [WMD] - 2.36; 95% confidence interval [CI] - 2.92, -1.81) and daily severity of moderate-to-severe VMS (WMD -0.22; 95% CI -0.31, -0.13). Also, fezolinetant significantly improved the quality of life (WMD -0.42; 95% CI -0.58, -0.26) and sleep disturbance (WMD -1.10; 95% CI -1.96, -0.24). There were no significant differences between groups in adverse events. These findings support the efficacy and safety of fezolinetant for the treatment of VMS related to menopause.
Topics: Humans; Female; Hot Flashes; Menopause; Randomized Controlled Trials as Topic; Middle Aged; Treatment Outcome; Vasomotor System; Quality of Life
PubMed: 38619017
DOI: 10.1080/13697137.2024.2334083 -
AIMS Public Health 2024The increasing lifespan of women and their extended time spent in menopause pose significant challenges for health care systems, primarily due to the impacts of... (Review)
Review
The increasing lifespan of women and their extended time spent in menopause pose significant challenges for health care systems, primarily due to the impacts of postmenopausal estrogen deficiency and aging on health. Menopause's onset is linked to a heightened prevalence of obesity, metabolic syndrome, cardiovascular disease, and osteoporosis. Diet is particularly relevant during menopause given its impact on quality of life and longevity and its modifiability. Because the Mediterranean diet is currently regarded as one of the healthiest dietary models in the world, the aim of this systematic review was to assess current evidence regarding the effectiveness of studies on the Mediterranean diet as an intervention for menopausal women. A systematic review of intervention-based studies involving the Mediterranean diet among menopausal women was performed in Scopus, PubMed, and Web of Science. The results of seven that met the inclusion criteria suggests that adherence to the Mediterranean diet can have beneficial impacts on menopausal women's health, including reductions in weight, blood pressure, blood ω6: ω3 ratio, triglycerides, total cholesterol, and LDL levels. Those results seem to be relevant for public health interventions aimed at improving menopausal women's quality of life.
PubMed: 38617417
DOI: 10.3934/publichealth.2024005 -
Quality of Life Research : An... Apr 2024To verify the effects of Pilates exercises on health-related quality of life (HRQoL) in postmenopausal women. (Review)
Review
OBJECTIVE
To verify the effects of Pilates exercises on health-related quality of life (HRQoL) in postmenopausal women.
METHODS
A systematic search was conducted in the following databases: PubMed, Embase, CENTRAL, CINAHL, Web of Science, LILACS, SportDiscus, Scielo, and PEDro. Randomized clinical trials (RCTs) that intervened with Pilates and had HRQoL as an outcome were eligible. The methodological quality of each RCT was assessed using the PEDro scale and the certainty of the evidence using the GRADE system. Meta-analyses were conducted by standardized mean difference (SMD).
RESULTS
Initially, 760 records were located. After screening, 11 RCTs were included in the systematic review. Five studies presented low risk of bias (PEDro score ≥ 6). Evidence of very low to moderate certainty demonstrated significant effects in favor of Pilates exercises vs control groups for five of the nine HRQoL domains analyzed: bodily pain (SMD = 0.96), physical functioning (SMD = 0.85), social functioning (SMD = 0.45), role physical (SMD = 0.79), and role emotional (SMD = 0.61). Subgroup analyzes demonstrated that Pilates had a positive impact on more domains whens administered for ≥ 48 sessions (eight domains) vs < 48 sessions (three domains); and when administered on equipment (seven domains) vs mat (three domains).
CONCLUSION
Pilates exercises, in general, allowed significant effects to improve HRQoL in postmenopausal women, especially when performed on equipment and when administered for at least 48 sessions. However, no analysis showed high certainty of evidence, and more RCTs of high methodological quality are needed to confirm these findings.
PubMed: 38602630
DOI: 10.1007/s11136-024-03651-x -
Menopause (New York, N.Y.) May 2024Physical activity during menopause can be effective in reducing the physiological changes associated with reproductive aging that increase risks for noncommunicable...
IMPORTANCE
Physical activity during menopause can be effective in reducing the physiological changes associated with reproductive aging that increase risks for noncommunicable diseases, yet many women do not meet the recommendations for physical activity.
OBJECTIVE
This study aimed to synthesize factors influencing physical activity for women across menopausal transition phases using a socioecological approach.
EVIDENCE REVIEW
The Preferred Reporting Items for Systematic Reviews and Meta-Analysis was used to systematically search 10 databases between 2001 and 2021. A comprehensive search strategy was used to identify studies on physical activity of women in various stages of menopause. A socioecological model was used to categorize the reported barriers and enablers.
