Eligible Randomized Controlled Trials Research Articles

High-intensity electroacupuncture is superior to low-intensity electroacupuncture for knee osteoarthritis: a meta-analysis of randomized controlled trials.

Electroacupuncture (EA) has been demonstrated to be efficacious and safe in patients with knee osteoarthritis (KOA), yet the optimal current intensity for pain control in KOA remains unspecified. The present meta-analysis aimed to compare the effects of high-intensity and low-intensity EA in terms of pain relief and functional improvement in KOA. A thorough and comprehensive literature search for randomized controlled trials (RCTs), all looking at the intensity of EA for KOA, was carried out in PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), China Science Journal Citation Report (VIP) and Wanfang database, as well as ClinicalTrials.gov. All databases were searched from their inception until April 2022. Study quality was assessed using the Cochrane risk of bias (RoB)2 tool. Finally, a meta-analysis of all eligible RCTs was performed using Review Manager 5.3. Three studies with 472 individuals were included in the meta-analysis. The pain intensity reductions were significantly different between the high-intensity EA group and low-intensity EA group (mean difference (MD) = -0.22, 95% confidence interval (CI) = -0.26 to -0.18, p < 0.00001). There was no significant difference between the two groups in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores (MD = -3.62, 95% CI = -12.22 to 4.98, p = 0.41). High-intensity EA significantly improved emotional scale (ES) scores compared to low-intensity EA (MD = -0.72, 95% CI = -0.76 to -0.67, p < 0.00001). The findings of this systematic review and meta-analysis indicated that high-intensity EA provides superior pain relief and has a bigger impact on emotional scale scores in patients with KOA.

Behavior change theory and behavior change technique use in cancer rehabilitation interventions: a secondary analysis.

There is limited evidence depicting ways that behavioral theory and techniques have been incorporated into cancer rehabilitation interventions. Examining their use within cancer rehabilitation interventions may provide insight into the active ingredients that can maximize patient engagement and intervention effectiveness. This secondary analysis aimed to describe the use of behavior change theory and behavior change techniques (BCTs) in two previously conducted systematic reviews of cancer rehabilitation interventions. Secondary analysis of randomized controlled trials (RCTs) drawn from two systematic reviews examining the effect of cancer rehabilitation interventions on function and disability. In-person and remotely delivered rehabilitation interventions. Adult cancer survivors. Data extraction included: behavior change theory use, functional outcome data, and BCTs using the Behavior Change Technique Taxonomy (BCTTv1). Based on their effects on function, interventions were categorized as "very", "quite" or "non-promising". To assess the relative effectiveness of coded BCTs, a BCT promise ratio was calculated (the ratio of promising to non-promising interventions that included the BCT). Of 180 eligible RCTs, 25 (14%) reported using a behavior change theory. Fifty-four (58%) of the 93 BCTs were used in least one intervention (range 0-29). Interventions reporting theory use utilized more BCTs (median=7) compared to those with no theory (median=3.5; U=2827.00, P=0.001). The number of BCTs did not differ between the very, quite, and non-promising intervention groups (H(2)=0.24, P=0.85). 20 BCTs were considered promising (promise ratio >2) with goal setting, graded tasks, and social support (unspecified) having the highest promise ratios. While there was a wide range of BCTs utilized, they were rarely based on theoretically-proposed pathways and the number of BCTs reported was not related to intervention effectiveness. Clinicians should consider basing new interventions upon a relevant behavior change theory. Intentionally incorporating the BCTs of goal setting, graded tasks, and social support may improve intervention efficacy.

Effectiveness of N-3 fatty acids supplementation on spondyloarthritis: A systematic review and meta-analysis

Background & AimsThe study aims to systematically review and meta-analyze randomized controlled trials (RCTs) assessing the effects of n-3 fatty acids (FA) supplementation on spondyloarthritis (SpA) disease activity, inflammatory markers, and imaging. MethodsThe study protocol was developed and registered online in advance. The PubMed, SCOPUS, and Cochrane Central Register of Controlled Trials (CENTRAL) electronic databases were systematically searched for RCTs up to April 2024. Two independent reviewers screened, assessed for eligibility, and extracted data from the eligible RCTs. The revised Cochrane Risk of Bias tool was used to assess the quality of trials. The random-effects model was used to calculate the pooled estimates. ResultsWe included four RCTs, involving 245 patients with SpA. Supplementation with n-3 FA did not improve physician-reported outcomes [number of tender joints (four trials, standardized mean difference (SMD): -0.22; 95% confidence interval (CI): -0.74 to 0.29; I2=61%), number of swollen joints (two trials, SMD: -0.13; 95% CI: -0.42 to 0.15; I2=0%)], and patient-reported outcomes [pain (three trials, SMD: -0.16; 95% CI: -1.03 to 0.70; I2=74%), Health Assessment Questionnaire (three trials, SMD: -0.04; 95% CI: -0.78 to 0.70; I2=71%). The other nine pre-specified outcomes were not analyzed due to lack of information from the original RCTs which were evaluated as «some concerns» or «high risk» of bias. ConclusionsIn the present systematic review and meta-analysis including placebo-controlled RCTs, n-3 FA supplementation did not show improvement in the reported outcomes. Future RCTs should be conducted with homogenous intervention, placebo, and outcomes to re-examine possible beneficial effects.

A scoping review of randomized controlled trials of parenting and family-based interventions for 10 – 17 year-olds with severe and persistent conduct problems

ABSTRACT Purpose A scoping review of randomized controlled trials (RCTs) of parenting and family-based interventions that aim to reduce severe and persistent conduct problems among 10–17 year-olds. The review also examined feasibility for conducting a network meta-analysis of common therapy elements measured by RCTs. Materials and methods The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA- ScR). Searches were conducted in ERIC, PsycINFO, and MEDLINE without limits on publication year, language or publication country. Study methodological quality was assessed using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for RCTs. Results Twenty-five eligible RCTs were identified. The studies trialed nine interventions, with Multisystemic Therapy (MST) being the most evaluated (N = 10), followed by Functional Family Therapy (FFT, N = 4), and Treatment Foster Care Oregon (TFCO, N = 3). Only 10 of the 25 RCTs revealed treatment effect on conduct problems, including 6 of 9 MST, 1 of 4 FFT and all 3 TFCO trials. Discussion Surprisingly few RCTs of parenting and family-based interventions have been carried out exclusively with this population. Available data suggests that MST and FFT have uncertain effectiveness for reducing severe and persistent conduct problems. While the quality of the reviewed studies was generally high, only two reported substantive data on common therapy elements. Conclusion There is need for more RCTs of parenting and family-based interventions delivered for older children and adolescents with severe and persistent conduct problems. Future RCTs should systematically measure common therapy elements with a view to advancing intervention science.

7792 Efficacy of Retatrutide for Weight Reduction and Its Cardiometabolic Effects Among Adults: A Systematic Review and Meta-Analysis

Abstract Disclosure: D.C. Lopez: None. J.T. Pajimna: None. M.D. Milan: None. G.V. Jasul: None. G. Orpilla: None. I. Zapanta: None. B. Serquiña: None. G. Dychiao: None. Background: Obesity remains to be a global health challenge and it is associated with several complications such as diabetes, cardiovascular disease, fatty liver disease, and reduced life expectancy. Although lifestyle modifications are the mainstay for weight management, long term maintenance of weight loss can be a challenge for many affected adults. There have been proven safe and effective pharmacologic interventions but these remain limited to date. One of the novel anti-obesity drugs, retatrutide, is a single peptide with agonist activity at the GLP-1, glucose-dependent insulinotropic polypeptide (GIP), and glucagon receptors. The aim of this systematic review and meta-analysis is to evaluate the effectiveness of this triple-hormone receptor agonist, Retatrutide, in weight reduction and assess its cardiometabolic effects in adults. Methodology: An extensive electronic database search was done to identify studies published from inception until December 2023. All randomized controlled trials (RCT) that evaluated the use of retatrutide for adult patients were included. The Cochrane Risk of Bias 2.0 tool was used to assess the risk of bias of each study. Meta-analysis was conducted to determine weight reduction and glycemic control using random effects model which was reported at 95% confidence interval. Statistical heterogeneity was assessed using I2 statistics and random effects analysis and sensitivity analysis were done to control for the heterogeneity. Results: A total of 3 eligible RCTs were included in the study, all of which had risk of bias ranging from low to unclear. Of these articles, in 2 RCTs involving 353 participants with type 2 diabetes mellitus, retatrutide showed significant weight reduction by 11.89kg as compared to placebo (MD -11.89; 95% CI -13.53 to -10.25) and decreased glycosylated hemoglobin (HbA1C) by 1.64% as compared to placebo (MD: -1.64%, 95% CI [-2.38, -0.89]). Using direct comparison, retatrutide 12mg reduced body weight by 11.83kg as compared to dulaglutide 1.5mg with significant difference (MD -11.83; 95% CI -18.50 to -5.16), and retatrutide showed slight decrease in HbA1C by 0.61% as compared to dulaglutide (MD -0.66; 95% CI -0.66 to -0.56). In another 1 RCT involving 338 non-diabetic adult patients with obesity, retatrutide decreased least-squares mean percentage in body weight by 24.2% and 83% of participants who received retatrutide achieved weight reduction of 15% or more at 48 weeks. Conclusion: The use of retatrutide may result in substantial reductions in mean body weight and HbA1C as compared to controls in adult patients, with low to moderate certainty of evidence. In addition, retatrutide showed marked decrease in body weight but with modest glucose lowering effect when compared to a single GLP1 agonist drug. Presentation: 6/3/2024

Representation of obesity in contemporary atrial fibrillation ablation randomized controlled trials.