FINDINGS
Twenty studies met the inclusion criteria. The findings highlight several intrapersonal barriers such as existing health complaints versus enablers such as awareness of the health benefits of physical activity during menopause. Ensuring women's safety, preventing injury, and enhancing exercise self-efficacy were important components of programs. Social support was also an important enabler of women's engagement in activities.
CONCLUSIONS AND RELEVANCE
Several barriers and enablers were identified and can inform practitioners and future interventions to encourage physical activity among women in various stages of menopause. For instance, when encouraging physical activity during menopause, practitioners should consider other health complaints, safety, and injury prevention while discussing the benefits of physical activity related to managing menopausal symptoms. There was a lack of theoretically informed studies exploring the barriers and enablers to physical activity for women in various stages of menopause; thus, research designs may not have fully accounted for influences. Future research that combines socioecological and individual theories of behavior is needed to comprehensively understand the complexity of physical activity among women across the menopausal transition.
Topics: Humans; Female; Exercise; Menopause; Social Support; Women's Health; Middle Aged; Self Efficacy
PubMed: 38595173
DOI: 10.1097/GME.0000000000002337 -
The Cochrane Database of Systematic... Apr 2024Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Etidronate belongs to the bisphosphonate class of drugs... (Review)
Review
BACKGROUND
Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Etidronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts - bone cells that break down bone tissue. This is an update of a Cochrane review first published in 2008. For clinical relevance, we investigated etidronate's effects on postmenopausal women stratified by fracture risk (low versus high).
OBJECTIVES
To assess the benefits and harms of intermittent/cyclic etidronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.
SEARCH METHODS
We searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE, Embase, two clinical trial registers, the websites of drug approval agencies, and the bibliographies of relevant systematic reviews. We identified eligible trials published between 1966 and February 2023.
SELECTION CRITERIA
We included randomized controlled trials that assessed the benefits and harms of etidronate in the prevention of fractures for postmenopausal women. Women in the experimental arms must have received at least one year of etidronate, with or without other anti-osteoporotic drugs and concurrent calcium/vitamin D. Eligible comparators were placebo (i.e. no treatment; or calcium, vitamin D, or both) or another anti-osteoporotic drug. Major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events. We classified a study as secondary prevention if its population fulfilled one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (≤ -2.5), or aged 75 years or older. If none of these criteria were met, we considered the study to be primary prevention.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. The review has three main comparisons: (1) etidronate 400 mg/day versus placebo; (2) etidronate 200 mg/day versus placebo; (3) etidronate at any dosage versus another anti-osteoporotic agent. We stratified the analyses for each comparison into primary and secondary prevention studies. For major outcomes in the placebo-controlled studies of etidronate 400 mg/day, we followed our original review by defining a greater than 15% relative change as clinically important. For all outcomes of interest, we extracted outcome measurements at the longest time point in the study.
MAIN RESULTS
Thirty studies met the review's eligibility criteria. Of these, 26 studies, with a total of 2770 women, reported data that we could extract and quantitatively synthesize. There were nine primary and 17 secondary prevention studies. We had concerns about at least one risk of bias domain in each study. None of the studies described appropriate methods for allocation concealment, although 27% described adequate methods of random sequence generation. We judged that only 8% of the studies avoided performance bias, and provided adequate descriptions of appropriate blinding methods. One-quarter of studies that reported efficacy outcomes were at high risk of attrition bias, whilst 23% of studies reporting safety outcomes were at high risk in this domain. The 30 included studies compared (1) etidronate 400 mg/day to placebo (13 studies: nine primary and four secondary prevention); (2) etidronate 200 mg/day to placebo (three studies, all secondary prevention); or (3) etidronate (both dosing regimens) to another anti-osteoporotic agent (14 studies: one primary and 13 secondary prevention). We discuss only the etidronate 400 mg/day versus placebo comparison here. For primary prevention, we collected moderate- to very low-certainty evidence from nine