The prevalence and impact of obesity on outcomes of atrial fibrillation (AF) ablation randomized controlled trials (RCTs) have not been well studied. To examine the proportion of participants with obesity enrolled in RCTs of AF ablation and outcomes of ablation when subgroup analysis of participants with obesity were available. We systematically searched PubMed and EMBASE for AF ablation RCTs published between January 1, 2015 to May 31, 2022. When body mass index (BMI) data were available, normal distribution was assumed and a z score was used to estimate the proportion of obesity. Results categorized by BMI or body weight status were reviewed. Authors were contacted for additional information. Of 148 eligible RCTs with 30174 participants, 144 (97.30%) RCTs did not report the proportion of participants with obesity, while published information regarding BMI was available in 63.51%. Three trials excluded patients based on BMI. Using reported BMI, we estimated the proportion of participants with obesity varied greatly across these trials, ranging from 5.82%-71.9% (median 38.02%, interquartile 29.64%, 49.10%). Patients with obesity were represented in a greater proportion among trials conducted in North America (50.23%) and Asia (44.72%), compared to others (32.16%), p < .001. Subgroup analysis or analysis adjusting for BMI was reported in only 13 (8.78%) RCTs; four (30.77%) of these suggested that BMI or body weight might negatively affect primary outcomes. Obesity is a common comorbidity among AF patients. However, most AF ablation RCTs underreported the proportion of participants with obesity and its impact on the primary outcomes.

Comparative Efficacy and Safety of Potassium-Competitive Acid Blocker-Based Dual, Triple, and Quadruple Regimens for First-Line Helicobacter pylori Infection Treatment: A Systematic Review and Network Meta-Analysis.

In the last few years, numerous new potassium-competitive acid blocker (P-CAB)-based randomized controlled trials (RCTs) concerning the first-line regimens for Helicobacter pylori infection treatment from various countries have been published. However, no network meta-analysis (NWM) exists, which examines the comparative efficacy and safety of P-CAB-based dual, triple, and quadruple treatments, and, therefore, in this NWM, we examined this matter comparing efficacy and safety of these P-CAB-based regimens. Databases were searched for identification, screening, eligibility, and inclusion of relevant RCTs. Extracted data were entered into a Bayesian NWM, and the ranking order for each regimen was evaluated by means of the surface under the cumulative ranking area values. Twenty-five eligible RCTs were included with 7,605 patients randomized to 6 first-line regimens, i.e. P-CAB dual therapy, P-CAB triple therapy, P-CAB quadruple therapy, PPI dual therapy, PPI triple therapy, and PPI quadruple therapy. The surface under the cumulative ranking area values (%) for these 6 regimens were 92.7, 62.5, 33.9, 75.1, 19.4, and 16.3, respectively. The comparative effectiveness ranking showed that P-CAB dual therapy regimen ranked first for efficacy and last for adverse effects and had the best profile for integrated efficacy-safety. In this NWM concerning the comparative efficacy and safety of P-CAB-based dual, triple, and quadruple regimens for the first-line H. pylori infection treatment, the overall results showed that P-CAB-based dual treatment ranked first for efficacy with the best-integrated efficacy-safety profile. This is of importance, since the dual regimens overcome the crucial issue of clarithromycin resistance. Consequently, these findings are expected to be useful in helping clinical decision making and future guidelines.

The Impact of Point-of-Care Ultrasound-Guided Resuscitation on Clinical Outcomes in Patients With Shock: A Systematic Review and Meta-Analysis.

To determine the impact of point-of-care ultrasound (POCUS)-guided resuscitation on clinical outcomes in adult patients with shock. We searched MEDLINE, Embase, and unpublished sources from inception to December 2023. We included randomized controlled trials (RCTs) that examined the use of POCUS to guide resuscitation in patients with shock. We collected data regarding study and patient characteristics, POCUS protocol, control group interventions, and outcomes. We identified 18 eligible RCTs. POCUS slightly influences physicians' plans for IV fluid (IVF) and vasoactive medication prescription (moderate certainty), but results in little to no changes in the administration of IVF (low to high certainty) or inotropes (high certainty). POCUS may result in no change in the number of CT scans performed (low certainty) but probably reduces the number of diagnostic echocardiograms performed (moderate certainty). POCUS-guided resuscitation probably reduces 28-day mortality (relative risk [RR] 0.88; 95% CI, 0.78-0.99), the duration of vasoactive medication (mean difference -0.73 d; 95% CI, -1.16 to -0.30), and the need for renal replacement therapy (RRT) (RR 0.80; 95% CI, 0.63-1.02) (low to moderate certainty evidence), and lactate clearance (high certainty evidence). POCUS-guided resuscitation may results in little to no difference in ICU or hospital admissions, ICU and hospital length of stay, and the need for mechanical ventilation (MV) (low to moderate certainty evidence). There is an uncertain effect on the risk of acute kidney injury and the duration of MV or RRT (very low certainty evidence). POCUS-guided resuscitation in shock may yield important patient and health system benefits. Due to lack of sufficient evidence, we were unable to explore how the thresholds of operator competency, frequency, and timing of POCUS scans impact patient outcomes.

A Comparison of Incisional Dressings and Negative-Pressure Wound Therapy for the Prevention of Infection and Wound Complications After Primary Total Hip and Knee Arthroplasty: A Network Meta-Analysis of Randomized Controlled Trials.

Incisional dressings may decrease wound complications and joint infection after total hip and knee arthroplasties (THA; TKA). However, there is no consensus on the superiority of a particular product. This study compared infection and wound complications among randomized controlled trials (RCTs) across various dressing types after primary THA and TKA. Scopus, Ovid/MEDLINE, PubMed, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials were queried in May 2024. A frequentist model network meta-analysis of eligible prospective RCTs compared minor and major wound complications and dressing changes using P-scores. Of 3,067 compiled studies, 12 RCTs of 1,939 patients with median (interquartile range) follow-up of 42 (382) days undergoing primary THA (n = 880, 45.4%) or TKA (n = 1,059, 54.6%) with alginate (n = 208; 10.7%), absorbent (n = 236; 12.2%), gauze (n = 474; 24.4%), or hydrofiber (n = 683; 35.2%) dressings or negative-pressure wound therapy (NPWT; n = 338; 17.4%) were included for meta-analysis. Compared with gauze, alginate and hydrofiber dressings were associated with fewer postoperative changes (mean difference [MD], -12.1; 95% confidence interval [CI], -15.08 to -9.09, p < 0.001; MD, -3.5; 95% CI, -6.30 to -0.74, p = 0.013, respectively). In a subanalysis, silver-ion hydrofiber also was associated with fewer changes (MD, -5.0; 95% CI, -5.70 to -4.39; p < 0.001). Overall, there was no statistically significant risk of increased minor nor major wound complications including superficial and deep infections among all dressing types and NPWT compared with gauze. Despite no association between wound complications nor infection risk among various incisional dressings and NPWT vs. gauze, the alginate, hydrofiber, and silver hydrofiber dressings had statistically fewer mean postoperative changes. Future studies are required to assess whether these dressings confer reduced infection risk. Therapeutic, Level I. See Instructions for Authors for a complete description of levels of evidence.

Comparative effectiveness and safety of four traditional Chinese medicine injections with invigorating blood circulation, equivalent effect of anticoagulation or antiplatelet in acute myocardial infarction: a Bayesian network meta-analysis.

Background: Traditional Chinese medicine injections with invigorating blood circulation (TCMI-IBCs), which have been used as antithrombosis therapies, are widely employed by Chinese clinicians as adjuvant therapy for acute myocardial infarction (AMI). Objective: A Bayesian network meta-analysis was conducted to contrast the effectiveness and safety of four TCMI-IBCs in AMI. Methods: Eight Databases were thoroughly searched before 31 December 2023, for randomized controlled trials (RCTs) focusing on the application of TCMI-IBCs combined with conventional treatments (CT) to treat AMI. All-cause mortality (ACM) was the major endpoint. Secondary outcomes included bleeding events, malignant arrhythmia (MA), recurrent myocardial infarction (RMI), left ventricular ejection fraction (LVEF), and adverse events. Stata17.0 and GeMTC software were employed for Bayesian network meta-analysis. Results: A total of 73 eligible RCTs involving 7,504 patients were enrolled. Puerarin injection (PI), Danhong injection (DI), sodium Tanshinone IIA Sulfonate injection (STSI), and Danshen Chuanxiongqin injection (DCI) combined with CT can significantly reduce the occurrence of ACM and improve LVEF in AMI (P < 0.05), while without significant impact on bleeding events or MA (P > 0.05). STSI + CT would be the optimal treatment strategy in lowering RMI and ACM. DI + CT was the most likely to be the optimal strategy in reducing MA occurrence and improving LVEF. CT was likely the most effective strategy in reducing bleeding events. However, DI + CT exhibited the least favorable safety. Conclusion: TCMI-IBCs + CT had potential benefits in the treatment of AMI. STSI + CT showed the most favorable performance in treating AMI, followed by DI combined with CT. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=384067, identifier CRD42022384067.

Clinical evidence of coenzyme Q10 pretreatment for women with diminished ovarian reserve undergoing IVF/ICSI: a systematic review and meta-analysis

Background To quantitatively evaluate the effect of coenzyme Q10 (CoQ10) pretreatment on outcomes of IVF or ICSI in women with diminished ovarian reserve (DOR) based on the existing randomized controlled trials (RCTs). Methods Nine databases were comprehensively searched from database inception to November 01, 2023, to identify eligible RCTs. Reproductive outcomes of interest consisted of three primary outcomes and six secondary outcomes. The sensitivity analysis was adopted to verify the robustness of pooled results. Results There were six RCTs in total, which collectively involved 1529 participants with DOR receiving infertility treatment with IVF/ICSI. The review of available evidence suggested that CoQ10 pretreatment was significantly correlated with elevated clinical pregnancy rate (OR = 1.84, 95%CI [1.33, 2.53], p = 0.0002), number of optimal embryos (OR = 0.59, 95%CI [0.21, 0.96], p = 0.002), number of oocytes retrieved (MD = 1.30, 95%CI [1.21, 1.40], p < 0.00001), and E2 levels on the day of hCG (SMD = 0.37, 95%CI [0.07, 0.66], p = 0.01), along with a reduction in cycle cancellation rate (OR = 0.60, 95%CI [0.44, 0.83], p = 0.002), miscarriage rate (OR = 0.38, 95%CI [0.15, 0.98], p = 0.05), total days of Gn applied (MD = −0.89, 95%CI [–1.37, −0.41], p = 0.0003), and total dose of Gn used (MD = −330.44, 95%CI [–373.93, −286.96], p < 0.00001). The sensitivity analysis indicated that our pooled results were robust. Conclusions These findings suggested that CoQ10 pretreatment is an effective intervention in improving IVF/ICSI outcomes for women with DOR. Still, this meta-analysis included relatively limited sample sizes with poor descriptions of their methodologies. Rigorously conducted trials are needed in the future.