studies (one to four years in length) including 740 postmenopausal women at lower risk of fractures. Compared to placebo, etidronate 400 mg/day probably results in little to no difference in non-vertebral fractures (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.20 to 1.61); absolute risk reduction (ARR) 4.8% fewer, 95% CI 8.9% fewer to 6.1% more) and serious adverse events (RR 0.90, 95% CI 0.52 to 1.54; ARR 1.1% fewer, 95% CI 4.9% fewer to 5.3% more), based on moderate-certainty evidence. Etidronate 400 mg/day may result in little to no difference in clinical vertebral fractures (RR 3.03, 95% CI 0.32 to 28.44; ARR 0.02% more, 95% CI 0% fewer to 0% more) and withdrawals due to adverse events (RR 1.41, 95% CI 0.81 to 2.47; ARR 2.3% more, 95% CI 1.1% fewer to 8.4% more), based on low-certainty evidence. We do not know the effect of etidronate on hip fractures because the evidence is very uncertain (RR not estimable based on very low-certainty evidence). Wrist fractures were not reported in the included studies. For secondary prevention, four studies (two to four years in length) including 667 postmenopausal women at higher risk of fractures provided the evidence. Compared to placebo, etidronate 400 mg/day may make little or no difference to non-vertebral fractures (RR 1.07, 95% CI 0.72 to 1.58; ARR 0.9% more, 95% CI 3.8% fewer to 8.1% more), based on low-certainty evidence. The evidence is very uncertain about etidronate's effects on hip fractures (RR 0.93, 95% CI 0.17 to 5.19; ARR 0.0% fewer, 95% CI 1.2% fewer to 6.3% more), wrist fractures (RR 0.90, 95% CI 0.13 to 6.04; ARR 0.0% fewer, 95% CI 2.5% fewer to 15.9% more), withdrawals due to adverse events (RR 1.09, 95% CI 0.54 to 2.18; ARR 0.4% more, 95% CI 1.9% fewer to 4.9% more), and serious adverse events (RR not estimable), compared to placebo. Clinical vertebral fractures were not reported in the included studies.
AUTHORS' CONCLUSIONS
This update echoes the key findings of our previous review that etidronate probably makes or may make little to no difference to vertebral and non-vertebral fractures for both primary and secondary prevention.
Topics: Humans; Female; Osteoporotic Fractures; Etidronic Acid; Wrist Fractures; Secondary Prevention; Calcium; Postmenopause; Osteoporosis; Spinal Fractures; Hip Fractures; Vitamin D; Wrist Injuries
PubMed: 38591743
DOI: 10.1002/14651858.CD003376.pub4 -
Archives of Gynecology and Obstetrics Jun 2024The effect of platelet-rich plasma (PRP) on ovarian reserve markers in poor ovarian response (POR) is challenging. (Meta-Analysis)
Meta-Analysis Review
CONTEXT
The effect of platelet-rich plasma (PRP) on ovarian reserve markers in poor ovarian response (POR) is challenging.
AIM
This systematic review and meta-analysis was, therefore, designed to evaluate the effectiveness of intra-ovarian injection of autologous PRP on improving ovarian reserve markers and assisted reproductive technology (ART) outcomes in infertile women with POR.
METHODS
A systematic search was conducted for the efficacy of intra-ovarian injection of autologous PRP on the improvement of ovarian reserve markers and ART outcomes in infertile women with POR. The methodological quality of the included studies was checked and eligible studies were included in the meta-analysis to find pooled results. Keywords were primary ovarian insufficiency, premature menopause, poor responder, poor ovarian response, diminished/decreased ovarian reserve, platelet-rich plasma, and intra-ovarian or a combination of them. The effect of PRP on fertility indices was evaluated using the standardized mean difference (SMD). The analysis was performed through STATA version 13.
KEY RESULTS
13 studies containing 1289 patients were included. Mean age, body mass index (BMI) and duration of infertility was 37.63 ± 2.66 years, 24 ± 1.23 kg/m and 4.79 ± 1.64 years, respectively. Most of the studies measured the outcomes 2-3/3 months after intra-ovarian injection of autologous PRP. The antral follicular count (AFC) after treatment by PRP is higher with an SMD of 0.95 compared to before treatment. The day 3 follicle-stimulating hormone (FSH) after treatment by PRP is lower with an SMD of - 0.25 compared to before treatment. The day 3 estradiol (E2) after treatment by PRP is higher with an SMD of 0.17 compared to before treatment. The anti-Mullerian hormone (AMH) after treatment by PRP is higher with an SMD of 0.44 compared to before treatment. The total oocytes number after treatment by PRP is higher with an SMD of 0.73 compared to before treatment. The number of MII oocytes after treatment by PRP is higher with an SMD of 0.63 compared to before treatment. The number of cleavage-stage embryos after treatment by PRP is higher with an SMD of 1.31 compared to before treatment. The number of day 5 embryo after treatment by PRP is higher with an SMD of 1.28 compared to before treatment. Pooled estimation of a meta-analysis of prevalence studies reported a prevalence of 22% for clinical pregnancy, 5% for spontaneous pregnancy and 21% for ongoing pregnancy following PRP therapy.