The effects of raspberry consumption on anthropometric indices and liver function tests in adults: a GRADE-assessed systematic review and meta-analysis.

In recent years, the therapeutic effects of raspberry have been the subject of several randomized control trials (RCTs). However, there is no consensus about the effect of raspberry consumption on anthropometric indices and liver function tests. So, the present review aims to investigate this effectiveness by conducting a meta-analysis. PubMed, Web of Science, and Scopus databases were searched to identify eligible randomized control trials (RCTs) up to March 2024. The overall effect sizes were estimated using the random-effects model as weighted mean difference (WMD) and 95% confidence intervals (CIs). Nine studies (10 arms) with 355 participants were eligible for inclusion in this review. This meta-analysis showed that raspberry consumption did not lead to significant changes in anthropometric indices (weight, body mass index, and waist circumference) and liver function tests (aspartate aminotransferase and alanine aminotransferase). This review revealed that raspberry consumption had no significant impact on anthropometric indices or liver function tests. However, more RCTs with a larger sample size and higher sensitivity are needed to draw definite conclusions.Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=477568, PROSPERO ID: CRD42023477568.

Efficacy of High-Intensity and Low-Level Laser Therapy Combined With Exercise Therapy on Pain and Function in Knee Osteoarthritis: A Systematic Review and Network Meta-analysis.

Introduction: High-intensity laser therapy (HILT) and low-level laser therapy (LLLT) combined with exercise therapy (ET) have emerged as effective treatment options for musculoskeletal pain. However, there have remained uncertainties regarding the magnitude of their effects in reducing pain and improving function in patients with knee osteoarthritis. Hence, we performed a systematic review and network meta-analysis of available evidence in the literature to answer this query. Methods: A literature search was carried out in Embase, PubMed, and Scopus databases without any language restrictions from 1 January 1990 to 31 December 2023. We examined randomized controlled trial (RCT) studies that investigated the efficiency of HILT or LLLT plus knee osteoarthritis ET in pain and functional improvement of the knee. We performed a network meta-analysis and provided the standardized mean difference (SMD) with a 95% confidence interval (CI) by pooling the continuous data on the visual analogue scale (VAS) pain score and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score using a random-effects model. Results: In total, 11 eligible RCTs were included. Our analysis revealed significant improvements in the VAS pain and WOMAC function scores on weeks 4 and 8 after interventions in groups treated with LLLT+ET and HILT+ET compared with placebo+ET. Moreover, HILT+ET showed a greater reduction in the VAS pain score (SMD=-1.41; 95% CI: -2.05 to -0.76) and improvement in the WOMAC function score (SMD=-2.20; 95% CI: -3.21 to -1.19) than LLLT+ET in week 8. Conclusion: Based on our findings, both HILT+ET and LLLT+ET treatments effectively reduced pain and improved function, but HILT+ET showed a more significant improvement in both outcomes compared to LLLT+ET.

Surgical outcomes of sacrospinous hysteropexy and hysteropreservation for pelvic organ prolapse: a systematic review of randomized controlled trials.

In several randomized controlled trials (RCTs), sacrospinous hysteropexy and other forms of hysteropreservation have been compared. Nevertheless, there is no definitively best treatment. This study summarized RCT evidence for various uterine preservation surgical procedures. From each database inception to August 2023, we searched PubMed, Embase, Cochrane Library, and Web of Science for eligible RCTs. A comparison was made between sacrospinous hysteropexy and other hysteropreservation, including vaginal and abdominal surgery. For categorical and continuous variables, relative risks (RRs) and mean differences (MDs) were calculated using random-effects models. We reviewed a total 1,398 studies and ultimately included five RCTs that met all inclusion criteria. These five studies included a total of 1,372 uterine POP cases all of whom received transvaginal surgery and had a follow-up period for assessment of recurrence from 12 months to 5 years. There were no significant differences between sacrospinous hysteropexy and other hysteropreservation for the incidences of recurrence (RR,1.24; 95% CI, 0.58 to 2.63; p = 0.58) or hematoma (RR,0.70; 95% CI, 0.17 to 2.92; p = 0.62). Moreover, neither sacrospinous hysteropexy nor hysteropreservation had any significant effect on the risk of mesh exposure (RR,0.34; 95% CI, 0.03 to 4.31; p = 0.41), dyspareunia (RR,0.45; 95% CI, 0.13 to1.6; p = 0.22), urinary tract infection (RR,0.66; 95% CI, 0.38 to 1.15; p = 0.15), bothersome bulge symptoms (RR,0.03; 95% CI, -0.02 to 0.08; p = 0.24), operative time (MD, -4.53; 95% CI, -12.08 to 3.01; p = 0.24), and blood loss (MD, -25.69; 95% CI, -62.28 to 10.91; p = 0.17). However, sacrospinous hysteropexy was associated with a lower probability of pain (RR,4.8; 95% CI, 0.79 to 29.26; p = 0.09) compared with other hysteropreservation. There was no difference between sacrospinous hysteropexy and hysteropreservation in terms of recurrence, hematoma, mesh exposure, dyspareunia, urinary tract infection, bothersome bulge symptoms, operative time, pain, and blood loss. PROSPERO [CRD42023470025].

Influence of acupuncture and moxibustion on gastrointestinal function and adverse events in gastric cancer patients after surgery and chemotherapy: a meta-analysis.

The impact of acupuncture and moxibustion on postoperative complications and adverse events (AEs) of chemotherapy in patients with gastric cancer (GC) has been investigated. Through a meta-analysis of existing randomized controlled trials (RCTs), this study sought to strengthen the evidentiary basis to help investigators further understand the effects of moxibustion and acupuncture on postoperative complications and AEs of chemotherapy among GC patients. Embase, Web of Science, PubMed, The Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Database, and VIP Database for Chinese Technical Periodicals were searched to collect RCTs on effects of acupuncture and moxibustion on gastrointestinal function and AEs among GC patients undergoing surgery and chemotherapy. Outcome measures included postoperative gastrointestinal recovery (bowel sound recovery time, time to first flatus/defecation/feeding), the incidence of AEs (nausea and vomiting, abdominal distension, and diarrhea), myelosuppression (white blood cells, hemoglobin, and platelet), and immune function indicators (CD3+ and CD4+). To assess quality, the Cochrane Risk of Bias Tool was utilized. Review Manager 5.4 was implemented to do the meta-analysis. Fifteen eligible RCTs involved 1259 patients. Meta-analysis results showed that the experimental group had a significantly shorter bowel sound recovery time (MD = - 14.57, 95% CI = [- 18.97, - 10.18], P < 0.00001), time to first flatus (MD = - 17.56, 95% CI = [- 22.23, - 12.88], P < 0.00001), time to first defecation (MD = - 17.05, 95% CI = [- 21.02, - 13.09], P < 0.00001), and time to first feeding (MD = - 23.49, 95% CI = [- 28.81, - 18.17], P < 0.00001) than the control group. There were significant decreases in the incidence of nausea and vomiting (RR = 0.46, 95% CI = [0.21, 1.02], P = 0.05) and abdominal distension (RR = 0.45, 95% CI = [0.27, 0.75], P = 0.002) observed in the experimental group in comparison with the control group. The experimental group demonstrated a significant increase in white blood cell counts in comparison with to the control group (MD = 0.89, 95% CI = [0.23, 1.55], P = 0.008). The experimental group showed significantly higher levels of CD3+ (MD = 7.30, 95% CI = [1.86, 12.74], P = 0.009) and CD4+ (MD = 2.75, 95% CI = [1.61, 3.90], P < 0.00001) than the control group. Among GC patients, acupuncture and moxibustion can aid in gastrointestinal function recovery, reduce the incidence of AEs of surgery and chemotherapy, and improve immune function.

P-336 Efficacy of Gonadotrophin (GnRH) antagonists for endometriosis-associated pelvic pain - A systematic review and meta-analysis

Abstract Study question Are Gonadotropin-releasing hormone (GnRH) antagonists effective and safe in managing pain associated with endometriosis? Summary answer GnRH antagonists seem effective and safe in managing endometriosis-associated pain for at least 12 weeks of use. There is uncertainty with the evidence. What is known already GnRH agonists are commonly used as effective second-line treatment for endometriosis-associated pain. However, these agonists have drawbacks and are not well-tolerated by many women. GnRH antagonists, offer potential advantages over the agonists while providing similar efficacy. They lack the initial stimulatory effects thereby avoiding the initial flare-up of symptoms, which is common with agonists. Furthermore, unlike agonists, which are mainly available as injections, the antagonist are also available as oral preparations, which allow titration of doses. In-vitro and animal studies have shown antagonists to induce regression of endometriotic lesions by apoptosis. However, their efficacy in relieving endometriosis-related pains remains uncertain. Study design, size, duration Extensive electronic search was conducted by the Cochrane Gynaecology and Fertility group, up to October 2023 to identify randomised controlled trials (RCTs) evaluating efficacy of GnRH antagonists in managing endometriosis-related pains compared with placebo and/or GnRH agonists. The main searched databases included CENTRAL, MEDLINE and EMBASE. Screening and selection of suitable studies were undertaken. Study eligibility criteria included treatment for ≥12 weeks, laparoscopically confirmed endometriosis and assessment of pelvic pain scores as the primary endpoint. Participants/materials, setting, methods Primary end-point was a change in endometriosis-related pain score after 12-week treatment with GnRH antagonists compared with placebo and/or GnRH agonists. Changes in pain and quality of life (QoL) scores and adverse-events of GnRH-antagonists were compared between the antagonist versus the agonist/placebo groups. Data were analysed using RevMan software (V5.4) to calculate the standard mean difference (SMD) for continuous data, and the risk ratios (RRs) with 95% confident intervals (95% CI) for categorical data. Main results and the role of chance Seven eligible RCTs (n = 3043) were included, all of which compared GnRH-antagonist versus placebo, and only three also compared versus GnRH-agonist (leuprorelin). The GnRH-antagonists included ASP1707, Elagolix, Linzagolix and Relugolix. Meta-analysis of overall pelvic pain data from seven RCTs (n = 1684) showed significantly greater reduction in pain scores after 12 weeks of GnRH-antagonist versus placebo at low (SMD -0.29 95%CI -0.39 to -0.19; I2=0) and high doses (SMD-0.53 95%CI -0.63 to -0.43, I2=38%). Similarly, meta-analysis of other pains (dysmenorrhoea, non-menstrual pain, and dyspareunia) showed significantly greater pain score reduction with GnRH-antagonists versus placebo. Meta-analysis of overall pelvic pain from two RCTs (n = 263) comparing GnRH-antagonist versus leuprorelin showed comparable reduction in pain scores after 12 weeks at low (SMD 0.33 95%CI 0.09 to 0.58, I2=44%) and high doses (SMD 0.06 95%CI -0.19 to 0.30, I2=0%). Similarly, meta-analysis of other forms of pain revealed comparable reductions of pain scores between both drugs. Meta-analysis of QoL data (2RCTs, n = 259) revealed significantly greater improvements in scores with leuprorelin versus antagonists at low (SMD 0.74 95% CI 0.46 to 1.01; I2=98%) and high doses (SMD 0.35, 95%CI, 0.09 to 0.60, I2=97%). The most frequently reported treatment-related side-effects were hot-flushes, headaches and nasopharyngitis. No life-threatening side-effects were reported. Limitations, reasons for caution There was high heterogeneity between studies (e.g. differences in antagonists and pain scoring systems). No information was provided on prior endometriosis surgery, which is a confounding factor. Additionally, declared COI by authors of all trials could introduce high risk of bias. Evidence certainty was therefore deemed low to very low. Wider implications of the findings GnRH-antagonists seem to offer a promising treatment for endometriosis-related pain, with comparable efficacy to the agonists, but with several potential advantages. However, given the low quality and uncertainty of the evidence in this meta-analysis, high quality RCTs with robust designs are needed before making any firm recommendations for clinical practice. Trial registration number not applicable