CONCLUSION
Intra-ovarian injection of PRP improved ovarian reserve markers with increasing AFC, serum level of AMH and day 3 E2 and decreasing serum level of day 3 FSH. In addition, this treatment improved ART outcomes through the increasing of number total oocytes, number of MII oocytes, number of cleavage-stage embryos and number of day 5 embryos in POR women.
IMPLICATIONS
Although treatment of POR women remains challenging, the use of intra-ovarian injection of autologous PRP in POR patients prior to IVF/ICSI cycles is a sign of new hope for increasing the success of IVF/ICSI. However, further well-organized, randomized controlled trials should be conducted to substantiate this result and recommend intra-ovarian injection of PRP as part of routine treatment in women with POR.
Topics: Humans; Platelet-Rich Plasma; Female; Ovarian Reserve; Infertility, Female; Ovulation Induction; Pregnancy; Ovary; Pregnancy Rate; Treatment Outcome; Injections; Anti-Mullerian Hormone; Reproductive Techniques, Assisted
PubMed: 38589612
DOI: 10.1007/s00404-024-07442-0 -
Neurourology and Urodynamics Jun 2024Although antibiotic prophylaxis (AB) demonstrated a statistically significant reduction in bacteriuria after invasive urodynamics (UDS), no significant decrease in the...
INTRODUCTION
Although antibiotic prophylaxis (AB) demonstrated a statistically significant reduction in bacteriuria after invasive urodynamics (UDS), no significant decrease in the incidence of urinary tract infections (UTI) has been confirmed. No absolute recommendations on the use of AB in case of relevant potential risk of UTI have been reported, though some categories of patients at increased infective probability after UDS have been recognized. The aim of this study is to report the experts' consensus on the best practice for the use of AB before UDS in the main categories of patients at potential risk of developing UTI.
MATERIALS AND METHODS
A systematic literature review was performed on AB before UDS in males and females. A panel of experts from the Italian Society of Urodynamics, Continence, Neuro-Urology, and Pelvic Floor (SIUD) assessed the review data and decided by a modified Delphi method on 16 statements proposed and discussed by the panel. The cut-off percentage for the consensus was a ≥70% of positive responses to the survey. The study was a Delphi consensus with experts' opinions, not a clinical trial involving directly patients.
RESULTS
The panel group was composed of 57 experts in functional urology and UDS, mainly urologists, likewise gynaecologists, physiatrists, infectivologists, pediatric urologists, and nurses. A positive consensus was achieved on 9/16 (56.25%) of the statements, especially on the need for performing AB before UD in patients with neurogenic bladder and immunosuppression. Urine analysis and urine culture before UDS are mandatory, and in the event of their positivity, UDS should be postponed. A consensus was reached on avoiding AB in menopausal status, diabetes, age, gender, bladder outlet obstruction, high postvoid residual, chronic catheterization, previous urological surgery, lack of urological abnormalities, pelvic organ prolapse, and negative urine analysis.
CONCLUSIONS
Antibiotic prophylaxis is not recommended for patients without notable risk factors and with a negative urine test due to the potential morbidities that may result from antibiotic administration. However, AB can be used for risk categories such as neurogenic bladder and immunosuppression. The evaluation of urine analysis and urine culture and postponing UDS in cases of positive tests were considered good practices, as well as performing AB in the neurogenic bladder and immunosuppression.
Topics: Humans; Delphi Technique; Urodynamics; Urinary Tract Infections; Antibiotic Prophylaxis; Consensus; Female; Male; Italy; Anti-Bacterial Agents; Risk Factors; Urology
PubMed: 38587242
DOI: 10.1002/nau.25463 -
African Journal of Reproductive Health Mar 2024Menopause represents the physiological transition when a woman's reproductive period ends associated with a variety of symptoms, including vasomotor symptoms, such as... (Meta-Analysis)
Meta-Analysis
Menopause represents the physiological transition when a woman's reproductive period ends associated with a variety of symptoms, including vasomotor symptoms, such as night sweats and hot flashes. This systematic review and meta-analysis aimed to assess the effectiveness and safety of oral Fezolinetant for treating vasomotor symptoms associated with menopause. Five electronic databases were searched from their inception until May 2023. Via the Cochrane risk of bias tool, two reviewers assessed the studies' quality. The primary outcomes were a decrease in VMSs frequency and severity and safety outcomes at 4 and 12 weeks. Data were extracted and then analyzed using RevMan software. This meta-analysis included six trials with a total of 3291 women that compared Fezolinetant to a placebo in the treatment of menopausal VMSs. After 4 and 12 weeks of therapy, fezolinetant at 30 mg QD or 45 mg QD substantially decreased the frequency and severity of VMSs per 24 hours compared to placebo. Fezolinetant at 90 mg BID, 30 mg QD, or 45 mg QD did not show a significant difference in the rate of treatment-emergent adverse events (TEAEs), headache, and TEAEs leading to permanent discontinuation compared to placebo. Fezolinetant proves to be a successful and well-tolerated remedy for menopausal women suffering from VMSs. Notably, the 45 mg daily dosage over 12 weeks exhibited significant efficacy. Nonetheless, extensive future trials are necessary to ascertain its long-term safety, effectiveness, and relative potency compared to alternative VMS treatments like hormone therapy.