O-286 Weight loss interventions prior to infertility treatment does it make sense?

Abstract Obesity in women is negatively associated with reproductive outcomes such as decreased natural conception and pregnancy rate in assisted reproductive technique (ART), as well as increased risks of miscarriage and maternal and foetal complications, including risks of perinatal and neonatal death. The reproductive consequences of obesity stem from a combination of ovarian, uterine and systemic pathophysiological changes, although not all fully elucidated. These alterations contribute to reduced oocyte and embryo quality, reduced uterine receptivity and systemic inflammatory responses. Various guidelines recommend lifestyle interventions based on dietary and/or physical activity targeting at a 5 to 10% reduction in body weight as an initial step prior to fertility treatment for women with infertility and overweight or obesity. However, evidence from well powered randomised controlled trials (RCTs) assessing the effectiveness of lifestyle interventions aiming at weight loss prior to fertility treatments is scarce and not unequivocally positive with respect to reproductive outcomes. First, this presentation will focus on the effectiveness of pre-conception lifestyle intervention targeting weight loss, on reproductive outcomes documented in the latest systematic review (SR) and meta-analysis and preliminary results of an individual participant data meta-analysis (IPDMA). The latest SR in 2021 (Obesity reviews DOI: 10.1111/obr.13325) including 15 RCTs until March 2020 (N = 1852 women) suggests more weight loss in the intervention group. An increase in live birth rates (LBR) in nine RCTs (N = 1203 women) and a higher natural conception rate following lifestyle intervention compared to no intervention were reported. However, no effect of lifestyle intervention preceding ART in six RCTs (N = 1040 women). With respect to potential harm of lifestyle intervention there is no significant increased risk of early pregnancy loss. Complications during pregnancy, such as early pregnancy loss and maternal, fetal and neonatal outcomes are underreported in most included studies. The VENUS IPDMA (BMJ Open 2022;12:e065206) analyzed individual patient data of 11 RCTs of 14 eligible RCTs (N = 1903 participants; 1010 in the intervention group and 893 in the control group). Preliminary data (abstract ESHRE 2023) showed that physical activity and/or dietary interventions prior to fertility treatment resulted in more weight reduction compared to those in the control group in 11 RCTs. The intervention group, however, did not have a significantly higher rate of LBR in nine RCTs (N = 1702 participants). Compared to the control group, the intervention group had smaller waist and hip circumference, lower systolic and diastolic blood pressure, and lower triglycerides, total cholesterol, glucose, and insulin levels at the time of study follow up. Do we have a definitive answer to the question: “weight loss interventions prior to fertility treatment; does it make sense” using data of IPDMA? Shortcomings of the available evidence regarding the effectiveness and safety of dietary and/or physical activity interventions in women with overweight or obesity prior to fertility treatments will be presented. Limitations of the studies and future perspectives and challenges in this field of research will be highlighted. Finally, the question “does it make sense” is broader than the effectivity of the intervention. Do we as clinicians adopt our role as health advocates to advice and guide future parents to adopt a healthy lifestyle, with weight reduction as a result? Could this lead to a healthier lifestyle for the future of parents and children? To conclude: “does it make sense” is not an easy question to answer.