Topics: Humans; Female; Menopause; Hot Flashes; Heterocyclic Compounds, 2-Ring; Thiadiazoles
PubMed: 38583073
DOI: 10.29063/ajrh2024/v28i3.11 -
Journal of Ovarian Research Apr 2024To comprehensively evaluate the effect of low birth weight on premature ovarian insufficiency. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To comprehensively evaluate the effect of low birth weight on premature ovarian insufficiency.
METHODS
We performed a systematic review of the literature by searching MEDLINE, EMBASE, Web of Science, Scopus, Wanfang and CNKI up to August 2023. All cohort and case-control studies that included birth weight as an exposure and premature ovarian insufficiency as an outcome were included in the analysis. Data were combined using inverse-variance weighted meta-analysis with fixed and random effects models and between-study heterogeneity evaluated. We evaluated risk of bias using the Newcastle Ottawa Scale and using Egger's method to test publication bias. All statistical analyses were performed with the use of R software.
RESULTS
Five articles were included in the review. A total of 2,248,594 women were included, including 21,813 (1%) cases of premature ovarian insufficiency, 150,743 cases of low birth weight, and 220,703 cases of macrosomia. We found strong evidence that changed the results of the previous review that low birth weight is associated with an increased risk of premature ovarian insufficiency (OR = 1.15, 95%CI 1.09-1.22) in adulthood compared with normal birth weight. No effect of macrosomia on premature ovarian insufficiency was found.
CONCLUSIONS
Our meta-analysis showed strong evidence of an association between low birth weight and premature ovarian insufficiency. We should reduce the occurrence of low birth weight by various methods to avoid the occurrence of premature ovarian insufficiency.
Topics: Infant, Newborn; Female; Humans; Birth Weight; Fetal Macrosomia; Infant, Low Birth Weight; Menopause, Premature; Primary Ovarian Insufficiency
PubMed: 38570862
DOI: 10.1186/s13048-024-01357-9 -
Osteoporosis International : a Journal... Apr 2024Vasomotor symptoms (VMS) adversely affect postmenopausal quality of life. However, their association with bone health has not been elucidated. This study aimed to... (Review)
Review
BACKGROUND/AIMS
Vasomotor symptoms (VMS) adversely affect postmenopausal quality of life. However, their association with bone health has not been elucidated. This study aimed to systematically review and meta-analyze the evidence regarding the association of VMS with fracture risk and bone mineral density (BMD) in peri- and postmenopausal women.
METHODS
A literature search was conducted in PubMed, Scopus and Cochrane databases until 31 August 2023. Fracture, low BMD (osteoporosis/osteopenia) and mean change in lumbar spine (LS) and femoral neck (FN) BMD were assessed. The results are presented as odds ratio (OR) and mean difference (MD), respectively, with a 95% confidence interval (95% CI). The I index quantified heterogeneity.
RESULTS
Twenty studies were included in the qualitative and 12 in the quantitative analysis (n=49,659). No difference in fractures between women with and without VMS was found (n=5, OR 1.04, 95% CI 0.93-1.16, I 16%). However, VMS were associated with low BMD (n=5, OR 1.54, 95% CI 1.42-1.67, I 0%). This difference was evident for LS (MD -0.019 g/cm, 95% CI -0.03 to -0.008, I 85.2%), but not for FN BMD (MD -0.010 g/cm, 95% CI -0.021 to 0.001, I 78.2%). These results were independent of VMS severity, age and study design. When the analysis was confined to studies that excluded menopausal hormone therapy use, the association with BMD remained significant.
CONCLUSIONS
The presence of VMS is associated with low BMD in postmenopausal women, although it does not seem to increase fracture risk.
PubMed: 38563960
DOI: 10.1007/s00198-024-07075-8