Systematic review on the efficacy and safety of ixabepilone-based chemotherapy regimen in triple-negative breast cancer

Context: Triple-negative breast cancer (TNBC) has poor prognosis, high mortality, and recurrence rates. Ixabepilone or ixempra could be a promising agent for TNBC, especially in the taxane- and/or anthracycline-resistant population. Aims: To evaluate the efficacy and safety of ixabepilone-based chemotherapy compared to ixabepilone-free chemotherapy in TNBC patients. Methods: This review followed the preferred reporting items for systematic reviews and meta-analysis guidelines. The eligibility criteria included randomized control trials (RCTs) in 2013-2023 comparing ixabepilone-based with ixabepilone-free chemotherapy regimen in TNBC. Results: This study identified four eligible RCTs. One study showed that patients treated with ixabepilone had a significant improvement in disease-free survival, had a better response, and a lower risk of disease recurrence compared to those treated with taxane-based regimen. However, two studies showed no differences in terms of overall survival (OS), disease-free survival, and pathological complete responses rates in both treatment arms. Ixabepilone addition to capecitabine significantly prolonged progression-free survival and objective response rate in TNBC patients, but did not significantly improve OS (n = 1). Conclusions: The effectiveness and safety of ixabepilone-based chemotherapy versus ixabepilone-free treatment for triple-negative breast cancer (TNBC) patients vary among studies. More research is needed to better understand the effectiveness and safety of ixabepilone-based chemotherapy versus ixabepilone-free treatment in TNBC patients.

Effect of melatonin supplementation on body composition and blood pressure in adults: A systematic review and Dose–Response meta-analysis of randomized controlled trial

BackgroundSeveral randomized controlled trials (RCTs) have explored the impact of melatonin on body composition and blood pressure (BP). However, the findings from these studies remain a topic of debate. This systematic review and meta-analysis of RCTs sought to evaluate the effects of melatonin consumption on body composition (body weight (BW), body mass index (BMI), waist circumference (WC), hip circumference (HC)) and asleep/daytime BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) in adults. MethodsIn order to identify eligible RCTs, a systematic literature search was carried out up to June 2024 in PubMed, Embase, Scopus, and Web of Science without any language restrictions. The I2 statistic was used to perform heterogeneity tests on the selected studies. After evaluating random effects models based on heterogeneity tests, the weighted mean differences (WMD) with a 95 % confidence interval (CI) were calculated using pooled data. ResultsOverall, 28 studies (n = 1,543 participants) met our inclusion criteria. A pooled analysis of studies demonstrated that melatonin consumption led to a significant reduction in HC (WMD: 1.21 cm; 95 % CI: 1.94 to −0.49; P = 0.001), and daytime DBP (WMD: 1.40 mmHg; 95 % CI: 2.46 to −0.34; P = 0.009) in comparison with the control group. However, no substantial effects were observed on BW, BMI, WC, and SBP compared to the control group. Conclusion: The current meta-analysis of RCTs shows that treatment with melatonin reduces HC and daytime DBP levels in adults. However, further well-designed RCTs with large sample sizes and long durations are necessary to determine the effect of this supplement on body composition and BP.

Comparison of different doses of Tripterygium glycosides treating in IgA vasculitis nephritis: A Bayesian network meta-analysis

BackgroundTripterygium glycosides (TG) is extracted from the roots of Tripterygium wilfordii Hook F (Lei gong teng, a traditional Chinese medicine). It is widely used in China to treat immunoglobulin A vasculitis nephritis (IgAVN), which is a common secondary glomerular disease. As there are no guidelines for the rational application of TG, we performed this study to evaluate the efficacy and safety of different doses of TG and to determine the optimal treatment for IgAVN. MethodsTen databases were searched from their inception to April 2023 for randomised controlled trials (RCTs) using TG, TG combined with glucocorticoids (GC), or TG combined with traditional Chinese medicine (TCM) to treat IgAVN. A network meta-analysis was performed following the protocol (CRD42023401645). ResultsForty-four eligible RCTs involving 3402 patients were included. For effective rate, TG 1.5 mg/kg/d (TG1.5) + TCM was ranked as the best intervention, followed by TG 1.0 mg/kg/d (TG1.0) + TCM, TG1.5, TG1.0+GC, TG1.0, TCM, GC, and routine treatment (RT). TG1.0+TCM ranked best in reducing recurrence, followed by TG1.0+GC, GC, TG1.5, and RT. Compared with TG1.0, TG1.0+TCM and TG1.5+TCM effectively reduced liver injury events. Compared with TG1.5, TG1.5+TCM and TG1.0+TCM effectively reduced leukopenia events. No significant differences in the reduction of gastrointestinal events were observed between the interventions. Subgroup analyses explored the effects of the participants’ age. The intervention rankings of the outcomes generally remained consistent. Only a small difference was observed in gastrointestinal events. TCM was the best treatment for reducing gastrointestinal events in paediatric patients. ConclusionsThe results showed a positive correlation between dose and efficacy, whereas no relationship was found between dose and adverse events. TCM can boost the efficacy and reduce adverse events when combined with TG. In conclusion, we consider TG1.5+TCM as the best treatment for IgAVN. However, further research is required to confirm these findings.